Applying AAMI Standards to Real-World SPDs

October 1, 2005


Applying AAMI Standards to Real-World SPDs


By Jennifer Schraag


ICT takes a roundtable approach in examining the challenges
and ensuing implications of applying AAMI standards in todays
production-driven SPDs.

The Association for the Advancement of
Medical Instrumentation (AAMI) has been at the forefront of developing standards
for proper sterilization procedures for more than three decades, but just how
well are AAMIs standards addressing real-world sterile processing departments
(SPDs), and are these standards truly practical and doable? We asked some
industry experts their opinion on the topic.

In my opinion, Id say were doing an excellent job as
far as producing documents that are becoming our American national standards for
end users to follow, says Chuck Hughes, general manager/educator with SPS
Medical Supply Corp. Hughes currently serves on 10 AAMI sterilization working
group committees. I think they are very practical and thats reinforced by
the end users that are involved with the AAMI standards and contribute
aggressively to the documentation.

Speaking of being involved, Linda Clement, BSM, CRST,
consulting service manager of STERIS Corp., says AAMI would benefit highly from
more such participation. I think the AAMI committee members who work on the
user documents do a great job focusing on the real world challenges in
sterile processing. Although I think the working groups could greatly benefit
from more user participation actual SPD managers, technicians, etc. There is
a small number of users who work in healthcare institutions and consistently
attend and participate in the meetings, she states.

Hughes says another issue involving the standards and its
ensuing compliance has to do with getting the word out. Were doing a
horrible job getting that information out to users, he says. Not everyone
can attend a conference or a seminar. How are we going to be able to reach those
people who work in the trenches? Those people who come to work everyday and are
good hardworking individuals, but cannot leave their facility for this kind of
information. That really is going to continue to be a challenge over the next
years in our industry.


Do you notice any particular areas of widespread noncompliance
of the AAMI standards? Are there any you feel may have a higher compliance rate
than others?

In consulting with SPD and operating room (OR) AAMI
standards, I have observed the physical environment in SPD areas and flash
sterilization in the OR. In the SPD space is rarely adequate. Temperature and humidity levels are frequently outside
acceptable ranges, ventilation and airflow are not within recommended practice
guidelines, and workflow is often inefficient. These issues are primarily a
result of poor department design and lack of awareness by facility management of
the types of services provided by the department and the volume of items they
process. Flash sterilization in the OR is over used and improperly monitored
with biological and chemical indicators. In addition, record-keeping has often been poor or
non-existent. However, in the past few years I have seen much improvement in
compliance with the use of personal protective equipment (PPE) and sterilization
monitoring and recordkeeping in SPDs.

Linda Clement, BSM, CRST,
consulting service manager, STERIS Corp.

Quite a few. Its rare for a facility to receive an
extremely high grade from us in terms of full compliance. Generally what we find
is that the supervisor that is in charge of the department may be thinking that
certain aspects are being followed within the department, when in fact people
are people and they tend to take shortcuts. So, sometimes there is a difference between shifts or there
certainly can be a difference between facilities.

Chuck Hughes, general manager/
educator, SPS Medical Supply Corp. and AAMI committee member

In
terms of compliance and how well the users are going to comply with AAMI really
depends on education and how well they know the standards and whether the
standards make sense in the real world.

Marcia Frieze, CEO, Case Medical
and AAMI committee member


Do SPDs commonly have the proper materials to uphold the AAMI
standards or are financial constraints inhibiting absolute compliance?

Many SPDs do not have current copies of AAMI standards or
other valuable educational or reference materials in their departments. In addition, SPDs, although extremely important to a hospital,
are still often overlooked when it comes to requests for equipment, materials,
or human resources. They offer critical support to the largest revenue producing
department in the hospital the OR. However, they usually are not high on the
priority list when it comes to allocating financial resources. Without adequate
financial support, compliance can be prohibitive.

Linda Clement, BSM, CRST,
consulting service manager, STERIS Corp.

I think they have the resources, its just a matter of
knowledge and discipline. Once the information is there, its a matter of
discipline on whether or not that information is adhered to. Id say in
general we do a poor job. Theres a long way to go. Many hospitals, were delighted to see their adherence, but
there are healthcare facilities that are out there that seem to not be paying
attention as well.

Chuck Hughes, general
manager/educator, SPS Medical Supply Corp. and AAMI committee member

Everywhere
I have worked, and particularly at St. Josephs, the materials for compliance
are readily available. In my previous experience there have been some facilities
that lack the appropriate supervisory personnel to adequately maintain absolute
compliance among all staff members which is why we have a supervisor available
for all shifts and relief lead technicians for those times when we [the
supervisors] are not available.

