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Questions can be sent
to:jakridge@hpnonline.com
called in to Jeannie Akridge at HPN:(941) 927-9345 ext.202
or mailed to:
HPN CS Questions, 2477 Stickney Point Road, Suite 315B,
Sarasota, FL 34231
Names and hospital identification will be withheld upon
request. |
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Is manual cleaning enough? Peel pouch size? Count sheets in trays?
by Ray Taurasi
Q I am a sales representative, and I recently spent
several days working at a hospital where I was assisting a customer in the
implementation of a new product. I observed that items being manually cleaned in
the decontamination area were being passed through to the preparation and
Sterilization area without being disinfected. I was of the opinion that all
items needed to be disinfected either via a thermal or chemical process in order
to render them safe to handle during further processing. By not disinfecting
items after cleaning aren’t the CS workers being placed in risk of cross
infection?
A The objective of decontamination is to clean
medical devices and to reduce the bio burden for both personnel safety and to
ensure intimate contact with sterilants or disinfecting agents. Excessive bio
burdens could impact the efficacy and ability of sterilants to be effective
within the established parameters. Depending on the level of decontamination
required the final phase of the decontamination process may or may not include a
microbial process. The complexity and design of a medical device may affect this
decision. As with any process the instructions of the medical device
manufacturer regarding care, handling, decontamination and sterilization must be
followed.
To assure users that an item can be successfully decontaminated, the medical
device manufacturer is required to provide decontamination recommendations that:
a) provide for thorough cleaning of the medical device and the defined
microbial lethality; where appropriate this should include instructions for
manual and or automated washers – this may or may not include a microbial
process following decontamination
b) can be performed in the healthcare facility using commonly available
chemicals, supplies, and equipment;
c) can be replicated by healthcare personnel
It is important to remember that decontamination/disinfection processes do
not render an item sterile – such processes normally remove and/or destroy all
but the hardiest organisms (spores) and significantly reduce the microbial load
rendering objects safe for handling. It is essential for CPD staff to use good
microbial common sense when handling medical devices and to follow proper work
procedures and personal hygiene. Frequent and proper hand washing is critical to
minimize the potential of cross contamination. Technicians working in the
preparation and assembly area should be in good health; there should be no
breaks or cuts in the skin. When appropriate, proper PPE should be utilized and
good infection control techniques should be practiced.
Q When
packaging instruments and supplies in peel pouches are there any recommendations
or requirements relative to the size of the peel pouch in relation to the size
of the item to be packaged?
A There really isn’t any
specific recommendation relative to exact dimension of sizing in relation to the
peel pouch and items to be packaged. AAMI ST79 8.3.4 addresses the use of paper
plastic pouches. Paper plastic pouches should only be used for small,
lightweight, low profile items such as, a few hemostats, scissors, or small Army
Navy retractors. Placing heavy and large devices such as orthopedic drills and
instruments in a peel pouch could create sterility maintenance issues of
inadequate drying, wetness, punctures and tears. Proper sizing and use of peel
pouches is essential to allow for adequate air removal, sterilant permeation,
and drying. Aseptic presentation and sterility maintenance must be considered
when packaging items in a peel pouch. AAMI ST79 states that instruments should
be positioned within a peel pouch in accordance with hospital policies and
procedures. Some healthcare facilities clearly state in their policy/procedure
manuals what items can be packaged in a peel pouch and include the peel package
size to be used for each item. Some hospitals use a standard guide line which
advises allowing a minimum of a one inch margin around the radius of the device
being packaged and the parameter of the peel pouch. Diagrams and/or pictures in
the procedure manual can be an excellent guide to employees.
Q I
recently heard that instrument tray count sheets should not be placed inside
trays to be sterilized. If I understood correctly this would be because of the
possibility of a chemical transfer to the instruments from either the paper or
the toner/ink used to create the instrument list. I don’t recall seeing this in
any of the material I read to help me keep current on what the latest trends and
ideas are in our field. Can you supply any information on this? I would
certainly appreciate it.
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Figure 1 |
A Currently there is no
published documentation, technical data or proven evidence that the non medical
grade paper and toner inks used for printed count sheets can pose a risk to the
patient. Many hospitals have seen evidence of ink leaching and transference onto
instruments, trays and containment devices during the sterilization process.
Others claim they have never seen any visible sign of leaching. AORN Recommended
Practice IV published in 2007 states that count sheets should not be placed
inside of wrapped sets or rigid containers due to the lack of research regarding
the safety of placing them inside and the potential for a theoretical risk. AAMI
documentation, on the other hand does not address the issue nor advise against
the practice. Each hospital must develop their own policy relative to count
sheet placement within sets. Many hospitals continue to place the count sheets
inside of the sets and have instituted practices they feel reduce the potential
for leaching by placing barriers between the count sheets and the
instrumentation. A widely used practice includes folding count sheets with the
print side in and placing them in medical grade paper bags with non leaching,
non toxic medical grade inks which have been validated for sterilization within
wrapped and containerized sets.
(See figure 1).
Ray Taurasi is Eastern Regional Director of Clinical Sales and Services for
Healthmark Industries. His healthcare career spans over three decades as an
Administrator, Educator, Technologist and Consultant.He is a member of AORN,
ASHCSP, AAMI and a past president of IAHCSMM and has served on and contributed
to many national committees with a myriad of professional organizations,
manufacturers, corporations and prestigious healthcare networks. Taurasi has
been a faculty member of numerous colleges teaching in the divisions of business
administration and health sciences. In addition to this column he has authored
several articles and has been a featured speaker on the international scene.
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