Reprocessing: Making the Impossible Possible

December 1, 2004

Reprocessing: Making the Impossible Possible

By Kathy Dix and Kris Ellis

Reprocessing is a complicated beast. The reprocessing of both
singleuse devices (SUDs) and multiple-use devices (MUDs) can be a cause of
conflict for cost-conscious hospital managers. The decision to keep reprocessing
of MUDs in-house or send to a third-party reprocessor is one issue. But other
elements come into question as well: what constitutes a good training program?
Where does reprocessing go wrong? Does the government need to involve itself further in the
industry?


Single-Use Devices

The reprocessing of SUDs continues to be a somewhat
contentious issue. Recent years have seen an increasing amount of scrutiny and
regulation imposed upon third-party reprocessors of SUDs; however, many
hospitals across the country are sending their SUDs to third-party reprocessors.

The practice of reprocessing SUDs is probably decades old,
says Dan Vukelich, deputy executive director of the Association for Medical
Device Reprocessors (AMDR), a Washington, D.C.-based trade association
representing third-party reprocessors of medical devices labeled for single-use.
Probably about 10 years ago, the third-party industry started to crop up and
weve really seen the market solidify in the last five years or so. This is
due in part to the Food and Drug Administration (FDA)s regulations
implemented in 2000, which formally put in place the requirements that
reprocessors meet the same specifications as the original manufacturers. That really put hospitals out of the business of doing it.

In October 2002, additional requirements were enacted through
the Medical Device User Fee and Modernization Act (MDUFMA). This legislation
directed the FDA to enforce further safety checks such as pre-market reports on
reprocessed SUDs.

Included in MDUFMA is a provision that requires
reprocessors to provide pre-market validation data on a pre- and post-market
basis, says Vukelich. Everybodys validation data gets reviewed
on a post-market basis, but now FDA through MDUFMA has the authority to review
that information, for our devices only, on a pre-market basis.

Vukelich explains that this added requirement helps to ensure
the safety and viability of reprocessed SUDs. In short, we like to say that
these devices are more regulated than any other segment of the device industry.

Some questions regarding the safety and efficacy of
reprocessed SUDs were answered in a report from the Government Accounting Office
(GAO) in June 2000. Titled Single-Use Medical Devices: Little Available
Evidence of Harm from Reuse, But Oversight Warranted, the report concludes
that if the appropriate cleaning, testing and sterilization procedures are
followed, evidence suggests some SUDs can be safely reprocessed. For example,
electrophysiology (EP) catheters are cited in the report as being supported by
extensive clinical literature in terms of reprocessing. The report also notes
that the GAOs investigation of several alleged incidents involving adverse
events caused by reprocessed instruments revealed ambiguous or inaccurate
evidence supporting these claims. Nonetheless, the GAO advises caution and notes
that some instruments/devices cannot be reprocessed safely. The report also
recommends that the practice be monitored as a whole.

According to Vukelich, the FDAs regulations have provided a
thorough and effective means of providing this monitoring of third-party
reprocessing. Its odd for an industry to thank Congress for regulating it,
but we are thankful to the Congress because now we are, beyond a doubt,
providing safe and effective devices for hospitals.

The reuse of SUDs is fairly cut and dried, says Douglas
Nelson, MD, a gastroenterologist at Minneapolis VA Medical Center and an
associate professor of medicine at the University of Minnesota Medical School.

FDA regulates anyone who reprocesses an SUD as an original
equipment manufacturer (OEM), requiring a 510(K). Hospitals really cant do
this, which effectively ended the practice for hospitals. My understanding is
that hospitals that continue to reprocess SUDs themselves are in violation of
FDA law. There are four national companies that reprocess SUDs, and have filed
510(K)s with FDA. Hospitals can subcontract to these groups and be compliant.

I dont reprocess SUDs here, says Richard Schule, BS,
CST, CRCST, CHMMC, FEL, manager of the surgical processing department at the
Cleveland Clinic. Its a company stipulation that this will not be done
here, for the simple fact that we do not have the equipment or capability of
validating the reprocessing of those devices. Theres a lot more intricacy
that goes into that validation piece. Leave it up to the third party to do such
a thing.


Cleaning of Multi-use Devices

Immediately after their use, a multi-enzyme foam spray should
be sprayed on to multi-use devices in order to prevent biofilm from drying onto
the surface. This makes it easier for the person cleaning the multi-use
devices and helps speed up turn around time, says Jack Kinville, director of
marketing for Ruhof. When cleaning a multi-use device, whether it is manually
or by a washer decontaminator, it is absolutely necessary to use a multi-tiered
enzymatic cleaner. A multitiered enzymatic cleaner contains multiple enzymes
to break down the different components of biofilm. If an enzymatic detergent
does not have a specific enzyme to remove each individual component, then
residual biofilm will remain on the instrument no matter how rigorous the
cleaning procedure.

