STATEMENT BY

MICHAEL A. FRIEDMAN, M.D.

ACTING COMMISSIONER

FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

BEFORE THE

SPECIAL COMMITTEE ON THE YEAR 2000 TECHNOLOGY PROBLEM

U.S. SENATE

JULY 23, 1998

INTRODUCTION

WHAT IS A MEDICAL DEVICE?

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, fetal stents, and kidney dialysis machines.

FDA is responsible for promoting and protecting public health by helping to ensure that medical devices are safe and effective. FDA carries out its mission by evaluating new products before they are marketed; assuring quality control in manufacture through inspection and compliance activities; and monitoring adverse events in already marketed products, taking action, when necessary, to prevent injury or death. A device manufacturer must comply with all the requirements of the FD&C Act, including: establishment registration and device listing, premarket review, use of good manufacturing practices (GMPs), reporting adverse events, and others.

As diverse as medical devices are, so are the range and complexity of problems which can arise from their use. These problems include mechanical failure, faulty design, poor manufacturing quality, adverse effects of materials implanted in the body, improper maintenance/specifications, user error, compromised sterility/shelf life, and electromagnetic interference among devices.

COMPUTER SOFTWARE

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

Embedded 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 would not be impacted 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 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 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 the current date for proper operation and might be affected by the Year 2000 date change.

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 non-embedded software devices include: conversion of pacemaker telemetry data; conversion, transmission, or storage of medical images; off-line analysis of ECG data; digital analysis and graphical presentation of ECG data; calculation 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, we believe that the Year 2000 risk needs to be mitigated through proactively working with manufacturers.

POTENTIAL IMPACT OF THE YEAR 2000

Letter to Medical Device Manufacturers

In light of the review of the impact of the Year 2000 on some medical device computer systems and software applications, FDA sent a letter dated June 25, 1997, to 13,407 medical device manufacturers (8,322 domestic and 5,085 foreign) to ensure that manufacturers address this issue and review both embedded and non-embedded software products. We 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. We requested that the manufacturers review the software used to determine if there is any risk.

FDA recommended specific actions to ensure the continued safety and effectiveness of these devices. For currently manufactured medical devices, manufacturers should conduct hazard and safety analyses to determine whether device performance could be affected by the Year 2000 date change. If these analyses show that device safety or effectiveness could be affected, then appropriate steps should be taken to correct current production and to assist customers who have purchased such devices. For computer-controlled design, production, and quality control processes, manufacturers should assure that two-digit date formats or computations do not cause problems beginning January 1, 2000.

In our letter to industry, we reminded manufacturers that under the GMP regulation and the current Quality System Regulation (which incorporates a set of checks and balances in manufacturers' design processes to assure a safe, effective finished product), they must investigate and correct problems with medical devices. This includes devices which fail to operate according to their specifications because of inaccurate date recording and/or calculations.

We expect manufacturers who identify products which have a date-related problem which can pose a significant risk to the patient to take the necessary action to remedy the problem. This might include notification of device purchasers so that their device can be appropriately modified before the Year 2000. Manufacturers who discover a significant risk presented by a date problem are required to notify FDA and take appropriate action. Again, we do not anticipate any significant problems with individual medical devices provided appropriate corrections are made, however, we want to ensure the continued safety and effectiveness of these devices.

For future medical device premarket submissions, manufacturers of devices whose safe operation could be affected by the Year 2000 date change will be required to demonstrate that the products can perform date recording and computations properly, i.e., Year 2000 compliant.

DATA COLLECTION AND ESTABLISHMENT OF THE WORLD WIDE WEB SITE

In a letter dated January 21, 1998, Department of Health and Human Services (DHHS) Deputy Secretary Kevin Thurm, asked approximately 16,000 biomedical equipment manufacturers to voluntarily provide information on the Year 2000 compliance status of their products. Included in the mailing were all registered manufacturers irrespective of the specific kind of device produced, even though only about 2,700 manufacturers are believed to produce computerized products which might be 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 gave instructions on ways to submit the data 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.

The product database was established and 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 under the Chief Information Officer's Councils' Subcommittee on the Year 2000. The web site is intended to give the general public, government agencies, and the healthcare and research communities one comprehensive source of information about this issue. The Web site is found at: http://www.fda.gov/cdrh/yr2000/year2000.html. Manufacturers also may establish a World Wide Web link to their own web site where the requested information is provided to the public, if they so choose.

