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Source: Wikimedia Commons and CBS Television

Poor Research Quality Hits FDA Approved High-Risk Devices?!

Elizabeth Hofheinz, M.P.H., M.Ed. • Thu, May 25th, 2017

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When it comes to high-risk medical device, how safe is safe? How effective is effective? Researchers from the School of Medicine at the University of Missouri in Kansas City were determined to find out.

Their research, “The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices,” was published in the May 3, 2017 edition of The Journal of Bone and Joint Surgery.

Jordan Barker, M.D., senior orthopedic surgery resident at the University of Missouri, and a co-author on the study, told OTW, “FDA device regulation is a fascinating yet controversial topic, highlighted both in the peer-reviewed literature and lay press. Our particular area of interest was the quality of research a device manufacturer must demonstrate for their device to be deemed safe and effective by the FDA. Two studies have been published in the cardiology literature regarding device research methodology, but none in orthopaedics. With more and more devices reaching market each year, we felt this was the opportune time to investigate this topic.”

“We utilized the publicly accessible Summaries of Safety and Effectiveness Data, found in the FDA online database. These summaries include details of the research submitted by device manufacturers seeking approval by the FDA.”

“We analyzed 41 high-risk orthopaedic devices that were FDA approved in the last 15 years. Ninety percent [90%] of these devices utilized just one supporting clinical study. Ninety-four percent [94%] of the studies were prospective, 76% randomized, and 96% controlled in some form. Only 60% of studies utilized blinding (of the 35 studies reporting blinding). Our investigation manifests the variability in reporting and strength of clinical research methodology accepted by the FDA to approve high-risk orthopaedic devices.”

“We were surprised by the variability of study methodology accepted by the FDA to support high-risk device approval. Some devices were approved using a single case series while others were substantiated by a double blinded randomized controlled trial.”

“We urge all orthopaedic surgeons to become more familiar with the FDA device process, and better understand the research accepted by the FDA to approve a device. This study demonstrates that many high-risk orthopaedic devices currently being implanted may not have been investigated using standardized methods intended to minimize bias.”

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