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 bothsingleuse devices (SUDs) and multiple-use devices (MUDs) can be a cause ofconflict for cost-conscious hospital managers. The decision to keep reprocessingof MUDs in-house or send to a third-party reprocessor is one issue. But otherelements 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 theindustry?

Single-Use Devices

The reprocessing of SUDs continues to be a somewhatcontentious issue. Recent years have seen an increasing amount of scrutiny andregulation imposed upon third-party reprocessors of SUDs; however, manyhospitals 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 MedicalDevice Reprocessors (AMDR), a Washington, D.C.-based trade associationrepresenting third-party reprocessors of medical devices labeled for single-use.Probably about 10 years ago, the third-party industry started to crop up andweve really seen the market solidify in the last five years or so. This isdue in part to the Food and Drug Administration (FDA)s regulationsimplemented in 2000, which formally put in place the requirements thatreprocessors 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 throughthe Medical Device User Fee and Modernization Act (MDUFMA). This legislationdirected the FDA to enforce further safety checks such as pre-market reports onreprocessed SUDs.

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

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

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

According to Vukelich, the FDAs regulations have provided athorough and effective means of providing this monitoring of third-partyreprocessing. 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 DouglasNelson, MD, a gastroenterologist at Minneapolis VA Medical Center and anassociate professor of medicine at the University of Minnesota Medical School.

FDA regulates anyone who reprocesses an SUD as an originalequipment manufacturer (OEM), requiring a 510(K). Hospitals really cant dothis, which effectively ended the practice for hospitals. My understanding isthat hospitals that continue to reprocess SUDs themselves are in violation ofFDA law. There are four national companies that reprocess SUDs, and have filed510(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 theCleveland Clinic. Its a company stipulation that this will not be donehere, for the simple fact that we do not have the equipment or capability ofvalidating the reprocessing of those devices. Theres a lot more intricacythat goes into that validation piece. Leave it up to the third party to do sucha thing.

Cleaning of Multi-use Devices

Immediately after their use, a multi-enzyme foam spray shouldbe sprayed on to multi-use devices in order to prevent biofilm from drying ontothe surface. This makes it easier for the person cleaning the multi-usedevices and helps speed up turn around time, says Jack Kinville, director ofmarketing for Ruhof. When cleaning a multi-use device, whether it is manuallyor by a washer decontaminator, it is absolutely necessary to use a multi-tieredenzymatic cleaner. A multitiered enzymatic cleaner contains multiple enzymesto break down the different components of biofilm. If an enzymatic detergentdoes not have a specific enzyme to remove each individual component, thenresidual biofilm will remain on the instrument no matter how rigorous thecleaning procedure.

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

The Importance of Pre-cleaning

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

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

One of the big concerns that I have in the cleaning andreprocessing process is that we must be validating that ourwashers/decontaminators are effectively doing the needed cleaning and that thesoil 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 MedicalCenter. If the cleaning process is not thoroughly doing its job,then the sterilization process will not be successful. The first step tosterilization is thorough cleaning, and I would bet that 85 percent ofprocessing departments do not validate this most important part of the process.

The need to maintain focus on the basics is an importantconsideration for many. Sometimes these mundane cleaning, contact and rinsingchores are not given enough attention, says Norman Miner, PhD, director ofresearch at MicroChem Laboratory. The very important parts of reprocessinginvolve very careful cleaning of the devices, very thorough rinsing to removedebris and microbes, care to assure contact between the device and thedisinfectant, and then very thorough rinsing to remove all residues of the toxicdisinfectant.

The presence of soil or organic material on medical devicescan reduce disinfection or sterilization effectiveness, says Fernandez. Usean effective enzymatic cleaning detergent that facilitates the cleaning ofinstruments prior to disinfection and sterilization. We recommend using anenzymatic 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, thenyou can not sterilize the instrument. That is why it is necessary to use amultitiered enzymatic detergent to ensure completer removal of all thecomponents of biofilm.

Healthcare workers (HCWs) must also be aware of uniqueconsiderations that may exist for specific instruments and devices. For example,difficult-to-access channels must be given special attention during the cleaningprocess. Hospitals do not often read the reprocessing instructions of complexdevices, says Lawrence Muscarella, PhD, chief of infection control for CustomUltrasonics, Inc. As a result, hospitals are often unaware of internalsurfaces and channels that, if left unclean, can result in nosocomialinfections.

Wake-up Call

Communication and strong leadership must be present in the SPDto 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 proceduresat the facility to be tested for hepatitis B, hepatitis C and HIV. At the rootof this scare were poor reprocessing practices namely, the failure of SPDpersonnel to document disinfectant testing for 12 days.

If the cleaning process at the North Shore UniversityHospital had been validated, as I believe every department should be doing on atleast 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 stepup to the plate and use what is available on the market to eliminate these kindsof errors.

