ISO 14971:2007

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

Revision information
Revises: ISO 14971:2000
Revises: ISO 14971:2000/Amd 1:2003

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ISO 14971:2000
Medical devices -- Application of risk management to medical devices
International Organization for Standardization / 01-Dec-2000 / 32 pages
REPLACED by ISO 14971:2007 AMENDED by ISO 14971/Amd1:2003

ISO 14971:2007 - Medical devices - Application of risk management to medical devices
This product Is related to:
DOXPUB 09-0006-SOP - Device History Record
DOXPUB 09-0007-SOP - Device Master Record
DOXPUB 09-0006-SOP-1.0 - Device History Record
DOXPUB 09-0007-SOP-1.0 - Product/Device Master Record
This product referenced by:
IEC 60601-1 Ed. 3.0 b:2005 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
BS EN ISO 22803:2005 - Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file
BS EN 13532:2002 - General requirements for in vitro diagnostic medical devices for self-testing
BS EN 14180:2003 - Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
BS EN 1639:2004 - Dentistry. Medical devices for dentistry. Instruments
BS EN 1640:2004 - Dentistry. Medical devices for dentistry. Equipment
BS EN 1642:2004 - Dentistry. Medical devices for dentistry. Dental implants
BS EN 556-2:2003 - Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices
BS EN 60601-1-6:2004 - Medical electrical equipment. General requirements for safety. Collateral standard. Usability
BS EN 60601-1-8:2004 - Medical electrical equipment. General requirements for safety. Collateral standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
BS EN 61010-2-081:2002 - Safety requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
BS EN 61010-2-101:2002 - Safety requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for in vitro diagnostic (IVD) medical equipment
BS EN ISO 10451:2002 - Dental implant systems. Contents of technical file
BS EN ISO 10993-12:2004 - Biological evaluation of medical devices. Sample preparation and reference materials
BS EN ISO 11197:2004 - Medical supply units
BS EN ISO 13485:2003 - Medical devices. Quality management systems. Requirements for regulatory purposes
BS EN ISO 14155-2:2003 - Clinical investigation of medical devices for human subjects. Clinical investigation plans
BS EN ISO 15001:2004 - Anaesthetic and respiratory equipment. Compatibility with oxygen
BS EN ISO 15197:2003 - $7IIn vitro$7R diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
BS EN ISO 16672:2003 - Ophthalmic implants. Ocular endotamponades
BS EN ISO 17510-2:2003 - Sleep apnoea breathing therapy. Masks and application accessories
BS EN ISO 21647:2004 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of respiratory gas monitors
BS EN 556-1:2001 - Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices
BS EN 60601-1:2006 - Medical electrical equipment. General requirements for basic safety and essential performance
BS EN 60601-2-12:2006 - Medical electrical equipment. Particular requirements for the safety of lung ventilators. Critical care ventilators
BS EN ISO 19054:2006 - Rail systems for supporting medical equipment
BS EN ISO 22523:2006 - External limb prostheses and external orthoses. Requirements and test methods
BS EN 455-3:2006 - Medical gloves for single use. Requirements and testing for biological evaluation
BS EN ISO 5840:2005 - Cardiovascular implants. Cardiac valve prostheses
BS ISO/IEC 16085:2006 - Systems and software engineering. Life cycle processes. Risk management
BS 03/311404 DC - IEC 61010-1. Ed.3. Safety requirements for electrical equipment for measurement, control, and laboratory use. Part 1. General requirements
BS 04/30057165 DC - BS EN 14931. Pressure vessels for human occupancy (PVHO). Multi-place pressure chambers for hyperbaric therapy. Performance, safety requirements and testing
BS 04/30084855 DC - prEN ISO 10083. Oxygen concentrator supply systems for use with medical gas pipeline systems
BS 04/30099768 DC - prEN ISO 8835-3. Inhalational anaesthesia systems. Part 3. Anaesthetic gas scavenging systems. Transfer and receiving systems
BS 06/30146511 DC - BS ISO 18113-1. Clinical laboratory testing and in vitro diagnostic medical systems. Information supplied by the manufacturer (labelling). Part 1. Terms, definitions and general requirements
BS PD ISO/TR 21730:2007 - Health informatics. Use of mobile wireless communication and computing technology in healthcare facilities. Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices
BS EN ISO 10651-2:2004 - Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Home care ventilators for ventilator-dependent patients
BS EN ISO 10993-17:2002 - Biological evaluation of medical devices. Establishment of allowable limits for leachable substances
BS EN ISO 14155-1:2003 - Clinical investigation of medical devices for human subjects. General requirements
BS EN ISO 14534:2002 - Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
BS EN ISO 14698-1:2003 - Cleanrooms and associated controlled environments. Biocontamination control. General principles and methods
BS EN ISO 14630:2005 - Non-active surgical implants. General requirements
BS ISO 8600-1:2005 - Optics and photonics. Medical endoscopes and endotherapy devices. General requirements
BS ISO 16038:2005 - Rubber condoms. Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms
BS ISO 25539-1:2003 - Cardiovascular implants. Endovascular devices. Endovascular prostheses
BS PD IEC TR 60788:2004 - Medical electrical equipment. Glossary of defined terms
BS PD ISO/TR 14969:2004 - Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003
BS EN 285:2006 - Sterilization. Steam sterilizers. Large sterilizers
BS EN 61326-2-6:2006 - Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic (IVD) medical equipment
BS ISO 15378:2006 - Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2000, with reference to good manufacturing practice (GMP)
BS EN ISO 21969:2006 - High-pressure flexible connections for use with medical gas systems
BS DD ISO/TS 10993-19:2006 - Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials
BS EN ISO 10524-1:2006 - Pressure regulators for use with medical gases. Pressure regulators and pressure regulators with flow-metering devices
BS PD CEN ISO/TR 14969:2005 - Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003
BS 07/30151731 DC - BS IEC 80601-2-35. Medical electrical equipment. Part 2-35. Particular requirements for basic safety and essential performance of blankets, pads and mattresses, intended for heating in medical use
BS EN 13544-1:2007 - Respiratory therapy equipment. Nebulizing systems and their components
BS 07/30168572 DC - BS IEC 61010-1. Safety requirements for electrical equipment for measurement, control, and laboratory use. Part 1. General requirements
BS EN ISO 15378:2007 - Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)
BS EN 60601-1-8:2007 - Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
BS EN ISO 10524-3:2006 - Pressure regulators for use with medical gases. Pressure regulators integrated with cylinder valves
This product replaces:
ISO 14971-1 - Medical devices -- Risk management -- Part 1: Application of risk analysis
ISO/FDIS 14971 - Medical Devices - Application of Risk Management to Medical Devices - DRAFT
Browse Product Family: ISO 14971:2007 - 01-Mar-2007 ISO 14971/Amd1:2003 - 01-Mar-2003 » ISO 14971:2000 - 01-Dec-2000 ISO/FDIS 14971 - 01-Jul-1999 ISO 14971-1 - 01-Oct-1998
People Who Bought This Also Bought:
ISO 14971/Amd1:2003 - Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements
ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes
IEC 60601-1-4 Ed. 1.1 b:2000 - Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems CONSOLIDATED EDITION
ISO 15223:2000 - Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied
ISO 9001:2000 - Quality management systems -- Requirements
ANSI/AAMI SW68 - Medical device software - Software life cycle processes
ANSI/ASQ Z1.4-2003 - Sampling Procedures and Tables for Inspection by Attributes
ISO 19011:2002 - Guidelines for quality and/or environmental management systems auditing
BS EN 980:2003 - Graphical symbols for use in the labelling of medical devices
ISO/TR 14969:2004 - Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003
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Import of Medical Devices to India

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medical device clinical trials

Risk management for IVDs

Part 4: Monitoring patient risks throughout the product life cycle
Donald M. Powers
Donald M. Powers, PhD, is president and principal consultant of Powers Consulting Group (Pittsford, NY) and is a member of IVD Technology’s editorial advisory board. He can be reached at powers@frontiernet.net. The first three articles in this series discussed the significance of risks from IVD devices, the importance of risk management planning, and the advantages of the risk assessment and control principles of ISO 14971.1–3 This fourth article will look at the monitoring phase of the risk management process of ISO 14971, which continues as long as a product is in use.4 It will also explore ways to integrate risk management activities into a quality management system.
Monitoring Risks throughout the Product Life Cycle
A new product launch begins the most challenging phase of risk management for IVD companies. Up to this point, product risks are only theoretical, but when devices are in use the manufacturer learns whether all the significant hazards were taken into account and whether the risk estimates were correct.
This is also the phase during which conformance to ISO 14971 tends to break down. In general, IVD manufacturers do a good job incorporating risk management into their design, development, and manufacturing processes, but they sometimes fail to enlist other key functions to close the loop. Such departments may include customer service, equipment service, purchasing, distribution, information technology, and, surprisingly, even regulatory affairs. The situation is exacerbated in companies where manufacturing sites are geographically distant from the company’s headquarters. Problems can also arise when companies are organized so that these departments operate at the fringe of an established quality management system (QMS). This often occurs when support departments are more closely aligned with business or marketing operations than with manufacturing operations.
Because ISO 14971 is often perceived as necessary for conducting business internationally, but overkill for complying with U.S. regulations, companies often try to add risk management to their quality management system as a separate, discrete process. The intent of ISO 14971 is just the opposite. If a company operates with a quality management system—and these days a global IVD company must do so—risk management is expected to be fully integrated into all of its processes. Otherwise, serious discontinuities become inevitable. The risk management process of ISO 14971 is an efficient way to satisfy U.S. requirements, as well as those of Europe, Canada, Japan, and many other countries.

