Sterilized items including those
wrapped or containerized must be allowed to thoroughly cool prior to
distribution or handling. As to how long that will take, it will vary but they
should be completely cooled to the touch. It is important to place cooling racks
in a controlled, secure and safe environment away from any air/air conditioning
vents. Sterile goods should remain on the sterilization cart until cooled. The
cooling process actually begins within the sterilizer following the exhaust
phase. The door may be slightly opened at the end of the cycle and the sterile
goods left inside for a period of time to reduce the potential for condensate
formation when moved to a cooler environment.
Factors such as type of sterilizer, pack density, metal mass,
device design, packaging material used and temperature and humidity of the
ambient environment will impact cooling time. In most cases a minimum of 30
minutes is recommended. Warm sterile goods should never be moved from the
sterilizer cart and placed on cooler metal racks or surfaces for cooling.
Sterility maintenance dust covers should not be applied until packages are
completely cooled. Sealed rigid Sterilization containers are basically
impervious and thus touching a warm or hot container may not allow for strike
through to inner contents.
In the event that instruments which have been sterilized in
a sealed rigid container are needed prior to complete cooling it may be safe and
possible to transport the sealed container to the OR for immediate use. If the
filtering system does not provide a tortuous path caution will need to be taken
to avoid contact with the area of the filter which could present a potential
passage way for contaminates in handling and transit. The container should
remain in the upright position while transporting to the OR. Since rigid
containers vary in design and performance it is essential that you consult and
follow the manufacturers recommendations in this regard. To prevent burns and
personnel injury proper precautions should be followed and insulated gloves
should be used when ever handling hot containers.
The practice of cracking the sterilizer door and leaving goods
in the sterilizer to cool is not necessarily an essential step and this practice
should not be done as a means for extended drying. If packages are wet following
the sterilization process they should not be used; such wetness problems are
indicative of flaws and/or problems with the sterilization process and/or steam
quality and the source of the problem must be identified and resolved. The
controversial topic of cracking the sterilizer door for cooling has been
addressed in previous issues of HPN, for more information you can refer
to the articles listed below online:
May 2007 Self-study series:
"Cracking the steam sterilizer door: Dispelling the myth":
www.hpnonline.com/ce/pdfs/0705cetest.pdf
June 2007 CS Solutions:
www.hpnonline.com/inside/2007-06/0706-CSsolutions.html
August 2007 CS Solutions:
"Re-opening the cracked door debate":
www.hpnonline.com/inside/2007-08/0708-CSsolutions.html
August 2007 Letters to the Editor
"Time to close the cracking door debate":
www.hpnonline.com/inside/2007-08/0708-Letters.html
Before you even consider evaluating
any product in your hospital you should obtain and review all the technical data
including performance validations and instructions for use from the
manufacturer. You will also want to be certain that the packaging material has
FDA clearance to market the product for its intended use. The Food and Drug
Administration (FDA) classifies sterilization wrap as a Class II Medical
Device. Federal register, vol.45, No.205 states that a packaging device (sterile
packaging) must allow sterilization of the enclosed materials and also maintain
sterility of the enclosed device until used. As part of the FDA 510k application
process the manufacturer must provide evidence and validation that the packaging
material is capable of complying with Federal register, vol.45, No.205. The
validation will include all detail relative to the claim including sterilization
processes, parameters and conditions of use. You should request a copy of the
FDA 510k.
Once you have received, reviewed and are satisfied with the
documentation and have determined that the product is compatible with your
sterilization processes and needs you should obtain adequate samples and conduct
a thorough product evaluation. Some points to consider in your evaluation
include the following:
allow adequate air removal and sterilant permeation form package contents
suitable for intended sterilization processes
ease of use
conformity to contents
available in various sizes
has
wicking qualities to facilitate thorough and rapid drying
provide an adequate barrier to microorganisms or their vehicles
resist tearing and puncturing
allow method of sealing that results in complete seal that is tamper evident and
provides seal integrity
allows for ease of sterile presentation
be
free of toxic ingredients and non fast dyes
be
non linting
user and environmentally friendly
readily available
be
cost effective.
