(Hartford, CT) – U.S. Senator Richard Blumenthal (D-CT) today called for strong action to protect patients from faulty medical devices that cause serious injury, suffering, and death. Blumenthal was joined by consumer advocates, as well as a patient who has suffered from an implanted metal hip device that failed. They supported the Medical Device Patient Safety Act, legislation he introduced with Senators Chuck Grassley (R-IO) and Herb Kohl (D-WI) that would help protect patients from unsafe medical devices while fostering innovation by preserving the current system of medical device approvals. This bill gives the Food and Drug Administration (FDA) the tools to discover problems with faulty devices more quickly and better manage recalls when problems do occur, without delaying devices from reaching the market.
“Strong action is needed to stop defective medical devices from causing widespread, horrific injury and death, and dramatically raising health care costs,” said Blumenthal. “Thousands of faulty, dangerous devices are in use and implanted in patients because the current FDA system of oversight and surveillance is badly broken. Our commonsense, bipartisan reforms improve patient protection by empowering the FDA to conduct better recalls and stronger oversight and surveillance after a device becomes available. By establishing robust post-market consumer safeguards, these measures expedite initial FDA approval, so critical devices reach patients more promptly. We will vigorously continue our investigation into past practices and problems following our initial letters to five companies which should produce responses within the next three weeks.”
Faulty medical devices such as metal-on-metal hip implants, knee replacements, and defibrillators, which have been subject to major worldwide recalls in recent years, can have disastrous health effects when they fail in a patient, including debilitating pain, leakage of toxic chemicals causing antibiotic resistant infections, and permanent weakening of the surrounding bone.
Blumenthal was also joined by Jean Rexford, Executive Director of the Connecticut Center for Patient Safety, to reiterate the need to provide the FDA with the tools to get safe medical devices to patients faster.
“Currently the vast majority of medical devices are approved by showing substantial equivalence to products already on the market,” said Rexford. “This has allowed products to be marketed and used without comprehensive testing, which can put the healthcare consumer at risk. Preventable healthcare harm is unacceptable.”