Cleaning of reusable medical devices

摘要

Work has begun on a much needed new Australian Standard for the Performance of formulated cleaning products for the cleaning of reusable medical devices and equipment in health care, following a request made by the Medical Industry Association of Australia. A special Working Group, under the responsibility of Committee HE-023, held its inaugural meeting in mid-December and decided on the best possible approach to what is undoubtedly a difficult subject matter. Cleaning products are covered under the new Medical Devices Legislation and are classified as a Class 1 accessory to a medical device. The products need to meet the mandatory Essential Principles which cover safety and performance. The future Standard may not be mandatory, but if a manufacturer claims compliance with the Standard, then that manufacturer is deemed to meet the Essential Principles.