Georgia Injury Lawyer Blog

Defective medical devices have been a major source of injury and death for years. During previous administrations device makers have been basically unregulated due to lax enforcement by the Food and Drug Administration. This abdication of responsibility may soon end.

Federal regulators say they are moving to tighten their oversight of medical devices. Specifically included are infusion pumps, one of the most commonly used pieces of medical equipment. These pumps intravenously deliver drugs, food and other solutions to patients, and have been the subject of many failures for years.

Last Friday, the FDA issued preliminary guidelines that will require producers of infusion pumps to supply the agency with more test data on them before they can be approved for sale.

The FDA reports that over the last five years it has received reports of 710 patient deaths linked to problems with infusion pumps. FDA officials say they think the number may be significantly higher. Some of the reported deaths involved patients who suffered drug overdoses accidentally, either because a hospital worker entered incorrect dosage data into a pump or because the device’s software malfunctioned.

The FDA estimates that two million infusion pumps are used in hospital and clinical settings and hundreds of thousands more are used by patients in their homes.
The new initiative by the FDA is the result of the Obama administration trying to reestablish the role of the FDA after years of criticism by lawmakers and others that it was a rubber stamp for medical device industry.

A few years ago several top FDA scientists complained that their superiors had ignored both their recommendations and policy guidelines in approving the sale of infusion pumps. Along with reports of 710 deaths, the center also received more than 10,000 complaints annually about infusion pumps from 2005 to 2009.

A senior FDA official announced that new approach that the agency was taking toward infusion pumps might soon be extended to other types of medical devices.
The biggest makers of infusion pumps include Baxter Healthcare of Deerfield, Ill.; Hospira of Lake Forest, Ill.; and CareFusion of San Diego.

Under the infusion pump proposal, which could be completed by the end of the year, producers would be required to provide additional data to support the procedures they used to determine the effectiveness and safety of their devices. In addition, companies would have to conduct limited clinical trials to ensure their pumps were not susceptible to misuse or had design elements that could create errors.

The pump manufacturers say that most problems occur when a nurse or health care worker enters the wrong software data accidentally. FDA officials found that not to be the case. In the FDA review of pump complaints many more deaths and injuries related to the devices were the result of defective product design and engineering.

Under current FDA rules, life-sustaining devices like heart defibrillators must be subjected to clinical trials before they are approved for sale. But the FDA clears the sale of many other critical devices like pumps without clinical testing based on a manufacturer’s claim that a new device is similar to a product already on the market.