Risk Assessment and Post-Market Programs

How do the medical device industry and the FDA prevent risks to the end user once the product is marketed? There is no simple answer to this question. Post-market vigilance in terms of risk assessment involves complex issues. These issues involve a cost/benefit analysis in terms of a “best approach” to post-market co-vigilence. The FDA has specified programs in terms of post-market risk prevention. For example, the 1976 Medical Device Amendments, the 1990 Safe Medical Device Act and 1992 Medical Device Amendments have served as milestones in medical device legislation, resulting in a system in which manufacturers must track the device from manufacture through distribution to assure accurate tracing in the event of problems. The regulations for tracking are found in 21 CFR Part 821.

The Food and Drug Administration Modernization Act of 1997 went even further in terms of legislating a medical device surveillance network for adverse events. The system, called MedSuN, is aimed at improving the protection of the health and safety of patients, users, and others involved with medical devices. The Medical Device User Fee Modernization Act of 2002 (MDUFMA) went still further on the subject of post-market surveillance in terms of Congressional appropriations and accountability.

Key Web Site

www.gov/cdrh/index.html

The FDA MedWatch is a comprehensive post-market surveillance program. This large scale monitoring of products involves both voluntary and mandatory reporting. In addition, the FDA publishes safety information summaries on the Internet. Termed “Safety Information Summaries,” the listing includes “Dear Health Professional” letters, Public Health Alerts and FDA Talk Papers. In terms of unlawful sales of medical devices on the Internet, a MedWatch form may be used. However, the FDA Web site contains an online form for reporting non life-threatening and adverse reactions deemed not serious. The Medical Device Reporting (MDR) database maintained by the FDA contains mandatory MDRs from 1984-1996 and voluntary reports since June 1993. The Manufacturer and User Facility Device Experience (MAUDE) database contains voluntary reports since 1993, user facility reports since 1991, and manufacturer reports since August 1996. Online searching is available for these databases.

Health professionals can use the voluntary MedWatch form to report adverse events or problems related to medical products. Mandatory reporting is required for health professionals who work in a hospital or another user facility such as a nursing home, ambulatory surgical facility, outpatient treatment facility or outpatient diagnostic facility. However, physicians' offices are excluded from the user facility definition and are therefore exempt from mandatory reporting requirements, as are dentists, nurses, optometrists and nurse-practitioners. User facilities must report deaths to both the FDA and the manufacturer within 10 days. Serious injuries and/or illnesses must be reported to the manufacturer (or the FDA if the manufacturer is unknown) within 10 days as well. User facilities must file semi-annual reports with the FDA by January 1 and July 1. Manufacturer reporting requirements include reports to the FDA of death, serious injury or malfunction within 30 calendar days. Manufacturers must submit 5-day reports to the FDA for events that necessitate remedial action. Distributors have 10-day reporting requirements, both to the manufacturer and to the FDA, for death, serious injuries and/or illnesses and malfunctions. Specific reporting requirements are detailed under 21 CFR ' 803 and 807. FDA Form 3500A is used for mandatory reporting. Form 3500 is used for voluntary reporting. Forms 3500 and 3500A were revised in 2003 to include questions related to the use of reprocessed single-use devices.

Recalls, also known as corrections or removals from the marketplace, are sometimes necessary for public health and safety reasons. Medical device manufacturers and importers have 10 days from the time the firm initiates the recall to file a report with the FDA if the device correction or removal involves a “risk to health.” Recall authority or field corrections for medical devices with serious adverse health consequences or death are specifically authorized under 518(e), 21 U.S.C. ' 360(h) (e)(1) of the FDCA. The accompanying regulations under 21 CFR '' 7.3(g), 806 and 810 apply to recalls or field corrections and removals of a marketed medical device product. Manufacturers and importers are required to file a report with the FDA.

MDUFMA authorized additional funding for post-market surveillance through Congressional appropriations. The FDA is required to submit to Congress by January 10, 2007, studies relating to the effectiveness of post-market surveillance. MDUFMA imparts dual accountability by industry and the FDA.

