FDA: Subcommittee Testimony, U.S. House of Representatives, September 25, 1997
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Statement by Thomas Shope, PH.D., Acting Director, Division of Electronics & Computer
Science. Office of Science & Technology, Center for Devices and Radiological Health, FDA, Dept. of Health and Human Services. Subcommmittee on Oversight & Investigations Committee on Veteran's Affairs. EXCERPTS
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.
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.
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.
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.
Actual Letter to Manufacturers:
fda.gov
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I hope they're checking out RTC's (Real Time Clocks) too! A testing tool for this wasn't developed until this past August. Plus that "Time Dilation" thing (where seconds are speeded up a LOT) really worries me. While a lot of the equipment might not necessarily use a date, measurements are often before/after results based on seconds!
Message 2833788
Cheryl
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