Logs should be kept, says Muscarella. Qualityassurance programs need to be developed and implemented. Ideally, everyinstrument should be traceable to the patient on whom it was used.

Certain actions in the cleaning/reprocessing process are morelikely to be botched or ignored. Pre-cleaning/inspection is often ignored nowthat there are manufacturers of washers that claim this is no longer needed intheir device or unit, says Becki Jenkins, CST, RCST, CRCST, FEL, presidentand CEO of Sterilization by Design. Whereas these manufacturers have done theappropriate tests on the units sold, laboratory tests or mock tests done on-siteat beta hospitals do not always mirror the biological challenge the units willencounter in a given operation day. The consequence: potential ofcross-contamination of development of biofilm; potential that the instrument ordevice could be the vehicle for infection for patients or staff who willunwittingly handle improperly cleaned devices and perhaps will not be able tosee all debris that may or may not be present and visible after washing in amechanical 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 flowcharting that occurs at different levels; there are no shortcuts in processing. We tend to see shortcuts when the customer wants to maintainthe 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 turnaroundtime if its done properly. Therefore its more ignored than anything else. You have cleaning instructions, a system in place. If it needsto be changed, then do a review of that with the team, and identify what thatchange 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 themanufacturer or from the SUD third-party processor, observes Jenkins, Regulatoryguidance for each can be acquired through the FDA. The information needed forend users is the same: instructions for use, classification, cleaning anddisinfection procedures (where that applies) and sterilization methods (wherethat applies).

The Greatest Error

The single most significant error is not asking for orhaving available sterilization instructions, instructions for use and processinginstructions or FDA approval information for use, Jenkins adds. This canbe a very critical error that will definitely increase infection rates, as inour current healthcare settings there are varied devices with just as manyvaried instructions for use, processing requirement's and sterilizationparameters. To follow a course of action that includes This is how wehave always done it or The common practice in healthcare has always beenthis way is dangerous in this day of increasingly more innovative and varieddevices/equipment. The goal of manufacturers should be to hold to healthcareuniversally common and accepted standards, and the goal of healthcare should beto adhere to those standards and to follow/work with direction frommanufacturers of said devices or equipment.

Veteran Reprocessors

Veteran reprocessors who have been in the game for manyyears may still skip certain steps occasionally; if that is the case, however,their training is most likely to blame. Some veterans were not trained andtherefore, unless the individual has a formidable thirst to know how to do itright 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 beskipped or altered or may not know that the step exists, says Jenkins. Theuntrained individual will not always ask for instructions for use or validationinformation not because they are not intelligent, but because they are notfully educated.

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

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

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 processare 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. Inany process, there is immediately more accountability once a name is attached.Management must fully implement and track results, and there must be a setconsequence for results, whether that takes the form of revising policy,practice or staff.

Regulation

Regulations for reprocessing do exist, but experts believethere is room for more. For example, the Society of Gastroenterology Nurses andAssociates (SGNA) says that glutaraldehyde should be monitored at least once aday, but manufacturers labels often say to monitor it before each use. Whichguideline is correct?

Always follow the manufacturers recommendation, saysJenkins. Environmental Protection Agency (EPA) and FDA regulatoryguidelines are designed to give a direction but would be unable to fully devisea plan for all solutions because there are so many. The FDA/EPA will give ageneral outline, but the manufacturer must test the product and determine thedaily use parameters that will render it safe for end use. The manufacturer thenrenders these results to the FDA/EPA for review. The only way to make this partof the process better is to create a standard that generally falls toAssociation for the Advancement of Medical Instrumentation (AAMI). Then,following the standard must be strictly monitored by healthcare review agenciessuch as the Joint Commission on the Accreditation of Healthcare Organizations(JCAHO) that will in turn come with strong consequences for not following thestandard. Under the new working standard documents for sterilization,there is a fully explained and documented process of liquid sterilants and/ordisinfectants. The standards written and ultimately approved by AAMI arebest, because all aspects of the process are included by having members fromevery part of the healthcare industry.

Schule says, You always will follow the manufacturerslabeled instructions. You cant go wrong there. For the SGNA to step it up andsay once a day, thats nice, but if the OEM stipulates that just before use isfine, that can be held and supported in court. I think where we have difficultyare those healthcare facilities that dont have the resources to implementtracking systems. It becomes a manual method that is quite laborious. With atracking system such as what we have in place here, we have a number of stepsthat an instrument has to follow; depending on the makeup of device and how weveentered information into the database based on that particular devicestemplate, theyre required to meet certain parameters. If you have an itemthat requires low temperature sterilization, you cant scan into a loadconfiguration for steam; if you have a device that hasnt been sterilized andyou put an unsterile device on a case cart, the tracking system flags it bysaying, Youre putting unsterile instruments on your case cart.

