Awareness Alone Won’t Improve Medical Device Safety

By Marcus Schabacker, MD, PhD, President and CEO, ECRI Institute

December 11, 2018

A widely publicized series of reports issued by the International Consortium of Investigative Journalists (ICIJ) are making people aware that, over a 10-year period, more than 1.7 million injuries and about 83,000 deaths worldwide may have been caused by defective medical devices.

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 ECRI Institute, simply raising awareness is not enough to improve medical device safety. Our mission has always been to provide evidence-based guidance and actionable recommendations to the healthcare community. This creates free-market pressure that drives 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.

More than 5,000-member healthcare organizations worldwide rely on ECRI Institute to guide their procurement and safety decisions. They trust us because we’re unbiased, independent, and speak truth to power. We follow a strictly enforced conflict-of-interest policy which ensures our objectivity and integrity.

ECRI Institute 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.

About Marcus Schabacker
Marcus Schabacker is a board-certified anesthesiologist and intensive care specialist with 25 years of healthcare experience and more than 18 years of senior leadership responsibilities serving the medical device and pharmaceutical industries across the healthcare industry. He is president and CEO of ECRI Institute, an independent, nonprofit organization that serves as a trusted authority on healthcare practices and products that improve the safety, quality, and cost-effectiveness of patient care.

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