The Principles of Medical Device Decontamination

Procedures that the requirements of the standard have been deemed to address is assumed.

Key aims and principles of Standards

Standards are not necessarily mandatory or have a direct legal obligation, but they do form the basis of ‘best practice’- a methodology that, through experience and research, has proven to reliably lead to a desired result. This usually results in a pragmatic direction that allows a clear interpretation of the legal requirements.

Future trends in Healthcare Standards

Health care decontamination standards have evolved significantly over the last 20 years; the publication of many European standards within Europe has given a uniform approach from within the European Union. Increasingly, the Vienna Agreement has seen many ISO standards adopted as EN ISO standards, giving a globally harmonised approach to decontamination practice. There are, however, still necessary differences between health care practice and industrial practice in the pharmaceutical and medical device areas. These differences stem from the consistent load and consistent process approach used in industry to the variable and unpredictable load approach found in hospitals. These differences will always exist, however increasingly the disparities are being reduced as a consequence of possibly the biggest trend in standardisation currently, of using a science- based or evidence-based approach as the basis of standards decision making. Historically standards evolved from a combination of scientific principles coupled with strong personal views of opinion makers. Many of these principles and views were well founded, and form the basis of common practice found today, but when opportunities exist to re-think or justify a historical approach, an evidence-based or scientific rationale is increasingly required. Many of these principles and views were well founded, and form the basis of common

i In the context of European harmonised standards, Annex Z (or Annex ZA, ZB, ZZ) is an informative annex that links a standard to the essential requirements of relevant EU directives or regulations. It clarifies which clauses of the standard support which specific requirements of the legislation, providing a bridge between technical standard and the legal framework.

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