The Role of Forensic Engineering Investigations in Medical Device Reports. Issue 2 (April 2017)

• Record Type: Journal Article
• Authors: Block, Frank E.
• Is Part Of: Journal of clinical engineering. Volume 42:Issue 2(2017)
• Publication Date: 2017-04
• Subjects: Biomedical engineering -- Periodicals; 610.28
• DOI: 10.1097/JCE.0000000000000208
• Languages: English
• ISSNs: 0363-8855

Abstract

Abstract : The complexity of medical devices and their failures has increased dramatically. Understanding device failures from reports submitted to manufacturers and regulatory agencies helps to leverage the lessons learned from previous problems into future successes. User facilities are required to report events when a medical device caused or contributed to patient harm. Unfortunately, reports often do not contain the level of detail required to thoroughly convey the failure event, and this can impede the identification of potentially impactful safety signals. Forensic engineering investigative techniques, when applied, can improve the quality of reports and may contribute to improvements in the design, quality, safety, and effectiveness of medical devices.