Sixteen hospitals failed to submit required reports related to contaminated scopes.
The Los Angeles Times reported that a “Senate investigation of deadly infections spread by contaminated scopes found that not one of the 16 or more American hospitals where patients were sickened appeared to have properly filed” a “report required when a medical device kills or seriously injures a patient.” The “mandatory federal reports are meant to alert regulators to dangerous defects in devices so that lives can be saved.” Food and Drug Administration spokesperson Deborah Kotz said hospitals can face fines and other penalties for not filing the mandatory reports. According to Kotz, the FDA has “investigated cases and taken compliance actions but we are not aware of criminal prosecutions that have resulted from a failure to report adverse events.”
Kaiser Health News reports that a Senate investigation into tainted medical scopes “found that 16 hospitals around the US failed to file mandatory paperwork with the federal government after patients at their hospitals became infected or died.”
