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.
House Energy & Commerce Chair Frank Pallone explains that changing the definition of remanufacturing is too controversial to include in a consensus bill.