We rely on the OEM to provide the cleaning and
sterilization parameters for those devices, says Schule. In the best-case
scenario, were hoping that the manager and supervisor are provided with
cleaning and sterilization parameters prior to the purchase of those devices. In some cases, were running into issues to where it seems
to be that the FDA is approving 510(K)s without companies having to actually
provide that information. Theyre turning around and saying, We validated
one tray in a sterilizing load; its up to the hospital to verify the rest of
the load if they want to add anything to that item, and thats unrealistic. Nobodys going to run a sterilizer with that one item in a
sterilizer. So were running into a dilemma.


The Importance of Pre-cleaning

The safe and effective reprocessing of MUDs can be the
difference between an efficient and smoothly running facility and one that is
rife with controversy and potential adverse events. In this context, it is
imperative that sterile processing department (SPD) personnel be mindful of
possible pitfalls in the cleaning/reprocessing process.

Proper instrument reprocessing is vital to any facilitys
infection prevention program, says Rossana Fernandez, marketing manager of
Metrex. Policy, procedures and processing equipment vary from facility to
facility, and there is an array of pre-cleaners and lubricants that work with a
full range of washer decontaminators.

One of the big concerns that I have in the cleaning and
reprocessing process is that we must be validating that our
washers/decontaminators are effectively doing the needed cleaning and that the
soil is in fact being removed from the items, says Nyla Skee Japp, RN,
PhD, ACSP, nurse manager for CSPD at Mesa, Ariz.-based Banner Desert Medical
Center. If the cleaning process is not thoroughly doing its job,
then the sterilization process will not be successful. The first step to
sterilization is thorough cleaning, and I would bet that 85 percent of
processing departments do not validate this most important part of the process.

The need to maintain focus on the basics is an important
consideration for many. Sometimes these mundane cleaning, contact and rinsing
chores are not given enough attention, says Norman Miner, PhD, director of
research at MicroChem Laboratory. The very important parts of reprocessing
involve very careful cleaning of the devices, very thorough rinsing to remove
debris and microbes, care to assure contact between the device and the
disinfectant, and then very thorough rinsing to remove all residues of the toxic
disinfectant.

The presence of soil or organic material on medical devices
can reduce disinfection or sterilization effectiveness, says Fernandez. Use
an effective enzymatic cleaning detergent that facilitates the cleaning of
instruments prior to disinfection and sterilization. We recommend using an
enzymatic foaming spray for dissolving bioburden immediately after use.

Precleaning is the most important step in decontamination,
stresses Kinville. If you dont remove all biofilm during pre-cleaning, then
you can not sterilize the instrument. That is why it is necessary to use a
multitiered enzymatic detergent to ensure completer removal of all the
components of biofilm.

Healthcare workers (HCWs) must also be aware of unique
considerations that may exist for specific instruments and devices. For example,
difficult-to-access channels must be given special attention during the cleaning
process. Hospitals do not often read the reprocessing instructions of complex
devices, says Lawrence Muscarella, PhD, chief of infection control for Custom
Ultrasonics, Inc. As a result, hospitals are often unaware of internal
surfaces and channels that, if left unclean, can result in nosocomial
infections.


Wake-up Call

Communication and strong leadership must be present in the SPD
to ensure steps are not skipped and to take the guesswork out of reprocessing. A chilling illustration of this fact was seen last spring,
when it became known that North Shore University Hospital in Manhasset, N.Y. advised 177 patients who had undergone endoscopic procedures
at the facility to be tested for hepatitis B, hepatitis C and HIV. At the root
of this scare were poor reprocessing practices namely, the failure of SPD
personnel to document disinfectant testing for 12 days.

If the cleaning process at the North Shore University
Hospital had been validated, as I believe every department should be doing on at
least a weekly basis if not a daily basis, this would have never happened,
says Japp. Now is the time for all leadership in sterile processing to step
up to the plate and use what is available on the market to eliminate these kinds
of errors.

Logs should be kept, says Muscarella. Quality
assurance programs need to be developed and implemented. Ideally, every
instrument should be traceable to the patient on whom it was used.

