Revised AAMI Standard Addresses Risk Analysis, Other Hot Topics in Sterilization

As of press time in August, the Association for the Advancement of Medical Instrumentation (AAMI) was poised to release a major update of its steam sterilization standard, ST79, to incorporate new information on risk analysis and chemical indicators, among other topics. The AAMI Standards Board and the American National Standards Institute (ANSI) has approved 26 changes and additions to ANSI/AAMI ST79, known as the “Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities.”

The amendment is part of a continuous maintenance process for ST79, according to independent clinical consultant Cynthia Spry, RN, MSN, CNOR, who is co-chair of the AAMI Steam Sterilization Hospital Practices Working Group. In 2006, AAMI assembled five pertinent documents into one volume, to make it easier for users to access the information.

“Information comes out so quickly today because of the Internet and with the awareness of infection prevention being such a hot topic, AAMI wanted to get updates out to users more quickly,” Spry explains. “So we said we’d do continuous maintenance to the standards, and get information out to people so they have an opportunity to stay on top of things.”

The revised document contains several significant additions, including a focus on risk analysis. “It essentially says you must look at your facility’s processes, proactively determine what the risks are for some kind of failure, and take the necessary steps to prevent that risk of failure,” Spry says. “And if a failure happens, you must know what to do about it. I think it’s important to have a risk management component in everything you do today.”

A risk analysis includes a risk assessment, which identifies the source, likelihood and consequences of a sterilization failure. It also assesses the preparedness to manage a failure. Risk management, which encompasses selecting and implementing plans to ensure that sterilization failures are controlled, and risk communication are also addressed in the revised document. Other changes offer additional guidance on processing a sterilization failure, and the revised document includes a checklist to provide sterile processing department (SPD) personnel more detailed recommendations on what to do when there is a positive biological indicator or other indication of a sterilization failure.

In addition, ST79 now contains new information and guidance for chemical indicators, which are used to ensure that instruments are sterilized properly. Chemical indicators are divided into classes to suit different monitoring needs. Class 1, for example, indicates visually whether a load has been processed, and Class 5 monitors all critical parameters of sterilization. Some changes to ST79 update descriptions of chemical indicators to correspond with a recently revised standard, ANSI/AAMI/ISO 11140-1:2005, “Sterilization of Health Care Products—Chemical Indicators—Part 1: General Requirements.”

AAMI’s Steam Sterilization Hospital Practices Working Group, which is responsible for authoring and updating ST79, included information on a new class of chemical indicator, the Class 6 Emulating Indicator, which is designed to react to all critical variables (such as time and temperature) of a sterilization cycle. While the working group has introduced the definition of Class 6 so that users are aware of its existence and availability, it has not developed consensus recommendations for how it should be used.

“Everyone wants to hear about the Class 6 emulating indicator and what we’re going to say about it,” Spry confirms. “Historically, I understand that when any new product comes out, it takes a significant time for it to get into the AAMI document; however, having said that, we know that the users want information. I suggested we hold a subcommittee meeting prior to the November meeting to see if we can come out with something – but I don’t know what that will be yet. We have been approved to mention it exists but not really to say what the application is, which is what the user wants.”

Spry acknowledges that there is some disagreement over the Class 6 indicator within the community: “One group says you can use it to release implants, meaning you can use it to release all loads, which would include implants. The other group says it can’t be used for implants and so forth. I don’t know what kind of compromise we can come to. Personally, I would like to see something in the document addressing product selection so when these things arise in the future, there is some kind of interim guideline until the point at which time there is something official in the document regarding its application. For now, I don’t know what will come out of it.”

