Question: I re-cently
attended the IAHCSMM meeting in Cleveland. At one of the sessions there
was a lot of discussion relative to the varied extended sterilization
exposure and cycle times that are now being required by many device
manufacturers, especially orthopedic instrument and loaner tray
manufacturers. Most of these sets are extremely heavy and require a
longer exposure time and longer dry time, and the excessive weight of
the sets causes tears and holes in sterile wraps. Many CS practitioners
do not feel confident that sterilization is being achieved at these
extended sterilization cycle times since some sterilizer, packaging and
BI manufacturers have not validated their devices at the extended cycle
parameters. Many in attendance felt that practitioners should lobby to
have a weight limit of 25 lbs. or less placed on medical devices and
instrument sets intended for sterilization. As a panelist at one of
these sessions you seemed to be opposed to the weight restriction; why
is that?
Answer: Placing an
arbitrary weight restriction on devices intended for sterilization, in
my opinion, is an irrational and myopic response to a multi-faceted
issue. It assumes that these extended cycle parameters are a result of
the weight of the set or the medical device and that miraculously any
item below a certain weight can be sterilized easily at a lesser
exposure time. In actuality, weight alone has little to do with the
sterilization parameters. Density and metal mass may impact the time
required to reach temperature and may contribute to condensate and
affect drying time but this is not always the case. Many of the devices
and instrument sets that require the extended times are the result of
the complex design of the devices themselves and not merely weight. Many
devices have mechanical gears, movable parts, long narrow lumens,
channels, serrations, grooves, internal components and are made of
porous compositions which all present a greater challenge to the
sterilization process thus requiring special cycle parameters. Therefore
sterilization efficacy cannot be governed or controlled exclusively by
weight limitations. If a manufacturer of an instrument set, medical
device or container which is >25 lbs. can provide sterilization
validation and documentation consisting of both controlled lab and real
hospital testing and they have FDA 510k clearance to market their
product, they should not be precluded from doing such. Ergonomics and
worker safety are separate issues from sterilization efficacy and must
be addressed separately. If a user chooses to breakdown a validated set
into smaller components, in like packaging, for ergonomic reasons, they
can be confident of the sterilization efficacy based on the validation
and sterilization instructions provided by the manufacturer. In
addition, a weight restriction of devices >25 lbs. would have the
following adverse affects:
•Many critical devices
and instruments currently used exceed the weight limit and their use
would be curtailed, or in some instances, completely eliminated e.g.
Bookwalters, Iron intern, etc.
•Most surgical instrument
sets currently weigh between 15 - 25 lbs. (many are at higher weights).
Sterilization containers and cases range between 10 – 12 lbs. To comply
with a 25 lb. limit, hospitals may have to revert to the use of more
costly and inferior wrap packaging materials or increase container
inventory by 2 –3 times.
•Production costs would
increase as a result of more packages to be processed.
•Additional sterilizers
may be required to handle increased volume and through put resulting
from breaking components down to meet weight restrictions.
•More space would be
required to store and hold additional packages and sets approximately
twice as much as is currently used - both in CPD and OR.
Sterilization, medical
device, and container technology is evolving. Some instrument and
container manufacturers are working collaboratively and we know it is
possible to effectively sterilize contained devices at much heavier
weights and it is often possible, with appropriate assembly and
packaging, to do this within the current cycle parameters. Users need to
carefully select medical devices, and manufacturers who are responsive
and sensitive to their needs. Containment devices are not all equal some
are superior when it comes to sterility validation and universal
applications. The issue of logistics, weight and ergonomics can be
addressed by individual hospital policy, procedures, proper equipment
and good work practices
Question: When working in
the core I have often observed nurses coming out of a room and washing
instruments in the scrub sink prior to flashing them. When I question
them they claim it is just a few items that need to be flashed quickly
and they have no time to bring them to the utility room. Is this an
acceptable practice?
Answer: Instruments
should not be washed in the scrub sink or any sink used for hand
washing. The same principles for decontamination and cleaning apply
regardless of where the process is conducted. The scrub sink area is not
designed for decontamination of surgical instruments, and the necessary
supplies, detergents, brushes, protective attire and the like are not
readily available. Decontamination techniques must be adhered to
including environmental control. Appropriate personal protective
equipment must be worn to protect personnel from exposure to bloodborne
pathogens. Washing contaminated instruments in a scrub sink is an
unacceptable practice and can pose a risk to both patients and personnel
through cross contamination of microorganisms and pathogens left behind
after washing the instruments. Cleaning is the first and most critical
step in the sterilization process, including flash sterilization. It
should not be abbreviated for the sake of convenience. Shortcuts should
not be taken in any part of the sterilization process, including the
decontamination process. HPN
Ray Taurasi is Director
of Professional Services for Case Medical Inc. Ridgefield, NJ.
