Hazards of hospital bulk oxygen delivery systems.

Numerous problems can occur with liquid oxygen delivery systems, in part because of the complexities of such systems. These systems must comply with guidelines of the Joint Commission on Accreditation of Hospitals. During the past year, 18 major problems with the liquid oxygen delivery system have occurred at the authors' hospital. Five times, false alarms have resulted from calibration drift in line pressure sensors. Thrice, excessive depletion of the reverse supply has occurred because of pressure imbalance between the main and reserve systems. Twice, excessive depletion of the reserve supply occurred owing to failure of the vacuum seal on the reserve supply vessel. Eight other potentially serious mishaps have also been reported. These problems, which are inherent in liquid oxygen delivery systems, are for the most part preventable.

Health device legislation: an overview of the law and its impact on respiratory care.

The Medical Device Amendments of 1976 were intended to protect the public from unsafe and ineffective medical devices. The Food and Drug Administration (FDA) has general authority from this law to regulate medical devices but now must establish specific regulations to do so. In this process all devices are being classified in Class I (general controls), Class II (performance standards), or Class III (premarket approval). General controls impose relatively fewer restrictions, while premarket approval can require very strict laboratory and clinical testing. Classification panels have been grouping medical devices into these three classes. The Anesthesiology Device Classification Panel and the Pulmonary Function and Respiratory Therapy Subcommittee have recommended classifications for more than 200 types of devices. After comments from the public, the FDA will publish final device classifications, probably in 1979. The Medical Device Amendments also provide for release of safety and effectiveness data to the public, for tracing of devices in the field in case of recalls or problems, and for assistance to small manufacturers in complying with the law. The Medical Device Amendments should help to improve medical devices, but official regulations cannot accomplish everything. Users must also do their part by employing preventive maintenance and applying devices knowledgeably and safely.

Contamination of medical gas and water pipelines in a new hospital building.

Medical gases and water were sampled and tested for purity prior to the opening of a 176-bed addition to a 450-bed general hospital. Contamination was found. In delivered oxygen, compressed air, and nitrous oxide, this consisted of a volatile hydrocarbon at an initial concentration of 10 parts per million and a dust of fine gray particulate matter. In water from new taps bacterial contamination with as many 400,000 organisms per 100 ml was present. All these contaminants were considered potential hazards to patient safety. Studies were done to help delineate the nature and origin of these contaminants. Each contaminant was eventually largely eliminated by purging the respective pipeline systems with continuous flows. Planners, builders, and responsible medical personnel must be aware of the potential for such hazards in a new hospital building.