Safety and efficacy of extracorporeal blood oxygenators: a review.
A review of the scientific literature relative to safety and efficacy of disposable blood oxygenators, augmented by 20 years of clinical and laboratory experience utilizing heart-lung bypass devices, has produced tables and lists describing clinical problems associated with the use of disposable blood oxygenators, basic requirements for an effective and safe oxygenator, and parameters of oxygenators requiring testing for safety and efficacy. The current status of voluntary guidelines and regulatory standards for oxygenator safety and efficacy is reviewed.
D000056:Accident Prevention; D001769:Blood; D010106:Oxygenators / Q000009:adverse effects / Q000592:standards*; D013523:Surgical Equipment / Q000592:standards*