Is the Food and Drug Administration properly overseeing the approval and manufacturing of medical devices? This is the question brought by a House Energy and Commerce subcommittee who is seeking legislation to increase oversight of the FDA.

The Congressional subcommittee claims that the FDA has serious deficiencies in their reviewing processes, substandard postmarket surveillance, and that they irregularly inspected manufacturing facilities.

Their basic solution is this—allow consumers to file lawsuits against manufacturers of defective medical devices directly instead of just filing incidences with the FDA. This would prevent companies from being able to hide behind inadequate FDA standards for the products, thus ensuring safer devices.

Approximately 21,000 Kappa and Sigma pacemakers have been recalled by the FDA due to a wiring defect that could cause a severe heart injury or death.

Medtronic first notified physicians and patients of the pacemaker defects in May, reporting that there had been at least two fatalities potentially connected with the wiring. The FDA has now classified the action as a “Class I” recall, which indicates that the product carries a reasonable probability of adverse health consequences of death.

While the recall only applies to about 21,000 of the more than 1.7 million Kappa or Sigma pacemakers implanted throughout the world, approximately 15,200 patients with Medtronic Kappa pacemakers installed for five years or longer and another 6,100 patients with Medronic Sigma pacemakers installed for more than five years are included in the recall. Medtronic Kappa Series 600/700/900 pacemakers and Sigma Series 100/200/300 pacemakers could be affected by this latest recall. These devices were manufactured primarily between November 2000 and November 2002.

According to a letter sent to healthcare professionals on May 18, 2009, Medtronic did not recommend that physicians consider replacing the device unless a patient is pacemaker dependent or a device is already at the elective replacment time.

Patients experiencing problems with a defective pacemaker may show signs of lightheadedness and fainting, and should contact their doctor if these signs occur.

Hundreds of deaths and thousands of injuries can be traced to defective medical devices each year.

The Heart Rhythm Society has said that defibrillator lead wires need better surveillance to detect defects, and has called on hospitals to train doctors in the delicate procedure of removing such wires from patients.

The lead is a wire that connects an implantable defibrillator to the heart. If a lead breaks, the defibrillator can emit a massive and painful shock, and in the worst case scenario, preventing a defibrillator from sending a necessary shock to the heart.

In 2007, Medtronic Inc.’s Sprint Fidelis lead was removed from the market following reports of 5 deaths due to lead fractures with another 13 deaths caused by “possible or likely contributing factor” of defective leads.

Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators, and around 150,000 people are still implanted with a Sprint Fidelis lead.

The Heart Rhythm Society used the Sprint Fidelis recall in its request for a surveillance system to track lead performance in order to spot defective devices earlier. The group also said hospitals need to train more doctors to remove faulty defibrillator leads.

During the Sprint Fidelis recall, four deaths occurred when doctors tried to remove defect leads from patients. The group said physicians should perform at least 40 extractions under expert supervision before operating on their own. Supervising physicians should have performed at least 75 extractions with a high rate of success, the group states. They also recommended that such training take place only medical centers that perform a large number of lead extractions each year should train physicians to perform the surgery.

Finally, the group called on the FDA to require that new defibrillator leads be tested in humans before they are approved. Currently, most leads are approved through the agency’s fast track process, which is reserved for devices that are considered modifications of existing products. The fast track process does not require human studies.

If you or someone you love has been injured by a defective medical device, it’s important to seek out expert advice of an experienced defective drug attorney for valuable insight.