Figure 1. (click to enlarge) The process for integrating risk management into the quality control system. Investigations and immediate corrections are typically conducted within the process that caused the deviation.
There are three key components of an effective ongoing risk monitoring process: internal and external surveillance, corrective and preventive action (CAPA), and change control. Fortunately, these are essential elements of a quality management system. There is also a close relationship between risk management and the medical device reporting (MDR) and postmarket vigilance system (see Figure 1).
Postmarket Surveillance
Risk monitoring commences with the start of manufacturing. As part of a product’s launch readiness, manufacturers must have procedures in place to collect, review, and act upon any data that indicate the product may not be meeting its performance specifications. It is a simple matter to extend these procedures to monitor the risk profile of the product, which is the intent of ISO 14971, Clause 9: “Production and Postproduction Information.”
In theory, all the necessary data for risk monitoring should already be available from processes established to monitor the manufacture, distribution, installation, use, and servicing of a device, and from publicly available postmarket surveillance programs.
Complaint trend analysis proves an indispensable tool for identifying design deficiencies and inadequate instructions, as well as unanticipated effects of product or process changes on patient risk. The role of complaint monitoring in risk management is not only to identify new hazards or changes in risk, but also to test the original risk estimates and verify that these are correct. If data show the estimates are wrong, as manufacturers sometimes discover when products enter the real world, the risk analyses must be updated, and previous risk management activities must be reevaluated. Customer feedback can also be used to improve the risk assessment process so that future risk management decisions will be even better. When postproduction information is properly used, risk management becomes a model closed-loop process.
The top row of the diagram in Figure 1 shows several internal and external sources of quality indicators that require monitoring. Each process must have some built-in means of identifying significant product or process failures, investigating their causes, and determining whether a systemic issue exists that should be addressed through CAPA. For risk monitoring, the investigation procedures must include an evaluation to determine whether a failure represents a known hazard, or one that was not foreseen during the original risk analysis.
Risk management may be an imperfect process, but its effectiveness improves with time. Normally, a CAPA is opened when an unanticipated failure mode is encountered and a risk analysis is performed within the CAPA process—ideally, by the same experts who performed the original analysis. The results are evaluated against the predetermined acceptability criteria in the risk management plan. Then, additional risk control measures are applied to reduce the risk (following the hierarchy of risk controls discussed in Part 3 of this series), and the product risk assessment is updated with the results. An investigation should also address the reasons why a hazard was not identified. Does the risk analysis process need improvement? Were the right experts involved? Should the hazard have been identified with the information available?
If the failure mode was already addressed in a risk analysis, then the investigation must ask whether the original risk estimate was correct. Both components of risk—severity and probability of harm—need to be considered. If serious harm or a hazardous situation occurred that was not expected from the hazard, the probability or the severity was underestimated. If the hazardous situation was expected to occur at an acceptably low frequency, then a review of trend analysis data may reveal whether this prediction has been borne out. A CAPA can be opened to address the increased risk and any underlying systemic issues in the risk management process (i.e., what led to underestimation of the risk).
Risk assessments are living documents that must be available when investigating complaints and product failures. Risk monitoring requires a considerable amount of organization and coordination. The Global Harmonization Task Force recommends maintaining a risk table for each product, with entries traceable to the supporting risk assessments, thus making risk information available to those who need it.5
A common discontinuity in risk management involves complaint investigations. For example, the front end of the complaint handling system is often delegated to a dedicated group in marketing or customer service skilled in managing customer relations. These professionals are typically responsible for handling all communications with customers. After troubleshooting a customer’s call, those that meet complaint criteria are handed off to the designated complaint-handling unit for follow-up. Unfortunately, the complaints may not be categorized in a way that enables comparison to the failure modes identified in the product risk analyses, making it difficult to correlate this valuable user feedback with the original risk estimates. A modest upfront effort to develop a system that correlates failure categories with the potential failure modes identified during product design significantly reduces the time and effort of evaluating risk when adverse events and malfunctions occur. In addition, such a system can help convince FDA investigators looking into corrections or removals that the quality management system is working and the company is in a state of control.
While each department may collect its own postmarket data, postmarket surveillance is more effective when performed by a cross-functional team, preferably including the same knowledgeable experts that created the original risk estimates—development scientists, design and manufacturing engineers, human factors specialists, user advocates, medical experts, and risk management practitioners. The latter group is required because risk management has become a specialized discipline, and participants must be qualified to perform its functions.
Risk management lends itself to a team approach, but teams are only effective with strong leadership and the support of management. In addition to having the appropriate resources, successful postmarket risk monitoring depends on active participation, clear ownership of follow-up actions, and good performance metrics based on the action outputs and not the data inputs.
Risk monitoring can be conducted for the most part by using existing quality monitoring and investigation processes that feed the company’s CAPA system. In addition, although publicly available information is frequently overlooked or ignored, manufacturers should review these sources as part of the monitoring process—not only regarding their own devices, but also comparable medical devices that could provide insights into possible risks. These reviews will not occur unless specific individuals are assigned to review the data sources and report regularly on their findings. FDA’s Manufacturer and User Facility Device Experience (MAUDE) database is a public source of searchable information about actual and potential adverse events.6 Although MDR reports need to be carefully scrutinized to avoid overreaction—manufacturers frequently report events based on limited and inaccurate information—the early warning indicators should not be overlooked. Other external information available to IVD manufacturers includes customers’ quality control data, proficiency survey reports, and clinical laboratory and medical journals that publish product evaluations and user reports.
Relationship of Risk Management to Investigations and CAPA
Companies frequently have trouble defining the relationship of the risk management process to investigations and their CAPA system. This is often because they have not made risk management an integral part of their quality system processes, as illustrated in Figure 1. Investigations of possible malfunctions identified through complaints, service reports, manufacturing defects, engineering nonconformities, supplier audits, and QMS audits must evaluate the risks to patients. For example, a service report may indicate that incorrect results were generated by a laboratory because of a previously unrecognized failure mode. Review of the risk assessment documentation may show that the magnitude of error could be sufficient to affect a physician’s diagnosis and lead to patient harm. In addition to helping decide whether to report the malfunction as an MDR, the risk determination would ensure that root-cause analysis and corrective actions be given higher priority than if the risks were found to be low. The CAPA process coordinates and risk reduction activities to completion tracks.
Controlling Changes
Another important component of postlaunch risk management is a robust change-control system. Product and process changes may be initiated in response to corrective actions, quality improvement programs, or cost-reduction initiatives, as well as interruptions in raw material availability and other reasons outside the manufacturer’s control. Failure to connect change control to risk management is a common discontinuity in quality management systems. IVD manufacturers must be careful not to inadvertently introduce new hazards or increase patient risks when making changes to materials, processes, or product design. In addition, critical risk control measures can be subverted when changes do not take into account the risk mitigation decisions made at the time of product or process design.
Existing change management processes should be easily adapted to include consulting previous risk assessments before a change is made, performing a risk assessment whenever a new hazard or change in risk level is suspected, and updating the risk management file.

Figure 2. (click to enlarge) The integration of risk management into a change-control system.
The diagram in Figure 2 illustrates how risk management is integrated into a change-control system. When changes are proposed, they are evaluated against product and process risk assessments and change history. The change-control process asks whether any new hazards may have been introduced, whether the severity or probability of harm might be increased by the change, and whether existing risk controls will be maintained after the change. If the answer to these three questions is “yes” or “don’t know,” then a risk assessment is required before a decision on the change can be made.
Most manufacturing operations already check their failure mode and effects analyses when contemplating a process change, but purchasing controls and acceptance activities require the same degree of attention. Any decisions to allow changes that could affect the product must include consideration of risk to patients.
An effective change-control system must require that each change be evaluated to confirm it will not increase the probability of a failure that can lead to harm or increase the severity of harm, or affect an established risk control measure. Where applicable, the need to requalify equipment, facilities, or personnel or revalidate a process or test method must be considered because these are important risk controls. Manufacturers must be especially vigilant against risk creep—the cumulative effect that many minor changes may have on the overall risk level.
If the change is being introduced as part of a risk reduction activity, change control must check completion of the verification activities required by ISO 14971 to ensure the effectiveness of risk mitigation. Consulting the risk management documentation related to a proposed change should be an explicit, mandatory part of the change-control procedure.
Purchasing controls are another important aspect of risk management. Supplier qualification criteria and purchase specifications should be based upon risks related to the purchased products and services. Manufacturers should prescribe risk control measures to ensure that purchased product and services meet specified requirements. The degree of purchasing control, and the ratio of acceptance activities to purchasing control, should be commensurate with the residual risk associated with the outsourced product or service.
Conclusion
Although risk management requirements have been in effect in the United States for 10 years, and the European IVD Directive became fully effective in 2003, compliance audits and discussions with industry colleagues indicate that many IVD manufacturers are still struggling to integrate risk management into their quality management systems.7,8 This situation is not unique to the IVD industry, but the indirect risk to patients adds a challenging dimension for IVD manufacturers.
The final installment of this series will discuss the relationship of risk management to the MDR and postmarket vigilance systems, and it will highlight gaps sometimes found in ISO 14971 risk management programs. It will also discuss changes in the second edition of ISO 14971, which is scheduled for publication in 2007.
References
1. DM Powers, “Risk Management for IVDs, Part 1: Planning and Documenting the Risk Management Process,” IVD Technology 12, no. 2 (2006): 28–33.
2. DM Powers, “Risk Management for IVDs, Part 2: Assessing Risks to Patients from In-correct Test Results,” IVD Technology 12, no. 3 (2006): 24–31.
3. DM Powers, “Risk Management for IVDs, Part 3: Reducing and Controlling Risks to Patients,” IVD Technology 12, no. 4 (2006): 22–27.
4. ISO 14971:2000, “Medical Devices: Application of Risk Management to Medical Devices” (Geneva: International Organization for Standardization).
5. “Implementation of Risk Management Principles and Activities within a Quality Management System,” SG3/N15R8 (Global Harmonization Task Force).
6. Manufacturer and User Facility Device Experience (MAUDE) Database, Center for Devices and Radiological Health Web site (Rockville, MD: [cited 12 March 2006]); available from Internet: www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfMAUDE/search.cfm?searchoptions=1.
7. “Quality System Regulation,” Code of Federal Regulations, 21 CFR 820.
8. “Directive 98/78/EC of the European Parliament and of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices,” Official Journal of the European Communities L331 (1998).
Copyright ©2006 IVD Technology


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IEC 60601-1

Medical Device Industry:
A Welcome Step Forward for IEC 60601-1

The third edition of IEC 60601-1 will have a significant impact on both manufacturers of medical devices and certification organizations, but it will also result in safer and more effective devices.



Everyone involved in certification to IEC 60601-1 needs to understand that fundamental changes have accompanied the transition from the second edition (1988) to the third edition (2005) of this standard. In addition to making structural changes to the standard, the third edition takes on a broader range of products and has been modernized to take account of the past ten years of technological evolution and a different approach to standards development.

Some of the changes allow for a relaxation of requirements based on historical evidence, which makes for significant savings on the cost of medical equipment. For example, if a risk management process shows that a device or its components do not touch the patient, then that device or its components only need to meet the less stringent requirements of IEC 60950, because in such circumstances operator protection and not patient protection is the goal. In such cases, manufacturers can use components, such as power supplies and video displays that are used in IT applications.

