Medical Technology

Despite regulations intended to prevent the production and distribution of unsafe or ineffective medical devices, some critical and life-supporting items like emergency ventilators and heart valves have been recalled from the market recently due to manufacturing defects. GAO found that the Food and Drug Administration's (FDA) compliance program for medical devices, which assesses manufacturers' implementation of quality assurance requirements, has been plagued by weaknesses. Inspections have been too infrequent to meet statutory minimum requirements. When inspections have occurred, they often did not find problems that emerged later. When problems were identified and targeted, they often went unreported despite requirements to report them. In addition, FDA inspectors have not received enough training, and the agency's data systems contain major gaps. GAO summarized this report in testimony before Congress; see: Medical Technology: Implementing the Good Manufacturing Practices Regulation, by Eleanor Chelimsky, Assistant Comptroller General for Program Evaluation and Methodology, before the Subcommittee on Oversight and Investigations, House Committee on Energy and Commerce. GAO/T-PEMD-92-6, Mar. 25, 1992 (16 pages).

GAO found that: (1) FDA has changed its interpretation of the original 1978 GMP regulations, shifting to more stringent requirements; (2) the stronger requirements are not self-explanatory and require FDA inspectors to have extensive knowledge of device technology; (3) until 1990, the effectiveness of GMP inspections was limited by a lack of coordination with market introduction, but GMP inspections are now part of the approval process for certain high-risk devices that FDA must approve before marketing; (4) FDA began a pilot premarket review of another group of high-risk devices, which may also result in premature GMP inspection of the device manufacturer, but the pilot review program does not transmit technical data to FDA field offices to help them target inspections to the riskiest technology changes; (5) the shift to more stringent GMP requirements gives FDA inspectors greater authority and responsibility to assess technical dimensions of device specifications and manufacturing processes, but current classroom training and job assignment policies severely limit inspectors' knowledge of device technology and ability to identify quality assurance problems in complex devices and manufacturing; (6) district offices did not report 36 percent of potential GMP violations to central FDA files; (7) the missing data restricted FDA ability to monitor manufacturing problems nationally; (8) FDA has conflicting estimates for the inventory of domestic manufacturers' medium- and high-risk devices, and does not attempt to estimate the inventory of medical devices; (9) the new FDA Field Information System could address district reporting and data system problems; and (10) FDA has not met its minimum statutory obligation to inspect medium- and high-risk device manufacturers at least once every 2 years.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

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