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Critical equipment on list subject to change
You already know the year 2000 (Y2K) is right around the corner. You really don’t need to be reminded that there’s not much time left for health care organizations and facilities to make final preparations for Y2K-related problems. And it’s certainly not news to you that there is a wide range of computer-controlled and/or reliant medical devices that could be subject to failure when the coming new year dawns — possibly endangering your patients and exposing your organization to losses resulting from the ensuing litigation.
No one knows exactly to what extent the Y2K problem will affect medical devices. According to a statement from the Food and Drug Administra-tion’s (FDA) Center for Devices and Radiological Health (CDRH), "The vast majority of medical devices will function without any potential health or operational problem after Dec. 31, 1999. Some may have a minor problem, such as displaying an incorrect indication for the year (for example, 00 instead of 2000), and these will likely not significantly affect a patient’s health. A very small number of medical devices will encounter a real problem because of the switch to the new millennium, unless they are corrected prior to being used after Dec. 31, 1999."
In order to help health care organizations home in on potential problems with medical devices, the FDA has developed a list of types of computer-controlled, potentially high-risk medical devices that have the potential for the most serious consequences for the patient should they fail because of date-related problems.
According to a statement from the agency, inclusion of a type of device on this list does not mean that all devices of this type have a date-related problem (i.e., are Y2K-noncompliant) or, if they are Y2K-noncompliant, that they necessarily pose a significant risk to patients. Rather, this list includes those types of devices that could pose a risk to patients if the date-related failure affects the function or operation of the device.
FDA will use this list to identify those devices (along with their manufacturers) that would present the most serious risks to patients if they experienced a Y2K-related failure. This will help the agency to focus attention on the devices that could present the highest levels of risk.
The list includes the types of computer-controlled devices whose failure to function as designed or expected could result in immediate and serious adverse health consequences. These potentially high-risk devices are those that are:
1. used in the direct treatment of a patient, where device failure could compromise the treatment or could injure the patient;
2. used in the monitoring of vital patient parameters and whose data are immediately necessary for effective treatment;
3. necessary to support or sustain life during treatment or patient care.
The list does not include diagnostic devices whose failure would not result in immediate harm to the patient, even though the diagnostic information they provide might be unavailable or incorrect. However, a few diagnostic devices have been included if the results of calculations or other information processing by the device would not be readily apparent to the user, and a Y2K failure of the device could reasonably lead to serious adverse health consequences before being detected by the user.
This list of computer-controlled potentially high-risk devices will be used by the FDA for several purposes, according to the agency, and can also provide a guide to health care facilities regarding the types of devices that should receive priority in their assessment and remediation of medical devices.
The FDA will identify all manufacturers of these types of devices. These manufacturers will be candidates for further oversight to provide increased assurance that product Y2K status has been carefully assessed and that any Y2K-related upgrade has been developed and tested in accordance with the quality system regulations. That oversight may include facility inspection or audit. The FDA will also ascertain whether these manufacturers have made Y2K-status information available to users, and when appropriate, users have received notification regarding any necessary remedial action.
"This list should not be considered a definitive list of all high-risk devices," the FDA emphasizes. "It was developed by FDA staff based on their assessment of the types of devices that have the greatest potential for direct patient risk should they fail to correctly process date-related information. The list may change as FDA receives comments on the types of devices included in the list."
[For more information, contact:
• Thomas Shope, (HFZ-140), Center for Devices and Radiological Health, 9200 Corporate Blvd., Rockville, MD 20850. Telephone: (301) 443-3314, ext. 32.
• The CDRH Web site: http://www.fda.gov/cdrh/. Click on "Year 2000 Information."]