Our 22nd Year of Publication
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Cover Story

Medical Device Sterilisation : Key Essentials, Options And Challenges

The proper sterilisation of medical devices utilized in direct contact with patient is a critical aspect of the modern health care delivery system and directly impacts patient safety.

The Association for the Advancement of Medical Instrumentation (AAMI) defines sterilisation as: A process designed to remove or destroy all viable forms of microbial life, including bacterial spores, to achieve an acceptable sterility assurance level. Sterility is measured by probability expressed as sterility assurance level (SAL).

Sterilisation processes cannot be considered in isolation; rather, they are inextricably related to the product to be sterilised. They are also related to the packaging of the sterilised product. Except for the rare instances when the steriliser can be located where the sterile goods are to be used, there is a need for the sterilised products to be packaged in a manner that will preserve their sterility during storage, handling, and transport. The majority of sterile goods produced in the medical device industry and in healthcare facilities are terminally sterilised - that is, they are sterilised already packaged. They may be packaged only in their primary packaging or in multiple layers of packaging such as a unit pack, shelf pack, and shipping carton.

The industrial sterilisation market is dominated by two radiation technologies, gamma and electron beam (E-beam); and one gas technology, ethylene oxide (EO).

Increased concern over the toxicity of residuals and of the need to eliminate the use of chlorofluorocarbons (CFCs) has lead to development of new processes.

Regulatory bodies are putting increasing pressure on chemical (EO) and radioactive sterilisation processes. The EU implemented the REACH regulation, aimed at reducing the use of harmful chemicals. In 2013, the EU proposed all medical devices be designed and manufactured in a way that reduces danger from exposure to chemical or nuclear material.

Increasing regulatory requirements have a direct impact on technology processing costs. However, sterilisation industry is not going to change overnight and technology shifts will occur slowly over time.

In this issue, experts share their knowledge, vision and concerns related to Major Sterilisation key essentials, options and challenges.

Key Essentials Of Sterilisation Process

The efficacy of any sterilisation process is contingent on the following three essentials :

1) Conditions must be present to effectively destroy living organisms. In other words, the sterilant and sterilising equipment must be validated and appropriate in design and operation to achieve the correct combination of temperature and sterilant combination to be lethal to microorganisms.

2) Devices to be sterilised must be thoroughly cleaned to reduce bioburden (soil) in order to ensure the effectiveness of the sterilisation process. The higher the bioburden the greater the challenge to the sterilisation process. If bioburden is too great the established sterilisation parameters may not be adequate rendering the sterilisation process ineffective.

3) There must be intimate and adequate contact between the sterilant and all surfaces and crevices of the device to be sterilised.

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