David John Martin Jr., CRCST,
sterile processing evening shift supervisor, St Josephs Hospital and Medical
Center

Are facilities keeping up with revisions of
the standards? Do you find this to be another possible financial constraint?

No. Of the hospitals I have consulted with over the past
few years, some have never heard of AAMI, others have outdated standards, and
few have current standards available in their departments. I think this issue is
a combination of lack of awareness and information, and a lack of financial
resources.

Linda Clement, BSM, CRST,
consulting service manager, STERIS Corp.

Its a combination of things. Theyre not budgeting for
the purchase of these materials and somehow, somewhere, theyre using a few
hundred dollars as an excuse not to purchase them. I still feel it is simply
they do not have the information and that this information is not something that
is completely understood. We do an awful lot of seminars on the AAMI standards and what
were trying to do is to clarify them or help them to interpret their meaning.
One of the things that AAMI complains about is the fact that the information
doesnt get out there, people arent ordering them, but at the same time I
think there is a better marketing job that needs to be done, and letting people
know there are standards for their specific area. Right now were in the
middle of a major update for sterilization. Customers tend to get somewhat stalled. They dont know
whether to purchase the current standards or to wait six months to a year to
purchase the new standards. That is a bit problematic for the industry.

Chuck Hughes, general
manager/educator, SPS Medical Supply Corp. and AAMI committee member

What
area(s) may be the most challenging of the standards for SPDs to maintain and
control compliance?

The most challenging area is processing loaner orthopedic
total joint replacement instruments and other complex medical devices. The
orthopedic instrument sets are extremely heavy and are difficult to dry. These
sets dont always arrive in the SPD in a timely way to provide adequate
processing time, which can pressure SPD staff members to cut corners during
processing. They also have difficulty acquiring sterilization validation
documentation from the manufacturer. As surgical technology continues to evolve,
more and more complex medical devices are being manufactured and some of these
devices are extremely difficult to clean or verify their cleanliness.

Additional challenges to standards compliance are:

  • Instructions for processing these types of devices can be
    difficult to acquire from the manufacturer.
  • Representatives from the SPD are rarely included in the
    purchase planning process to evaluate processing needs and to ensure that
    available processes and sterilization technologies are available to process
    these devices.
  • Thorough product/device trials are not always conducted
    prior to purchasing a new device.

Linda Clement, BSM, CRST,
consulting service manager, STERIS Corp.

I think hospitals are probably doing a good job of
informing what the policies and procedures are, but they seem to not have the
resources to police them or to inspect they are indeed not being done properly. Of course, in
some cases, it is very challenging. To quote a good friend of mine, Were
trying to educate a parade. SPDs have the burden of not necessarily having a
stable workforce, so youre always getting new people and trying to teach them
proper policies and procedures to inform them and then inspect that theyve
actually followed those procedures it is an ongoing challenge.


Chuck Hughes, general manager/ educator, SPS Medical Supply
Corp. and AAMI committee member

What
specific steps can managers take to ensure AAMI compliance?

Managers should ensure that they have a copy of the most
current AAMI standards in their department and review them routinely. For new managers with little or no sterile processing
experience, national CS professional organizations and their local chapter
affiliates can provide valuable educational materials and certification programs
to assist in acquiring basic and ongoing knowledge of sterile processing
practices. Vendors also provide a wide variety of educational offerings from
educational videos, self-paced study guides, clinical support, consulting
services, and regional seminars to support best practices and standards
compliance.

Linda Clement, BSM, CRST,
consulting service manager, STERIS Corp.

Get out of their office. Manage by wandering around.
Sometimes its good to get out and stir the pot and look over peoples
shoulders and ask them questions. Nothing in my opinion takes the place of
management by wandering around and jumping in and doing hands-on with the staff
and observing first hand. As managers and supervisors, we inform but are we
inspecting? The old expression, seeing is believing, still applies in this
environment.


Chuck Hughes, general manager/educator, SPS Medical Supply
Corp. and AAMI committee member

Be involved!
Schedule time to work with the staff regularly. Our management team recognizes
the strengths and the areas for improvement in all of our staff members and our
processes. We use mistakes made as opportunities for growth and awareness, not
for punishment. It is amazing to see the difference this makes in productivity
and in the staff making their own decision to do the right thing. If you are on
a level playing field, and you remove the fear, you will have more open
communication with your staff and they will be much more comfortable sharing the
truth of what is going on in your department. We have found that celebrating
honesty, not punishing it, provides us with more effective avenues for educating
our staff. If there is ever a time that blatant disregard for compliance is
found or an employee is found to be negligent, the individual is put on a
comprehensive development plan of action. Adequate supervisory staff is always
essential.

