title: The human factors implications of peritoneal dialysis: cycler overfill incident reports.
abstract: Serious errors can occur with many medical devices (e.g., infusion pumps, ventilators, anesthesia machines), and even highly trained professionals can make critical errors. The FDA now requires that manufacturers consider the user when designing medical equipment and has issued a guidance document describing human factor (HF) problems and the HF design process. The Association for Advancement of Medical Instrumentation has also published guidelines, and the American Medical Association's National Patient Safety Foundation has selected reduction of medical errors as their mission. It is important that the medical community reinforce the patient-safety initiative by evaluating user-interface design and instructional manuals when purchasing such equipment. The payoff will be fewer incidents and less time required in device training. The FDA actively solicits help in identifying and reporting adverse events associated with medical devices. Health care practitioners employed by facilities subject to the FDA's user-facility reporting requirements should follow the user-reporting procedures established by their facility. Practitioners and users may want to directly report an incident to the MedWatch Program, the FDA's voluntary Medical Products Reporting Program.
authors.affiliation: US FDA, Center for Devices and Radiological Health, Rockville, Maryland 20857, USA.
authors.forename: M H
authors.initials: MH
authors.lastname: Reid
authors.forename: D
authors.initials: D
authors.lastname: Sawyer
mesh_terms: D000368:Aged; D004867:Equipment Design; D004868:Equipment Failure; D006804:Ergonomics; D017809:Fatal Outcome; D006801:Humans; D007223:Infant; D010530:Peritoneal Dialysis / Q000295:instrumentation* / Q000401:mortality* / Q000451:nursing; D012308:Risk Management