New Thinking

Perhaps the most significant change accompanying the third edition is the requirement for risk management. Clause 4.2 of the third edition states: ‘A risk management process complying with ISO 14971 shall be performed.’ Thus, to meet the requirements of the third edition, one must also comply with ISO 14971.

This single statement integrates process-based requirements into a test standard, which will have a significant impact on both manufacturers and Certification Organizations (COs). The manufacturer’s risk management process is used throughout the third edition to determine whether a particular requirement is applicable or not applicable; whether an alternative requirement can be substituted; and whether it can be satisfied with alternative test criteria or testing procedures.

Flexibility in Risk Management Standards

Clause 4.5 of the third edition allows the manufacturer to use an alternative means of managing any risk addressed by the standard, so long as the residual risk (estimated as part of the risk management process) can be demonstrated to be smaller. So, instead of designing a product to meet the third edition, risk management is used to design a standard the device must meet.

It might be an exaggeration to say that these are revolutionary ideas, but it is true to say that the risk management process allows the manufacturer more flexibility. In return for this flexibility, the manufacturer will be expected to demonstrate that its assessment of acceptable risk takes into account applicable regulations and standards, stakeholder concerns and state-of-the-art processes. The acceptable risk needs to be rationally based and measurable, so that the manufacturer can make good decisions at the design stage.

Implications for COs

What does the establishment of this risk management process mean for COs? Test parameters and even the application of specific tests can vary from device to device, depending on the intended use and resultant acceptable risk(s). This, in turn, raises the question of how this impacts on a CO’s ability to conduct testing cheaply and efficiently. Furthermore, COs will want to seek many parts (if not all) of the manufacturer’s risk management file, since the third edition has over 100 compliance statements where evidence of compliance is to be found in the risk management file. Thus, the documentation needed for certification will probably increase significantly.

Assessing Manufacturers’ Risk Management Processes

But what about the risk management process itself? Since one must have an ISO 14971 risk management process in place to conform to the third edition, it is logical that COs will want to assess the manufacturer’s risk management process as part of the certification process, as they now do for certification to the collateral standard for programmable electro-medical systems. Thus, certification to the third edition of IEC 60601-1 will probably include some sort of onsite audit to assess the manufacturer’s compliance to ISO 14971.



This article is co-written by Harvey Rudolph, Ph.D., Global Program Manager — Medical Devices, Joseph P. Murnane Jr., Principal Engineer, and Steve A. McRoberts, Principal Engineer, Underwriters Laboratories Inc.
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Pharmaceutical and Medical Device Risk Management - Implementing a Risk Management Process in Compliance with ICH Q9 and ISO 14971:2007

Pharmaceutical and Medical Device Risk Management - Implementing a Risk Management Process in Compliance with ICH Q9 and ISO 14971:2007

Who Will Benefit:
Risk Management personnel
Design and Development personnel
Regulatory Affairs staff
Quality Management
Quality Engineering,
Manufacturing Engineering

As part of Global Compliance Series of seminars, ComplianceOnline brings you the expert view on“Pharmaceutical and Medical Device Risk Management - Implementing a Risk Management Process in Compliance with ICH Q9 and ISO 14971:2007” by Edwin L Bills is the Principal Consultant, Bilanx Consulting LLC.

This seminar would benefits personnel from Biomedical industry including medical devices and pharmaceutical developers and manufacturers.
Venue -->Ahmedabad, Taj Residency, February 7th, 2008
Session Agenda
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THE TRAINER, EDWIN L BILLS

Edwin L Bills, has over 20 years experience in the field of quality and regulatory affairs. Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of the committee. Currently he is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management. Mr. Bills has also provided expert services to legal counsel in the area of risk management and FDA compliance.


SESSION AGENDA

A worldwide initiative to improve biomedical products by the use of risk management techniques has begun. Regulatory agencies have intensified efforts to implement risk management initiatives in product approval processes and inspection processes, and in internal resource management Both the medical device risk management standard, ISO 14971 and the pharmaceutical guidance published by ICH, Q9 are based on the same general risk management processes. This common base allows combination products to be developed and manufactured using common or similar risk management processes, eliminating confusion and duplicate efforts. This seminar will outline and explain the requirements of the two documents to provide a company with the information needed to develop their risk management system and meet regulatory requirements, while lowering exposure to product safety issues.

AGENDA ITEM
Overview of ISO 14971 Medical Device Risk Management
Risk Management Requirements in Other Standards
Introduction and Scope of the Standard
Definitions
Management Responsibilities
View of the Process
Integrating into ISO 13485 Quality System
Overview of ICH Q9 Pharmaceutical Risk Management
Introduction and Scope of the Guidance
Definitions
View of the Process
Integrating ICH Q9 into ICH Q10 Quality System (and ICH Q8 Product Development)
Beginning a Risk Management System
Establishing Risk Policy
Developing Risk Management Procedures
Risk Management Planning
Risk Management during Product Realization
Beginning the Risk Analysis-Which Tools to Use?
Intended Use
Characteristics Related to Safety
Developing the Hazards List
Hazardous Situations
Estimating the Risk
Performing the Risk Evaluation
Performing the Risk Evaluation
Which Risks Require Control?
Implementing Risk Control Measures
Residual Risk and New Hazards
Overall Residual Risk Evaluation
Verifying Risk Control
Verifying Risk Control Effectiveness
Risk Management Activities Involving Production
Risk Management Report and Completed Risk Management Summary
Risk Management Information Disclosure
Postproduction Risk Management
CAPA and Risk Management
Design Change Risk Management
Process Change Risk Management
Summary and Conclusion
Implementing Risk Management Processes
Combination Products and Risk Management
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ISO 13485:2003 and FDA QSR (21 CFR 820) CHECKLIST

ISO 13485:2003 and FDA QSR (21 CFR 820) CHECKLIST is used for
Learning about ISO 13485
Body of Knowledge
Related Competencies:
ISO 13485
EN 46000
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About ISO 13485 , EN 46000 :
Official ISO Standards Organization website


ISO 13485_2003 Manual and Procedures Software CD-ROM

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What Medical Device Manufacturers Need to Know about 21 CFR Part 820 and ISO 13485

- Q&A White Paper
5-page question and answer Q&A addresses:
--Who is covered by 21 CFR Part 820 and who is covered by ISO 13485?--What’s the relationship between 21 CFR 820 and ISO 13485?--Enforcement of 21 CFR 820 and ISO 13485?--What’s the connection between 820, ISO 13485, and MasterControl?

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Q&A:Compliance with 21 CFR Part 820 and ISO 13485 for Medical Devices
White Paper:Does Your CAPA System Need a CAPA?
White Paper: 21 CFR Part 11 - Are You Ready for an FDA Inspection?
White Paper:5 Ways to Ensure System Compliance with 21 CFR Part 11
White Paper: 21 CFR Part 11 Computer Systems Validation (Risk Mgmt. Plan)

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Good Manufacturing Practices (GMP) / Quality System (QS) Regulation

Introduction
Flexibility of the GMP
Applicability of the GMP
GMP Exemptions
Types of Establishments Exempt from GMP
Types of Establishments Subject to the GMP
Additional Quality System Information

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Risk Management

Risk Management for Medical Devices: Putting ISO/EN 14971 Into Practice
Instructor: Ron Schoengold
Product ID: 700132

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Risk management process including risk analysis, risk evaluation, risk control and post-production information.
Description Medical device companies are slow to implement robust risk analysis and risk management practices as an integral part of their quality system.
Good risk management requires that hazards be identified throughout the product life cycle and either eliminated or mitigated to achieve the highest standards of product safety and effectiveness. A quality system that continuously evaluates a product's hazard potential and implements changes, lowers the probability of causing harm. Each company is responsible for determining the risks associated with its product, putting appropriate controls in place and monitoring the effectiveness of the controls.Areas Covered in the seminar:
Risk management process including risk analysis, risk evaluation, risk control and post-production information.
Qualifications of risk management personnel.
Management responsibilities in risk management.
Risk management plan.
Risk management report.
Risk management file.
Risk analysis tools. Who Will Benefit:
Quality Managers
Regulatory Affairs Managers
Program Managers
Project Managers
Product Development Managers
Research and Development Managers
Instructor Profile: Ron Schoengold, is a consultant to the biotechnology and medical device industry, offering critical technical and business information on the effective commercialization and maintenance of products and services. Ron has been an active contributor to the industry for over 38 years and has developed commercially successful screening and diagnostic products for gastroenterology, infectious disease and point-of-care testing. Ron is a principal advisor for the Larta Institute which is supported by the NIH, Commercialization Assistance Program (CAP), for companies awarded SBIR and STTR grants. Schoengold has published, presented or contributed to more than 16 scientific journal articles, co-authored a book chapter on point-of-care testing and holds 8 patents related to point-of-care diagnostics. Schoengold earned his bachelor’s degree in biology and chemistry, did his master’s training in microbiology and biochemistry and completed additional graduate studies in microbiology, genetics, molecular biology and immunology.

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MDD

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Complain Process

CE-Marking Complain Process
Home » CE-Marking Complaint Process
Guideline to understand the Medical Device Directive
Carole Hamilton, ECCP, CPC
CE-Marking Complain Process

1. General Statement and aim of the EBCP CE Product complaint support activity.
2. Clarification as to the role, limits, and assistance of EBCP in individual cases.
3. CE medical device regulations, policy and guidelines
4. EBCP documentation and an information system for accidents, product failure, safety problems, and related reports.
5. Websites and Links: useful EMC/safety information.
6. EBCP Contact.


General Statement and aim of the EBCP CE-Product Complaint Support Activity

General Statement:
Since June 1998, CE Marking is a legal requirement stating that certain medical products sold to the countries of the European Union (EU) must be approved by a notified body indicating that they have met the essential requirements set out by the Medical Device Directives (MDD).
Although these requirements are six years ago, very little is known by the medical community regarding the steps in reporting product deficiencies and subsequent accidents.
The Aim of EBCP Support:
The EBCP is committed to providing assistance in this process by providing a central contact point through which questions may be directed regarding the steps involved in filing a product complaint and the contact numbers needed in reporting a product deficiency.
The EBCP intent is to improve patient safety through enhancing the initiation of a product complaint process and promoting the reporting of product deficiencies and any accidents related to a product by perfusionists.

