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U.S. Department of Health and Human Services

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Year 2000 date and Medical Devices


Statement of

Thomas Shope, Ph.D.
Special Assistant to the Director
Office of Science and Technology
Center for Devices and Radiological Health
Food and Drug Administration
Department of Health and Human Services

before

the Senate Committee on Veterans' Affairs

April 20, 1999

INTRODUCTION

Good afternoon, my name is Dr. Thomas Shope. I am the Special Assistant to the Director, Office of Science and Technology, Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA or the Agency). I am pleased to be here today to provide information on the Year 2000 date issue as it relates to medical devices. FDA has taken a number of constructive actions to work with manufacturers and provide information to users about medical device Year 2000 compliance.

FDA promotes and protects public health by helping to ensure that medical devices are safe and effective. The Center for Devices and Radiological Health (CDRH) is the component of FDA that has responsibility for regulating medical devices. CDRH helps carry out the Agency's mission by evaluating new products to determine if they can be marketed; assuring quality control in manufacture through inspection and compliance activities; monitoring adverse events in already marketed products; and taking action, when necessary, to prevent injury or death. A device manufacturer must comply with all applicable requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act, including, but not limited to, establishment registration and device listing, premarket review, use of good manufacturing practices, and reporting adverse events.

WHAT IS A MEDICAL DEVICE?

According to the definition in the FD&C Act, a "device" is:
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body and which does not achieve its primary intended purposes through chemical action and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

As this definition suggests, many different types of products are properly regulated as medical devices. Medical devices include over 100,000 products in more than 1,700 categories. The products regulated by FDA as medical devices range from simple everyday articles, such as thermometers, tongue depressors, and heating pads, to the more complex devices, such as pacemakers, intrauterine devices, diagnostic imaging devices, and kidney dialysis machines.

Any computer software which meets the legal definition of a medical device is within the scope of the law and must comply with applicable FDA regulations. Medical devices which use computers or software can take several forms including: products containing embedded microchips which are part, or components, of the devices; devices employing non-embedded software which is used with, or to control, the devices or to record data from the devices; or individual software programs that use or process patient data to reach a diagnosis, aid in therapy, or track donors and products.

Embedded Computer Software

Computer software frequently is embedded as a "component" of devices, i.e., software contained on a microchip to control device operation. Examples of such common, important devices are pacemakers, infusion pumps and ventilators. The majority of these products will not be affected by the Year 2000 problem since almost none of them require knowledge of the current date to operate safely and effectively. For example, pacemakers do not use the current date in their operation.

Non-embedded Computer Software

Non-embedded software is intended to be operated on a separate computer, often a personal computer or work station. Such software devices may be used to control or enhance the operation of another device or devices and, further, may use the two-digit year format. It is possible that non-embedded software devices may rely on date information for proper operation and might be affected by the Year 2000 date change if not designed appropriately.

An example of non-embedded software is a computer program used to plan radiation therapy treatments delivered using radioactive isotopes as the radiation source (teletherapy or brachytherapy). These treatments possibly could be affected if the computer program that calculates the radiation dose parameters uses only a two-digit year representation. The calculation of the length of time since the source was last calibrated could be in error and thus lead to an incorrect treatment prescription.

Other examples of uses of non-embedded software devices include: conversion of pacemaker telemetry data; conversion, transmission, or storage of medical images; automated analysis and interpretation of ECG data; programming or control of rate response for a cardiac pacemaker; perfusion calculations for cardiopulmonary bypass; and calculation of bone fracture risk from bone densitometry data. Since there is a chance that the two-digit format may affect the performance of these software devices, FDA believes that the Year 2000 risk requires that healthcare facilities take steps to identify and mitigate such problems through proactively working with manufacturers.

FDA EFFORTS TO ADDRESS YEAR 2000 ISSUE

Year 2000 Database

In order to give the general public, government agencies, and the healthcare and research communities one comprehensive source of publicly available information on the Year 2000 compliance status of biomedical equipment, the Federal Year 2000 Biomedical Equipment Clearinghouse database was established in March 1998 and is available to facilities via the World Wide Web. The Biomedical Equipment Clearinghouse provides Year 2000 product status information in five categories including: products that are Year 2000 compliant; products that do not use a date; products that have a date related problem; products whose status is provided on the manufacturer's website; and identification of manufacturers for whom no information is available (nonrespondents to FDA requests).

