Designing a pulse oximeter safety standard.
The development of a safety standard is a time-consuming and complex task. Many factors influence the stringency of the requirements, including history with the products and test methods, safety records, and the intended use of the standard and device. Four primary issues are used to illustrate the complexity of developing a safety standard for today's complicated software-controlled pulse oximeters: Can a patient simulator be used to assess performance? What is meant by motion artifact resistance? What is a safe surface temperature limit for the probe? What default low SpO2 limit should be required? Under ASTM's new standards development paradigm, ASTM may achieve consensus on the 2001 draft of ASTM F1415 but not publish it, electing instead to submit the standard to ISO for consideration as the internationally harmonized pulse oximeter safety standard.
Weininger
Sandy
S
Office of Science and Technology, Center for Devices and Radiological Health, US FDA, Rockville, MD 20857, USA. sxw@cdrh.fda.gov
D002138:Calibration; D006801:Humans; D010092:Oximetry / Q000592:standards*; D016544:Patient Simulation; D012449:Safety; D013696:Temperature