Effective standards and regulatory tools for respiratory gas monitors and pulse oximeters: the role of the engineer and clinician.
Developing safe and effective medical devices involves understanding the hazardous situations that can arise in clinical practice and implementing appropriate risk control measures. The hazardous situations may have their roots in the design or in the use of the device. Risk control measures may be engineering or clinically based. A multidisciplinary team of engineers and clinicians is needed to fully identify and assess the risks and implement and evaluate the effectiveness of the control measures. In this paper, I use three issues, calibration/accuracy, response time, and protective measures/alarms, to highlight the contributions of these groups. This important information is captured in standards and regulatory tools to control risk for respiratory gas monitors and pulse oximeters. This paper begins with a discussion of the framework of safety, explaining how voluntary standards and regulatory tools work. The discussion is followed by an examination of how engineering and clinical knowledge are used to support the assurance of safety.
From the Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland.
Sandy
S
Weininger
D000776:Anesthesiology / Q000295:instrumentation*; D001698:Biomedical Engineering; D002138:Calibration; D003257:Consumer Product Safety; D018795:Device Approval; D004867:Equipment Design; D004868:Equipment Failure; D006801:Humans; D033183:Interdisciplinary Communication; D008422:Materials Testing; D008991:Monitoring, Physiologic / Q000009:adverse effects / Q000295:instrumentation* / Q000592:standards; D010092:Oximetry / Q000009:adverse effects / Q000295:instrumentation* / Q000592:standards; D010819:Physician's Role; D017410:Practice Guidelines as Topic; D024382:Professional Role; D011786:Quality Control; D015203:Reproducibility of Results; D018570:Risk Assessment; D013997:Time Factors; D012122:Ventilators, Mechanical