Infection Control Today - 01/2004: Raising the Standard to the Standard

January 1, 2004

Raising the Standard to the Standard

By Becki Harter, CST,

Too many times in recent years, I have discovered that
there are deviations to the standards of practice. It seems in some instances
that a nomenclature standard has emerged to take the place of the current
standards. Healthcare systems are replacing best-practice standards with
common-practice standards because they are unable to make concession with the
varied medical device requirements that seem to ignore the universally accepted
standards designed to protect patients, not industry. The use of substandard practices in an attempt to make all-over-the- chart
sterilization cycles and weight configurations fit into a healthcare environment
is rampant.

For the most part, segments of industry have been allowed to ignore the
patient-safety needs of the healthcare systems they serve. This is not to say
that all manufacturers are at fault, but it is surprising to see that some
manufacturers routinely ignore standards of healthcare practice, and in fact,
vehemently oppose the acquisition of clarified regulatory protocols that will
help them get back to and or raise the standard so that patients are duly served
and protected.

There is a strong opposing voice by some in the orthopedic industry who have
expressed their disdain for raising the standard to the standard. This voice of
opposition largely stems from the fiscal fact that it is going to require
further testing and in some cases the implementation of testing for the first
time of many of the current devices being used in healthcare to include
sterilization packaging systems, all of which will cost time and money.

Not all orthopedic manufacturers feel this way; however, there is a
proportionate number who do. These manufacturers have gone to great lengths to
undermine the standards and to negate existing regulatory protocols concerning
orthopedic systems and the provided packaging systems they are shipped,
organized and sterilized in. These opponents have written letters to the Food
and Drug Administration (FDA) positioning themselves against positive
patient-safety directives and have told the healthcare industry that these
protocols and recommendations/regulations are erroneous and not needed.

These manufacturers have threatened the standards body as well as the FDA.
Orthopedic device manufacturers that agree with this stance create the most risk
for your patients, and should receive a clear message form healthcare that we
will accept nothing less than the best for our patients. Nothing says what we
must have other than purchasing practices that exclude any manufacturer that
will not adhere to the standards and regulatory protocols put in place to
provide safe effective devices to patients. If it cost too much to do the right
thing it will cost even more to continue to do the wrong thing if healthcare
bodies refuse to allow these manufacturers in their facilities until the
appropriate work has been done and universal standards, regulatory protocols and
device guidelines are met. The cost incurred by orthopedic manufacturers falling
outside of the protocols to get on the same page is by far less than injury that
may pass to patients, including potential for deathno price can measure the
value of a life or the quality of that life.

What can we do? Healthcare has got to take a stand. We have got to stand
behind the FDA and the Association for the Advancement of Medical
Instrumentation (AAMI) standards. Deviation from best practices according to the best standards cannot be
allowed to exist in our facilities. We must be the driving force that helps
industry understand that we take our patients safety seriously. Healthcare must
adhere to and completely understand the universal standards, and insist upon
nothing less from their facilities and from the healthcare device manufacturers
they choose to assist their patients on the road to good health. As a unified
force, we must start asking questions and insisting upon the right answers. We
have got to stop allowing manufacturers to dictate or manipulate the standard to
fit their products, leaving healthcare to clean up the mess that creates.

What are the issues?

  • Universal published healthcare sterilization cycles need
    to be strictly cleaved to. What are the universal published standard
    sterilization cycles? This cycle information is readily available in the owners
    manual of your sterilizer. It is also true that deviation of sterilization
    cycles away from the sterilizer manufacturer recommendations can void warranties
    and if not validated using AAMI ST8 (healthcare cannot validate but verify), can
    find the healthcare facility in violation of federal and local/state laws, and
    can cause such a facility to lose accreditation for insurance carriers if
    discovered. This information is also available for review in your sterilizer
  • Adhering to recommended weight limits by sterilizer
    manufacturers that have tested for sterility assurance levels (SAL) using test
    configurations weighing 16 to 20 pounds that will best support the SAL. While
    it is true that SAL can be achieved in weights exceeding 16 to 20 pounds, it
    is also true that your sterilizer manufacturer will not stand behind this and
    it is more difficult to stay within the universally available standard
    sterilization cycles to include dry times when this practice is allowed.
    Ergonomic considerations, being secondary, cannot be dispelled, as workman
    comp claims will rise as the recommended weight limit continues to be largely
    ignored. Variable cycles and configuration requirements place undue stress on
    already time-constrained departments trying to make productivity levels,
    sterilization requirements and customer service demands work when there are
    many times that an entire load that could contain up to 18 sets has one set in
    it; this is because the sterilization requirements are outside of the
    universally recommended standard for healthcare.
  • The key proponent issue is the use of Class I
    organizing trays, cassettes container and container systems inside of a
    sterilization process that does not have test data to support efficacy nor SAL
    the argued point being that because these devices do not maintain sterility
    the Class II 510 (k) requirement does not apply. However, these devices are
    accessories to the sterilization unit and can have a positive or negative
    impact on the ability of the sterilization unit to penetrate all surfaces of
    the containment device as well the medical devices contained with in them. Thus, they are indeed Class II medical devices and are held to
    the regulatory protocols for such devices to include:
  • Cleaning /disinfection
  • Processing/reprocessing
  • Sterilization methods as proven by manufacturer to
    include use of universally available cycles and parameters
  • 510(k) Pre market approval
  • Ignoring the standard will not make it go away but it
    will adversely affect the outcomes of your patients health.

Many manufacturers and healthcare providers agree that the return to
universal standards is long overdue. The purpose of standards is so that best
practices can be achieved universally. This is why it is called a standard. To
expect yo-yo, all-over-the-map instructions for use, sterilization cycles, crazy
weight limits and unrealistic device designs to ever support positive patient
care outcomes, is not prudent. Some manufacturers will say that there is no way
to meet the device demands with such limitations, but this is largely untrue
manufacturers that support patient safety achieve this every time they develop a
new device or upgrade a pre-existing one to include containment devices
(sterilization trays, cassettes, containers and container systems) within the
universal healthcare standard.

This information is not meant to tread on any one facility or manufacturer,
but to recognize that a very real problem needs to be actively addressed
considering the importance it has upon patient safety. We cant act as is
everything is OK when there are some very serious and potentially
life-threatening practices going unchecked or uncorrected within our system,
which includes device manufacturers.

Many device manufacturers have recognized the need to upgrade their protocols
and have made great strides in maintaining and raising the standard to the
standard. Healthcare facilities are becoming more aware and increasingly more involved
in the standards process, but we need everyone to get involved, either in
practice or in process. Our patients cannot afford for us to turn a blind eye or to continue with a
this is the way it has always been attitude. The truth is, in some cases,
it is poised the way it has been done, but not the way it was supposed to have
been done according to the standard.

We simply must raise the standard back to the standard. Getting something
through regulatory is not half as important as making sure the results are
universally achievable and repeatable in healthcare. Never lose sight of who we
are really working for. We are not trying to save industry time and money; if
manufacturing practices are done properly the first time, interest on both sides
can be achieved and fiscally tolerable. We are not trying to get things done as
fast as possible without consideration to patient safety. Our sole driving purpose should be to provide the best care, reaching the
best results for, the No. 1 reason for doing what we do our patients.

Becki Harter, CST, RCST, CRCST, FEL, is president and CEO of
Indianapolis-based consulting firm Sterilization By Design.