Just five months after opening its International Research Centre in Malaysia, ECRI Institute announces that it has released its first international device evaluations. The nonprofit organization established the international laboratory to rigorously evaluate medical devices used across all care settings in Europe and Asia.
After all, ECRI Institute officials say, more than 55% of the world’s medical devices are manufactured and sold outside the United States. “By conducting rigorous, hands-on testing of devices, ECRI Institute is helping medical professionals worldwide make informed decisions that improve patient safety,” says Marcus Schabacker, MD, PhD, president and CEO, ECRI Institute. “Often, this work leads to product improvement.”

Among ECRI’s just-released reports are evaluations of surgical lights made in Germany and Italy, and a large-volume infusion pump made in China.

“We uncovered a serious design flaw with the infusion pump that put patients at risk,” says Eric Woo, regional director of ECRI Institute’s Asia-Pacific office. Testing revealed that the infusion mechanism could be loaded backwards, causing it to extract blood from the patient instead of delivering the infusion solution. This delay in treatment would cause severe harm for some patients.

The next international devices to be evaluated include point-of-care blood gas analyzers, portable ultrasound machines, and continuous positive airway pressure (CPAP) units. Evaluations outside the United States are conducted with the same international protocols ECRI Institute has upheld for more than 50 years.

“These international evaluations provide crucial support not only for foreign hospitals and ministries of health, but also for American health systems who are opening facilities in Europe and Asia,” adds Schabacker.