Device Background Checks Could Reduce Safety Hazards - ECRI Institute
This article was originally published in The Gray Sheet
Executive Summary
Safety hazards could be greatly curtailed if more hospitals ran thorough background checks on new medical equipment before they purchase or commission them, according to executives at a non-profit research group
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Widespread failure to follow established cleaning and sterilization guidelines during reprocessing helped place "cross-contamination from flexible endoscopes" at the head of ECRI's list of the 2010 Top 10 Technology Hazards, released Dec. 2 by the nonprofit research group. "The best defense against endoscopy-related cross-contamination continues to be careful development of and strict adherence to comprehensive, model-specific reprocessing protocols," ECRI writes. Alarm hazards come in second on the list, and can be minimized if hospitals look for designs that limit nuisance alarms, which can desensitize staff, "possibly leading them to ignore true hazards," the report advises. Other top 10 hazards for health care providers to monitor include surgical fires; radiation from computed tomography, which the report suggests could be responsible for 6,000 additional cancers each year; devices or fragments left in patients following surgery; needlesticks or other sharps injuries; data communication errors with computerized equipment and systems; surgical stapler hazards; and ferromagnetic objects that can become magnetized in a magnetic resonance imaging environment
Regulatory News In Brief
FDA may post 'untitled' letters online: FDA is considering posting on its Web site "untitled" letters issued to manufacturers. "In an era of enhanced enforcement and greater transparency, that's being discussed," according to Larry Spears, deputy director of regulatory affairs in CDRH's Office of Compliance. His comments came during FDAnews' recent Fourth Annual FDA Inspections Summit in Bethesda, Md. Currently, the agency only posts redacted warning letters online. "Untitled letters don't really meet the threshold of a warning letter," Spears said. "That means they're not significant enough that we would take a follow-up action necessarily with what we see, but there are problems that need to be identified to the company because we've looked at the evidence and believe there are problems. So we want to identify those in an untitled letter.