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Commission launches much-awaited revision to the Medical Device Directives

Medical devices have become an increasingly important health care area in relation to their impact on health and health care expenditure. The sector covers some 10,000 types of products, ranging from simple bandages and spectacles, through life maintaining implantable devices, equipment to screen and diagnose disease and health conditions, to the most sophisticated diagnostic imaging and minimal invasive surgery equipment. The public expects that these devises meet the highest safety standards. Today, the European Commission has proposed amendments to the current legislative framework. The proposal has been developed involving extensive stakeholder consultation and has also been subject to a public consultation. This brought forward many relevant and important contributions which, where appropriate, were incorporated into the proposal. The most significant proposals concern conformity assessment, including design documentation and design review, clarification of the clinical evaluation requirements, post market surveillance, compliance of custom-made device manufacturers and the alignment of the original medical device directive 90/385/EEC.

Commission Vice President Günter Verheugen stated: “This is a good example of better regulation in this complex and highly diversified sector. We have listened to stakeholders and have clarified and simplified the current rules. At the same time we bring improved requirements for safety for the patients whilst continuing to provide a coherent legislative framework that fosters competitiveness.”

The proposal also brings increased transparency to the general public in relation to the approval of devices. It introduces the necessary regulatory clarification in order to continue the high level of protection of human health and support better implementation. It also foresees provisions necessary to regulate medical devices with an ancillary human tissue engineered product. This mirrors the proposed EU legislation on advanced therapies and fills a potential regulatory gap.

The proposal enjoys widespread support and it is anticipated, by authorities and industry alike, that its eventual adoption will see resurgence in this sector, both in terms of competitiveness and safety. Moreover, the proposal fits neatly into the European Commission’s policy to maintain the high competitiveness of this sector.

Indeed, a recent study commissioned by the European Commission has underlined again the importance of this sector which consists of some 7000 business entities in Europe, employing upwards of 350,000 Europeans and which regularly records the highest production growth rates amongst all industry sectors in the EU.
The Commission proposal will now be forwarded to the European Parliament and Council for co-decision. Additional information, including the text of the study and the Commission proposal, can be found at:

http://ec.europa.eu/enterprise/medical_devices/revision_mdd_en.htm
Information on the proposal on Advanced Therapies can be found at:

http://pharmacos.eudra.org/F2/advtherapies/index.htm

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Medical device directives

EU Directives

There are three European CE Marking Directives that specifically apply to medical devices manufacturers:
The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive,

The Active Implantable Medical Devices Directive (AIMDD) applies to all active devices and related accessories intended to be permanetly implanted in humans.

The In Vitro Diagnostics Directive (IVDD) applies to all devices and kits used away from the patient to make diagnosis of patient medical conditions.
View European Directives

CE marking is a legal requirement for devices intended for sale in Europe.
BSI is designated as a Notified Body with a comprehensive scope under the MDD and the AIMDD and can also provide services under the IVDD.

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Price war could put Indian hearts at risk

May 2004,
0739 hrs IST,TNN

MUMBAI: Price wars usually have a feel-good effect, but here is one that has left healthcare experts feeling more cautious than optimistic. For, it concerns the heart. Prices of medicine-coated stents—special rods used by cardiologists during angioplasty to unblock clogged arteries—have been falling over the last six months because of intense competition among the fast multiplying number of manufacturers. But this good news is laced with worry that in the absence of regulations, India could be flooded with inferior products which could "cause more harm than good", several experts said. The price revision has been triggered by the advent of new players, Surat-based Sahjanand Technoventions and the Bangalorebased arm of the British firm Vascular Concepts, who are selling medicine-coated stents at Rs 75,000 a piece. When drug-coated stents came to India a couple of years ago, they were priced at around Rs 1.7 lakh. Now, Johnson & Johnson has revised its price from 1.4 lakh two months ago to Rs 1.27 lakh, while another MNC, Boston Scientific sells at Rs 90,000. "One of the MNCs is likely to cuts its price by another Rs 5,000 to Rs 10,000," a cardiologist said. "Drug-coated stents are expensive because their prices have so far been decided by American healthcare policies," said M Swaminathan of Vascular Concepts. In the US and Europe, patients undergoing angioplasty are reimbursed the entire cost of the operation by insurance companies or government healthschemes. In India, however, the healthcare reality is different. "Most Indians pay for healthcare from their own pocket," said Dr D M Mardikar. A price revision is hence one of the best things to happen to India, where about 11 per cent of the population suffers from coronary artery diseases. "Only 25 per cent of the angioplasty done in India involve medicine-coated stents, while the rest are done with ordinary stents," said cardiologist A B Mehta of Jaslok Hospital. A public health official recalls how ordinary stents cost Rs 90,000 each when introduced in 1994-'95. "Now we have 50 players in this segment and the average price is Rs 40,000," he said, predicting a similar fate for medicinecoated stents. The standardisation process will occur sooner than later as 10 more players are likely to enter the Indian market in 2004-'05,he said.But this very flood of new players is worrying experts. "In India, stents don't require any certification process before entering the market," said Dr Mehta. While J&J and Boston have the allimportant US FDA clearance and European CE certification, Vascular Concepts has got the CE mark and the go-ahead to start clinical trails in Europe. Sahjanand has applied for the CE mark after being certified by independent agencies in India and abroad, said company official Tejas Pawar. Not that most Indian patients question their doctors or worry about certifications and clearances. "They blindly accept their doctor's decision, forgetting that the medical community too has some black sheep," said a consultant.

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Statutory and regulatory requirements for Medical Devices in india

Indian Medical Devices Regulatory Authority (IMDRA)
The Government of India is proposing to set-up the Indian Medical Devices Regulatory Authority (IMDRA). The IMDRA is expected to formulate appropriate guidelines to be a national certifying and regulatory agency in India for medical equipment and devices. The Defence Research & Development Organization has prepared a draft proposal towards establishing this National Regulatory Authority.
Comments of various experts are invited on this draft proposal on the setting up of this National Regulatory Authority. The comments will be appropriately acknowleged in the final document.
Download/View Draft Document
Dr K.Satyanarayana, Deputy Director General (Sr. Grade)Indian Council of Medical Research, V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi 110 029 ( e-mail : kanikaram_s@yahoo.com ).

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Monitoring medical devices
R. RAMACHANDRAN
The proposal to set up an Indian Medical Devices Regulatory Authority assumes importance in view of the necessity to stop the import of unreliable devices and for India to have a say in the international standardisation process.

AN 80-year-old patient goes to one of those high-tech private diagnostic centres that are mushrooming across the country for a Colour Doppler Echo Angiogram of an artery believed to have a high degree of blockage. The test result: "90 per cent blockage. Surgical intervention recommended." Surgery being a tricky proposition in such an advanced age, the patient goes to another centre on the advice of the physician for a repeat test in spite of having spent a couple of thousands of rupees on the first test. This time around, the result is: "70 per cent blockage. Consult physician." If the consulting physician is not skilled enough to interpret the test data properly, this could lead to all kinds of complications, besides mounting expenses. Even if the physician is good enough, there is the potential psychological impact on the patient. Given that nearly three-fourths of health care in the country is in private hands, this kind of situation is perhaps rampant with the proliferation of uncertified private clinics and diagnostic centres and the unregulated import of high-tech medical equipment under the garb of life-saving medical devices, whereas many of them may well be life threatening.

In the past couple of decades, for the right or wrong reasons, healthcare has become highly technology intensive. It is estimated that the medical devices market in India is worth $1.5 billion. Nearly 80 per cent of this industry is met by imports at very high costs - which no doubt is passed on to the patient - notwithstanding the impressive progress made in the field of biomedical technology in recent years with many indigenous devices trying to make a mark in the market. The government sector too spends a great deal on high-tech medical devices. According to reports, in 2000, an estimated one and a half million different medical devices, valued over $145 billion, were available in the world market and the figure is expected to exceed $260 billion by 2006.

Almost all countries that have a medical device industry have policies and regulatory processes or mechanisms in place. While the assurance of the quality of any marketed product is the responsibility of the manufacturer, the state also has the responsibility to protect the right of the consumer. In the case of medical devices, with potential health risks, the responsibility is even greater. In this scenario, it is indeed amazing that there is virtually no regulatory system in the country that ensures the reliability of these devices given that, like a drug or a vaccine, medical devices too, particularly those that are implanted in the human system, have attendant health risks. The more sophisticated is the underlying technology, the more complex becomes its calibration and operation and more serious are the potential errors due to malfunctioning and consequent harmful effects on a patient's clinical status. Therefore, like any drug, a medical device also requires to be evaluated for its quality, efficacy, reliability and safety before and after procedure for approval for its use in public health. If the device is implantable, it would also require systematic and rigorous pre-clinical and clinical studies, much like a drug.

India lacks any kind of regulatory framework for certification, quality assurance, safety evaluation and post-market surveillance of both imported and indigenous medical devices. Even the Drug Controller General of India (DGCI) does not have any mandate to regulate the medical devices market and the use of the devices in medicine. Apparently, the practice followed by the DGCI is to refer to matters relating to medical devices to the Indian Council of Medical Research (ICMR) on a case-to-case basis. Some low-technology devices like thermometers and weighing machines seek certification from the Bureau of Indian Standards (BIS) - for ISI marking - and that too is optional. Some imported high-tech devices, approved or cleared by their country of origin, as done by the United States' Federal Drug Administration (FDA), are apparently permitted to be marketed in India. It is not clear how the system operates and for which categories of devices this parent country approval is required.

In this context, it is pertinent to point out that not all devices permitted for export by other countries are allowed to be sold in the respective domestic markets. The export policy of the FDA says: "Although a device would not meet the requirements of the Federal Food, Drug and Cosmetics Act to be sold domestically, it may be exported legally and without FDA's permission." Provided that the device is: "In accordance with the specifications of the foreign purchaser; not in conflict with the laws of the country to which it is intended for export; labelled on the outside of the package that it is intended for export; and, not sold or offered for domestic commerce."

At the same time, for import into the U.S. a device must meet stringent controls of the FDA. It should be a device approved by its Centre for Devices and Radiological Health (CDRH) and should obtain a pre-market approval or equivalence to an existing device. This could involve some samples being tested by the FDA to ensure quality and other claims. As a result, India has become a dumping ground for obsolete or poor-quality Western devices that have been discarded abroad owing to their adverse effects. Usually such information is withheld and without an overseeing authority, there is no restraint on their imports.

