Cleaning, Disinfection, and Sterilization Validations: Considerations in Reusable Device Design
The colonoscope is a semi-critical
device because it contacts the mucous
membrane of the colon. Therefore, it
must be thoroughly cleaned and disinfected
using a high level disinfectant.
However, full liquid immersion or high
temperatures can harm the device and
the fragile camera lens. Given these constraints,
it was determined that manual
cleaning and disinfection using CIDEX
would be appropriate. CIDEX is no
longer commonly used, but at the time
of this validation it was one of the most
commonly used methods for endoscope
cleaning. CIDEX provides high-level disinfection
without corroding delicate
device parts.
The device was first cleaned with
water by partially immersing the device
and using a soft sponge and water to
clean the non-immersible parts. Next,
the device was partially immersed in
CIDEX OPA to enhance the cleaning.
To disinfect the colonoscope, CIDEX
Activated Dialdehyde Solution was
used. The colonoscope was again partially
immersed and was soaked for 12
minutes. A sponge was used to thoroughly
apply CIDEX to the nonimmersible
areas of the device. This
combination of soaking and sponge
application of disinfectant achieved the
required microbial reduction while
protecting the delicate instrumentation
of the colonoscope.
Summary
A great deal of thought goes into the
design of any medical device, and engineers
should be encouraged to thoroughly
examine the ways in which the
design of their device can facilitate or
hinder reprocessing. The best device
design facilitates the use of the device,
and also facilitates the reuse of the
device. However, some devices, in the
initial design, prove so difficult to
reprocess that the design must be
altered to facilitate cleaning and reuse.
By understanding the choices made in
creating a reprocessing methodology
and how device design and use puts constraints
on the reprocessing method,
engineers can save significant amounts
of time and speed device approval,
thereby ensuring that their devices get
to market as quickly as possible.
This article was written by Maria Lilibeth
Samillano, M.D., Microbiologist and Device
Team Leader; Diana Louie, Microbiologist;
and Aaron Burke, Director of Business
Development for Pacific BioLabs, Hercules,
CA. For more information, visit http://info.hotims.com/40429-163.