The Biomedical Equipment Clearinghouse database is being maintained by FDA on its World Wide Web site at the request of the Interagency Biomedical Equipment Working Group. This Working Group was organized early in 1997 under the Subcommittee on the Year 2000 of the Chief Information Officers' Councils. The database can be found at www.accessdata.fda.gov/scripts/cdrh/year2000/cdrh/yr2000/help/y2k-search-helpme.html. Manufacturers also may submit a World Wide Web link to their own website, if they so choose, where the requested information is provided to the public.

FDA and the Department of Veterans Affairs (DVA) have worked in partnership to develop a single data clearinghouse for biomedical equipment Year 2000 status information. DVA, as a purchaser of medical devices, collected information from its vendors as to the compliance status of the medical devices used in its facilities. This data, along with data from the Department of Defense, has been provided to FDA and following confirmation by FDA, has been added to the clearinghouse database. Both FDA and DVA are working with private sector associates, mostly professional associations and organizations such as the American Medical Association, the American Hospital Association, the Joint Commission on Accreditation of Healthcare Organizations, the Health Industry Manufacturers Association (HIMA), the Medical Device Manufacturers Association (MDMA), and the National Electrical Manufacturers Association (NEMA) that provide advice and assistance as requested.

RECENT LETTERS TO MANUFACTURES

March 29, 1999 Letter on Year 2000 Compliant Products

Biomedical equipment users have expressed the need for specific information on all Year 2000 vulnerable products that are compliant and have urged the establishment of a single, comprehensive source for this information. On March 29, 1999, FDA issued a letter requesting that medical device manufacturers submit a complete list of individual product models that are Year 2000 compliant to the FDA-operated Federal Year 2000 Biomedical Equipment Clearinghouse. Many biomedical equipment users have told FDA that a single statement that all of a manufacturer's products are Year 2000 compliant does not meet their need to have affirmatively identified specific compliant equipment. Once information on compliant products is received from medical device manufacturers it will be made available, with improved search tools, as part of the Biomedical Equipment Clearinghouse.

This database of Year 2000 compliant products is intended to provide information on products that biomedical equipment users might consider to be vulnerable to date-related problems because these products could utilize software, a computer or microprocessor control. Accurate Year 2000 status information on these products is critical to these users as they evaluate their product inventory and plan any needed remedial actions.

March 29, 1999 Letter on Interim Inspectional Policy Regarding Y2K Issues.

On March 29, 1999, the Director, Division of Emergency and Investigational Operations, Office of Regulatory Affairs (ORA), issued a memorandum to the FDA field instructing investigators to raise the awareness of potential Year 2000 problems to firms during FDA inspections. In this letter, ORA expanded the Year 2000 activities to include asking questions regarding what the firm has done to assure themselves that their computer controlled/date sensitive products, manufacturing processes and distribution systems are Year 2000 compliant, and to include information on this subject in their Establishment Inspection Reports when relevant. In addition, if the investigators encounter serious problems or concerns, or find the firm is not taking appropriate steps to avoid serious Year 2000 problems, this information must be reported to appropriate District and Center personnel.

January 13 and March 3, 1999 Letters on Non-Compliant Products

On January 13, 1999, FDA issued a letter to device manufacturers announcing FDA's intent to expand the product information maintained on the FDA-operated Federal Year 2000 Biomedical Equipment Clearinghouse and requested the continued cooperation of biomedical equipment manufacturers in this effort. The letter requesting this information was issued on March 3, 1999. In this letter FDA indicated that in some of the manufacturer responses to the earlier requests the information on the FDA website was not sufficiently detailed to adequately assist facilities in assessing the impact of non-compliant products. FDA requested that biomedical equipment manufacturers carefully review the Year 2000 status information that they have provided or intended to submit, and, where necessary, provide more specific information on non-compliant products.

PREVIOUS LETTERS TO MANUFACTURERS

June 25, 1997 Notification to Manufacturers

In light of the review of the impact of the Year 2000 on some medical device computer systems and software applications, FDA has been actively alerting the medical device industry through a series of letters to medical device manufacturers for approximately two years. The first alert letter was sent on June 5, 1997, to all CDRH registered medical device manufacturers (8,322 domestic and 5,085 foreign) indicating that manufacturers needed to address this issue and review both embedded and non-embedded software products. FDA reminded manufacturers that, in addition to potentially affecting the functioning of some devices, the two-digit year format also could affect computer-controlled design, production, or quality control processes. FDA requested that manufacturers review the software used in medical devices to determine if there is any risk.