Clearly, the situation in India is not a desirable one. Without a rigorous system of standards, criteria and regulatory mechanisms for market approval and post-market monitoring, health care in the country would become a victim of market influences and unscrupulous trade practices, putting consumers' lives at risk. The situation has an adverse impact on the fledgling domestic industry also. In the absence of a clear-cut government policy, there is a reluctance to invest in this capital-intensive industry, thus affecting research and development (R&D) in the field and the industry's growth, despite technological capabilities. With no domestic approval, it also affects the export potential of indigenous products. In the absence of a policy governing medical devices, some Indian manufacturers are making use of the agencies of international standards institutions like the International Organisation for Standardisation (ISO) to obtain ISO 9000/14000 certification for their processes and products and get the European CE (Essential Certificate) in order to gain entry into the European market. It also renders the indigenous devices vulnerable to medico-legal problems in case of an adverse effect of the device.

There is an international initiative known as "Global Harmonisation Task Force (GHTF)", which was conceived in 1992 in an effort to harmonise the medical device regulatory frameworks across nations. It comprises its five founding members, Australia, Canada, the European Union, Japan and the U.S. Each of them has an active medical-device industry and has a well-developed regulatory framework, representing three geographical areas (Europe, Asia-Pacific and North America).

In a bid to further the convergence in standards and regulatory practices, the GHTF publishes guidance documents for the harmonisation of basic regulatory practices. These documents, developed by four study groups, can be adopted/implemented by different national medical-device regulatory authorities. The technical committee members include representatives from national authorities as well as from the industry. In the emerging post-World Trade Organisation scenario of globalised trade - India will be fully part of this regime in 2005 - the absence of a policy or a regulatory framework will put India at a disadvantage in forums like the WTO and the consequent international trade practices. It is important that the Indian perspective on these issues is presented in any harmonisation initiative. South Korea, China and Brazil, which have put in place appropriate regulatory mechanisms, are participating in this initiative as observers.

What is even more interesting is that India does not even find a mention in the regional initiative, known as the Asian Harmonisation Working Party (AHWP), which is working with the GHTF and is involved in forging a common direction for the harmonisation of medical device regulation in Asia.

The AHWP aims to provide a forum for discussion and training, facilitate information exchange and initiate projects relating to the GHTF. It is important that India should seek to play a significant role at least in the regional set-up. Otherwise people would remain unaware of whatever benefits (avoidance of non-tariff barriers) or drawbacks of harmonisation there may be in the years to come.

Given this enormous lacuna in this area, the ICMR and the Society for Biomedical Technology (SBMT), an inter-ministerial organisation set up under the Defence Research and Development Establishment (DRDE) in 1993, have recently come out with a proposal for the creation of the Indian Medical Devices Regulatory Authority (IMDRA) as the apex body for the implementation of the country's regulatory system for biomedical devices. It is significant that the SBMT has taken this initiative because it constitutes the only organised effort in the country to coordinate the development and marketing of biomedical devices, albeit those which have come as spin-offs from defence technology.

Some time back, given the constraints faced by indigenous R&D efforts as well as manufacturers, Dr. T. Lazar Mathew, the then Director of the Defence Institute for Nuclear Medicine and Allied Sciences (INMAS) and Chief Executive of SBMT, conceptualised a regulatory framework for the Indian context. This document was circulated to the various government agencies as a concept paper in 2001. The ICMR hosted it on its web site and invited comments. Since there was a felt need for a short-term as well as a long-term policy framework - given the fast technological obsolescence (usually five years) of medical devices as against drugs whose pharmacopaeial specifications last for decades, and also the rapid proliferation of devices - the ICMR constituted a committee under the chairmanship of Dr. M.S. Valiathan, the eminent medical scientist and the present President of the Indian National Science Academy (INSA) to prepare a detailed proposal. This 13-member expert committee, in turn, constituted a four-member task force headed by Dr.Mathew. The task force has come out with a document that is likely to form the basis for a regulatory authority, called the IMDRA, in the country.
The basic objective for the regulation that is set forth in the document is "ensuring the safety and efficacy of the medical devices placed on the Indian market". The document has recommended creating a two-tiered system, combined with a third-party conformity assessment through a number of notified bodies, analogous to the system in operation for the E.U. countries as against the capital- and manpower-intensive and more bureaucratic, monolithic establishment like the FDA. Since the U.S. was the first to set up a regulatory system for medical devices, the laws came into existence under the FDA in the 1970s essentially in the backdrop of pharmaceutical regulations, which relied heavily on an exhaustive pre-market review of manufacturers' research data and clinical trials followed by approval and licensing. This time-consuming process very often meant that a certain device lost its timeliness in the context of fast-changing technology. The European system, on the other hand, derived the advantage of evolving later in the 1980s. It avoided the drawbacks and pitfalls of the U.S. model. Essentially, in the European model, the safety and efficacy and the quality assurance of a product is the responsibility of the manufacturers themselves. For high-risk devices, a third-party certification may be required, and for this the manufacturer has the choice of different procedures and institutions (the so-called Notified Bodies).

From the point of view of the manufacturer, clearly the European system is more expensive than the U.S. approach, with the state sharing a large burden of evaluation costs in the latter. The European model evolved basically from the requirements of a single European market. In harmonising the requirements of different E.U. nations, the approach was to formulate the common European Commission (E.C.) Medical Device Directives, which contain the essential requirements that are general and mandatory for quality control, safety and reliability. Products that comply with the directives - at present it is a set of three - carry the European CE mark of conformity, have legal sanction and can be marketed throughout Europe. Competent authorities such as health ministries are responsible for implementing the directives.

It is the responsibility of the manufacturer to comply with the standards set out by voluntary standards organisations such as the European Committee for Standardisation, which are empowered to write standards for the E.U. by drawing upon international standards institutions. For quality control certification, the manufacturer can get the product tested by any of the Notified Bodies (government and private laboratories) under a contract or otherwise. Given the flexibility inherent in this system, many other countries, like Canada and Australia, are adopting the basic principles of the E.U. system. Learning from the European experience, even the U.S. has, of late, begun to shed some of the baggage at least for low-risk products.

In the Indian context, too, the Mathew Committee has recommended the European model for adoption because of cost considerations, lack of technical infrastructure like the FDA, need for flexibility, and minimal bureaucratic control. However, as the document points out, Indian manufacturers are generally not as technically competent as their European counterparts, and placing on them the bulk of the responsibility for quality assurance and safety could act as a damper for the medical device industry in the country. The chief advantage of the European model is its long-term stability. By the laws themselves not being tied down by evolving technical standards, whose specifications have been left to international standards organisations with which the devices have merely to demonstrate conformity, the laws will not call for frequent changes. At the same time, the legal framework in terms of enunciated directives alone affords a great deal of flexibility to the manufacturer and, most importantly, the essence of timeliness of devices is not lost.

The system will include a pre-market strategy and a post-market one. The former will require a manufacturer to determine the risk categorisation of the device as per the proposed four-tier classification and submit the associated technical data for review and approval. The latter will involve surveillance and periodic assessment of the production process as well as quality and safety. The IMDRA is proposed to be assisted by various Conformity Assessment Bodies (CABs) - equivalent to the Notified Bodies of the E.U. system - and Certified Testing Laboratories (CTLs). The manufacturer or the CAB will get the product tested by a CTL and submit the results of the audit. To begin with, the IMDRA has been proposed to be set up as a small autonomous body under the Ministry of Science and Technology and located anywhere in India. It will include the maximum number of technocrats and operate as an autonomous entity. For the interim period (three to five years), it will have one main regulatory body and two or three sub-regulatory bodies, whose work will be overseen by an inter-ministerial council. The document has also recommended that the IMDRA be provided with all statutory and constitutional provisions to enforce the basic policy framework envisaged.
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Medical Device Regulations in India
BSI Medical Devices Email Update Service
Due to a recent court case on marketing drug eluting stents, the division bench of the Mumbai High Court has asked the Commissioner of the Food and Drug Administration to draft a notification to regulate medical devices in India.
The Ministry of Health (MOH) issued a notification to regulate, with immediate effect, 10 categories of medical devices. As of 6 October 2005, medical devices in each of these categories will be regulated as a "Drug":
- Cardiac Stents
- Drug Eluting Stents
- Catheters
- Intra Ocular Lenses
- I.V. Cannulae
- Bone Cements
- Heart Valves
- Scalp Vein Set
- Orthopedic Implants
- Internal Prosthetic Replacements
Detailed registration requirements and information concerning any transition period were not provided in the MOH notification. The American Chamber of Commerce (AmCham) of India issued a letter on 21 October 2005 to the MOH to ask for these details. BSI will continue to monitor the situation and provide email updates as news becomes available.
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PDF]
Good Clinical Practice Guidelines (India)
File Format: PDF/Adobe Acrobat - View as HTMLthe purpose of carrying out Clinical Trials in India. The Regulatory Authority approves the ...... Indian Medical Devices Regulatory Authority (IMDRA). ...unpan1.un.org/intradoc/groups/public/documents/APCITY/UNPAN009867.pdf - Similar pages

Taskforce to draft action plan for IMDRA set-up - Pharma News ...
INDIA MUSINGS. SUPPLEMENTS. LABWATCH. HOSPIUPDATE ... THE five-member task force on the proposed Indian Medical Devices Regulatory Authority (IMDRA) will ...www.expresshealthcaremgmt.com/20030915/pharmanews02.shtml - 22k - Cached - Similar pages

[PDF]
Q: What are the major trends in the use of medical technology in ...
File Format: PDF/Adobe Acrobat - View as HTMLNo such institutions exist in India. A government of India. committee recently proposed forming an Indian Medical Devices Regulatory Authority. (IMDRA) ...www.ifw-kiel.de/konfer/esf_ifw/newtech_0507/ajay_mahal.pdf - Similar pages

[PDF]
NATIONAL INSTITUTE OF EPIDEMIOLOGY (NIE), CHENNAI
File Format: PDF/Adobe Acrobat - View as HTMLfour centres in India and one centre in China with .... India and other countries/international agencies. ... (IMDRA) in the country. BIOMEDICAL ETHICS ...www.icmr.nic.in/annual/hqds2004/supporting.pdf - Similar pages
[PDF]

Microsoft PowerPoint - Regulatory Updates for Devices in Asia ...
File Format: PDF/Adobe Acrobat - View as HTMLNo device regulatory authority in India. No device registration process required. An Indian Medical Devices Regulatory Authority. (IMDRA) has been proposed ...pacificbridgemedical.com/publications/Asia_Device_Updates_2005.pdf - Similar pages

