The FDA announced new stricter regulation of infusion pumps in order to address malfunctions which have resulted in patient deaths. The agency has received reports of 710 deaths linked to problems with the medical devices over the last five years, as well as over 10,000 complaints annually. Infusion pumps intravenously deliver drugs automatically to patients. Now pump manufacturers will be required to conduct actual clinical trials on their products to provide more data about the safety of those devices before they can be approved for sale.
There are an estimated two million infusion pumps currently being used in hospitals and clinics across the country. The Obama administration has stepped up its efforts to reinvigorate the FDA after years of criticism that the agency was a rubber stamp for the medical device industry. The FDA’s Center for Devices and Radiological Health oversees numerous critical medical device products including heart implants, imaging equipment and the infusion pumps which have all come under particular scrutiny. The Center’s director said last week that the FDA had concluded the pumps could be made far safer. He also indicated the new, more vigorous approach pre-approval might be extended to other types of medical devices as well. The FDA says it intends to ratchet up the expectations for medical device manufacturers noting there have been 79 recalls involving infusion pumps alone in the past five years. That’s certainly good news to the innocent victims of defective medical devices they have entrusted their health to.
Under current FDA rules, life-sustaining medical devices like heart defibrillators must typically undergo clinical trials before they are approved for sale. Until now, the FDA has cleared other critical devices like the infusion pumps without clinical testing based solely on the manufacturer’s claim that the new device is “similar to a product that is already approved and on the market”. That will no longer be the case.
This FDA action is welcome, if not somewhat late, news for the safety of the general public who use these medical products.
Richard J. Arsenault, 2011
