Mikulski asked Dr. Hamburg if she would heed concerns made by whistleblowers, such as those made by a group of employees at the Center for Devices and Radiological Health that in January accused the FDA of carelessly approving medical devices which ultimately put patients’ health and safety at risk.

Dr. Hamburg replied that she would see to it that critical issues and concerns raised by whistleblowers would be addressed by the agency if she is confirmed as commissioner.

The scientists allege that the FDA had approved medical devices for sale even after their review of many medical devices had resulted in serious objections by the scientific team reviewing them. One device approved under such circumstances included Medtronic cardiac defibrillators. It was later found that many of the defibrillators had defective leads that had caused the defibrillators to unnecessarily shock patients or fail to work all together. According to a Supreme Court ruling last year, because the devices had been approved by the FDA, those injured by the faulty devices were unable to sue the manufacturer.

As a result, a large collation of consumer and patient safety groups teamed up to push the Medical Device Safety Act (MDSA), legislation that would restore the rights of patients who have been harmed by unsafe medical devices to seek justice in state courts.

SOURCE: Sprint Fidelis Lead Recall › Hamburg hopes to create a culture in FDA where concerns are heard