ECRI Institute Issues First International Medical Device Evaluations
Guidance released in celebration of International Patient Safety Day, September 17
September 16, 2019
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 firstname.lastname@example.org, or (610) 825-6000, or the Asia-Pacific regional office at email@example.com or +603-5613-2919.
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About ECRI Institute
ECRI Institute is an independent, nonprofit organization improving the safety, quality, and cost effectiveness of care across all healthcare settings. The combination of evidence-based research, medical device testing, and knowledge of patient safety makes ECRI uniquely respected by healthcare leaders and agencies worldwide. For more than 50 years, ECRI Institute has had an unwavering dedication to transparency and strict conflict-of-interest policies. The organization has earned a reputation as the trusted voice of unbiased, research-based assurance for tens of thousands of members around the world using its solutions to minimize risk and improve patient care.
ECRI Institute has the only medical device testing labs in North America and the Asia Pacific where biomedical engineers conduct hands-on independent device testing for safety and human factors usability. ECRI Institute is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. ECRI Institute PSO is listed as a federally certified Patient Safety Organization by the U.S. Department of Health and Human Services.
Visit www.ecri.org and follow @ECRI_Institute to learn more.
For more information, contact:
Laurie Menyo, Director of Strategic Communications
(610) 825-6000, ext. 5310