Act to keep patients safe: device-related adverse event reporting.
Primum non nocere- "Above all do no harm." Since the first year of medical school, we have all heard and spoken this dictum countless times. Translating this dictum into action may present challenges in our daily practice. Every day, clinicians must distinguish between scientific evidence, clinical experience, and marketing claims by industry vendors of improved efficacy and safety regarding medical devices. Adverse event reporting and device failure notification are generally laid out well in hospital practice settings. Reporting beyond the local level takes on a new dimension for most surgeons. Perceived stigma from peers and corporations, lack of confidentiality, and cynicism regarding protective actions for patients should not limit one from "raising the alarm" when concerns arise about device safety or performance. This commentary aims to explain the process for reporting device-related adverse events.
Schoem
Scott R
SR
Department of Otolaryngology, Connecticut Children's Medical Center, Hartford, CT, USA.
Shah
Udayan K
UK
D004864:Equipment and Supplies / Q000009:adverse effects* / Q000592:standards; D010036:Otolaryngology; D011358:Product Surveillance, Postmarketing; D012449:Safety