(c) 2016 Jon L Gelman, All Rights Reserved.

Friday, November 22, 2013

New Scrutiny for Medical Devices

Today's post was shared by FairWarning and comes from

Metal-on-metal replacement hips remain high-risk, but other devices are to be downgraded.

Metal-on-metal replacement hips remain high-risk, but other devices are to be downgraded.

Wayne Schneider’s heart stopped beating late last year while the Minneapolis paramedic was out on an emergency call.

Another medic performed CPR for a few minutes, and then used a medical device that delivered cardiac compressions mechanically for 64 minutes, until Mr. Schneider’s heart started beating normally on its own.

“I’m not sure people would have been able to sustain manual CPR for so long,” said Mr. Schneider, 57. “I’m a lucky guy.”

He may have been luckier than he knows. Though widely available, the machine used to keep him alive, called an external cardiac compressor, was never subjected to the rigorous premarket approval process that the Food and Drug Administration routinely requires for new drugs.

Now some researchers fear this medical device and nearly a dozen others may never be thoroughly evaluated by the agency.

“People would be shocked to know that the F.D.A. never got its act together to require the studies,” said Diana Zuckerman, president of the National Research Center for Women and Families.

The reason? These products have been around in one form or another since before the F.D.A. started regulating devices in 1976.

They were cleared for sale without close scrutiny because they were presumed to be roughly equivalent to products that already were in use. They also were designated by the F.D.A. as high-risk...
[Click here to see the rest of this post]


Jon L. Gelman of Wayne NJ is the author NJ Workers’ Compensation Law (West-Thompson) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson). For over 4 decades the Law Offices of Jon L Gelman  1.973.696.7900  have been representing injured workers and their families who have suffered occupational accidents and illnesses.