What Spry does know for certain, however, is that there is a significant need for awareness and education regarding decontamination and sterilization processes in a number of medical facilities. It can get particularly scary, she says, outside of the hospital and ambulatory surgery center arena. “Just yesterday I was conducting an audit of a facility preparing for a visit from the Joint Commission and I discovered they were washing endoscopes with Betadine,” Spry says. “You don’t have to be a nurse to know how crazy that is! It’s not that they got up in the morning and said, ‘I’m going to do it wrong,’ it’s a question of not knowing. Not every facility has an AAMI document, or not every facility even knows there is an AAMI document. Major hospitals know, but there are so many facilities that don’t know what AAMI is and don’t know there is a sterilization document and certainly don’t know what is in it. I think it behooves managers to have competencies in place, and ensure that people demonstrate their adherence to them. There is a need for strong leadership, and I think the move toward the certification of SPD personnel is helping.”

Spry emphasizes the need for improved awareness of standards and processes, coupled with accountability. “People must demonstrate competence then show accountability for their actions.” It’s a lack of critical skills that come to light during audits, Spry says. “I cannot begin to tell you about some of the horrors I have seen in some places. At one facility, they took home the linen in which they wrapped the instruments and put them in a home clothes washer once a week. That’s the exception to the rule, but I rarely find a place outside of the hospital or ambulatory surgery center that is doing what it is supposed to 100 percent. I have never found someone not doing what they are supposed to because they don’t feel like it, it’s just that they don’t know. It’s not about casting dispersion on these facilities, it’s about raising awareness. In many of these ‘doc-in-a-box’ places — where the physician does a little plastic surgery or a little podiatry or a little endoscopy — the physician doesn’t have an affiliation that affords them a communication channel through which to learn about sterilization standards. When I do these audits and provide them with information, they are grateful because they don’t know about it. The physician probably has hospital privileges but that’s as close of a connection to the hospital there is, and these docs often know very little, if anything, about sterilization. And if they haven’t had an infection problem, they don’t see a cause-and-effect situation.”

One other key issue Spry points out is the ongoing challenge of flash sterilization, a topic also addressed by the Joint Commission in a recent update indicating that the agency would take a broader look into facilities’ sterilization processes.

“While AAMI was not impacted by the Joint Commission’s statement, it did lead to some confusion,” Spry says, adding that the Association of periOperative Registered Nurses (AORN) and AAMI have reached out to the Joint Commission regarding its position and some of the concerns related to it. “Personally, I think that the Joint Commission’s position statement shouldn’t be a concern to the people who are already practicing according to standards,” she says. “If they are not trying to reduce the incidence of flash sterilization, they still need to do that. Flash sterilization is the one thing that might be the most disconcerting to people. The position statement might be interpreted to mean that it’s OK to flash and people might say to themselves, ‘Let’s just do it,’ without trying to see if there are ways to not do it, and if they have to flash, to do it correctly.”

Spry continues, “I think the intent of the Joint Commission is to no longer say, ‘Oh, you flash sterilize, you get cited.’ I think they will say, ‘There are times when you need to flash sterilize’ rather than just saying, ‘You did something bad.’ They are looking at the entire process, which is actually wonderful. Flash sterilization, the way it was practiced originally, was risky. It is not a question of whether the sterilizer can sterilize, it’s the process. Sterilizers are all equally able to achieve sterility, but the process often does not lend itself to appropriate cleaning or prevention of contamination. Things have changed, and in light of that, it doesn’t make sense to say, ‘You flashed, you’re bad.’ We need to say, ‘OK, since you flash sterilize, is this something you do routinely or for convenience? That’s not a good thing. But when did you do it, was it an appropriate time to do it?’ And then the next question is, ‘Did you conduct the process according to standard?’ That’s what the Joint Commission should be looking at, rather than looking at quantity alone. Certainly if a facility does all flash sterilization, or a significant percentage of flash sterilization, then quantity does become an issue. But if you are flashing at appropriate times, then it’s not a question of quantity, it’s a question of how it is done – the process is scrutinized.”

Other additions to ST79 include new recommendations for assessing the efficacy of cleaning equipment; revised recommendations for testing for rigid containers; and acceptance criteria for qualification testing of flash sterilization cycles. Prior purchasers of ST79 may download a free PDF of this amendment from www.aami.org.