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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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