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This article was originally published in The Gray Sheet

Executive Summary

MEDICAL DEVICE USER REPORTING COMPLIANCE PILOT STUDIES will end in September, according to staffers at FDA's Center for Devices and Radiological Health. FDA signed contracts in September 1992 with Massachusetts, Colorado and Texas to conduct the surveys, which are assessing the degree to which device user facilities are complying with medical device user facility reporting requirements. CDRH plans to use the data gathered from the surveys for a report to Congress on user reporting that is due in November. Under the protocol for the pilot studies the surveyors for each state are conducting a total of 175 audits of five types of user facilities (35 visits per user facility category). The five types of user facilities are: hospitals, nursing homes, outpatient clinics, diagnostic facilities and ambulatory surgical facilities. Trained at CDRH headquarters in Washington, D.C. in October, the state surveyors are determining whether the sites are training personnel to do MDR reporting and whether they are keeping adverse incident files. They also gather data on the amount of time and resources user facilities must allocate to reporting. The Safe Medical Devices Act of 1990 requires that two reports evaluating user reporting be submitted to Congress. The first is due in November, the second in August 1994. Under SMDA, FDA must submit an initial report to the House Energy and Commerce Committee and the Senate Labor and Human Resources Committee that includes "an evaluation of the cost effectiveness of the requirements." The November report also should contain details on "the safety benefits" of the requirements, "burdens placed on the Food and Drug Administration and on device user facilities by the requirements [and]...recommendations for legislative reform." CDRH staffers say that in addition to data gathered during the pilot study, they hope to include information from their own inspections of user facilities, which will begin after FDA's regulations governing medical device reporting are finalized in May or June. The report due in August 1994 necessitates a study of user facility compliance with reporting requirements and "actions taken by the manufacturers of devices in response to reports made to them." The findings of the report will determine whether or not user facilities will be subject to civil penalties for lack of compliance with the user reporting rules. SMDA specifies that if the report finds that "there has been substantial compliance with the requirements," civil penalties "shall not take effect" ("The Gray Sheet" Nov. 5, 1990, S-9 and S-16). CDRH receives data reports monthly from the three-state pilot study. Based on findings to date, hospitals are the most likely of the five types of facilities to be aware of the user reporting rule, according to the device center. CDRH recently sent three staffers to the states to accompany surveyors on site visits so that the agency would have an understanding of the surveyors' information gathering process.



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