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Ethical Guidelines for Biomedical Research on Human Subjects
File Format: PDF/Adobe Acrobat - View as HTMLbe followed in India for clinical research (1). ... India (DGCI), as is necessary under The ... (IMDRA). Until the guidelines are formulated ...medind.nic.in/taa/t05/i2/taat05i2p174.pdf - Similar pages

Straight Answers-City Supplements-Cities-The Times of India
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Appropriate Policies for Medical Device Technology: The Case of India
File Format: PDF/Adobe Acrobat - View as HTMLIn India, policy and research concern with the introduction and spread of medical ...... the IMDRA may find it worthwhile to piggyback on publicly ...www.whoindia.org/LinkFiles/Commision_on_Macroeconomic_and_Health_Appropriate_policies_for_Medical_Device_... - Similar pages

Indmedica - Journal of the Academy of Hospital Administration
... or abroad or whether clinical trials have been carried out outside India or not. .... named as the Indian Medical Devices Regulatory Authority (IMDRA). ...www.indmedica.com/journals.php?journalid=6&issueid=20&articleid=170&action=article - 28k - Cached - Similar pages

REGULATING MEDICAL DEVICES - Editorial
"Strategic partnerships will boost drug discovery activities in India" ... The first responsibility of IMDRA should be to make a registry of products and ...www.pharmabiz.com/article/detnews.asp?SecArch=&articleid=15352&sectionid=47 - 24k - Cached - Similar pages

ISO 10993

A Practical Guide to ISO 10993: Part 1—Introduction to the Standards

With so many versions of "harmonized" standards for the biological evaluation of medical devices, a fresh look at the basics might help clarify the issues. Note: this is the first installment of an ongoing series of articles dedicated to ISO 10993. Part 2, Materials Characterization, is also available for on-line reading.
Richard F. Wallin and Paul J. Upman

For nearly 10 years, Technical Committee 194 of the International Organization for Standardization (ISO) and its various working groups have been developing the documents known collectively as ISO 10993, a set of harmonized standards that address the biological evaluation of medical devices. During most of that period, the U.S. device industry has operated according to the Tripartite Guidance for medical device biocompatibility, which was introduced in 1987. That guidance was replaced in July 1995, when FDA issued its own version of ISO 10993-1, "Guidance on Selection of Tests" as a blue book memorandum. Currently, therefore, the status of globally harmonized standards for the biological evaluation of medical devices is as follows: those ISO 10993 standards that have been issued by ISO are used throughout Europe; the FDA version of ISO 10993-1 is used in the United States; and in Japan, even though ISO 10993 has been formally accepted, the "Japanese Guidelines for Basic Biological Tests of Medical Materials and Devices" favors certain test methods to evaluate specific categories of biological effects.

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Medical devices India

PDF]
Asia: Medical Device Regulatory Issues (HIMA Presentation)
File Format: PDF/Adobe Acrobat - View as HTML

India, which has no regulatory body for medical devices will also formulate ..... C. Biocompatibility (Safety) Data Requirement. • The KFDA’s requirement ...pacificbridgemedical.com/publications/Asia_MedDev_Regulatory_HIMA_2000.pdf - Similar pages - Note this

EN Standards for Medical Devices

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application of risk management for medical devices - ISO 14971

As the only international standard for risk management for medical devices, ISO 14971 has become an integral element for satisfying regulatory requirements in most major markets and should be incorporated into the medical device life cycle.ISO 14971 has been formally recognized by the U.S. Food and Drug Administration (FDA) and by Health Canada; the European Union has adopted it as a harmonized standard; Japan has designated it as a Japanese Industrial Standard; and Australia has made it their “de facto” standard for risk management.
The purpose of ISO 14971 is to assist medical device manufacturers in establishing, documenting and maintaining a risk management process to: 1) identify hazards and hazardous conditions; 2) estimate and evaluate the associated risks; 3) control those risks; and 4) monitor the effectiveness of the controls put in place throughout theproduct life cycle.
ISO 14971 is referenced in a number of other important medical device standards, including the third edition of IEC 60601-1(electrical safety), IEC 60601-1-6 (usability), ISO 13485:2003 (quality) and IEC 62304 (software), among others.
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http://www.ul-asia.com/NewsDetail.aspx?NewsId=226&SiteId=2&ref=NEWS&src=Home.aspx%3fSiteId%3d2

The Medical Device Directive

This section will be regularly updated with topical documents.
Medical Devices Directive The Medical Devices Directive.
In Vitro Diagnostics Directive The In Vitro Diagnostics Directive.



Draft EC Decision on Animal Derived Material This document is the draft decision that has been issued by the European Commission that will effect all CE Marking for devices that incorporate animal derived material.
EC Decision CTS This is the European Commission Decision on the Common Technical Specification (CTS) relevant to List A In Vitro Diagnostics.
RTTE Paper This is a question and answer style paper that provides some guidance on the requirements the RTTE Directive relevant to medical devices

http://asia.bsi-global.com/India+MedicalDevices/GuidanceDocs/OtherDocs.xalter

Categorization for Medical Devices

Fast Facts: Medical Device Directive (MDD)
Within the Intertek group there are four European Union based Notified Bodies located in Germany, Sweden, and the United Kingdom.
> Class IIa, IIb and Class III medical devices require Notified Body approval under the Medical Device Directive.
>> As part of the essential requirements for the medical device directive you must also provide technical documentation, a risk assessment, and implement a quality system.

Medical Device Directive (MDD)
The Medical Device Directive 93/42/EEC (MDD), at first glance, is filled with confusing rules, device classifications, and conformity requirements. In simple terms the aim of the MDD is as follows:
> To define the essential requirements that medical devices must meet before being placed on the market
> To establish conformity assessment procedures based on device classifications
> To create tracking and reporting mechanisms available to national authorities to ensure and protect public health

In order to market your medical device within the member states of the European Union your product must comply with the essential compliance requirements of the MDD. Compliance with harmonized standards such as EN 60601-1-2:2001 for EMC and EN 60601-1 for safety provide assumption of conformity to the technical requirements.

As part of the essential MDD requirements you must also provide the following:
>> Technical Documentation (Technical File) - Technical documentation should contain full construction details of your medical device
>> Risk Assessment - According to EN 14971:2000 your product’s Risk Assessment must include a construction evaluation, materials used, bio-compatibility analysis, infection, and cross infection risks
>> Quality System – The manufacturer must meet the quality system requirements of the MDD. Conformity to ISO 13485, which is a harmonized standard in the EU, is a way to demonstrate conformity to the quality system requirements of the MDD.

Depending on your product classification (see below) you may also need Notified Body Approval. Within the Intertek group there are four European Union based Notified Bodies to the MDD:
>> DEKRA ITS, German N/B No: 0124
>> Intertek Testing & Certification UK N/B No: 0359
>> Intertek Semko, Sweden N/B No: 0413
>> AMTAC Certification Services, UK N/B No: 0473

Once you have met all applicable essential requirements of the MDD, it is your responsibility to show conformity with the Medical Device Directive by affixing the CE Mark to the device.

Navigating the CE marking process does not have to be painstaking. In fact, Intertek makes getting a CE mark as easy as the following steps:
1. Classify your product - Class I, IIa, IIb, and III according to the following definitions:
>> Class I. Devices with low risk such as external patient support products.
>> Class IIa/b. Devices with medium risk such as electro-medical devices.
>> Class III. Devices with high risk such as cardiovascular catheters.

>> Note that: Some Class I and all Class IIa, IIb, and Class III devices require Notified Body approval.

2. Determine your certification process based on your device class - See the Class I, Class IIa/b, Class III certification process links under the resources section to the right of the page.

3. Fulfill the essential requirements - Ensure that your medical device fulfills the essential requirements of the Medical Device Directive.

4. Establish a monitoring system - As a manufacturer, you are required to monitor your products once they are on the market, in case accidents involving your products occur.

5. Establish an accident reporting system - If an accident or near-accident involving any of your products takes place, you are obligated to report this to the authorities.

6. Issue a Declaration of Conformity

7. Save the documentation for five years - Declaration of conformity, technical documentation, reports, and certificates from the Notified Body etc. must be kept for at least five years after the product has been taken out of production.

8. Register with the appropriate authorities in Europe

For more information on the Medical Device Directive (MDD) and its requirements, please contact us.

Classification of Medical Devices:
>> Class I. Devices with low risk such as external patient support products.
>> Class IIa/IIb. Devices with medium risk such as electro-medical devices.
>> Class III. Devices with high risk such as cardiovascular catheters.
>> Note: Class IIa, IIb and Class III devices require Notified Body approval.

Why Intertek?
With four Notified Bodies in Europe, Intertek has helped countless medical device manufacturers conform to the MDD and gain market access into the European Union. From navigating the certification process to assisting with the selection of standards related to your device class, our experts know your product and the requirements you must meet. We will work with you during all steps of the approval process from building your technical construction file and risk assessment to working towards your quality system registration. You can depend on our experience and expertise to quickly and cost effectively reach this ever-growing market.

http://www.intertek-etlsemko.com/portal/page/cust_portal/ITK_PGR/SELECT_YOUR_IND_PG/MEDICAL_DEVICES_PG/MEDICAL_SERVICES_PG/MDD_PG


Class of Risk
http://www.ul.co.in/TemplateArticle.aspx?SiteId=6&Ref=TECH-CORNER&id=2154



The Medical Devices Directive (MDD: 93/42/EEC)
Class 1: non-invasive electric/electronic equipment without a monitoring ... Any medical device requires a risk assessment according to EN 14971:2000. ...www.cetest.nl/mdd.htm - 13k - Cached - Similar pages

UL UL Designated to Certify Class III "High Risk" Medical ...
UL Designated to Certify Class III "High Risk" Medical Devices for EU ... Medical devices classified under the MDD must be registered with a Competent ...www.ul.com/newsroom/newsrel/nr032207.html - 9k - Cached - Similar pages

MDD - Medical Devices Directive
Class I devices are low risk. Examples are stethoscopes, scalpels, ... Class IIa are low-medium risk devices, with examples such as hearing aids, ...www.601help.com/Regulatory/mdd.html - 35k - Cached - Similar pages

MDD - The Medical Devices Directive
TUV Product Service - MDD - The Medical Devices Directive, ... Class I - generally regarded as low risk; Class IIa - generally regarded as medium to low ...www.tuvps.co.uk/mdd.asp - 25k - 2 Jun 2007 - Cached - Similar pages
[PPT]

510(k) 3rd Party Progrm Overview
File Format: Microsoft Powerpoint - View as HTML4 tier classification system based on potential risk posed by device (I, IIa, IIb, ... Class IIb. MDD Compliance Process (Conformity Assessment Procedure) ...www.nepss.org/PSES/IntertekETLSEMKOMedicalMay05.ppt - Similar pages

The Use and Misuse of FMEA

Originally Published MDDI March 2004
Regulatory Outlook
The Use and Misuse of FMEA in Risk Analysis Failure modes and effects analysis can be a helpful tool in risk management for medical devices, but it has several inherent traps that should be recognized and avoided.
Mike W. Schmidt

In 2000, ISO published the first standard for medical devices that takes a broad approach to identifying, evaluating, and mitigating risk: ISO 14971. In its class, this standard is unique. Unlike its predecessors (such as EN 1441), it does not look only at the identification, analysis, and control of the risks associated with a medical device. Rather, it adds significant detail to that process and extends it to the full life cycle of the device. In other words, ISO 14971 provides a comprehensive approach to reducing risk to the lowest reasonable level. In the United States, the standard has been recognized by FDA, and in Europe, it will replace EN 1441 in April of this year. (At the same time, EN 1441 will be withdrawn.) Compliance with ISO 14971 will therefore be crucial not only in assuring the safety of medical equipment, but in meeting regulatory requirements as well.While the new standard is much broader, many of its requirements are similar to those in standards such as EN 1441. The most fundamental of these are to analyze, evaluate, and control each risk.

