>From http://www.gao.gov/new.items/ai00026t.pdf: YEAR 2000 COMPUTING CHALLENGE Compliance Status Information on Biomedical Equipment Statement of Joel C. Willemssen Director, Civil Agencies Information Systems Accounting and Information Management Division Testimony Before the Subcommittee on Oversight and Investigations and the Subcommittee on Health and Environment, Committee on Commerce, House of Representatives GAO October 21, 1999 Excerpts: "Responsibility for oversight and regulation of medical devices, including the impact of the Y2K problem, lies with the Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS)." "HHS, on FDA�s behalf, initiated action to collect biomedical equipment information in January 1998 by issuing a letter to domestic and foreign manufacturers requesting information on the Y2K compliance of their product lines. All information received from these manufacturers was then to be made available to the public through an FDA web site. As we reported in September 1998, FDA�s database did not include product compliance information from many manufacturers who had already provided such information to VHA; further, VHA was not making this information available to the public." "(342 manufacturers) reported having date-related problems such as incorrect display of date/time. According to FDA, the 342 manufacturers reported 1,035 specific products with date-related problems. Compliance data for 429 manufacturers were reported on their web sites and linked through the FDA clearinghouse." "This total (4,288) excludes 132 manufacturers who, according to FDA, had not responded to the agency�s request for product compliance information as of October 4, 1999." "While FDA is aware of the number of products and their reported compliance status for those manufacturers providing this information to the clearinghouse, in testimony before these Subcommittees this past May, officials stated that they did not know the total number of biomedical equipment products reported by manufacturers on their web sites, or how many of them were noncompliant." "71 manufacturers� web sites either contained insufficient information on the number of products and their compliance status, or did not clearly distinguish biomedical equipment from nonbiomedical products" "The 4,053 noncompliant products that we identified were from the web sites of 214 manufacturers. This number of noncompliant products is about four times the number reported directly by FDA in its clearinghouse (1,035). Examples of these noncompliant products included a bedside monitor, film digitizer, ultrasound systems, radiology information systems, and laboratory information systems. Included among noncompliant PHRDs were ventricular assist devices and hemodialysis equipment." "Our review disclosed that the quality of the information on manufacturers web sites continued to vary significantly. It ranged from general assurances of compliance to detailed information on specific product make and model. For example: � A manufacturer reported that its products had no Y2K issues, but it did not identify the products. � A manufacturer reported that it was still assessing its products, and did not provide any detailed information on its web site. � A manufacturer did not list theY2K readiness of products but did report that the only Y2K problem it was having was with the software it used to run its business. � A manufacturer listed about 65,000 products, but did not sort them by type so that the biomedical products could be easily identified. � A manufacturer reported that for its 282 products, 79 were compliant, 50 were noncompliant, the status of 43 was currently unknown, and 110 were not affected by the Y2K problem. It also provided solutions for its reported noncompliant products." "In September 1998, we first reported that FDA did not require manufacturers to submit test results certifying product compliance. Rather, we noted, FDA relies on the manufacturer to validate, test, and certify that it has adequately addressed any Y2K problem." "Many of the 803 PHRD manufacturing sites identified by FDA are in foreign locations. Specifically, our review of the 803 sites on FDA�s list showed that 203 were located in 27 foreign countries (appendix II lists these countries). Of the 325 randomly selected for assessment, 233 were in the United States and 92 were in 22 foreign countries. Finally, of the 80 locations where manufacturers agreed to be assessed by FDA, 65 arelocated in the United States and 15 are located in 8 other countries: Canada (1 site), Finland (2), Germany (4), the Netherlands (1), Norway (1), Sweden (2), Switzerland (1), and the United Kingdom (3)." "While information is available on the Y2K compliance status of biomedical equipment through the FDA clearinghouse and other sources, it is not clear at this time how extensively health care providers are using this information to determine their Y2K readiness." "Responses to the HHS OIG survey varied significantly. For example, about 80 percent of the hospitals responding stated that they were aware of the clearinghouse, but less than half of the nursing facilities, home health agencies, and physicians responding stated this same awareness. Further, while about 60 percent of the responding hospitals reported that they used the clearinghouse, 25 percent or fewer of the responding nursing facilities, home health agencies, and physicians reported using the clearinghouse to obtain readiness information about their biomedical equipment." "Although compliance information on biomedical equipment is available through FDA�s clearinghouse, theY2K readiness status of equipment at health care providers� offices is not known because a significant number of providers did not respond to the surveys." ----------------------------------------------- Provided by: ================================================================= INTERNATIONAL CONGRESS OF INDEPENDENT INTERNET USERS http://www.iciiu.org (ICIIU) [EMAIL PROTECTED] Tel(718)846-7482 Fax(603)754-8927 =================================================================
