ECRI Institute, an independent, trusted authority on medical practices and products, is launching its first medical device evaluation laboratory outside the US.
Image: ECRI Institute has opened international medical device evaluation center in Selangor, Malaysia. Photo: courtesy of anankkml / FreeDigitalPhotos.net.
The ECRI International Research Centre will conduct rigorous, hands-on testing and evaluation of devices to help medical professionals make informed decisions that improve patient safety. The independent lab, located in Selangor, Malaysia, will evaluate medical devices used across all care settings in Europe and Asia.
“This research will help us better understand the safety and effectiveness of medical devices used around the world,” says Marcus Schabacker, MD, PhD, president and CEO, ECRI Institute. “That’s important to our international members as well as to foreign ministries of health.”
Devices sold internationally will be evaluated in Malaysia with the same independent, rigorous protocols ECRI Institute has upheld for more than 50 years. ECRI Institute’s experienced U.S. team trained Malaysian engineers to ensure accuracy, consistency and quality control.
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.
“The establishment of this research facility opens up many possibilities for the future,” says 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 twenty years ago to support healthcare technology decision making and patient safety throughout the region.
Source: Company Press Release