Reprocessing: Making the Impossible Possible

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.

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