This Just In: Headlines in Disinfection and SterilizationHot off the presses, front-page concerns and on-the-record
reactions from the front lines of infection control
By John Roark
Monitoring Reusable Germicides
The monitoring of glutaraldehyde and other reusable germicides is a contentious issue seemingly surrounded by confusion. Yet the answer, say the experts, is simple: read manufacturers instructions and product inserts.
This is definitely a concern in many infection control departments, says Don Gordon, CRST, FEL, network director, central service, North Bronx Healthcare Network, Jacobi Medical Center, and president-elect of the International Association of Healthcare Central Service Materiel Management (IAHCSMM). There can be a lack of continuity in monitoring concentrations in certain isolated areas of the hospital because usually its assigned to a particular staff person. If that person is sick or goes on vacation, that can stop the process and infringe on the patients safety. That is one reason hospitals prefer to centralize the use of glutaraldehyde in either central sterile or areas that can provide adequate staffi ng in order to do this monitoring. Our infection control team does periodic surveillance throughout the hospital to ensure that records are being kept and that its being used properly. Theyve removed certain areas from the use of glutaraldehyde because their records werent up to snuff. You need an infection control department that not only has the ability to do that, but also the muscle to do it within the hospital.
Monitoring guidelines from the Association for the Advancement of Medical Instrumentation (AAMI), the Association of periOperative Registered Nurses (AORN) and manufacturers say that you better test your germicide before you use it, says Nancy Chobin, RN, CSPDM, SPD/CS educator at Saint Barnabas Health Care System. A solution can be labeled that it will be good for 14 days, but thats predicated that you are cleaning the device and drying it before you put it in.
In my mind the primary concern is that of residuals following cleaning, which may be cytotoxic, since glutaraldehyde is, by design, cytotoxic, says Don Selvey, vice president of regulatory affairs and quality assurance for Alliance Medical Corporation. A satisfactory reprocessing program will include processes to ensure there is no unsafe residual, that all the glutaraldehyde has been rinsed completely.
In addition, the validation studies used to support the use of the glutaraldehyde (or any disinfectant) must also include a biocompatibility element, especially a cytotoxicity assay. There may be a disconnect of sorts regarding the acceptable level of residual.
Lack of Compliance With Guidelines
The only explanation I can come up with is that people have not been properly trained, or have not had their competencies verified, says Chobin when asked why a blind eye seems to be turned on established guidelines for disinfection and sterilization. The accepted methodology for training is you describe one, you demonstrate one, and you have the employee do one. In competency testing when you have that observation it is acceptable to assume in the absence of error that they are competent. But often we bring the product in, we dont have time to do the procedure right now, the sales rep is going on vacation, so he gives a quick and dirty and leaves. Twelve days later somebody says, Was I supposed to test the solution? Then we wind up with a problem.
There is a recognized standard for sterilization; so as far as I know, compliance is not an option, it is an expectation, says Selvey. This includes revalidation at least annually, or whenever a parameter changes.
Gordon agrees. To me, this is where education comes in. Thats the key element in making sure that all guidelines are followed. Im a very strong believer in mandatory certifi cation in all healthcare professions.
Im the type of person who wont do something unless I understand it I dont like to make mistakes, says Chobin. I have no problem 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 set come in to do a lap choly. The salesman came in, of course on a Friday at 2 p.m.: Here are the instruments, heres how you take them apart, heres how you put them together. Wash them, put them in steam, were doing a case Monday at 7 a.m. He left, and Im thinking, this doesnt seem too bad. So I took them apart, and I couldnt put them back together. No matter what I did, I could not figure it out. I finally called him and said, I dont know where you are, but you get back here and go over this again and put these instruments back together. I want you here all next week. Everybody in my department is going to know how to do this. Its bad enough if I cant do it. 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 been suppressed for so long that we have no authority, no knowledge, no power. You have to start asserting yourself, you have to get with infection control and risk management, and say, We have some serious issues here. You have to go out there and see what people are doing. If you see that people are not using glutaraldehyde correctly, you need to get them retrained.
I just cannot for the life of me believe that this is anything where people are saying, This is not my job, or This is not important. We have bigger problems in healthcare than anyone even wants to think about, if thats the issue. I just have to believe that people have not been 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 the beginning of 2005.
Were working on a water-quality document thats going to rock our world, she says. Im on that committee only to try to make them understand that we dont understand anything theyre saying. My comment was that we need a document called Water Quality for Dummies. If theyre going 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) on manufacturers instructions, says Chobin. This is where we will tell the manufacturers: this is the information that you must provide us with so that we can safely and effectively process these devices that you are making. You have to use sterilization cycles that are familiar to us. You have to provide us with information on what type of detergent and how is it going to react with the material if we use something else. What kind of water quality do we need? Is it a pre-vacuum cycle? Right now we get, Use your normal cycle.
