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Expression of Continuous Transcutaneous Recordings of P o2
Author(s) -
Watts J. L.,
Sinclair J. C.
Publication year - 1978
Publication title -
acta anaesthesiologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.738
H-Index - 107
eISSN - 1399-6576
pISSN - 0001-5172
DOI - 10.1111/j.1399-6576.1978.tb01401.x
Subject(s) - medicine , set (abstract data type) , medical physics , medical emergency , reliability engineering , computer science , engineering , programming language
The Medical Devices Amendments of 1976 (PL 94–295) will compel users of transcutaneous monitors to comply with Class 11, Performance Standards. These standards will have to provide reasonable assurance of the safety and effectiveness of the device. Similar standards are in preparation for other cardiac and respiratory monitors. Dangers of tcPoz monitors include shock and burn, which requires attention to the insulation of the monitor from the power line and from recorders used to record the output. Optimal safe time vs. temperature limits have not yet been established, and these may vary with age, skin site, blood pressure and body and environmental temperature. The usefulness of alarms for Po2, sensor temperature and heating power, and their limits remain to be defined by extensive clinical use. Standards for drift, reproducibility, recalibration interval and accuracy willhave to be set after more extensive clinical use especially by groups not involved in thinitial prototype development and testing. In order to prove that these devices are also effective, physicians will have to document that care would have been different, and mighthave impaired patient safety, if the device had not been used.