This Just In: Headlines in Disinfection and Sterilization

October 1, 2004

This Just In: Headlines in Disinfection and Sterilization

Hot off the presses, front-page concerns and on-the-recordreactions from the front lines of infection control

By John Roark

Monitoring Reusable Germicides

The monitoring of glutaraldehyde and other reusable germicidesis a contentious issue seemingly surrounded by confusion. Yet the answer, saythe experts, is simple: read manufacturers instructions and product inserts.

This is definitely a concern in many infection controldepartments, says Don Gordon, CRST, FEL, network director, central service,North Bronx Healthcare Network, Jacobi Medical Center, and president-elect ofthe International Association of Healthcare Central Service Materiel Management(IAHCSMM). There can be a lack of continuity in monitoring concentrations incertain isolated areas of the hospital because usually its assigned to aparticular staff person. If that person is sick or goes on vacation, that canstop the process and infringe on the patients safety. That is one reasonhospitals prefer to centralize the use of glutaraldehyde in either centralsterile or areas that can provide adequate staffi ng in order to do thismonitoring. Our infection control team does periodic surveillance throughout thehospital to ensure that records are being kept and that its being usedproperly. Theyve removed certain areas from the use of glutaraldehyde becausetheir records werent up to snuff. You need an infection control departmentthat not only has the ability to do that, but also the muscle to do it withinthe hospital.

Monitoring guidelines from the Association for theAdvancement of Medical Instrumentation (AAMI), the Association of periOperativeRegistered Nurses (AORN) and manufacturers say that you better test yourgermicide before you use it, says Nancy Chobin, RN, CSPDM, SPD/CS educator atSaint Barnabas Health Care System. A solution can be labeled that it will begood for 14 days, but thats predicated that you are cleaning the device anddrying it before you put it in.

In my mind the primary concern is that of residualsfollowing cleaning, which may be cytotoxic, since glutaraldehyde is, by design,cytotoxic, says Don Selvey, vice president of regulatory affairs and qualityassurance for Alliance Medical Corporation. A satisfactory reprocessingprogram will include processes to ensure there is no unsafe residual, that allthe glutaraldehyde has been rinsed completely.

In addition, the validation studies used to support the use ofthe glutaraldehyde (or any disinfectant) must also include a biocompatibilityelement, especially a cytotoxicity assay. There may be a disconnect ofsorts regarding the acceptable level of residual.

Lack of Compliance With Guidelines

The only explanation I can come up with is that people havenot been properly trained, or have not had their competencies verified, says Chobin when asked why a blind eye seems to be turned onestablished guidelines for disinfection and sterilization. The acceptedmethodology for training is you describe one, you demonstrate one, and you havethe employee do one. In competency testing when you have that observation it isacceptable to assume in the absence of error that they are competent. But oftenwe bring the product in, we dont have time to do the procedure right now, thesales rep is going on vacation, so he gives a quick and dirty and leaves. Twelvedays later somebody says, Was I supposed to test the solution? Then wewind up with a problem.

There is a recognized standard for sterilization; so as faras I know, compliance is not an option, it is an expectation, says Selvey. This includes revalidation at least annually, or whenever aparameter changes.

Gordon agrees. To me, this is where education comes in.Thats the key element in making sure that all guidelines are followed. Ima very strong believer in mandatory certifi cation in all healthcareprofessions.

Im the type of person who wont do something unless Iunderstand it I dont like to make mistakes, says Chobin. I have noproblem asking you 50 questions, or asking you to redo it 50 times. For example,when the minimally invasive instruments first came on the market, we had a setcome in to do a lap choly. The salesman came in, of course on a Friday at 2p.m.: Here are the instruments, heres how you take them apart, heres howyou put them together. Wash them, put them in steam, were doing a case Mondayat 7 a.m. He left, and Im thinking, this doesnt seem too bad. So I tookthem apart, and I couldnt put them back together. No matter what I did, Icould not figure it out. I finally called him and said, I dont knowwhere you are, but you get back here and go over this again and put theseinstruments back together. I want you here all next week. Everybody in mydepartment is going to know how to do this. Its bad enough if I cant doit. At least I could be used as a reference tool for them.

