Journal of Gastroenterology and Hepatology (2000) 15, G86G89
spective of this author is to treat as large a number ofpatients as possible, accepting the minimal risk associ-ated with reuse as opposed to treating a smaller numberof patients for whom the risk of reuse is eliminated.This principle applies to a system with finite financialresources, but may not be acceptable to an individualwith unlimited resources.
The ideal solution would be to establish a programmethat can provide reprocessed single-use devices equallyas safe and effective as reusable devices after processing.
The cost of disposable accessories is easy to establishbased on the manufacturers price, but further minorcosts are incurred, such as the cost of disposal. Furtherconsideration should be given to the environmentalimpact of a non-biodegradable product for which adollar value is difficult to assign.
The single most important motivation for establishinga policy for reutilization of accessories is the cost con-straint imposed by health-care systems with limitedresources. This applies equally to open-access nationalhealth-care programmes and to private medical institu-tions or health maintenance organizations. As universalhealth care is realized in countries with sufficient eco-nomic means, provision of adequate medical care to allcitizens will demand cost containment. In the disciplineof endoscopy, this applies both to endoscopes andprocessors, as well as to accessories. Various mono-graphs have provided a comprehensive overview of thisissue.13 The present report will address the issues thatare germane to reutilization of devices labelled orintended for single use only.
The concern of adopting a single-use policy for thosedevices so labelled is the probability that such a policywill limit access to care, because budgets are not suffi-cient to implement this directive without reducing thenumber of cases treated.The greater good from the per-
WORKING PARTY REPORT: CARE OF ENDOSCOPES
Reutilization of accessories in gastrointestinal endoscopic practice
The Centre for Advanced Therapeutic Endoscopy and Endoscopic Oncology,Wellesley Hospital,Toronto,Ontario, Canada
Abstract The key issues that determine the decision between reusable versus disposable accessoriesare cost and functionality. In most health-care systems the availability and dissemination of endoscopicservices relates directly to the resources (i.e. budget) of that system. Given the limitations of health-carebudgets, access to endoscopic services will depend upon the cost efficiency of endoscopic practice.Theonus on endoscopists and health-care providers, therefore, is to meticulously evaluate the necessarysteps for safe reutilization of accessories. This paper addresses the principles of reuse, quality assuranceand particularly disinfection practices. Any change to a more costly disposable accessory policy mustbear the responsibility of denied access to endoscopic services in a system with finite resources. 2000 Blackwell Science Asia Pty Ltd
Key words: cost effectiveness of endoscopy, disposable accessories, endoscopic accessories, endoscopiccomplications, endoscopic retrograde cholangiopancreatography (ERCP) baskets, ERCP sphinc-teromes, endoscopy practice, reusable accessories.
Correspondence: Dr GB Haber, The Centre for Advanced Therapeutic Endoscopy and Endoscopic Oncology, The WellesleyHospital, 160 Wellesley Street East, Toronto, Ontario M4Y1J3, Canada. Email: email@example.com
Reutilization of endoscopic accessories G87
The reuse of a single-use item is predicated on thecost savings achieved by the substantially lower pur-chase price. However, many other cost elements comeinto play with reuse and must be factored into the equa-tion. These include: (i) device handling and transportto and from the endoscopic facility; (ii) mechanicalcleaning, labelling and repackaging; (iii) sterilization;(iv) labour for all of these; (v) a quality assurance pro-gramme; (vi) administrative costs for programme devel-opment and maintenance; and (vii) potential legal costsfor possible litigation.
The per-item cost when considering these factorsbecomes highly dependent on volume and this may varyconsiderably in different practice settings. As the costdifferential between a reusable and a single-use itemdecreases, the value of reprocessing a single-use itemmay diminish.
In addition to cost considerations, the other criticalfactor is the functionality of the accessory with eachadditional use. If the mechanical integrity of theproduct is affected, the procedure may be lengthenedto accomplish the task intended, or aborted due tofailed function with the need to replace the product.There is a cost associated with such unforeseen prob-lems, not to mention the issue of safety. In that respect,pretesting a product for functional integrity may be necessary, and comprises part of a quality assuranceprogramme.