Medical Device Tracking

Source: http://www-lawjournalnewsletters.iproduction.com/Admin/cgi-bin/udt/www.fda.gov/cdrh%20/devadvice

Manufacturers are required to track certain devices from their manufacture through the distribution chain when they receive an order from the agency to implement a tracking system for a certain type of device. The purpose of device tracking is to ensure that manufacturers of certain devices establish tracking systems that will enable them to promptly locate devices in commercial distribution. Tracking information may be used to facilitate notifications and recalls ordered by the FDA in the case of serious risks to health presented by the devices.

Manufacturers must adopt a method of tracking devices whose failure would be reasonably likely to have serious, adverse health consequences; or which are intended to be implanted in the human body for more than 1 year; or are life-sustaining or life-supporting devices used outside of a device user facility. The regulations implementing the tracking requirements became effective on Aug. 29, 1993 and can be found in 21 CFR Part 821.

The 1998 Modernization Act gives the FDA discretion to order manufacturers of certain types of Class II or Class III devices to initiate a program to track their medical devices down to the patient level. The tracking provision is intended to ensure that manufacturers can expeditiously remove potentially dangerous or defective devices from the market and/or notify patients of significant device problems. Tracking augments the FDA's authority to order mandatory recalls and require notification to health professionals and patients regarding unreasonable risk of substantial harm associated with a device.

Manufacturers of a tracked device must establish a written standard operating procedure that includes a method for tracking the device throughout distribution, and a quality assurance program including audit procedures. Final distributors of these devices will be required to provide manufacturers with patient information.

Device tracking is required for the useful life of the device. The types of devices subject to a tracking order may include any Class II or Class III device: 1) the failure of which would be reasonably likely to have serious adverse health consequences; 2) which is intended to be implanted in the human body for more than 1 year; or 3) which is intended to be a life sustaining or life supporting device used outside a device user facility.

The Modernization Act also allows patients receiving a tracked device to refuse to release, or refuse permission to release, their name, address, social security number, or other identifying information for the purpose of tracking.

Next month's article reviews other key Web sites.

How do the medical device industry and the FDA prevent risks to the end user once the product is marketed? There is no simple answer to this question. Post-market vigilance in terms of risk assessment involves complex issues. These issues involve a cost/benefit analysis in terms of a “best approach” to post-market co-vigilence. The FDA has specified programs in terms of post-market risk prevention. For example, the 1976 Medical Device Amendments, the 1990 Safe Medical Device Act and 1992 Medical Device Amendments have served as milestones in medical device legislation, resulting in a system in which manufacturers must track the device from manufacture through distribution to assure accurate tracing in the event of problems. The regulations for tracking are found in 21 CFR Part 821.

The Food and Drug Administration Modernization Act of 1997 went even further in terms of legislating a medical device surveillance network for adverse events. The system, called MedSuN, is aimed at improving the protection of the health and safety of patients, users, and others involved with medical devices. The Medical Device User Fee Modernization Act of 2002 (MDUFMA) went still further on the subject of post-market surveillance in terms of Congressional appropriations and accountability.

Key Web Site

www.gov/cdrh/index.html

The FDA MedWatch is a comprehensive post-market surveillance program. This large scale monitoring of products involves both voluntary and mandatory reporting. In addition, the FDA publishes safety information summaries on the Internet. Termed “Safety Information Summaries,” the listing includes “Dear Health Professional” letters, Public Health Alerts and FDA Talk Papers. In terms of unlawful sales of medical devices on the Internet, a MedWatch form may be used. However, the FDA Web site contains an online form for reporting non life-threatening and adverse reactions deemed not serious. The Medical Device Reporting (MDR) database maintained by the FDA contains mandatory MDRs from 1984-1996 and voluntary reports since June 1993. The Manufacturer and User Facility Device Experience (MAUDE) database contains voluntary reports since 1993, user facility reports since 1991, and manufacturer reports since August 1996. Online searching is available for these databases.

