ECRI INSTITUTE ISSUES FIRST INTERNATIONAL MEDICAL DEVICE EVALUATIONS

Guidance released in celebration of International Patient Safety Day, September 17

PLYMOUTH MEETING, PA—ECRI Institute, an independent, trusted authority on medical practices and products, has released its first international device evaluations just five months after opening its International Research Centre in Malaysia. ECRI established the international laboratory to rigorously evaluate medical devices used across all care settings in Europe and Asia.

More than fifty five percent 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 independent, rigorous 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.

Members of ECRI Institute’s Technology Decision Support services can access the Health Devices evaluations by logging into the membership website at www.ecri.org. Additional resources are available on ECRI Institute’s International Patient Safety Day Resource Center. To learn more about ECRI Institute, contact the U.S. headquarters at clientservices@ecri.org, or (610) 825-6000, or the Asia-Pacific regional office at asiapacific@ecri.org or +603-5613-2919.