ASSESSMENT OF MECHANICAL INTEGRITY
Each accessory must be deemed adequate for theintended purpose prior to reuse. There are no clearguidelines as to the impact of handling, cleaning andsterilization on disposable materials. An empiricalapproach to each product with each successive use isrequired. The steps to be followed include:
1. Ensure correct labelling of the product and whenin doubt, seek the advice of fellow staff and especiallythose involved with the reprocessing. If necessary,compare the repackaged product to an unused newproduct to verify the dimensions. Repackaged itemsmay not have manufactures guidelines as to physicaldimensions, inflation pressures of function (e.g. fixedballoon diameter or variable diameter). This applies inparticular to balloons with varied diameters and infla-tion pressures. Likewise, wire diameters are at times dif-ficult to determine by eyeballing the product. Thedifferences between a 0.021 and a 0.025 or 0.018 inchwire are not easily appreciated. The necessary precau-tions should be undertaken to ensure inclusion of theseguidelines with repackaging when appropriate.2. Check repackaged items for integrity of the sealand date of processing.3. Carefully inspect residue or debris not adequatelycleaned.4. Pretest the accessory for patency of the lumen (e.g.flush a catheter), mobility of moveable parts, any defor-mities or loss of elasticity (e.g. with opening of abasket).
5. Check all electrical contacts to ensure a good fitand test for current transmission either in vitro (e.g.heater probe or bicap) or in vivo (e.g. test pulse withbicap on normal mucosa).6. Ensure that a new product is available if the reuseditem fails or is discarded.
The cumulative effects of repeated reuse varies con-siderably depending on the clinical situation. Intuitively,however, repeated use will eventually lead to deteriora-tion of function and the threshold for disposal of aproduct should be relatively low. Namely, at the earli-est sign of impaired function of an accessory, the endo-scopist should ensure that the product is discardedeither during or after the procedure, depending on thenature of the fault. Moreover, there may be an advan-tage to sequential marking that indicates the number ofprior uses of the device, to enhance awareness of poten-tial malfunction.
TRANSMISSION OF INFECTION
Although most of the published literature has docu-mented transmission of infectious agents via improperlycleaned or disinfected endoscopes, many accessories are equally capable of transmission, especially ifmechanical cleansing is impaired by the design of theproduct.
Microorganisms transmissible via endoscopy includethe full range of bacteria, viruses, fungi and parasites.Bacteria are ubiquitous and are the most common con-taminants of endoscopes and accessories. Most reportsdocument transmission of Gram-negative bacilli,especially those that thrive in a moist environment.Pseudomonas aeruginosa is the most common isolate, butothers include Klebsiella, Enterobacter, Serratia marces-cans, Escherichia coli and Salmonella species. Helicobacterpylori transmission is a recent addition to the list.Mycobacteria with a capsular coat are particularly dif-ficult to destroy and require a longer exposure time todisinfectants. The same is true for spore forming bacteria.
Viruses can be classified according to their lipidcontent and envelope. Lipophilic viruses have a lipidenvelope and are more easily killed by disinfectants thanhydrophilic viruses. Lipophilic viruses include measles,mumps, hepatitis B and HIV. Hydrophilic virusesinclude hepatitis A. However, no cases of hepatitis A orHIV viral transmission from accessories have beenrecorded to date.
Fungal contamination and infectivity have been documented for Trichosporon beigelii, Rhodotorula rubraand Trichosporon cutaneum, among others.
CLINICAL TRIALS ON REUSE
There are few prospective trials that have evaluated thecost utility and functionality of reuse of accessorydevices designed or labelled as single-use devices.
Kozarek et al. have demonstrated that disposablesphincterotomes have the potential to be reused.4 Their
G88 GB Haber
study addressed the ability to achieve high level disin-fection and sterilization, as well as the level of electricalcurrent transmission, of single-use sphincterotomes.Each sphincterotome was used to incise a piece of meatwith 15 s of blended current. Each sphincterotome was then contaminated with a definite inoculum ofMycobacterium chelonei. Following enzymatic cleaningand a glutaraldehyde soak, four of five double-lumensphincterotomes (with non-irrigatable wire channels)grew bacteria. Three of 10 sphincterotomes developeda wire fracture between four and eight uses, but currenttransmission remained constant in all unbroken wireswith up to 10 uses.These results highlight the difficultyof glutaraldehyde soaking alone for decontamination ofaccessories with inaccessible channels for irrigation.However, the functionality of these sphincterotomesremained adequate for a mean of 8.7 in vitro uses.
Cohen et al. have reused papillotomes and basketswith the endoscopists blinded to the number of prioruses.5 All accessories underwent enzymatic and manualcleaning followed by ethylene oxide sterilization. Thisstudy is not strictly applicable to the topic of reuse ofsingle-use items, because the Olympus products usedwere designated as reusable. However, the careful costanalysis that was undertaken highlights the considerablesavings achieved by reuse and is the only prospectiveblinded evaluation of repeated usage.Twenty-five papil-lotomes were used a mean of 9.8 times and 15 basketsa mean of 12.9 times. Projected yearly cost savings com-pared with the use of a single-use device were US$62000 for papillotomes and US$41 000 for baskets.
