GAO to Investigate FDA Oversight on Device Recalls

Federal watchdog the General Accounting Office (GAO) will be investigating the FDA and its oversight of medical device recalls, highlighted by health crises related to Philips Respironics’ ventilators and CPAP devices.

Following a scathing report on FDA device oversight authored by ProPublica and the Pittsburgh Post-Gazette in December, Sens. Richard Blumenthal (D-Conn.) and Dick Durbin (D-Ill.) requested the GAO investigate the agency’s role in policing a massive health issue involving hazardous particles from deteriorating sound abatement foam being inhaled by patients using Philips’ breathing machines. A second Class I recall of the device was issued last April.

The GAO probe is the latest in a series of harsh headlines involving Philips, including a recently-exposed debacle with its MRI scanners and potential explosions.

To read the whole story, click here to subscribe.

Related Topics