Device manufacturers who identify products that have a date-related problem are required to take appropriate action to remedy the problem. An example of appropriate action in some instances would be notification to device purchasers so that their devices can be appropriately modified before the year 2000.

January 21, 1998 Request for Information

In a letter dated January 21, 1998, Department of Health and Human Services (DHHS) Deputy Secretary Kevin Thurm asked approximately 16,000 medical device and biomedical equipment manufacturers to voluntarily provide information on the Year 2000 compliance status of their products. Included in the mailing were all FDA registered manufacturers without respect to the specific kind of device produced, even though FDA estimates that only approximately 2,000 manufacturers make products listed in the categories which include computerized products potentially sensitive to Year 2000 problems. Approximately 3,000 of the manufacturers included in the mailing are not regulated by FDA; for example, scientific instrument manufacturers. The letter detailed instructions on ways to submit the data requested and explained that to be Year 2000 compliant products must function as intended regardless of the date. Manufacturers also were given the opportunity to certify that their products are not affected, if that is the case, or certify that none of their products use computers or date information.

Targeted Follow-up with Manufacturers of Computerized Devices

On June 29, 1998, FDA issued a targeted, follow-up letter to specific manufacturers of computerized devices urging them to respond to our January 21 request to submit product data. This list was derived from the names of those firms which have registered as manufacturers of devices in the categories where Year 2000 vulnerability is likely.

Then on September 2, 1998, FDA issued a follow-up to the June 29, 1998 letter, directed to the manufacturers of potentially computerized devices who had not responded to the previous requests to specific manufacturers for information on the Year 2000 status of their devices. In the letter, FDA requested that the manufacturers respond to FDA within two weeks with the Year 2000 compliance status of their devices, or at least indicate that a complete response was being developed.

On August 14, 1998, Dr. Bruce Burlington, then Director, CDRH, and on September 2, 1998, Dr. Friedman, then Acting Commissioner of the Food and Drug Administration, issued letters to HIMA requesting that HIMA take aggressive and immediate actions to encourage and assist medical device equipment manufacturers in providing information to FDA about the Year 2000 compliance status of their products.

In late September 1998, FDA decided that it would be useful to provide an indication of whether a particular manufacturer of computerized devices potentially susceptible to Year 2000 concerns has or has not provided information on Year 2000 compliance. To that end, FDA posted on the website those manufacturers of selected product categories which are likely to include vulnerable products that had not provided a response to FDA's inquiries. FDA will continue to work with manufacturers to obtain this data and report to Congress on the status of these Year 2000 requests.

ADDITIONAL OUTREACH AND GUIDANCE

In addition to the website and the letters, CDRH has been conducting extensive outreach to the device industry and to other consumers on this issue. CDRH's Division of Small Manufacturers Assistance provided an article entitled "Biomedical Equipment Manufacturers Urged to Share Year 2000 Information" to 12 medical device trade press contacts and to 65 U.S. and 35 foreign medical device trade associations in order to facilitate the dissemination of information to their members regarding the website database and to encourage the posting of data by manufacturers. The website and database were mentioned in the FDA Column of the June 3, 1998, Journal of the American Medical Association and in an article in FDA's Medical Bulletin that was sent to approximately 700,000 healthcare practitioners this past summer.

In the Spring of 1998, CDRH developed a Guidance Document on FDA's expectations of medical device manufacturers concerning the Year 2000 date problem. The guidance is available on the FDA website. The guidance was published in the Federal Register on June 24 for greater dissemination. The guidance re-emphasizes the provisions in existing regulations that require manufacturers to address any date problems which may present a significant risk to public health.

FDA also developed an article addressed to the users of radiation treatment planning systems regarding the need to assess these systems. The article was published in the newsletters of relevant professional associations. Staff of CDRH have participated in numerous conferences and video teleconferences devoted to the Year 2000 problem in healthcare in order to communicate with healthcare facilities regarding the Biomedical Equipment Clearinghouse and the need to address the Year 2000 issue with devices.

Although most devices are regulated by CDRH, FDA's Center for Biologics Evaluation and Research (CBER) regulates blood bank software, which is of particular concern for potential Year 2000 problems. In January 1998, CBER posted guidance for industry entitled "Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products" on the FDA website. The guidance provided specific recommendations to assist industry in its evaluation of computer and software systems used in the manufacture of blood products and to assist in evaluating the impact of potential Year 2000 problems.

WHAT IS THE DATA TELLING US THUS FAR?