But too often people arent that assertive, she continues. As sterile processing managers, we have beensuppressed for so long that we have no authority, no knowledge, no power. You have to start asserting yourself, you have to get withinfection control and risk management, and say, We have some serious issueshere. You have to go out there and see what people are doing. If you see thatpeople are not using glutaraldehyde correctly, you need to get them retrained.

I just cannot for the life of me believe that this isanything where people are saying, This is not my job, or This is notimportant. We have bigger problems in healthcare than anyone even wants tothink about, if thats the issue. I just have to believe that people have notbeen properly trained. And you see it across the board.

New AAMI Guidelines

Chobin, who serves as a member of AAMI advisory committees,reports that major changes and new guidelines should be in place at thebeginning of 2005.

Were working on a water-quality document thats goingto rock our world, she says. Im on that committee only to try to makethem understand that we dont understand anything theyre saying. My commentwas that we need a document called Water Quality for Dummies. If theyregoing to make a document for us to use, weve got to be able to understand it.This document is going to define the water quality for cleaning, disinfection,liquid chemical germicide rinsing.

Also pending is a new technical information report (TIR) onmanufacturers instructions, says Chobin. This is where we will tell themanufacturers: this is the information that you must provide us with so that wecan safely and effectively process these devices that you are making. You haveto use sterilization cycles that are familiar to us. You have to provide us withinformation on what type of detergent and how is it going to react with thematerial if we use something else. What kind of water quality do we need? Is ita pre-vacuum cycle? Right now we get, Use your normal cycle.

A new document titled ST-79 also is on the way. Whatwe are doing is taking all of the steam documents including steam sterility andsterility assurance, decontamination, rigid containers, fl ash sterilization,reusable textiles, liquid germicide and the steam sterilization in ambulatory dental and offi ce-based practicesettings. They are all going to be combined into one compendium.

Re-use of Single-use Devices

A message posted on Aug. 3, 2004 by the U.S. Food and DrugAdministration (FDA) announced that the review deadline of the SupplementalValidation Submissions (SVSs) was extended by 90 days to Nov. 1, 2004. The newdeadline will give some reprocessors who have submitted good but inadequateinformation the opportunity to submit additional supporting documentation fortheir devices and give FDA reviewers time to complete the SVS review.

Under the Medical Device User Fee and Modernization Act of2002, single use device (SUD) reprocessors of critical SUDs, were requiredto submit additional information about cleaning, sterilization, andfunctionality for FDA to review in order for their devices to continue to be commercially marketed.1

In my view, this was a prudent action on the part of FDA,says Selvey. I know the manufacturers and their trade associations object,and claim the reason reprocessors havent submitted data is that there isnone. This is patently false. The reality is that at least onereprocessor submitted more than 10,000 pages of data from cleaningvalidation studies, to performance standard development and implementation, tosterilization process validations and all the subsets of information thatgoes with it, such as packaging validation.

By extending the deadline, FDA is offering their ownreviewers the opportunity to carefully review the data submitted, ask clarifyingquestions, and then make an appropriate determination whether the data areadequate.

Gordons facility has a policy of discarding single-usedevices after use, but he recognizes that for hospitals facing financialchallenges, this is one area where possible savings can be found. Gordon hasconfidence in the practice and should his facility go this route, he wouldrecommend using a third-party reprocessor.

There are a number of things I would look at when choosingthat third-party reprocessor, Gordon says. We would want to know if theywere inspected and approved by the FDA, when the FDA last inspected theirfacility, and what the results of that inspection were. We would require properdocumentation indicating that the company was approved, and review their recordsthat they maintain for sterilization, and make sure they meet the FDAsquality system regulations.

In addition, Gordon would ask the following:

  • What aspects of the overall process have been validated:cleaning, packaging, sterilization?

  • What are the companys limits on the number of times anitem can be reprocessed, and how do they determine that number?

  • Do they follow certified AAMI recommendations, and havetheir sterilizers routinely calibrated?

  • What is the companys tracking system and turnaroundtime?

