Medical device error and failure reporting: Learning from the car industry

Background Improving the design of technology relies in part, on reporting performance failures existing devices. Healthcare has low levels formal and failure medical equipment. This paper examines methods car industry healthcare aims to understand differences identify opportunities for improvement within healthcare. Methods A literature search was carried out Pubmed, Medline, Embase, Engineering Village, Scopus. NHS England MHRA publications guidelines were also reviewed. Focus placed current system both industries, known degree patient harm, initiating factors, barriers, quality incident investigation their validity. The findings used compare error two industries. Results Derivation data from different sources means full extent harm is not known. For example, 2012 there 13,549 38,395 incidents reported by NRLS (National Reporting Learning System) respectively leading uncertainties problem. emphasises role source ensuring quality. Utilising some aspects this approach might benefit reporting. These include a specific that stresses importance organisational learning improving safety recognises limitations root cause analysis. Conclusions systems may help sector improve its own reporting, aiding performance.