Question: We have been
looking at various sterilization containers and plan to select 3-4
brands to evaluate. We want to select a container that is durable,
suitable for all means of sterilization, and one that has longevity and
excellent serviceability. We have ruled out plastic composites and are
focused on metallic products. I understand that many containers are
constructed of aluminum, stainless steal or in some instances a
combination of both. What is the significance or importance of a
container that is composed of anodized aluminum verses one that is non –
anodized?
Answer: Aluminum is a
superior conductor of heat that allows for more even and rapid heat
transference and distribution throughout a sterilization container. The
transmission of heat and even temperature distribution affects the
efficacy of the sterilization process. The faster the total contents
reach the required sterilization temperature the sooner the dwell time
can commence. Aluminum components will also retain heat longer during
the cooling phase of the sterilization cycle with a more even
distribution of the heat, which will facilitate more thorough drying.
Due to the composition and molecular structure of some metallic
containers, especially those consisting of aluminum, stainless steel and
plastic components, the heat up time may take longer and the dry time
may also need to be significantly extended to produce dry contents. Some
container manufacturers may suggest the use of tray liners and towels to
act as a wicking mechanism to aid in the drying process. Of course the
use of such wicking materials not only increases production costs but
they also increase the challenge to the sterilization process. If
production costs, total cycle times and dryness are important to you,
you may want to consider a container manufacturer that can provide
products and component parts, such as baskets, that are made of aluminum
vs. stainless steel or plastic.
Anodizing is a process,
which gives aluminum a protective surface of aluminum oxide, which is
scratch and corrosion resistant and is not electrically conductive. A
non-anodized metal is not corrosion resistant and it can become reactive
having an adverse affect on other metals, which come into contact. An
electrolytic couple reaction dissolves and corrodes other
metals. Further a non-anodized aluminum material will oxidize when
exposed to steam or water during routine cleaning and decontamination,
and sterilization leaving a white powdery film. In addition non-anodized
aluminum scratches easily and will discolor through routine use becoming
cosmetically unsightly. Surgical instruments can also corrode, rust and
stain when they come in contact with the non-anodized material. What is
imperative is to keep metals protected from corrosion. In fact, aluminum
material has a mil spec for corrosion resistance that all manufacturers
of sterilization containers need to meet in order to sell product to the
federal government. That is why pH neutral detergents are necessary for
cleaning aluminum containers to avoid corrosion when the caustic or
acidic cleaning agents or chemicals remove the anodized surface. Most
sterilization containers have limited clearance for use. Currently there
is only one sterilization container manufacturer who’s product has
clearance for universal use in all common methods of sterilization used
in hospitals eg steam, pre vac, gravity, EO, gas plasma and flash. To
select the product that will meet all your needs be sure to ask for and
obtain the FDA 510k documents as well as all other technical and
validation data from the manufacturer and never attempt to use any
containerized system in a sterilization method or in a manner not
consistent with the manufacturer’s instructions.
Question: Our SPD
department has tried to comply with the ever-changing sterilization
parameters of the orthopedic companies we deal with for our total knee,
hip, and other complicated sets. We demand sterilization parameters from
any loaner company that we might use, as well. Recently, we received an
updated list of parameters from one of our main orthopedic vendors which
states; use Pre vac for 15 minutes of sterilization followed by 90
minutes of dry time. We have always prided ourselves with putting the
patient first, but these parameters will make our turn around time
unmanageable.
1.Should we be altering
our sterilization parameters constantly to follow the manufacturer’s
recommendations?
2.Are manufacturers
required to have FDA validation (510k) for their surgical instruments?
Answer: Loaner trays and
other orthopedic instrument sets are really presenting a great challenge
to the cleaning and sterilization processes. This is fast becoming a
very hot topic and has been a source of discussion within many
professional associations and various AAMI committees which will result
in new recommendations and demands for manufacturers to address many of
the issues. Surgical instruments are classified as medical devices and
must have FDA 510k clearance. Manufacturers are required to provide
care, use and reprocessing instructions. Users in turn are required and
expected to follow manufacturers’ instructions. If users deviate from
the parameters provided by the manufacturer they must be able to
validate and verify the efficacy of their process. The validation
process is very complex and scientifically based. To conduct the
validation process correctly requires expertise, skills and resources
which are likely beyond the capability of a typical hospital CS
department and hospital laboratory. The extended sterility dwell time of
15 minutes is likely the result of the instruments’ complexity and
design coupled with the instrument case and manner of the instrument
arrangement in the container which may require more time for the
sterilant to penetrate all points and for the metal mass to reach the
required temperature. Due to the complexity and design features of some
instrumentation you will find that manufacturers in many instances have
issued instructions for extended dwell times; some require an exposure
time of as much as 40 minutes. I agree that a 90 minute dry time seems
quite excessive. Obviously thorough drying is essential to sterility
maintenance. You may want to consider breaking the sets down into
smaller packages, and investigate other packaging or container devices,
which will result in thorough drying in less time. Some container and
instrument manufacturers are working together and have been successful
in assisting users in facilitating changes in instrument set assembly,
arrangement and containment which can enhance the efficacy of the
sterilization process, provide maximum protection of critical
instrumentation and minimize drying time with excellent results. I
suggest you contact your container manufacturer and discuss your
concerns and needs with them. They may be able to provide you with the
clinical, technical and material resources with the documentation you
need to improve your situation. HPN
Ray Taurasi is Director
of Professional Services for Case Medical Inc. Ridgefield, New Jersey.
His healthcare career spans over three decades as an Administrator,
Educator, Technologist and Consultant. He is 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.