Within the medical device industry, by far the most common tool for documenting these processes is an adaptation of failure modes and effects analysis (FMEA) or its close variant, failure modes, effects, and criticality analysis (FMECA). For the purposes of this article, the term FMEA encompasses both.It has been estimated that roughly 80% of manufacturers use some form of FMEA for risk analysis, evaluation, and control.

While this approach can be effective, there are several inherent traps that can reduce the effectiveness of the risk management process. This article will attempt to identify those traps and offer ways to overcome them. Risk Management BasicsBefore going into the specifics of using FMEA, a brief review of the risk analysis phase of risk management is in order.

In analyzing risk, the first step is to identify all hazards and harms associated with the device based on its characteristics and intended use. Why distinguish between hazard and harm? Because while a hazard is a potential source of harm, many hazards (such as electrical, mechanical, or thermal energy) result in multiple forms of harm. It is in fact the harm that we are addressing in the risk analysis process. Sometimes, of course, a given hazard may be linked with a single harm. In this case, the two terms can (and frequently are) used interchangeably.

Once all hazards and harms have been identified, the analysis process is completed by estimating the likelihood that the harm will occur and, in the event that it does, the severity of the resulting damage. Combining likelihood and severity (either graphically or mathematically) results in an expression of the risk associated with the hazard.Following this analysis, the risk is evaluated.

Is it necessary to reduce the risk? Or is it inherently acceptable? Where the risk is not considered acceptable, specific actions, or mitigations, are identified to reduce, or control, the risk. After putting these controls in place, a new value for risk is established for the hazard or harm. The mitigation is then evaluated to determine whether any new hazards or harms have been created. Then the evaluation and, if necessary, control processes are repeated until the risk is found to be acceptable. While the description above is only a brief overview of the process, it does establish a context for the following discussion of the use of FMEA.

FMEA and Risk
Where should one look for guidance on using FMEA and FMECA to manage medical device risk? Among the first sources one should consider are ISO and IEC standards. These standards frequently carry a presumption of compliance with device safety regulations in most developed countries. In the ISO and IEC catalogs, only one standard, IEC 60812, addresses the subject.

Titled Analysis techniques for system reliability—Procedure for failure modes and effects analysis (FMEA), it was published in 1985. As its title indicates, this standard does not directly address the issue of using FMEA as a tool for managing risk. It does, however, provide insight into the general use of FMEA.The first characteristic of traditional FMEA that complicates its use in risk management is right in the title: failure modes.

It is certainly true that many risks associated with medical devices are in fact created by failures (such as the “single faults” identified in IEC 60601-1). But medical devices have many risks associated with their use under normal conditions and as intended by the manufacturer.

Many medical devices derive clinical benefit by effectively doing controlled harm. A scalpel that cannot cut tissue might be considered extremely safe—but is useless for surgery. This is a crucial point, since both ISO 14971 and EN 1441 require that these inherent risks be analyzed, evaluated, and reduced as far as is reasonably possible. It is not uncommon for risk management processes based on FMEA to lose sight of this fact, and to focus only on failures of the equipment or those using it. Such implementations of risk management are incomplete and do not comply with either standard.Another characteristic of FMEA that must be carefully scrutinized is found in clause 2.2.4 of IEC 60812:

FMEA is extremely efficient when it is applied to the analysis of elements which cause a failure of the entire system.However, FMEA may be very difficult and tedious for the case of complex systems which have multiple functions consisting of a number of components. This is because of the quantity of detailed system information which must be considered. This difficulty can be increased by the number of possible operating modes, as well as by including consideration of repair and maintenance policies.

In the medical device industry, not just devices but also the environment in which they are used have become extremely complex. Moreover, the circumstances in which they are used have nearly unlimited permutations and combinations.

To properly perform risk analysis per EN 1441 or risk management per ISO 14971, all of these combinations must be evaluated. Doing so correctly using FMEA techniques as defined in the IEC standard can be daunting and, in the end, inefficient. Fault Tree AnalysisOne way to overcome these difficulties is to use fault tree analysis to focus the FMEA on the components and subassemblies that can actually result in hazards. A true FMEA would evaluate each component’s failure modes to determine whether they would result in a hazard. By contrast, fault tree analysis begins by looking at the equipment and its interface with its expected operating environment to determine what harm can occur. It then traces those harms back to all possible sources, including component or subsystem failures and harms that arise from the use of the device or environmental effects. FMEA is then applied only to those elements of the design that could result in hazards. The ideal application of these two techniques would involve evaluating all components using FMEA and fault tree analysis to trace all hazards back to the component level, thereby validating the outcome of each against the other. But doing so can be time- and resource-consuming.

By using fault tree analysis to direct FMEA efforts, those resources are applied most efficiently.Detectability and RiskIn applying FMEA to risk management, some manufacturers use the concept of detectability to generate an initial risk priority number (RPN). This troubling practice is not found in IEC 60812. It comes not from design FMEA techniques but from the use of FMEA to evaluate manufacturing processes. As defined in ISO 14971, RPN involves numeric techniques to represent the relative severity of risk. The value to be given to the severity of each risk is determined by assigning a value indicating the significance of the harm that would occur. This number is multiplied by a value assigned to the probability that the harm will occur. (Risk as defined in the standard is the product of severity and likelihood of occurrence.)

This process is virtually identical to the one described for device FMEA in IEC 60812.
However, process FMEA introduces a third term into the calculation. During manufacture, when a defect that could result in harm is detected, action can be taken to either repair the defect immediately or impound the product until it is repaired. In these circumstances, the use of detectability to figure the RPN is completely appropriate. The time lag between detection during manufacture and the actual use, where the harm typically occurs, is substantial. However, detection of a hazard during use of the device may not assure that the harm will be avoided.

An example of how detection can be virtually irrelevant to preventing harm would be as follows: The pin is pulled from a hand grenade with a 10-second fuse. After waiting eight seconds, the grenade is tossed into the room. It is detected, and then everyone in the room is dead. Detection in fact was irrelevant to the prevention of harm. While the example is extreme, it shows that considering detectability as equivalent to severity and probability in determining the base RPN value is inappropriate when use is involved. Detection is in fact a mitigation of risk. It reduces the likelihood that the harm will occur. Therefore, its value in preventing the harm must reflect several aspects of the circumstances under which the hazard is detected. The first is the amount of time available to take action. The second is whether those present will have the presence of mind to recognize what is happening and take appropriate action.

Finally, the knowledge and training of those present will determine whether they know what action must be taken to avoid the harm. These significant factors (and there may be others) may certainly be considered during the determination of a value for detectability. But without specific instructions on how these factors are to be evaluated in determining that value, consistency will suffer.

In addition, the evaluation of each factor and the underlying assumptions must be documented for each hazard. Otherwise, the value will be virtually meaningless when the risk analysis is reviewed and updated throughout the product’s life cycle (a critical element of risk management as defined in ISO 14971).

How, then, can detectability be built into the evaluation of risks without compromising the analysis?Ideally, detectability becomes a mitigation that reduces the RPN (generated by severity and likelihood only), just like inherently safe design, guarding, or warnings. By identifying detection and the necessary action to avoid the harm as one mitigating factor, the elements time, presence of mind, and knowledge will be evaluated and the assumptions validated. This ideal approach would ensure that the evaluations are consistent and that the results and validations are documented. The documentation will then be available when design changes are made, so that the changes do not inadvertently negate the effects of detection. It also allows the assumptions made to be reviewed, should field data cast doubt on the original results of the risk analysis. Unfortunately, the ideal is not always practical.

In an organization that has been using detectability in calculating the RPN for risks, resistance caused by the perception that detectability is being taken away can be formidable.I was working with a device manufacturer recently in an attempt to bring its risk management process into full compliance with ISO 14971. While meeting with design engineering personnel to understand their current process (which used severity, likelihood, and detectability to calculate the RPN for each risk) I was told of a major disadvantage to using detectability: They often encountered hazards that were in fact undetectable. For purposes of this example, we will look at a shock hazard presented by an unearthed piece of metal on the outside of the device with insulated wiring behind it (carrying a hazardous voltage). We will say that the severity scale used is 1 to 10, with 10 being death. The likelihood scale is the same, with 10 being a certainty of occurrence (probability = 1). Finally, detectability will be assigned a scale of 1 to 4, with 1 being completely detectable and 4 being undetectable. The potential severity of the electric shock in our example is a 10, because the voltage could result in fibrillation. However, because robust insulation is used (double insulation as defined in IEC 60601-1), the likelihood is extremely low, so we will give the likelihood a 1. But if the insulation is broken and the unearthed metal is energized, there is no way to detect the condition until someone touches it and is injured. Therefore detectability is set at 4. The resulting RPN (10 ¥ 1 ¥ 4) is 40.Unfortunately, the threshold number for mitigation is 30.

This means that mitigating action must be taken, even though we have already established that the likelihood is so low that no action should be required. And if detectability had not been included in the calculation, no action would have been required. When we suggested eliminating detectability from the equation, the designers were relieved.For organizations with cultural resistance to eliminating detectability, there are alternative ways to address concerns about detectability while allowing it to be used in calculating the RPN.