Health professionals can use the voluntary MedWatch form to report adverse events or problems related to medical products. Mandatory reporting is required for health professionals who work in a hospital or another user facility such as a nursing home, ambulatory surgical facility, outpatient treatment facility or outpatient diagnostic facility. However, physicians' offices are excluded from the user facility definition and are therefore exempt from mandatory reporting requirements, as are dentists, nurses, optometrists and nurse-practitioners. User facilities must report deaths to both the FDA and the manufacturer within 10 days. Serious injuries and/or illnesses must be reported to the manufacturer (or the FDA if the manufacturer is unknown) within 10 days as well. User facilities must file semi-annual reports with the FDA by January 1 and July 1. Manufacturer reporting requirements include reports to the FDA of death, serious injury or malfunction within 30 calendar days. Manufacturers must submit 5-day reports to the FDA for events that necessitate remedial action. Distributors have 10-day reporting requirements, both to the manufacturer and to the FDA, for death, serious injuries and/or illnesses and malfunctions. Specific reporting requirements are detailed under 21 CFR ' 803 and 807. FDA Form 3500A is used for mandatory reporting. Form 3500 is used for voluntary reporting. Forms 3500 and 3500A were revised in 2003 to include questions related to the use of reprocessed single-use devices.

Recalls, also known as corrections or removals from the marketplace, are sometimes necessary for public health and safety reasons. Medical device manufacturers and importers have 10 days from the time the firm initiates the recall to file a report with the FDA if the device correction or removal involves a “risk to health.” Recall authority or field corrections for medical devices with serious adverse health consequences or death are specifically authorized under 518(e), 21 U.S.C. ' 360(h) (e)(1) of the FDCA. The accompanying regulations under 21 CFR '' 7.3(g), 806 and 810 apply to recalls or field corrections and removals of a marketed medical device product. Manufacturers and importers are required to file a report with the FDA.

MDUFMA authorized additional funding for post-market surveillance through Congressional appropriations. The FDA is required to submit to Congress by January 10, 2007, studies relating to the effectiveness of post-market surveillance. MDUFMA imparts dual accountability by industry and the FDA.

Medical Device Tracking

Source: http://www-lawjournalnewsletters.iproduction.com/Admin/cgi-bin/udt/www.fda.gov/cdrh%20/devadvice

Manufacturers are required to track certain devices from their manufacture through the distribution chain when they receive an order from the agency to implement a tracking system for a certain type of device. The purpose of device tracking is to ensure that manufacturers of certain devices establish tracking systems that will enable them to promptly locate devices in commercial distribution. Tracking information may be used to facilitate notifications and recalls ordered by the FDA in the case of serious risks to health presented by the devices.

Manufacturers must adopt a method of tracking devices whose failure would be reasonably likely to have serious, adverse health consequences; or which are intended to be implanted in the human body for more than 1 year; or are life-sustaining or life-supporting devices used outside of a device user facility. The regulations implementing the tracking requirements became effective on Aug. 29, 1993 and can be found in 21 CFR Part 821.

The 1998 Modernization Act gives the FDA discretion to order manufacturers of certain types of Class II or Class III devices to initiate a program to track their medical devices down to the patient level. The tracking provision is intended to ensure that manufacturers can expeditiously remove potentially dangerous or defective devices from the market and/or notify patients of significant device problems. Tracking augments the FDA's authority to order mandatory recalls and require notification to health professionals and patients regarding unreasonable risk of substantial harm associated with a device.

Manufacturers of a tracked device must establish a written standard operating procedure that includes a method for tracking the device throughout distribution, and a quality assurance program including audit procedures. Final distributors of these devices will be required to provide manufacturers with patient information.

Device tracking is required for the useful life of the device. The types of devices subject to a tracking order may include any Class II or Class III device: 1) the failure of which would be reasonably likely to have serious adverse health consequences; 2) which is intended to be implanted in the human body for more than 1 year; or 3) which is intended to be a life sustaining or life supporting device used outside a device user facility.

The Modernization Act also allows patients receiving a tracked device to refuse to release, or refuse permission to release, their name, address, social security number, or other identifying information for the purpose of tracking.

Next month's article reviews other key Web sites.