Investigations of Adverse Device Events in UK Take Less Time

Medical device companies being investigated in the UK this past year for adverse events spent less time under the microscope, especially those undergoing an in-depth investigation.

Half of the standard investigations of adverse incidents involving medical devices in 2007 were completed within 12 weeks, according to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). In 2006, it took up to three weeks longer to wrap up standard investigations, which are conducted by the companies themselves, for nearly 50 percent of the cases.

The shorter time frame was largely due to “the parallel completion of a large number of related investigations arising from numerous reports of a particular problem with a particular device,” the MHRA says in a January device bulletin.

The bulletin also offers updated guidance on reporting and disseminating information about device-related adverse events. It includes requirements on the quarantine, labeling and storage of equipment involved in such incidents.