The first way is to require that the assumptions behind the value assigned to detectability be documented in writing. The assumptions are then referenced adjacent to the detectability value. To save time, it is reasonable to require the documentation only in those cases where the value assigned to detectability reduces or eliminates the need to further mitigate the risk.The second way is to combine detectability and probability into a single number. The effect of detectability on risk levels is to reduce the likelihood that harm will occur. Therefore, it makes some sense to simply combine the two. This was the approach ultimately taken by the manufacturer I mentioned earlier. We included the concept of detection in the scale for likelihood, resulting in a scale of 1 to 40 for the numbers used in the example.To acknowledge the role of presence of mind in detection, the impact of detection on the likelihood value was made variable. In short, detection is not used at the lowest likelihood values. The reasoning is that users of the equipment will be unfamiliar with infrequent events and therefore unlikely to remember what action to take. They may well be confused enough that even if they did remember, they may not act on it for lack of presence of mind. As the likelihood of events increases, detectability may be considered as a factor in adjusting the assigned likelihood value. In this case, detectability will be a significant factor for events likely to occur frequently.

Effectively, this approach puts detectability onto a sliding scale relative to likelihood.ConclusionThere is nothing inappropriate about factoring the detectability of an event that could result in harm into the estimation of risk associated with the hazard. In fact, detectability can be a significant factor as long as the three cardinal factors of detectability are considered and documented: • Is there enough time to react after detection? • Is information provided to the user to indicate specific actions and their sequence to avoid the harm? • Will the user have the presence of mind to remember what is to be done and take action?If these factors are considered each time detectability is used and the results of those considerations are documented, compliance with the intent of ISO 14971 is assured.

Thus, should the risk analysis ever become part of litigation, there should be no embarrassing moments for those involved in doing the analysis in explaining it on the witness stand.
Copyright ©2004 Medical Device & Diagnostic Industry

http://www.devicelink.com/mddi/archive/04/03/001.html

Guidance on Implementation of ISO 14971 to Meet EU Requirements

BSI Clients have raised questions regarding the transition to ISO 14971 and BSI's expectations. BSI strongly encourages the use of harmonized standards for demonstrating compliance with requirements, regulatory and voluntary. Manufacturers are reminded that risk analysis for devices is required by the European Directives and ISO 13485:1996 and that risk management is a requirement of ISO 13485:2003.

The Requirements:
The Medical Devices Directives essential requirements 1 & 6 require manufacturers to define acceptable risks and essential requirement 2 requires manufacturers to eliminate and/or reduce risks wherever possible and warn, by alarms or information, of any residual risks.
The manufacturer is required by the Directives to include the results of the risk analysis within their technical documentation. The risk analysis should address all hazards known or reasonably foreseeable for the particular product types and technologies involved, together with the likelihood and consequences of occurrence and measures taken to reduce the resulting risks to acceptable levels. This should address all relevant risks. For example, in the case of devices incorporating e.g. a medicinal substance or materials of animal origin, or natural rubber latex, the risk analysis should include the additional risks and benefits associated with incorporation of such substances. The results must demonstrate that an appropriate risk analysis has been performed and provide a conclusion, with appropriate evidence, that the remaining risks are acceptable when weighed against the intended benefits to the patient. The results of the risk analysis should be reviewed and approved by the manufacturer. There are a number of published techniques for performing a risk analysis. It is recommended that the risk analysis performed in connection with an EU Directive conformity assessment should follow the appropriate European harmonized standard.

The routes to conformity with the Directives, as set out in their Annexes, require manufacturers to have technical documentation that includes the results of a risk analysis. ISO 13485:1996 requires that throughout the design process, the supplier shall evaluate the need for risk analysis and maintain records of any risk analyses performed. Under ISO 13485:2003, the manufacturer is required to establish documented requirements for risk management throughout product realization and to maintain records arising from risk management.

A note in ISO 13485:2003 refers to ISO 14971 for guidance related to risk management.
From April 2004 EN 1441 will be considered a withdrawn standard and ISO 14971 will be the harmonized standard for risk assessment of medical devices under the medical devices directives and referred to in ISO 13485:2003.

Harmonized standards are not mandatory but, Notified Bodies will expect to see manufacturers conducting risk analysis for devices under the Directives and risk management is required by the new quality assurance standard. As the harmonized standard, ISO 14971 is the model that represents current "state of the art" thinking that Notified Bodies will be expecting manufacturers to use as a basis for risk management.

For manufacturers of devices currently on the market with CE marking, this does not mean that all risk assessments have to be immediately updated and changed. As with any new standard, there needs to be a proportional transition plan to move to meet the changed requirements.

Notified Bodies expect to see a risk analysis in place for all current devices and expect manufacturers to have implemented or be implementing risk management throughout product realization. There are many factors that will influence the manufacturers priorities, including the relevancy and appropriateness of the existing risk analysis (whether to EN 1441 or not), the quality of available post market surveillance data, plans to review / make changes to existing device designs, plans to validate existing devices / designs, and the plans to implement risk management.

ISO 14971 provides a model for risk management and accepted tools for conducting risk assessment. It is for manufacturers to review the standard and determine how / whether to apply the standard in full or in part and justify decisions to deviate from what is recognized as the current EU harmonized standard. Whether or not ISO 14971 is implemented, Notified Bodies will expect manufacturers to be conducting risk management and will expect to see evidence of appropriate risk assessment for all devices within the manufacturer's technical documentation.

NOTE: This email is provided by BSI as a BSI opinion. It is intended to be helpful in assisting manufacturers in making appropriate considerations in addressing the relevant requirements. This is not a substitute for manufacturers fulfilling their responsibility for taking appropriate legal advice to ensure that they are always in full compliance with the regulations.
In an upcoming E-mail Update, we will be providing information on our exclusive Webinars. Topics include an overview of CMDCAS and an overview of ISO 14971. If you would like more information immediately, please contact inquiry.msamericas@bsi-global.com

Paul Brooks
BSI
http://www.bsiamericas.com/MedicalDevices/Updates/030404.xalter



Medical devices - Application of risk management to medical devices
ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.


PDF]
ISO 14971 Gap Analysis Checklist
File Format: PDF/Adobe Acrobat - View as HTMLISO 14971 Gap Analysis Checklist. Clause Title. Item. Comments/Questions. 3.2. Risk Management. process. Proceduredescribing the risk management process ...www.ul.com/hitech/iso14971/ISO14971GapAnalysisChecklist.pdf - Similar pages - Note this

UNAPPROVED MEDICAL DEVICES
Wednesday, February 21, 2007 08:00 IST P A Francis

Medical devices are critical implants increasingly used in patients' bodies for treating various disease conditions world over including in India. And the use of drug eluting stents (DES) is most widespread as they are considered necessary for the survival of thousands of cardiac patients. DES combines a drug with a medical device to provide more effective care for patients with heart disease. The US FDA approved the use of DES based on a review of laboratory and animal tests and two clinical studies of safety and effectiveness as well as a review of its manufacturing procedures. DES slowly releases the drug and has shown in clinical studies in the US to significantly reduce the rate of re-blockage which occurs in as many as 15 to 30 per cent of patients who receive a bare metal stent.
http://www.pharmabiz.com/article/detnews.asp?articleid=37671&sectionid=47

Guidance documents

ISO 13485 Requirements
http://praxiom.com/iso-13485.htm

Guidance on ISO 14971 Risk Assessment
http://www.bsiamericas.com/MedicalDevices/Updates/030404.xalter

http://www.jelincoln.com/14971.phtml


Medical Device Regulations in India
http://www.bsiamericas.com/MedicalDevices/Updates/121505.xalter


For Consultancy, contact www.tqmc.org

Medical Devices Directory

http://www.bsi-global.com/MedicalDevices/CEmarking/index.xalter


Classification of Medical Devices
http://www.ce-marking.org/Guidelines-for-Classification-of-Medical-Devices.html

Some Non-active medical devices
skeleton implants
functional implants
single use medical products
reusable medical instruments
surgical instruments
wound dressing and bandages
sutures and surgical clips
instruments and equipment fordentistry
dental materials
dental implants
MDO, Annex 3
Ref: 93/42/EEC, annex II, V, VI- Full quality assurance system- Production quality assurance- Product quality assurance

Some Active medical devices
patient storage and transport equipment
dental equipment
diagnostic devices withoutIonising radiation
measuring equipment asaccessories to medicaldevices
prosthesis and equipment for rehabilitation

ISO 13485 and Dental Implants

dental implants
http://www.laxmidental.com/site.php/pfm.htmdental
crowns, cosmetic dentistry
http://www.tkanda.com/kellydentallab.pdf

all u wanted to know about dental implants http://apps5.oingo.com/apps/domainpark/domainpark.cgi?client=netw8744&s=ULTIMADENTAL.COM


Industry terms explained ..
Industry Terms: Medical Devices
CBTL: CB Testing Laboratory
CMDCAS: Canadian Medical Devices Conformity Assessment System

EMC: Electro-magnetic Compatibility
FDA: Food and Drug Administration

IEC: International Electrotechnical Commission
IECEE: IEC System for Conformity Testing and Certification of Electrical Equipment

IEEE: Institute of Electrical and Electronics Engineers
ISO: International Organization for Standardization

IVDD: In Vitro Diagnostic Directive (Directive 98/79/EC)MDD: Medical Device Directive (Directive 93/42/EEC)

NCB: National Certification Body
NRTL: Nationally Recognized Testing Laboratory


Medical Devices ...
Understanding the New EMC Standard for Medical Devices: What Manufacturers Need to Know Now http://www.devicelink.com/mddi/archive/02/08/003.html

ISO 13485 in simple terms, a summary
http://praxiom.com/iso-13485.htm


tired of reading all this heavy stuff?
go here for some laffs on consultants http://managementconsultant-tqmcintl.blogspot.com/ ....

tqmcintl Industry: Consulting Location: Mumbai : Maharashtra : India ISO 9001 QMS ISO 13485 ENGINEERING NEWS UP-DATE ISO 22000 Explosion protected not Flame proof WTO CRO ISO TQM Information Security Management and ISO 27001 Software QA ISO 17025 CE Marking ISO 14000 GMP requirements SA 8000 ISO 20000 COBIT COPC STANDARD Lean Six Siqma ISO 17021 5 S Energy Manager boiler and pressure vessels eSCM useful Reference tables ERP Management Consultant hotels and restaurants Fami QS Food borne diseases and infections storing food grains Halal and Kosher wet tissues ready made garmets marking Inspection, measuring and testing equipment