When it comes to the use of medical devices, adverse event reporting is a key factor in maintaining patient safety. Data collected from adverse event reports can be shared with device manufacturers to ensure that defects, usability issues and other problems are properly addressed.
But adverse event reporting can be an imprecise science. One user may report a “breakdown” while another user reports a “failure” for the same event. This lack of standards in terminology has created confusion, said Yadin David, director of Biomedical Engineering Consultants LLC in a recent press release. “Overall, it does not make our field able to focus on the real issues surrounding device safety,” he added.
To help alleviate some of this confusion, the Association for the Advancement of Medical Instrumentation (AAMI) has created a glossary of terms related to adverse events. AAMI’s Clinical Engineering Management Committee (CEMC) created the glossary of about 400 terms by collecting from various sources and references including the FDA, National Cancer Institute Thesaurus, Global Medical Device Nomenclature, ECRI Institute and the International Organization for Standardization.
With alarm fatigue listed as one of the top hospital tech hazards for 2011, it’s not surprising the glossary contains five different terms related to alarms. An alarm could be reported as defective, delayed, low audible, not visible or false.
The CEMC hopes the use of this new glossary will lead to more accurate reporting of adverse events, which in turn will lead to better research and, ultimately, better device safety.