As indicated above, FDA believes that approximately 2,000 manufacturers may produce equipment that may be affected by the Year 2000 problem. As of March 30, 1999, FDA has entered a total of 4,305 responses from the 16,000 manufacturers originally contacted. The data from all of these manufacturers who have responded have been entered into the database on the FDA website. These numbers change daily as data are entered, corrected or even removed at the request of manufacturers. Of the 4,305 manufacturers who have responded, 3,153 have reported that their products do not use date-related data or are compliant. Six hundred seventy-three manufacturers have reported one or more products with date-related problems. Four hundred manufacturers have provided World Wide Web links (URLs) to data provided on their own manufacturer-operated websites. There are a few submissions in which the data were incomplete or unclear in some manner. FDA is communicating with these manufacturers to obtain clarification before entering the information into the database. FDA will continue to post additional responses as they are received.

In reviewing the data received from the manufacturers so far, FDA sees no indication of widespread problems which will place patients at risk, if and only if the solutions being developed and offered by manufacturers are implemented as they have indicated. Of course, FDA can not make assurances about manufacturers who have not reported product status. FDA believes that the information received to date confirms our original expectation that the Year 2000 problems with medical devices will not be significant or widespread if facilities take appropriate actions to address this issue. There will be specific problems which need correction; however, the current assessment is that they are much more likely to disrupt patient care rather than be of direct danger to patients. Nonetheless, such disruption could be serious and the potential for it to happen certainly merits rigorous attention to the problem.

One indication of FDA's belief that Year 2000 problems are not significant or widespread has been borne out by DVA in their testimony and responses to questions before the House Committee on Veterans' Affairs, Subcommittee on Oversight and Investigations. The DVA indicated that they had received answers from manufacturers on all of the critical care device components and they expected to be ready for Year 2000.

Legal Authority

FDA's Quality System Regulation (QSR) (21 CFR 820) places on manufacturers an ongoing responsibility to take corrective and preventive actions that may include recall for problems with current production. Devices automated with computer software are subject to all requirements of Title 21, Code of Federal Regulations (CFR), Part 820, unless expressly exempted by regulation. The regulation puts in place a system whereby manufacturers must incorporate a set of procedures and processes in their design and manufacturing activities to assure that products being manufactured are safe, effective finished products. The QSR regulation does not require the submission of any reports to FDA, however, it does require firms to maintain internal procedures and documentation of corrective and preventive actions (21 CFR 820.100).

The Removals and Corrections Regulation (21 CFR 806) requires manufacturers to submit reports to FDA. In order to be reportable, a Year 2000 problem must pose a "risk to health" as defined in section 806.2(j). Many of the problems reported in the Biomedical Equipment database or on manufacturers' Year 2000 Web pages concern date recording or display problems that are readily apparent to the user and are unlikely to pose a risk to health. In the Year 2000 context, a decision to correct a problem may occur long before the correction itself is actually announced to customers. Once the decision for action is made, however, and if the action is to correct a risk to health, then the firm has 10 working days to notify the Agency through a report of correction or removal. A firm that previously notified FDA about a removal or correction through a Medical Device Report (under 21 CFR 803) does not have to submit an additional report under 21 CFR 806.

FDA will continue to emphasize to manufacturers the importance of reporting on the Year 2000 compliance status of their products and take additional steps to boost the response rate. Healthcare facilities need information from all manufacturers to properly prepare and plan for any actions they need to take to assure their devices needing corrections or updates receive these well before the Year 2000.

CONCLUSION

Thank you for the opportunity to update you about the issue of the Year 2000 and medical devices. Let me assure you that FDA takes this issue very seriously and is committed to a scientifically sound regulatory environment which will help provide Americans with the best medical care. In the public interest, FDA's commitment must be coupled with a reciprocal industry commitment: that medical device firms will meet high standards in the design, manufacture, and evaluation of their products. FDA recognizes that this can only be attained through a collaborative effort -- between government and industry -- grounded in mutual respect and responsibility. The protections afforded the American consumer, and the benefits provided the medical device industry, cannot be underestimated.

FDA will continue to provide any assistance it can to address specific problems that any other agency, such as the DVA, identifies. FDA also is working with other agencies, patient groups, medical associations and industry to optimize data collection and information sharing. FDA will continue urging manufacturers to ensure the continued safety and effectiveness of their medical devices by ensuring that their devices can perform date recording and computations that will be unaffected by the Year 2000 date change.

Thank you for the opportunity to testify.