Long-term Mechanical Circulatory Support System reliability recommendation by the National Clinical Trial Initiative subcommittee.
The Long-Term Mechanical Circulatory Support (MCS) System Reliability Recommendation was published in the American Society for Artificial Internal Organs (ASAIO) Journal and the Annals of Thoracic Surgery in 1998. At that time, it was stated that the document would be periodically reviewed to assess its timeliness and appropriateness within 5 years. Given the wealth of clinical experience in MCS systems, a new recommendation has been drafted by consensus of a group of representatives from the medical community, academia, industry, and government. The new recommendation describes a reliability test methodology and provides detailed reliability recommendations. In addition, the new recommendation provides additional information and clinical data in appendices that are intended to assist the reliability test engineer in the development of a reliability test that is expected to give improved predictions of clinical reliability compared with past test methods. The appendices are available for download at the ASAIO journal web site at www.asaiojournal.com.
Lee
James
J
Worldheart Incorporated, Oakland, California, USA. jim.lee@worldheart.com
D004867:Equipment Design; D019544:Equipment Failure Analysis / Q000379:methods* / Q000592:standards*; D006353:Heart-Assist Devices / Q000592:standards*; D006801:Humans; D015203:Reproducibility of Results