Kozarek et al.,6 in another study, prospectively evaluated the function of double lumen sphinctero-tomes in a non-blinded fashion. The methodology ofthis assessment closely resembled clinical practice. Themean number of uses was 3.4, which was less than themean number of reuses as seen in their in vitro study.4
The estimated annual cost savings was US$66 000. Nosystematic evaluation of disinfection procedures wasundertaken in this study.
In an attempt to define whether disposable orreusable biopsy forceps are more cost effective, aprospective evaluation has shown that reusable biopsyforceps become cost effective after seven uses.7
A quality control protocol is critical to a reuse pro-gramme, especially when the product is designated as asingle use by the manufacturer.This programme shouldincorporate evaluation for absence of infective agents,endotoxins or pyrogens, as well as mechanical functionand electrical current transmission when appropriate.Quality assurance should be undertaken at regularintervals with random sampling of accessories and ade-quate documentation. This will ensure that all devicesare evaluated and properly recorded for review in theevent of possible litigation. In essence, the health-carefacility must adopt the rigorous standards imposed onmanufacturers. The following steps will ensure that anappropriate programme is in place:
1. Each step of the reprocessing procedure should beitemized to allow for systematic monitoring.2. Written guidelines should be established withdetailed instructions as to the exact performance ofeach step.This will provide a consistency in the processwhen personnel change.3. The reprocessing procedure should include self-evaluation with specific internal controls to validate theprocess. This may be accomplished by in vitro inocula-tion of specific quantities of problematic bacteria (e.g.spore forms) into various accessories prior to reprocessing.4. Revalidation should be undertaken when any stepin the procedure is altered (e.g. soak time) and whenany cleaning product is changed. Likewise, when newaccessories are introduced a protocol should be in placefor initial evaluation.5. A training programme for personnel emphasizingthe rationale for each step of the reprocessing procedurewill help to reinforce the importance of assiduousadherence to the procedure outlined.6. Regular committee meetings should monitor com-pliance and review results compared with previouslyestablished acceptable standards or guidelines. Thecommittee should comprise representatives from allstakeholders in the process, including an infectiousdisease expert, the endoscopist, gastrointestinal assis-tant and cleaning personnel. Employee safety is anappropriate issue for such a committee.7. Cost impact should be periodically reviewed todetermine whether or not a reuse programme is stillwarranted for any particular product, especially with substantial changes in the cost of a product or thereprocessing. This will change considerably in differentjurisdictions where labour or material costs may varygreatly.
In a climate of finite resources and a move towards uni-versal health-care access, the savings achieved withreuse of accessories is a major incentive to establishingsuch a practice. However, a meticulous assessment ofall direct and indirect costs associated with reprocess-ing must be undertaken, along with a careful evaluationof the functionality of each particular device. The fearof transmission of microorganisms is real but a system-atic approach to disinfection can eliminate these con-cerns. Continued surveillance and evaluation of reuseprogrammes is warranted, given the dearth of prospec-tive clinical trials to date.
1 The reuse of single use medical devices. Ottawa: CanadianHealthcare Association, 1996.
2 Sullivan P. Speakers offer vastly different views on dispos-able health care products. Can. Med. Assoc. J. 1990; 143:134255.
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3 Turi ZG. Reuse of disposables. Cathet. Cardiovasc. Diagn.1996; 38: 1334.
4 Kozarek RA, Sumida SE, Raltz SL et al. In vitro evaluationof wire integrity and ability to reprocess single use sphinc-terotomes. Gastrointest. Endosc. 1996; 45: 11721.
5 Cohen J, Haber GB, Kortan P et al. A prospective study ofthe repeated use of sterilized papillotomes and retrievalbaskets for ERCP: Quality and cost analysis. Gastrointest.Endosc. 1997; 45: 1227.
6 Kozarek RA, Raltz SL, Ball TJ et al. Reuse of disposablesphincterotomes for diagnostic and therapeutic ERCP: Aone year prospective study. Gastrointest. Endosc. 1999; 49:3942.
7 Kozarek RA, Raltz SL, Merriam DL et al. Disposable versusreusable biopsy-forceps: A prospective evaluation of costs.Gastrointest. Endosc. 1996; 43: 1013.