The rise of recalls on medical devices is a concern for anyone who uses them or has a loved one who uses them. Very often, a person is using a medical device to keep them healthy and alive, so a malfunction is often life threatening.

Todays increasingly complex production environments, company mergers, and the use of international supply sources, are causing quality problems in the medical device sector to increase. The U.S. Food and Drug Administration (FDA) device recalls for 2008 were at an all-time high, over double that of 1998. An alarming amount of these recalls were Class 1 recalls which is the most severe type as there is potential for serious injury or death.

Almost every nation has some type of governing body in place to regulate manufacturers and import/export activities. Although these systems vary, most recognize the ISO-13485:2003 standard as basic requirements for the design and manufacturing of medical device products.

In the United States, the FDA regulates and supervises the quality of the United States food, pharmaceutical and other related products. Over the years their responsibilities have increased to include regulating the safety and supervision of dietary supplements, vaccines, blood products, biological products and medical devices, plus the regulation of cosmetics, veterinary products and radiation-emitting devices.

In 1992 Congress passed the Prescription Drug User Fee Act (PDUFA), which imposed tight deadlines for drug evaluation. The FDA maintains that it has not lowered its standards, but meeting these deadlines can be difficult. Reviewers say they “have felt pressured to approve or recommend approval” of a drug despite “reservations about its safety and quality". Because the FDA lacks the legal authority to force companies to do the necessary research, often these medical devices are put on the market without the proper testing.

Many of the nation's leading doctors, scientists and lawmakers now agree that the FDA is in crisis. The agency learns of dangers too late and then moves too slowly to remedy them. According to David Graham, MD, a drug safety expert who has worked at the agency for 24 years, now is the time to get things fixed. The window of opportunity has been pried open by the breakdown of the FDA.

The government has stared to do this by increasing funding to the FDA. This money will go to hiring new reviewers and to improving there databases. Allowing the FDA to use the Veterans Health Administration, Medicare and HMO's databases, the tracking of side effects is made easier and faster. The FDA also allows doctors and patients to report problems at www.fda.gov/medwatch.