A new document titled ST-79 also is on the way. What we are doing is taking all of the steam documents including steam sterility and sterility assurance, decontamination, rigid containers, fl ash sterilization, reusable textiles, liquid germicide and the steam sterilization in ambulatory dental and offi ce-based practice settings. 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 Drug Administration (FDA) announced that the review deadline of the Supplemental Validation Submissions (SVSs) was extended by 90 days to Nov. 1, 2004. The new deadline will give some reprocessors who have submitted good but inadequate information the opportunity to submit additional supporting documentation for their devices and give FDA reviewers time to complete the SVS review.
Under the Medical Device User Fee and Modernization Act of 2002, single use device (SUD) reprocessors of critical SUDs, were required to submit additional information about cleaning, sterilization, and functionality 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 is none. This is patently false. The reality is that at least one reprocessor submitted more than 10,000 pages of data from cleaning validation studies, to performance standard development and implementation, to sterilization process validations and all the subsets of information that goes with it, such as packaging validation.
By extending the deadline, FDA is offering their own reviewers the opportunity to carefully review the data submitted, ask clarifying questions, and then make an appropriate determination whether the data are adequate.
Gordons facility has a policy of discarding single-use devices after use, but he recognizes that for hospitals facing financial challenges, this is one area where possible savings can be found. Gordon has confidence in the practice and should his facility go this route, he would recommend using a third-party reprocessor.
There are a number of things I would look at when choosing that third-party reprocessor, Gordon says. We would want to know if they were inspected and approved by the FDA, when the FDA last inspected their facility, and what the results of that inspection were. We would require proper documentation indicating that the company was approved, and review their records that they maintain for sterilization, and make sure they meet the FDAs quality 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 an item can be reprocessed, and how do they determine that number?
- Do they follow certified AAMI recommendations, and have their sterilizers routinely calibrated?
- What is the companys tracking system and turnaround time?
- How many of their technicians are certified?
We would also want to review their companys policy and procedures and quality assurance documents, and visit where they do the work. Id like to see it, and risk management would also probably like to get involved.
A lot of these companies also have multimillion-dollar insurance policies, and Im sure risk management would like to look at that, continues Gordon, who adds, Even with all of these policies, it could really ruin a hospital if there was even one problem. Thats why its so important that you choose a company that has an excellent reputation and really has been scrutinized by the FDA.
Becki Jenkins, CST, RCST, CRCST, FEL, president of Sterilization by Design, remains cautious. I know that there are companies that certainly do a good job, and they follow all the rules, but if the manufacturer designs it as single-use, it should be single-use, she says. The only problem with reusing a single-use device is that you cannot guarantee that it is 100 percent where it was when it was first opened. As a consultant I never say no, definitely you cant do that, but I do say this: make sure you research the third-party processor very well. Make sure that you have visited the plant and make sure you know exactly what they are doing, and make sure theres some sort of quality insurance in place. But personally, if I were a patient, 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 their issues in their hospital, says Chobin. The OR people said, Sometimes they have to scope a person at night, and because the GI lab isnt open, they bring 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 who wants Pentax, one who wants Fuji and one who wants Olympus. They are all different in terms of how to clean them and different in terms of the adaptors you need for the processors. If people dont know this and are not competent in each one of these, this is where we get into trouble.
This is such a highly technical area that requires highly trained staff who perform this function frequently, says Gordon. I stress the term frequently, because when you do something over and over, and you do it right and are well-versed on it, youre less apt to have errors. There are so many possible causes of infections that can result from the improper processing of an endoscope that the staff members performing these procedures really have to be experts to ensure patient safety.
In addition to patient safety, there is high cost associated with improper handling of endoscopic equipment repair. For this reason there is a trend in the healthcare industry to contract an outside vendor responsible for providing all endoscopic services, including employing an expert individual within the hospital to do endoscopic processing and to help in performing the procedures, says Gordon. Often its been demonstrated that it is very cost-effective to do that. Almost every hospital I know of has staffi ng problems, and discovering as time goes on that theres an ever-increasing use of endoscopic procedures in the OR and throughout the hospital. Thats why I think this outsourcing in this particular area is a vital service. I think youre going to see an increased trend in people contracting these experts from the outside who do nothing but handle all the endoscopic instrumentation within a hospital.
Danger Lies in Insulated Forceps
Another hot topic, largely ignored, says Chobin, is the integrity of insulation on insulated forceps. When the surgeon is in the belly during surgery, hes only seeing the distal third of that instrument when hes operating. If you get a leak in Zone 2, which is in the middle, or Zone 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 lighted magnification.
I actually had examined 15 instruments, and they were all fine, continues Chobin. Then we were given an insulation tester to try. I was shocked 12 of the 15 instruments failed. People cannot rely on visualization, and the problem is the smaller the hole, the worse it is for the patient because the energy can exceed 700 degrees F. If its out of the physicians field of vision, we could be burning and destroying tissue, which can 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 [the insulation] fl aking off, then its OK. Weve got to start drawing some attention to this.