He adds, There are FDA regulations; most of them are gearedin a couple of different ways. One, they help the OEM and their submission for510(K) or pre-clearance when theyre looking at introducing new medicaldevices; its also a safety net, which under the Safe Medical Device Actprovides an opportunity or forum for the end user to submit nonconformities orissues with a particular product that has caused a safety issue in use with thepatient, or even cleaning and sterilization might be an opportunity to bring tothe FDAs attention that the device isnt properly documented for those parameters. I use FDA asa resource; if I have a question, I can search their Web site. I dontnecessarily have their regulations in a library that I have to follow. Theyremore for the original equipment company than the user and hospitals, providedthat youre not reprocessing single-use devices; thats where we open upPandoras box and say, Now hospitals are choosing to follow manufacturersguidelines, which falls under FDA, and hospitals tend to not want to do that.

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

Competency Testing

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

Japp adds, Until we can get certification as a minimumrequirement for working in CS/SPD in every state, validating a personscompetency prior to entering the profession will be very difficult. However, Ibelieve that their competency must be validated through their orientation to thedepartment as well as on an annual basis. The bigger problem is having enoughCS/SPD instructors capable of the training that is needed. Once the training iscompleted, certification should be the next step. All staff should be certifiedwithin 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 willfall into place. In addition, all manufacturers would follow the universallyaccepted and available standards of practice in healthcare without exception orargument, says Jenkins.

I think organizations like the International Association ofHealthcare Central Service Materiel Management (IAHCSMM) and the AmericanSociety of Healthcare Central Sterile Professionals (ASHCSP) with AAMI need tocome together and identify standards for the country, and it doesnt existright now, Schule says. We tend to work in our own silos to a certaindegree; I think there are experts who would like to see a standard identifiedacross the country. Together, it would be a very powerful group to put togetheran educational foundation that would support the profession, and it would makethe job a lot easier for managers, supervisors, educators and quality assurancetechnicians, in the various 5,000 reprocessors around the country, to know thatwere all working off one standard, one set of guidelines.

In the ideal world, processing would be the firstdepartment, not the last, to get new equipment and the latest technology.Certified staff would be the minimum requirement and wages would reflect theirimportance, 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 amongthe 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/SPDis not a part of the infection control cycle, and that less attention is paid toprocessing than should be from healthcare to manufacturers of medical devices.

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

Once you correct those process issues, and you have a soundprogram in place, then we can begin to look at the person. But theaccountability is challenging, because not a lot of people consider themselvesaccountable for some of the jobs they do. You shouldnt have to rely onsomebody looking over your shoulder. You should inherently want to do a qualityjob.

Japp continues, The biggest problem for bad reprocessing isthe lack of knowledge on the parts of both the manager and the processing staff. Until we in this profession mandate competence in theleadership and staff of every CS/SPD department throughout this country, we willcontinue to read about processing errors that could have been prevented. Untilwe demand a fair salary for all staff, we will continue to have low self-esteemin 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 neededpersons in healthcare. If we do not believe in ourselves, then no one else isever going to see the importance we play in our facilities.

Perhaps the lack of appropriate training for processingpersonnel is a large reason for bad reprocessing, says Pate. The infectioncontrol process and how processing personnel can directly affect it must bestressed. 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. Continuingeducation is a must, and communication between the staff and management plays avital 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) atAtlantabased Emory University Hospital has been confirmed by a nationallaboratory in Cleveland, according to Emory University. The Centers for DiseaseControl 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 brainand spine surgery patients of the very slight chance they might have beenexposed to the prion that is thought to be responsible for CJD.

We continue to seek the best available guidance andinformation from experts at other medical centers and from agencies such as CDCand Department of Health and Human Services, says William Bornstein, MD, PhD,chief quality officer for Emory Healthcare. The extreme rarity of thisdisease and the nature of the potential exposure, which is so small that itcannot be quantified, make it challenging to find published guidelines which areapplicable to our situation. Nevertheless, we are fully committed to finding and sharingwith our patients the best available information.

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

All sterilized surgical equipment in the hospital has beenre-sterilized using the enhanced procedures recommended for this rare disease, says Bornstein. We have also instituted a new policy thatexceeds hospital norms and call for treating every brain biopsy as a potentialcase of CJD and sterilizing the instruments using the enhanced process, nomatter how unlikely CJD may appear at the time.

The initial sterilization followed the facilitys normalprocedures all instruments were cleaned in solution and then heated to 270degrees Fahrenheit for four minutes in a pre-vacuum surgical autoclave. On Sept. 15, after preliminary biopsy results pointed to thepossibility of CJD, all neurosurgical equipment was re-sterilized using enhancedmeasures 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 areextremely small, we cannot guarantee they are zero, says Allan Levey, MD,PhD, chair of neurology at Emory School of Medicine. That is why Emory istaking every possible step to deal with this matter.