So far, the overall response from manufacturers has been incomplete. As indicated above, FDA believe that approximately 2,700 manufacturers may produce equipment that may be impacted by the Year 2000 problem. We believe approximately 500 of that 2,700 have responded. To date, approximately 10 percent of the total 16,000 manufacturers (many of which do not produce medical devices which could be affected by a Year 2000 problem) contacted through the January 21 letter have provided the information requested. We know, however, that there are companies still in the process of assessing their devices, and we requested that complete information be submitted. While manufacturers may report that specific products have not been assessed, we expect that some companies prefer to complete assessment before reporting.

FDA's Center for Devices and Radiological Health's (CDRH) Division of Small Manufacturers Assistance recently 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 web site database and to encourage the posting of data by manufacturers.

In addition, the web site and database are 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 summer.

In addition to the informational efforts, FDA issued a targeted, follow up letter to about 2,732 specific manufacturers of computerized devices urging that they respond to the January 21 request to submit product data. This letter was sent out on June 29, 1998, and is another request for voluntary submission of data. FDA will continue to work with manufacturers to obtain product data.

WHAT IS THE DATA TELLING US THUS FAR?

As of July 16, FDA has received 1,790 responses from manufacturers. Of these, data from 1,782 manufacturers had been entered into the database served on the FDA web site. These numbers change daily as data is entered, corrected or even removed at the request of manufacturers. Of the manufacturers, 1,649 have reported that their products do not use date-related data or are compliant. Of the 1,649, 392 manufacturers have reported that all of their products are compliant. Eighty-eight manufacturers have reported one or more products with date-related problems. Fifty-three manufacturers have provided World Wide Web links (URLs) to data provided on their own manufacturer-operated Web Sites. There are submissions for which the data submitted were incomplete or unclear in some manner. We are communicating with these manufacturers to obtain clarification before entering the data into the database.

With regard to the data submitted, the great majority of the problems described are of minor importance, typically involving incorrect display or printing of a date. There are a few reported instances where the device will not function or operate at all unless the date problem is corrected. There are also a number of reports which indicate that the device will function correctly, provided the personal computer (PC) with which it is used is compliant. For many of these PCs, the correction required to correct the date is a rather straightforward operation. In general, manufacturers are indicating that currently or recently produced products will be corrected at no cost. For devices produced some years ago, the response is quite varied, i.e., free upgrades, upgrades at a cost, or no upgrade or solution being offered.

In reviewing the data received from the manufacturers so far, we see no indications that there will be significant problems which will place patients at risk, assuming the solutions being developed and offered by manufacturers are implemented. Of course, we can not make assurances about manufacturers who have not reported product status to us. We believe that the data received to date confirm our original expectations that the Year 2000 problems with medical devices are not significant or widespread problems, although there will be specific problems which need correction. With only a 10 percent response rate, however, it is not possible to draw definitive conclusions at this point. We will continue to emphasize to manufacturers the importance of reporting and have taken 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.

OTHER INITIATIVES

In January 1998, FDA's Center for Biologics Evaluation and Research (CBER) posted a guidance for industry entitled "Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products" on the FDA web site. 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. In the Spring of 1998, CDRH developed a Guidance Document on the Agency's expectations of medical device manufacturers, concerning the Year 2000 date problem. The guidance already has been made public and is available on the FDA web site. The guidance also was published in the Federal Register on June 24, for greater dissemination. The guidance re-emphasizes the requirements in existing regulations that require manufacturers to address any date problems which may present a significant risk to public health.

FDA staff organized, with the staff of the Emergency Care Research Institute, a half-day session on the Year 2000 date problem at the June 2, 1998 annual meeting of the Association for the Advancement of Medical Instrumentation. This meeting was attended by hospital clinical engineers, representing the device purchasers and users, medical device researchers and developers, and device manufacturers. The session permitted an exchange of information on all aspects of the Year 2000 problem as it relates to medical devices and the actions healthcare facilities should be taking to address this issue.

A video teleconference on the Year 2000 issue for device manufacturers is planned for September 1998.

CONCLUSION

Thank you, for the opportunity to update you about the issue of the Year 2000 and medical devices. Let me assure you, we at FDA take this issue very seriously as we do all problems which could affect the public health. We are committed to a scientifically sound regulatory environment which will provide Americans with the best medical care. In the public interest, FDA's commitment to industry must be coupled with a reciprocal commitment: that medical device firms will meet high standards in the design, manufacture, and evaluation of their products. We recognize that this can only be attained through a collaborative effort -- between FDA 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's role is to assure that medical devices are safe and effective and manufactured in accordance with their specifications. The Agency, of course, will provide any assistance it can to address any specific problem any other agency, such as the Department of Veterans Affairs, identifies. FDA also is working with other agencies, patient groups, medical associations and industry to optimize data collection and information sharing. FDA also 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.