A 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.
In a statement, ECRI Institute President and CEO Marcus Schabacker, MD, PhD, addressed the reports, commenting that “simply raising awareness is not enough to improve medical device safety.” ECRI Institute’s mission, for instance, has always been to “provide evidence-based guidance and actionable recommendations to the healthcare community”—something, he says, that “creates free-market pressure that drives manufacturers and regulators to take concrete actions that keep patients safe.”
In the past two years, ECRI Institute’s engineering team has performed 170 evaluations on medical devices in 50 categories, including patient monitoring, imaging, infusion therapies, anesthesia and respiratory care, and infection reduction, Schabacker says in a statement. “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,” he adds.
Schabacker touts this as the best approach to facilitate medical device safety. “More than 5,000-member healthcare organizations worldwide rely on ECRI Institute to guide their procurement and safety decisions,” he says. “We follow a strictly enforced conflict-of-interest policy, which ensures our objectivity and integrity.”
Even so, he says that ECRI Institute acknowledges that additional steps need to be taken to keep patients safe. “We are committed to continuing our market-pressure approach to make medical devices safer,” Schabacker says. “We welcome full collaboration with the healthcare community and all interested parties to continue our important work.”