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Medical Device Ethylene
Oxide (ETO/EO) Sterilization: Validation and other
challenges
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Mr. Sanjay Shah
Director
Unikal Consultants |
What is a medical device? A
definition is referred in article in this Issue.
Why there is an emphasis on medical
device with right quality and performance?
This is to elevate the focus of all
medical device stakeholders from baseline regulatory
compliance to sustained, predictive practices that
advance medical device quality and safety to achieve
better patient outcomes.
Quality standards which are
established should be treated as base line and not the
ceiling of quality.
We are consistently talking of Make
in India and export to the world with acceptable
quality. We must also work on make for India. We
should expect and demand same quality of healthcare
products; medicines and medical devices, that is
available in the developed world. We must get the same
treatment with our experienced medical fraternity, in
the environment and, with healthcare products of world
class quality. |
In medical device field, it must be
designed with the latest technology and made of the
material accepted all over. More on this and where we are
lacking can be the content of a separate article. Today we
are talking of specific requirements and challenges of EO
sterilization process and validation.
Why some medical devices need to be
sterilized?
A sterile medical device is one that is
free of viable microorganisms. Medical devices produced
under standard manufacturing conditions in accordance with
the requirements for quality management systems (EN ISO
13485 and acceptable under MDSAP); might, prior to
sterilization, have microorganisms on them, albeit in low
numbers. Such medical devices are nonsterile. The purpose
of sterilization is to inactivate the microbiological
contaminants and thereby transform the nonsterile medical
devices into sterile ones.
The kinetics of inactivation of a pure
culture of microorganisms by physical and/or chemical
agents used to sterilize medical devices can generally
best be described by an exponential relationship
between the numbers of microorganisms
surviving and the extent of treatment with the ethylene
oxide (EO); inevitably this means that there is always a
finite probability that a microorganism might survive
regardless of the extent of treatment applied.
Challenge is to reduce the same to a level
acceptable in the current scenario. To do so, not only the
equipment, methodology and sterilant used is appropriate,
a validation of the process and equipment needs to be
done. Basis for this article arises from these
requirements.
For a given treatment, the probability of
survival is determined by the number and resistance of
microorganisms and by the environment in which the
organisms exist during treatment. It follows that the
sterility of any one medical device in a population
subjected to sterilization processing cannot be guaranteed
and the sterility of a processed population is defined in
terms of the probability of there being a viable
microorganism present on a medical device.
What are the challenges: To achieve
certain level of acceptable sterility level, many factors
need to be considered. Type of materials the medical
device is made from, manufacturing process, packaging
line, packing material compatibility, and bio load on the
medical device; final application, or use of the medical
device is a critical factor as well.
Challenges start in finding right
sterilization method, which is effective, cost effective,
safe to use, has long history of use, and handling of the
sterilant and equipment is acceptable.
Why Is Ethylene Oxide Used to Sterilize
Medical Devices?
Ethylene oxide sterilization is an
important sterilization method that manufacturers widely
use to keep medical devices safe. Learn more about
sterilization methods in the Submission and Review of
Sterility Information in Premarket Notification (510(k))
Submissions for Devices Labeled as Sterile Guidance. (ref
- FDA Guidelines)
Literature shows that about fifty percent
1,2,3 of all sterile medical devices in the U.S. are
sterilized with ethylene oxide. The types of devices that
are sterilized with ethylene oxide range from devices used
in general health care practices (for example, wound
dressings) to more specialized devices used to treat
specific areas of the body (for example, stents).. |
