Summary: Manufacturers of critical medical devices, such as heart valves and pacemakers, are required to operate tracking systems to quickly locate and remove defective devices from the market and notify patients who use them. Weak oversight of manufacturer tracking and recall systems, however, threatens the Food and Drug Administration's (FDA) ability to adequately protect the public. FDA's inspections of the tracking systems do not include independent audits to verify the completeness and accuracy of data in the systems. Instead, the inspections focus on reviews of the manufacturers' written standard operating procedures for tracking. Despite good manufacturing practice standards that require FDA to inspect manufacturers of tracked devices at least once every two years, only about half of the 238 manufacturers subject to tracking were inspected during 1996 and 1997. FDA officials said that they plan to revise their inspection program to include an audit plan to better assess manufacturers' compliance with the tracking requirements and redirect FDA's compliance priorities toward high-risk devices, such as implants. The details for most of these plans, however, have yet to be determined. GAO also found that manufacturers and FDA have not acted promptly to correct and remove defective devices from the market. Less than one-third of the 54 recalls initiated from 1994 through 1996 were completed by manufacturers within six months, as specified by FDA's guidelines. FDA has also had problems terminating device recalls in a timely manner.
