FDA Begins Guarding the Gate — Increase in Medical Device Monitoring

The medical device division of the FDA is acting more like a watchdog than a lapdog according to a new analysis.

The Center for Devices and Radiological Health (CDRH) reportedly issued one-third more warning letters in 2011 for dangerous devices than it did in 2008.

Since 2007 there has been a 250 percent increase in the number of medical device recalls.

WatchDog — Trampphotog© 2011

Greenleaf Health Consultancy looked at enforcement and compliance actions by the CDRH and found there’s been an almost 40 percent increase in inspections of medical device plants since 2008.

Oneof the most important regulatory moves required filing of a premarket approval (PMA) for two different metal-on-metal (MoM) hips, the cemented and uncemented acetabular components.

Surgeons are being advised to evaluate patients both before and after a MoM hip implant and to conduct metal ion testing and soft image testing. The FDA issued guidelines that surgeons carefully select patients for MoM hips and only after the risk-benefit ratio has been studied for that patient.

Compare this to an agency formerly mostly asleep allowing about 90 percent of medical devices to take the easy street to approval under the 510(k) process. All a manufacturer has to do is name a similar “predicate” device already being marketed in an exchange of paperwork to get their device on the market.

No clinical trials are required which has allowed dangerous and defective surgical meshes, knee and hip implants to flood the market and injure Americans mostly in the dark about the lack of federal oversight over medical devices.

FDA Commissioner Margaret Hamburg is reportedly behind the enforcements, reports Medical Device and Diagnostics Industry. 

As we’ve learned from experience, many in the industry are driven by sales figures and not by scientists working in a patient’s best interest. With a CDRH underfunded and understaffed, and the revolving door between industry and the agency, many have questioned whether there was any focus on patient safety at all.

That’s why the role of a federal watchdog agency is so important.  Let’s hope this new focus continues and receives funding to follow-though on its mandate to protect Americans from dangerous and defective medical devices.