The Clarifying Remanufacturing to Protect Patient Safety Act of 2022—a bill that would seek to define remanufacturing as repackaging a device, changing its labeling, or “engaging in any act that could significantly change the performance or safety specifications, or intended use”—was stalled by a large collective of health network leaders, hospitals, ISOs, and other industry professionals.
Along with leaders from health networks with a combined 253 hospitals, 11 independent service organizations and three biomedical professional societies, U.S. PIRG was able to help stall a manufacturer-backed amendment to the Medical Device User Fees Amendment (MDUFA), a must-pass piece of legislation, on Wednesday.
The bill, H.R. 7253 introduced by Rep. Scott Peters (CA), would have instituted a broad definition of “remanufacturing” that could regulate some hospital biomedical depts and independent service organizations (ISOs) out of existence, harming patient safety and healthcare costs in the process.
Read the full article at U.S. PIRG.