Certain actions in the cleaning/reprocessing process are more
likely to be botched or ignored. Pre-cleaning/inspection is often ignored now
that there are manufacturers of washers that claim this is no longer needed in
their device or unit, says Becki Jenkins, CST, RCST, CRCST, FEL, president
and CEO of Sterilization by Design. Whereas these manufacturers have done the
appropriate tests on the units sold, laboratory tests or mock tests done on-site
at beta hospitals do not always mirror the biological challenge the units will
encounter in a given operation day. The consequence: potential of
cross-contamination of development of biofilm; potential that the instrument or
device could be the vehicle for infection for patients or staff who will
unwittingly handle improperly cleaned devices and perhaps will not be able to
see all debris that may or may not be present and visible after washing in a
mechanical washer unit.

Schule says, In order for that to happen, theres a breakdown in
connectivity with orientation, or with annual competencies. If you have a sound program, that should not happen. We have various flow
charting that occurs at different levels; there are no shortcuts in processing. We tend to see shortcuts when the customer wants to maintain
the device in the operating room, and theyll clean it and flash-sterilize it,
saying that its quicker. Well, there is no such thing as a quicker turnaround
time if its done properly. Therefore its more ignored than anything else. You have cleaning instructions, a system in place. If it needs
to be changed, then do a review of that with the team, and identify what that
change could be, agree on that change and have everybody do it the same way.


Data Supporting Efficacy

The data available for SUDs/MUDs comes from the
manufacturer or from the SUD third-party processor, observes Jenkins, Regulatory
guidance for each can be acquired through the FDA. The information needed for
end users is the same: instructions for use, classification, cleaning and
disinfection procedures (where that applies) and sterilization methods (where
that applies).


The Greatest Error

The single most significant error is not asking for or
having available sterilization instructions, instructions for use and processing
instructions or FDA approval information for use, Jenkins adds. This can
be a very critical error that will definitely increase infection rates, as in
our current healthcare settings there are varied devices with just as many
varied instructions for use, processing requirement's and sterilization
parameters. To follow a course of action that includes This is how we
have always done it or The common practice in healthcare has always been
this way is dangerous in this day of increasingly more innovative and varied
devices/equipment. The goal of manufacturers should be to hold to healthcare
universally common and accepted standards, and the goal of healthcare should be
to adhere to those standards and to follow/work with direction from
manufacturers of said devices or equipment.


Veteran Reprocessors

Veteran reprocessors who have been in the game for many
years may still skip certain steps occasionally; if that is the case, however,
their training is most likely to blame. Some veterans were not trained and
therefore, unless the individual has a formidable thirst to know how to do it
right and has learned well over the years, there will be breaks in the process,
because the average untrained individual does not know why steps should not be
skipped or altered or may not know that the step exists, says Jenkins. The
untrained individual will not always ask for instructions for use or validation
information not because they are not intelligent, but because they are not
fully educated.

One such vital step that veterans might skip is the
utilization of personal protective equipment (PPE), says Janet Pate, RN, BSN,
MHA, manager of infection control at the Kirkland Clinic in Birmingham, Ala. This
could be a result of the lack of training in this area many years ago, she
says. At that time, the importance and availability of PPE did not exist.

Although it is stressed today, once a staff member is in a
hurry, etc., it could be the step they omit. There needs to be an increased
focus on the importance of protection for these employees. The focus needs to
include gloves, face shields, and gowns which minimize the opportunity for
exposure.


Monitor, Monitor, Monitor

Checks and balances to ensure that every step has been done,
every time, are crucial. The only way to make sure all parts of any process
are done every time is to monitor, monitor, monitor, Jenkins confirms. There must be documentation that will support the plan.
Each person involved must be accountable via sign-off or bar code signature. In
any process, there is immediately more accountability once a name is attached.
Management must fully implement and track results, and there must be a set
consequence for results, whether that takes the form of revising policy,
practice or staff.


Regulation

Regulations for reprocessing do exist, but experts believe
there is room for more. For example, the Society of Gastroenterology Nurses and
Associates (SGNA) says that glutaraldehyde should be monitored at least once a
day, but manufacturers labels often say to monitor it before each use. Which
guideline is correct?

Always follow the manufacturers recommendation, says
Jenkins. Environmental Protection Agency (EPA) and FDA regulatory
guidelines are designed to give a direction but would be unable to fully devise
a plan for all solutions because there are so many. The FDA/EPA will give a
general outline, but the manufacturer must test the product and determine the
daily use parameters that will render it safe for end use. The manufacturer then
renders these results to the FDA/EPA for review. The only way to make this part
of the process better is to create a standard that generally falls to
Association for the Advancement of Medical Instrumentation (AAMI). Then,
following the standard must be strictly monitored by healthcare review agencies
such as the Joint Commission on the Accreditation of Healthcare Organizations
(JCAHO) that will in turn come with strong consequences for not following the
standard. Under the new working standard documents for sterilization,
there is a fully explained and documented process of liquid sterilants and/or
disinfectants. The standards written and ultimately approved by AAMI are
best, because all aspects of the process are included by having members from
every part of the healthcare industry.

