Title: Medical devices: a new approach to the quality dilemma
Abstract: 49 One of the odder aspects of society's reaction to technological advance is its sometimes inconsistent attitude to risk. This is particularly striking in the field of medicine. The unavoidable risks accompanying the growth of medical technology have sometimes been ignored until serious accidents occurred, and the attention of regulators and the public alike has commonly been devoted to selected issues to the neglect of others. Whereas the quality of drugs and medicines, for example, has occupied society intensively for at least a century, the technical quality of devices, instruments and materials has in most countries received little attention. And in those few countries where an attempt has been made to address the issue, much of the effort has so far gone into risk assessment and information programmes and very little into quality assurance, quality management and quality control. Have the risks been underestimated, or has society simply not known how to approach them? It is more than evident that a broad range of health care workers are today very much dependent in their work on apparatus and materials; a hospital is as dependent upon its equipment as a factory. If health care is to function properly, the right devices must be purchased and installed; they must function as reliably as they are supposed to do; and staff must be trained to maintain them and use them properly and to carry out necessary repairs when needed. That faults in all these respects impede medical care, cause injury and in the worst case cost lives goes almost without saying, although the consequences of failure often do not become public knowledge. If one can, on the other hand, ensure that proper standards are both set and met, one will have provided a cornerstone to quality assurance in health care as a whole.
Publication Year: 1990
Publication Date: 1990-01-01
Language: en
Type: article
Indexed In: ['crossref', 'pubmed']
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