David John Martin Jr., CRCST,
sterile processing evening shift supervisor, St Josephs Hospital and Medical
Center

What measures can regularly be taken in
educating staff on the standards?

AAMI standards review should be incorporated into routine
department educational programs. In doing this, all staff members receive consistent and
current information regarding standards and this can also be used as a good tool
for department self-assessment of current work practices.

Linda Clement, BSM, CRST,
consulting service manager, STERIS Corp.

Have routine educational programs. The more compliant
facilities that I visit actually make time on a weekly basis to in-service.
Inservices on a monthly, or even on a weekly, basis should not be limited to
just product inservices, but should include specific standards and servicing. Thats something thats not been readily
available.


Chuck Hughes, general manager/educator, SPS Medical Supply
Corp. and AAMI committee member

What can be done to
ensure all staff is abiding by PPE standards?

Ive seen tremendous improvement in staff compliance with
wearing PPE. The most common issue is the availability of appropriate, quality
PPE in decontamination areas. The PPE purchasing decision-making process should
not only be cost. PPE must be adequate to ensure the safety of staff members
performing decontamination activities. I think focusing on educating staff
members on the importance of PPE in the workplace and the OSHA standards
regarding standard precautions has also increased safety awareness and
compliance among SPD personnel.

Linda Clement, BSM, CRST,
consulting service manager, STERIS Corp.

I used to hear from supervisors I just cant get Mary
to do it right. OSHA changed that its a violation of federal law if
healthcare facilities personnel in high risk areas do not provide proper PPE and
ensure that it is used properly. I think today, the enforcement of proper use of PPE is clearly
there.
Chuck Hughes, general manager/educator, SPS Medical Supply
Corp. and AAMI committee member
First, educate!
Then monitor compliance regularly and re-educate if necessary. Last, if
noncompliance is an issue for an individual employee they need to be disciplined
using a comprehensive development plan that outlines what the questionable
behavior is, what the appropriate performance/behavior expectation is, and an
opportunity for the employee to determine the best plan of action for themselves
to attain the desired behavior/performance objective. People succeed much more
often when they get to make their own decisions as to how to best accomplish a
behavior/ performance goal.

David John Martin Jr., CRCST,
sterile processing evening shift supervisor, St Josephs Hospital and Medical
Center

How can managers ensure their staff isnt
cutting corners when the lengthy processes required by the standards go against
the requirement of staff to be highly productive?

This can be a tall order for SPD managers who work
diligently to comply with standards and recommended practices on a daily basis. Developing a good working relationship with their hospital
infection control practitioner (ICP) is a good place to begin. ICPs can be
invaluable allies and champions for the SPD when it comes to fighting these
types of battles with the many internal customers that SPDs have, such as the OR
staff, who also struggle with a busy surgery schedule, unreasonable room
turnover expectations, demanding surgeons, and insufficient inventories of
surgical instruments.

Linda Clement, BSM, CRST,
consulting service manager, STERIS Corp.

We have increased our dry time from the 20 minute standard
to 40 minutes to accommodate the density of the larger consignment trays. We run
a rapid readout biological monitor with every steam load to ensure the
performance of each sterilizing cycle and thus assuring the sterility of each
load sterilized. Recommended practice is once a week and with each load of
implants. We use the STERIS sterilant to decontaminate our fiber optics and
heat/pressure sensitive items. The standard suggested is the use of a high-level
disinfectant.

David John Martin Jr., CRCST,
sterile processing evening shift supervisor, St Josephs Hospital and Medical
Center

Are there any other common concerns related
to compliance with AAMI standards in SPDs?

Its been in the AAMI standards for quite some time and
will continue to be in the standards that SPD personnel be certified both at
the staff and management level and its unfortunate that a lot of the
industry is waiting for the states to pass it as a law. I really believe the
answer is to simply make that a policy or requirement in each institution and
not wait for big brother to look over your shoulder and tell you to do the right
thing.

Chuck Hughes, general
manager/educator, SPS Medical Supply Corp. and AAMI committee member

Our
industry is faced with more challenges than it ever had, like heavy sets,
devices with lumens, power equipment, and robotic devices. The mission of AAMI
was to focus on the science of sterilization and of setting standards for
sterilizing these newer complex and challenging devices. If we dont address
the challenge of sterilization and decontamination at AAMI, the healthcare
community will not have guidance and realistic standards to follow. I think the beauty of AAMI is that it brings manufacturers and
users together, and people from the scientific community. We may disagree and
come with different perspectives, but in the end there is consensus and everyone
comes to a decision that is in the best interest of the patient.

Marcia Frieze, CEO, Case Medical
and AAMI committee member