When we have surgery, we trust that the surgeon has been tested and successfully demonstrated his or her ability to successful complete the operation in the past.  And the surgeons themselves have faith that the instruments and implants they use have similarly been tested to the highest standards.  Or so we’d like to think.

Consumer groups are decrying the lack of testing for medical devices such as hip replacements and heart stents.  In an article from the Fowler Tribune, Consumers Union project director Lisa McGiffert says that more than 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to FDA clearance for distribution or sale.  The Federal Government’s General Accounting Office states that more than 700 medical devices are recalled every year.

Hip Implant

X-Ray Image of a Hip Implant

Watchdog groups like the Consumers Union are watching Congress to ensure the Medical Device User Fee Act is reauthorized this year.  While this bill would maintain some oversight into the use of implanted medical devices, consumer groups are demanding stricter regulation.

In a recent letter to FDA Commissioner Margaret Hamburg, 12 consumer groups including the Consumers Union called for stricter testing for medical devices before they are approved for general use, as reported by the Washington Post.  They point to the release of a recently-approved device used in patients with complications following an endovascular graft to treat aneurysms.  The groups say the device was evaluated under a process that was not comprehensive enough.

Bone Screws

Bone Screw Implants

Despite these efforts from consumer groups and victims of faulty medical devices, medical device manufacturers continue to gain political momentum in Congress according to a report from the Minneapolis Star Tribune.  One bill recently introduced would give outside reviewers expanded authority in the approval process for some implanted medical devices.  Another loosens conflict-of-interest rules for those who review the safety of medical devices.

At the same time, rules to create an identification system for medical devices to help recall unsafe products have stalled.  The medical device industry has called the ID system burdensome.

There is a desire among politicians and medical device manufacturers to find the balance between speed and safety.  Too many regulations might bog down research and development of new devices, inhibiting innovation.  Too little regulation might expose the public to unnecessary and serious health risks.

The UK publication The Guardian reports that medical device testing standards are also of concern in Europe, where a startling number of metal-on-metal hip implants are failing.  In some series of implants, half of all hip implants had to be removed after six years.  Unlike the US, regulatory data and clinical data in Europe are not publicly accessible.  There are also several instances of ambiguity in the regulations themselves, leading to confusion.

Bone Implants

Bone Implants

However governments and the medical device manufacturing industry proceed in regards to regulation and testing of medical devices, manufacturers themselves should be wary of bringing on lawsuits if it is found that their devices were improperly tested.  The FDA recently reached a $1 million settlement with Globus Medical after investigators had learned that Globus had marketed its NuBone Osteoinductive Bone Graft product without proper premarket approval or clearance.  More egregious errors or lapses in testing could result in even costlier financial repercussions.

ADMET believes in thorough and rigorous testing of medical devices and their components.  Our range of universal testing machines allows device manufacturers to be certain of the strength and durability of their products.  If you believe your company should be doing more materials testing, contact us today and we would be happy to discuss your needs with you.

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