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U.S. Department of Health and Human Services

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Year 2000 and Medical Devices


Statement of

Thomas Shope, Ph.D.
Acting Director
Division of Electronics and Computer Science
Office of Science and Technology
Center for Devices and Radiological Health
Food and Drug Administration
Department of Health and Human Services

before

the Subcommittee on Oversight and Investigations
House Committee on Veterans' Affairs

September 25, 1997

INTRODUCTION

Good morning, Mr. Chairman and Members of the Subcommittee. My name is Dr. Thomas Shope. I am the Acting Director, Division of Electronics and Computer Science, Office of Science and Technology, Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA). Having previously testified before this Subcommittee at the June 26, 1997, hearing, I am pleased to be here today to provide information on the "Year 2000" date issue as it relates to medical devices. Although FDA has not received any information since the previous hearing to indicate that there will be significant problems with medical devices, I am here to assist the Subcommittee in its efforts to examine the issue.

WHAT IS A MEDICAL DEVICE?

According to the definition in the Federal Food, Drug, and Cosmetic Act (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. These 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 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 enforcement 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.

Any computer software which meets the legal definition of a medical device is subject to applicable FDA medical device 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.

An issue which has been identified as warranting review is the impact of the "Year 2000" on some medical device computer systems and software applications. These products could be impacted by the "Year 2000" date problem only if they use a date in their algorithm or calculations, or in record keeping; and a two-digit year format was used in their design. Manufacturers of such products are the only reliable source of information as to the details of the methods used in the programming and whether these two conditions are met. While we are in the process of reviewing this issue, we do not currently believe that there will be any major impact on medical device safety.

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 devices are: pacemakers, infusion pumps, ventilators, and many others. It is unlikely that most of these products would be impacted by the "Year 2000" problem. Almost none of these devices 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, further, may use the two-digit year format. Such products 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 used to calculate 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. While there is a chance that the two-digit format may affect the performance of these software devices, we believe that the "Year 2000" risk will be mitigated through proactively working with manufacturers.

LETTER TO MEDICAL DEVICE MANUFACTURERS

In light of our review of the impact of the "Year 2000" on some medical device computer systems and software applications, CDRH sent a letter in July to 13,407 medical device manufacturers, 8322 domestic manufacturers and 5,085 foreign manufacturers, 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.

CDRH 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 became effective June 1 and 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.

As a result of our letter, 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 CDRH and take appropriate action. Again, we do not anticipate any significant problems with individual medical devices, 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.

CONCLUSION

Thank you, Mr. Chairman, for the opportunity to tell you about the issue of "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.