More needs to be done to ensure safety of medical devices

A widely publicized series of reports issued recently by the International Consortium of Investigative Journalists is making people aware that more than 1.7 million injuries and about 83,000 deaths worldwide over a 10-year period may have been caused by defective medical devices (“Device that’s alternative to opioids shocks, burns patients,” ModernHealthcare.com, Nov. 25).

The ICIJ reports point to potential serious systemic problems in the medical device industry, such as insufficient testing, inadequate regulation and financial conflicts of interest.

For the ECRI Institute, simply raising awareness is not enough to improve medical device safety. Our mission has always been to provide evidencebased guidance and actionable recommendations to the healthcare community. This creates free-market pressures that drive manufacturers and regulators to take concrete actions that keep patients safe.

In the past two years, our engineering team conducted 170 evaluations on devices in 50 medical categories, including anesthesia and respiratory care, imaging, infection reduction, infusion therapies and patient monitoring. As a result, manufacturers voluntarily made significant improvements to 55 medical devices—improvements directly attributed to ECRI’s research and influence in the healthcare community.

We believe our approach is the quickest, most-effective way to make medical devices safer. And we’re the only independent organization in the world doing this.

ECRI agrees that more needs to be done to ensure patient safety. We are committed to continuing our market-pressure approach to make medical devices safer. We welcome full collaboration with the healthcare community and all interested parties to continue our important work.

Dr. Marcus Schabacker President and CEO ECRI Institute Plymouth Meeting, Pa.