Schule says, You always will follow the manufacturers
labeled instructions. You cant go wrong there. For the SGNA to step it up and
say once a day, thats nice, but if the OEM stipulates that just before use is
fine, that can be held and supported in court. I think where we have difficulty
are those healthcare facilities that dont have the resources to implement
tracking systems. It becomes a manual method that is quite laborious. With a
tracking system such as what we have in place here, we have a number of steps
that an instrument has to follow; depending on the makeup of device and how weve
entered information into the database based on that particular devices
template, theyre required to meet certain parameters. If you have an item
that requires low temperature sterilization, you cant scan into a load
configuration for steam; if you have a device that hasnt been sterilized and
you put an unsterile device on a case cart, the tracking system flags it by
saying, Youre putting unsterile instruments on your case cart.

He adds, There are FDA regulations; most of them are geared
in a couple of different ways. One, they help the OEM and their submission for
510(K) or pre-clearance when theyre looking at introducing new medical
devices; its also a safety net, which under the Safe Medical Device Act
provides an opportunity or forum for the end user to submit nonconformities or
issues with a particular product that has caused a safety issue in use with the
patient, or even cleaning and sterilization might be an opportunity to bring to
the FDAs attention that the device isnt properly documented for those parameters. I use FDA as
a resource; if I have a question, I can search their Web site. I dont
necessarily have their regulations in a library that I have to follow. Theyre
more for the original equipment company than the user and hospitals, provided
that youre not reprocessing single-use devices; thats where we open up
Pandoras box and say, Now hospitals are choosing to follow manufacturers
guidelines, which falls under FDA, and hospitals tend to not want to do that.

I do not believe the FDA needs to make manager decisions
when it comes to managing central sterile (CS) or an SPD, Japp says. I
think we have enough government regulation but I do see a need for stronger
leadership throughout the CS/SPD profession. Glutaraldehyde monitoring should be
done at least once a day if it is being used daily. Again, here is where the
leadership of the department needs to be evaluating what their needs are and
what is necessary to ensure patient safety.


Competency Testing

I dont think we do enough of it, given some of the
problems we hear from day to day, Schule says. Competency testing should
fall into a couple of different modes; one, you have your annual competency,
which we do for the Occupational Safety and Health Administration (OSHA) and
bloodborne pathogens, and a number of other areas such as ergonomics. I think
with competencies we need to do something more on a monthly or quarterly
schedule, something that would allow the employee to sit at a computer, read a
synopsis on a particular topic, answer questions and get a return on knowledge
from that particular abstract. In an ideal world, that test would be graded on a
computer, they would get a direct result right away, and it would be archived
into their personnel file for later review by JCAHO or the registrar in charge
of viewing inspection for ISO certification and reuse.

Japp adds, Until we can get certification as a minimum
requirement for working in CS/SPD in every state, validating a persons
competency prior to entering the profession will be very difficult. However, I
believe that their competency must be validated through their orientation to the
department as well as on an annual basis. The bigger problem is having enough
CS/SPD instructors capable of the training that is needed. Once the training is
completed, certification should be the next step. All staff should be certified
within one year of starting employment.


In An Ideal World

All staff considering or actively working in CPD/SPD,
including management, would be certified. If this is done, everything else will
fall into place. In addition, all manufacturers would follow the universally
accepted and available standards of practice in healthcare without exception or
argument, says Jenkins.

I think organizations like the International Association of
Healthcare Central Service Materiel Management (IAHCSMM) and the American
Society of Healthcare Central Sterile Professionals (ASHCSP) with AAMI need to
come together and identify standards for the country, and it doesnt exist
right now, Schule says. We tend to work in our own silos to a certain
degree; I think there are experts who would like to see a standard identified
across the country. Together, it would be a very powerful group to put together
an educational foundation that would support the profession, and it would make
the job a lot easier for managers, supervisors, educators and quality assurance
technicians, in the various 5,000 reprocessors around the country, to know that
were all working off one standard, one set of guidelines.

In the ideal world, processing would be the first
department, not the last, to get new equipment and the latest technology.
Certified staff would be the minimum requirement and wages would reflect their
importance, Japp says.


