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Medical device companies are jeopardizing patient safety

Posted Feb 06 2012 2:44pm

Monday, February 6th, 2012

By Ed Howe
Former president and CEO, Aurora Health Care

Jim Guest , president of Consumer Reports recently explained that millions of medical devices, 700 different products each year, from artificial hips to contact lens solution, to heart stents and pacemakers, are being recalled. And the vast majority of recalled products were never safety tested in humans because the manufacturer claimed they were "similar" to something already on the market.

Guest says medical devices need to meet the same standards as any new drug would in order to hit the market.

I have blogged for some time now that medical device companies seem to run their R & D departments under the direction of the marketing department rather than being the responsibility of someone with clinical and engineering expertise. In addition to this, too often there is a financial relationship with practicing physicians that seems ethically questionable.

The idea of following the sometimes overly strict standards of the drug industry may be going too far, but we need to clean this mess up. GPOs can provide valuable oversight on product quality given their transparency and the standards they have in place when vetting devices.

Medical devices need stricter oversight if we are going to ensure patient safety and have products that really work.

Every new prescription drug must undergo rigorous testing on humans before it can be sold, even if it is similar to another drug already in use. Why would we allow a different standard for medical devices?

Click here to send a note to lawmakers and to let them know stricter guidelines are needed.

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