Year 2000 Computing Crisis: Biomedical Equipment Items
DIANE Publishing, 1999 - 117 pages
This report assesses the status of Veterans Health Administration's (VHA) and Food and Drug Administration's (FDA) Year 2000 biomedical equipment programs. Biomedical equipment may employ computers or computer chips to operate &/or may be adversely affected by the Year 2000 problem. In addition, the FDA has responsibility for oversight and regulation of medical devices, including the impact of the Year 2000 problem. Includes testimony by Joel C. Willemssen, Director, Civil Agencies Information Systems, Accounting and Information Management Division, General Accounting Office (GAO).
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2000 compliance status 2000 COMPUTING CRISIS 2000 Project Manager 2000 Project Office American Hospital Association American Medical Association American Nurses Association Biomedical Devices biomedical engineers biomedical equipment manufacturers certify concur conditional-compliant equipment contingency plans continuity and contingency defibrillator Department of Health Department of Veterans develop Devices Still Unknown Drug Administration equipment is compliant Federal Food and Drug Health and Human health care providers House Committee Human Services identity of manufacturers information provided Internet World Wide inventory January July letter longer in business manufacturers to validate medical devices nearly 100 manufacturers noncompliant biomedical equipment noncompliant equipment patient safety percent provided compliance information provided VHA and/or received compliance information recommendation requested Secretary of Health Secretary of Veterans single data clearinghouse status of biomedical Subcommittee test results U.S. Postal Service users of biomedical Veterans Health Administration VHA and/or FDA vha medical facilities visns and medical World Wide Web
Page 23 - App. 2. (b) The President shall designate a Chairperson from among the members of the Committee. Sec. 2. Functions, (a) The Committee shall report to the President through the Secretary of Defense, the Secretary of Veterans Affairs, and the Secretary of Health and Human Services. (b) The Committee shall provide advice and recommendations based on its review of the following matters: (1) Research: epidemiological, clinical, and other research concerning Gulf War veterans
Page 5 - We requested written comments on a draft of this report from the Secretary of Health and Human Services or her designee. The Inspector General of the Department of Health and Human Services provided us with written comments. These comments are discussed in the Agency Comments and Our Evaluation section of the report and are reprinted in appendix n.
Page 22 - National Patient Safety Partnership is a coalition of public and private health care providers, including VA, the American Medical Association, the American Hospital Association, the American Nurses Association, and the Joint Commission on Accreditation of Healthcare Organizations. 14 GAO/ATMD-98-240, September 18. 1998. the manufacturers' equipment was compliant, including performing independent verification and validation of the manufacturers
Page 18 - Federal Food, Drug, and Cosmetic Act.20 This rule protects public health by ensuring that FDA has current and complete information regarding actions taken on medical devices. These reports are expected to improve FDA'S ability to evaluate device-related problems, as well as enable it to take prompt action regarding devices, that pose a health risk. Under the new rule, the affected manufacturer is required to submit a report of action taken to correct the problem or remove the device from service....
Page 8 - We have previously reported that most manufacturers citing noncompliant products listed incorrect display of date and/or time as the Y2K problem.9 According to VA, these cases do not present a risk to patient safety because health care providers, such as physicians and nurses, can work around the problem. Of more serious concern are situations in which devices depend on date calculations-the results of which can be incorrect.
Page 23 - HHS stated that it did not concur with our recommendation to review test results supporting medical device equipment manufacturers' certifications that their equipment is compliant. It believed that the submission of appropriate certifications of compliance was sufficient to ensure that the certifying manufacturers are in compliance. HHS also stated that it did not have the resources to undertake such a review, yet we are not aware of HHS' requesting resources from the Congress for this purpose.
Page 1 - The problem is rooted in how dates are recorded and computed. For the past several decades, systems have typically used two digits to represent the year — such as "97" for 1997 — to save electronic storage space and reduce operating costs.
Page 8 - ... on the printout. However, VHA recognizes that incorrect date-time representation or use could pose a risk when the date is used in a calculation or when records generated by the equipment is sorted automatically to present a patient's condition, over a period of time, to a physician for diagnosis and treatment. Specifically, when records are sorted by date of recording, the Compliant 694 3,873 Intra-aortic balloon pump, dialysis machine Noncompliant 34 182 Defibrillator monitor.
Page 39 - ... clearinghouse that provides compliance information to all users of biomedical equipment. Development of this clearinghouse should involve representatives from the health care industry, such as the Department of Defense's Health Affairs, American Hospital Association, American Medical Association, and Health Industry Manufacturers Association. At a minimum, the clearinghouse should contain (1) information on the compliance status of all biomedical equipment by make and model, (2) the identity...
Page 21 - We recommend that the Secretary of Veterans Affairs and the Secretary of Health and Human Services work jointly to develop immediately a single data clearinghouse that provides compliance information to all users of biomedical equipment. Development of this clearinghouse should involve representatives from the health care industry, such as the Department of Defense's Health Affairs, American Hospital Association, American Medical Association, and Health Industry Manufacturers Association.