ECRI Institute said it is launching its first medical device evaluation laboratory outside the United States.
The ECRI International Research Centre in Selangor, Malaysia will evaluate medical devices used across all care settings in Europe and Asia to help medical professionals make informed decisions that improve patient safety, according to the nonprofit, independent organization. It is scheduled to open April 11.
Devices sold internationally will be evaluated in Malaysia under the same protocols ECRI Institute has used in the U.S. for more than 50 years. A U.S. team has trained Malaysian engineers to ensure accuracy, consistency and quality control, the organization said.
The international evaluation program will assess performance, workflow, maintenance, safety and human factors usability for all technologies under review. The first devices to be evaluated include large-volume infusion pumps, surgical lights, point-of-care blood gas analyzers, portable ultrasound machines, continuous positive airway pressure (CPAP) units and digital radiography systems.
“This research will help us better understand the safety and effectiveness of medical devices used around the world,” said ECRI president & CEO Dr. Marcus Schabacker in a prepared statement. “That’s important to our international members as well as to foreign ministries of health.”
“The establishment of this research facility opens up many possibilities for the future,” added Eric Woo, regional director of ECRI Institute’s Asia-Pacific office, “including possible collaborations with government regulators.”
Other plans include using the lab for training programs and for accident investigations involving medical devices. ECRI established its Asia-Pacific office more than 20 years ago to support healthcare technology decision making and patient safety throughout the region.
In July 2018, ECRI Institute said it would replace the U.S. National Guideline Clearinghouse (NGC) website, shuttered by the federal government after 20 years, and run it privately. Funding to support the federal Agency for Healthcare Research and Quality’s (AHRQ) clinical practice guideline website ended on July 16. ECRI Institute developed and maintained NGC since its inception in 1998.