  • How many of their technicians are certified?

We would also want to review their companys policy andprocedures and quality assurance documents, and visit where they do the work. Idlike to see it, and risk management would also probably like to get involved.

A lot of these companies also have multimillion-dollarinsurance policies, and Im sure risk management would like to look at that,continues Gordon, who adds, Even with all of these policies, it could reallyruin a hospital if there was even one problem. Thats why its so importantthat you choose a company that has an excellent reputation and really has beenscrutinized by the FDA.

Becki Jenkins, CST, RCST, CRCST, FEL, president ofSterilization by Design, remains cautious. I know that there are companiesthat certainly do a good job, and they follow all the rules, but if themanufacturer designs it as single-use, it should be single-use, she says. Theonly problem with reusing a single-use device is that you cannot guarantee thatit is 100 percent where it was when it was first opened. As a consultant Inever say no, definitely you cant do that, but I do say this: make sure youresearch the third-party processor very well. Make sure that you have visitedthe plant and make sure you know exactly what they are doing, and make suretheres some sort of quality insurance in place. But personally, if I were apatient, I would not want a single-use device used on me. Can it be done? Yes.Should it be done? Not so sure.

Flexible Endoscope Cleaning

I was having a meeting with the CSP people on some of theirissues in their hospital, says Chobin. The OR people said, Sometimesthey have to scope a person at night, and because the GI lab isnt open, theybring the scopes to us and tell us to clean them. I asked what the issue was,and they said, We dont know how; nobody has ever showed us. I asked what they do, and they said, We do the best we can.

My first recommendation was, you shouldnt be cleaning anything if you dont know how to do it. I would no sooner get into a car or do brain surgery if I didnt know what I was doing. The biggest issue Im seeing is education. Competencies are so critical. You might have 15 different kinds of scopes. If you have a big GI center, you might have one doctor whowants Pentax, one who wants Fuji and one who wants Olympus. They are alldifferent in terms of how to clean them and different in terms of the adaptorsyou need for the processors. If people dont know this and are not competentin each one of these, this is where we get into trouble.

This is such a highly technical area that requires highlytrained staff who perform this function frequently, says Gordon. I stressthe term frequently, because when you do something over and over, and youdo it right and are well-versed on it, youre less apt to have errors. Thereare so many possible causes of infections that can result from the improperprocessing of an endoscope that the staff members performing these proceduresreally have to be experts to ensure patient safety.

In addition to patient safety, there is high cost associatedwith improper handling of endoscopic equipment repair. For this reason thereis a trend in the healthcare industry to contract an outside vendor responsiblefor providing all endoscopic services, including employing an expert individualwithin the hospital to do endoscopic processing and to help in performing theprocedures, says Gordon. Often its been demonstrated that it is verycost-effective to do that. Almost every hospital I know of has staffi ngproblems, and discovering as time goes on that theres an ever-increasing useof endoscopic procedures in the OR and throughout the hospital. Thats why Ithink this outsourcing in this particular area is a vital service. I think youregoing to see an increased trend in people contracting these experts from theoutside who do nothing but handle all the endoscopic instrumentation within ahospital.

Danger Lies in Insulated Forceps

Another hot topic, largely ignored, says Chobin, is theintegrity of insulation on insulated forceps. When the surgeon is in thebelly during surgery, hes only seeing the distal third of that instrumentwhen hes operating. If you get a leak in Zone 2, which is in the middle, orZone 3, which is up near the optical piece, its out of his field of vision.Many of these breaches in the insulation cannot even be seen under lightedmagnification.

I actually had examined 15 instruments, and they were allfine, continues Chobin. Then we were given an insulation tester to try. I wasshocked 12 of the 15 instruments failed. People cannot rely onvisualization, and the problem is the smaller the hole, the worse it is for thepatient because the energy can exceed 700 degrees F. If its out of thephysicians field of vision, we could be burning and destroying tissue, whichcan lead to peritonitis and death.

Nobody is addressing this, says Chobin. Its an expense,and we dont know about it, and we assume that if we dont see [theinsulation] fl aking off, then its OK. Weve got to start drawing someattention to this.