The Cause of Bad Reprocessing

Bad reprocessing practice can be blamed on many things
lack of funding, undertrained staff, unclear regulations, or complacency among
the personnel and their superiors. When asked which is the greatest offender,
Jenkins replies, All of the above, as well as the inherent view that CPD/SPD
is not a part of the infection control cycle, and that less attention is paid to
processing than should be from healthcare to manufacturers of medical devices.

Schule agrees, saying, I think its all of the above. I
think first and foremost, you have to have accountability. If we want to be
viewed as professionals, you hold yourself above all accountable for the quality
of work you produce. Dr. Deming states that its not the individual that is
the problem its the process that is the problem. We need to look at the
process first and foremost, and upon a review of the process, youll determine
if you have a lack of education, a lack of good equipment; youll determine
what your customers expectations are, if theyre unrealistic or not
recognized.

Once you correct those process issues, and you have a sound
program in place, then we can begin to look at the person. But the
accountability is challenging, because not a lot of people consider themselves
accountable for some of the jobs they do. You shouldnt have to rely on
somebody looking over your shoulder. You should inherently want to do a quality
job.

Japp continues, The biggest problem for bad reprocessing is
the lack of knowledge on the parts of both the manager and the processing staff. Until we in this profession mandate competence in the
leadership and staff of every CS/SPD department throughout this country, we will
continue to read about processing errors that could have been prevented. Until
we demand a fair salary for all staff, we will continue to have low self-esteem
in our profession. We must stand up as a profession, all of us, not just a few,
and make a statement that we are the most important and most critically needed
persons in healthcare. If we do not believe in ourselves, then no one else is
ever going to see the importance we play in our facilities.

Perhaps the lack of appropriate training for processing
personnel is a large reason for bad reprocessing, says Pate. The infection
control process and how processing personnel can directly affect it must be
stressed. Personnel must be trained on the consequences of not doing their job,
not only as an employee, but to the patients that may be affected. Continuing
education is a must, and communication between the staff and management plays a
vital role in the appropriate implementation of the infection control process.


Emory Hospital Patients Notified of Possible CJD Exposure

By Kris Ellis

A suspected case of Creutzfeldt-Jakob disease (CJD) at
Atlantabased Emory University Hospital has been confirmed by a national
laboratory in Cleveland, according to Emory University. The Centers for Disease
Control and Prevention (CDC)s initial diagnosis of CJD following a Sept. 10,
2004 brain biopsy of a patient at Emory prompted officials to notify 98 brain
and spine surgery patients of the very slight chance they might have been
exposed to the prion that is thought to be responsible for CJD.

We continue to seek the best available guidance and
information from experts at other medical centers and from agencies such as CDC
and Department of Health and Human Services, says William Bornstein, MD, PhD,
chief quality officer for Emory Healthcare. The extreme rarity of this
disease and the nature of the potential exposure, which is so small that it
cannot be quantified, make it challenging to find published guidelines which are
applicable to our situation. Nevertheless, we are fully committed to finding and sharing
with our patients the best available information.

The hospital also notified 418 patients who received
non-neurosurgical operations at the hospital between Sept. 10 and Sept. 27 of
the event. Officials explained that the risk of exposure in these cases is even
lower than in brain and spine surgery patients, if any risk exists at all
the six known cases of CJD transmission via surgical equipment all involved
brain procedures. Furthermore, these six cases all occurred prior to 1976, when
modern sterilization and surgical techniques were not nearly as prevalent as
they are today.

All sterilized surgical equipment in the hospital has been
re-sterilized using the enhanced procedures recommended for this rare disease, says Bornstein. We have also instituted a new policy that
exceeds hospital norms and call for treating every brain biopsy as a potential
case of CJD and sterilizing the instruments using the enhanced process, no
matter how unlikely CJD may appear at the time.

The initial sterilization followed the facilitys normal
procedures all instruments were cleaned in solution and then heated to 270
degrees Fahrenheit for four minutes in a pre-vacuum surgical autoclave. On Sept. 15, after preliminary biopsy results pointed to the
possibility of CJD, all neurosurgical equipment was re-sterilized using enhanced
measures specific to CJD as specified by the World Health Organization (WHO).
This procedure was repeated on Sept. 27 as a further precaution.

Although we believe the chances of an exposure are
extremely small, we cannot guarantee they are zero, says Allan Levey, MD,
PhD, chair of neurology at Emory School of Medicine. That is why Emory is
taking every possible step to deal with this matter.