- ECRI Institute, a nonprofit patient safety organization, will open its first medical device evaluation laboratory outside the United States on April 11 in Selangor, Malaysia.
- The ECRI International Research Centre will conduct rigorous testing on technologies' performance, workflow, maintenance, safety and usability, the organization said Thursday. The independent lab will evaluate medical devices used across all care settings in Europe and Asia.
- The first devices up for review 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, ECRI said.
Pennsylvania-based ECRI is designated as an Evidence-based Practice Center by the Agency for Healthcare Research and Quality. ECRI Institute PSO is listed as a federally certified Patient Safety Organization by HHS.
The organization established its Asia-Pacific office more than 20 years ago to support healthcare technology decision making and patient safety throughout the region. It also has regional offices in the United Kingdom and United Arab Emirates.
Devices sold internationally will be evaluated in Malaysia with the same rigorous protocols ECRI has always followed, it said. The international evaluation program in Malaysia will assess performance, workflow, maintenance, safety and human factors usability for all technologies under review. Its U.S. team trained Malaysian engineers for accuracy, consistency and quality control.
Other plans include using the lab for training programs and for accident investigations involving medical devices.
"The establishment of this research facility opens up many possibilities for the future, including possible collaborations with government regulators," Eric Woo, regional director of ECRI Institute's Asia-Pacific office, said in a statement.
The institute was founded 50 years ago after a malfunctioning medical device caused a child’s death in a Philadelphia emergency room. It touts the strictest conflict-of-interest rules in the healthcare industry and transparent reporting.
ECRI says that more than 5,000 healthcare institutions and systems worldwide, including four out of every five U.S. hospitals, use its services to guide their operational and strategic decisions. Clients include public and private payers, federal and state agencies, policymakers, ministries of health, associations and accrediting agencies.
The nonprofit publishes an annual Top 10 Patient Safety Concerns list. Earlier this month it released its 2019 list, which named diagnostic errors and improper management of test results in electronic health records as the most pressing patient concerns facing healthcare leaders.
Last year, the institute developed the ECRI Guidelines Trust, a publicly available repository of clinical guidelines, in response to the federal government’s defunding of the National Guideline Clearinghouse.