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2000 biomedical equipment 2000 compliance status 2000 Project Manager 2000 Project Office According to VHA’s American Hospital Association American Nurses Association biomedical engineers biomedical equipment manufacturers biomedical equipment programs certify Compliance Categories conditional-compliant equipment contingency plans continuity and contingency cost information date-time defibrillator Department of Health Department of Veterans Director of FDA’s embedded systems equipment is compliant FDA’s Division Health and Human health care providers House Committee Human Services information provided Internet World Wide inventory January July 29 letter longer in business manufacturers to validate medical devices nearly 100 manufacturers noncompliant and conditional-compliant noncompliant biomedical equipment noncompliant equipment patient safety percent problem provide VHA received compliance information research instruments scientific and research Secretary of Health Secretary of Veterans status of biomedical Subcommittee test results U.S. Postal Service Veterans Affairs Veterans Health Administration VHA medical facilities VHA’s biomedical equipment VISNs and medical World Wide Web
Page 22 - 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 21 - 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 - Manager told us that VHA believed it would need the manufacturers' permission before it could share this information. He said that VHA is concerned about the proprietary nature of the products, potential legal issues, and manufacturers' price structure for Year 2000 compliant products. VHA had shared some of Year 2000 compliance status information provided by manufacturers with federal agencies, such as the Department of Defense and the National Institutes of Health (NIH), with the caveat that it...
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 9 - If the physician or other clinician did not pay close attention, a faulty diagnosis or treatment decision could be made based on a misreading of the data. VHA also recognizes that an equipment function that depends on a calculation involving a date and that is performed incorrectly as a result of a date problem, could present a risk to the patient. One example reported by a manufacturer is a product used for planning the delivery of radiation treatment using a radioactive isotope as the source. An...