title: Heimlich valve orientation error leading to radiographic tension pneumothorax: analysis of an error and a call for education, device redesign and regulatory action.
abstract: Medical errors are commonly multifactorial, with adverse clinical consequences often requiring the simultaneous failure of a series of protective layers, termed the Swiss Cheese model. Remedying and preventing future medical errors requires a series of steps, including detection, mitigation of patient harm, disclosure, reporting, root cause analysis, system modification, regulatory action, and engineering and manufacturing reforms. We describe this process applied to two cases of improper orientation of a Heimlich valve in a thoracostomy tube system, resulting in enlargement of an existing pneumothorax and the development of radiographic features of tension pneumothorax. We analyse elements contributing to the occurrence of the error and depict the implementation of reforms within our healthcare system and with regulatory authorities and the manufacturer. We identify features of the Heimlich valve promoting this error and suggest educational, design, and regulatory reforms for enhanced patient safety.
authors.affiliation: Department of Surgery/Division of Emergency Medicine, Duke University School of Medicine, Durham, North Carolina, USA.
authors.forename: Joshua S
authors.initials: JS
authors.lastname: Broder
authors.affiliation: Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA.
authors.forename: James W
authors.initials: JW
authors.lastname: Fox
authors.affiliation: Duke University Hospital, Durham, North Carolina, USA.
authors.forename: Judy
authors.initials: J
authors.lastname: Milne
authors.affiliation: Department of Surgery/Division of Emergency Medicine, Duke University School of Medicine, Durham, North Carolina, USA.
authors.forename: Brent Jason
authors.initials: BJ
authors.lastname: Theiling
authors.affiliation: Department of Advanced Clinical Practice, Duke University Hospital, Durham, North Carolina, USA.
authors.forename: Ann
authors.initials: A
authors.lastname: White
mesh_terms: D000328:Adult; D015505:Chest Tubes / Q000009:adverse effects*; D004322:Drainage / Q000379:methods; D004867:Equipment Design; D006801:Humans; D008297:Male; D019300:Medical Errors / Q000517:prevention & control*; D011030:Pneumothorax / Q000209:etiology / Q000628:therapy*; D011785:Quality Assurance, Health Care / Q000379:methods*; D013907:Thoracostomy / Q000193:education / Q000295:instrumentation*