Rep. Frank Pallone (D-NJ) who chairse a House Energy and Commerce subcommittee, characterized the country’s oversight of medical devices “broken”. Citing FDA inaction and lack of appropriate response in some instances, Pallone is trying to determine is new federal legislation or more FDA oversight is necessary to fix the problem.
Pallone cited what many industry analysts have been saying for quite some time. The safety measures and quality control presently in place is inadequate and is not protecting the public from defective or unsafe medical devices.
Examples of such recent defective medical devices are numerous. We’ve been involved in some of these matters including the Stryker hip, Kugel Mesh, Zimmer Durom Hip, and the Medtronic Sprint Fidelis defibrillator leads. These cases represent a danger to the general public who rely on these products for their safety and health.
According to a Reuters report, “Cardiologist William Maisel, who heads the nonprofit
Medical Devices Safety Institute, said recent recalls of
defibrillator wires and other devices raised questions about
the FDA’s ability to identify safety problems promptly. “Additional consumer safeguards are needed. Only bydemanding more thorough, scientific device evaluations can theFDA hope to reestablish consumer confidence in its ability to protect the public’s health,” Maisel told a House of Representatives Energy and Commerce subcommittee.