surgical instruments

Immediate Use Sterilization: A Review of the Basics

<p>Some habits die hard, but healthcare professionals should be making a concerted effort to use the term "immediate-use sterilization" instead of "flash sterilization" to describe a quick turnaround of an instrument, but more importantly, facilities must know when and why this approach should or should not be taken. This article is a review of the protocol and the reasoning behind it related to fast sterilization of a surgical instrument.</p>

By Kelly M. Pyrek

Some habits die hard, but healthcare professionals should be making a concerted effort to use the term "immediate-use sterilization" instead of "flash sterilization" to describe a quick turnaround of an instrument, but more importantly, facilities must know when and why this approach should or should not be taken. This article is a review of the protocol and the reasoning behind it related to fast sterilization of a surgical instrument.

In the summer of 2009, the Joint Commission (JC) announced it was taking a new approach toward examining a healthcare facility's sterilization practices that broadened its scrutiny of what was then called flash sterilization. Instead of targeting which method was employed, JC surveyors would be looking at the entire sterilization process -- cleaning and decontamination, sterilization, storage or return to the sterile field -- noting that, "If a complete and effective process of sterilization is used, it will be considered an effective sterilization method," it clarified in a subsequent update.

Surveyors were also asking staff whether they followed manufacturers' instructions and recommendations for sterilization and wrapping/packaging, but a significant challenge arose when sterile processing professionals attempted to follow instructions pertaining to extended cycles and other parameters that fall outside of a range of instructions cleared by the Food and Drug Administration (FDA).

The Joint Commission's actions set off a flurry of questions from the operating room and sterile processing community, with a number of professionals wanting to know if the JC had established what it considered to be an acceptable level of flash sterilization. The answer was that it hadn't, but urged facilities not to resort to flashing as a matter of convenience because it had not adequately planned for instruments' utilization during cases. Professionals were also hoping for a better definition of what constituted flash sterilization, which has been essentially sterilization for 3 minutes at 270 degrees F (132 degrees C) and between 27 to 28 pounds of pressure.

Due in part to some of the confusion and the questions that persisted, in 2010 the Association for the Advancement of Medical Instrumentation (AAMI) partnered with other healthcare organizations and regulatory agencies to craft new recommendations for sterilization of items intended for immediate use, in response to concerns that the process was misunderstood and misused by many healthcare institutions. At a summit where this group discussed when to use and what to call the process historically known as flash sterilization, it was decided that the process should be called immediate-use steam sterilization. Although this abbreviated cycle of steam sterilization is meant for instruments to be used immediately (as opposed to terminal sterilization, where the items are sterilized and stored for later use), experts acknowledged that healthcare organizations were indeed using abbreviated cycles for safe and efficacious instrument processing for immediate use, as long as the critical steps of cleaning, decontamination and aseptic transport were followed.

Cynthia Spry, RN, MA, MSN, CNOR, an independent consultant who chaired the working group that developed the comprehensive steam sterilization standard for AAMI, acknowledges the fact that most professionals understand the steps involved in the cleaning, disinfection and sterilization process, but lingering questions remained about when it is acceptable to use immediate-use sterilization. Confusion surrounding flash sterilization has led to abuses and shortcuts in some operating rooms, which could lead to improperly processed instruments being used on patients.

In March 2011, a new multi-society position statement addressing immediate-use steam sterilization of medical instruments was released by AAMI, the Association of periOperative Registered Nurses (AORN) and several other organizations. As part of the effort to clarify the process for this commonly used method of sterilization, the statement endorses replacing the term "flash sterilization" with "immediate use steam sterilization." The statement reads in part: "'Flash sterilization is an antiquated term that does not fully describe the various steam sterilization cycles now used to process items not intended to be stored for later use," says the statement, which defines the entire process, from cleaning and sterilization to transporting items for immediate use.

"People would flash sterilize equipment and hold it over for cases down the road," says Spry, who adds that using the term "immediate use" can help to reinforce the intent of this sterilization process. It is defined in the statement as "the shortest possible time between a sterilized items removal from the sterilizer and its aseptic transfer to the field." Spry adds, "I think people who have been doing it right all along wont find anything in here that is revolutionary. This document will help people who need clarification."

Spry says that for the most part, acceptance of the newer terminology of immediate-use sterilization has been swift. "At a recent FDA meeting on medical devices where stakeholders talked about immediate-use steam sterilization, never once did I hear the word 'flash,'" she says. "I think this terminology was embraced as quickly as it has because it really does reflect what it's all about -- flash simply doesn't cover it anymore. What I hear people say is, 'Oh we don't do any flash sterilization' and typically I don't believe that. I will look around and find something that's being flashed. I had an OR director tell me they never flash and that they went so far as to remove all of the sterilizers from the operating room. Now, that's not safe, and she actually admitted that. She was lobbying to get one or two of the sterilizers returned to the OR."

While this may be an extreme situation, Spry says at most facilities, OR and sterile processing professionals are working through an appropriate response to what is expected of them by regulatory agencies. "I think people are really getting it in a sense that they know they are not supposed to flash for convenience's sake. They know that they are supposed to examine carefully what they are sterilizing for immediate use and why they are doing it, and refraining from this process if they don't have to resort to it. I think most people understand that they shouldn't go crazy, as there's nothing in the literature that correlates flash sterilization with patient infection -- except for eye instruments, and not necessarily because they are being flashed, it's because of residual debris left in the lumens of these instruments. The key is that if you do it right, it's OK, but the point is not to ever do immediate use sterilization for the convenience of it or ibecause you do not have enough instruments."

A lack of instrumentation inventory can be the real culprit in some cases, but Spry emphasizes that most often, it's due to a lack of advance planning and forethought on the part of the healthcare facility. "I think a very real issue is the eye instruments. Facilities must get a handle on the configuration of their eye trays. A very simplistic response to the fact that facilities never have enough eye trays (especially when they can do 17 cataracts before noon and they have only four or five trays) is to conduct a quality improvement exercise in which all of your eye instruments are listed and someone checks off what's really used during cases. What you will probably discover is that it's only about eight instruments being used all of the time. The problem is that some doctors have outlier instruments that they want; this is fine if they can be picked at the same time the whole tray is wrapped. It can be tough when you have different eye doctors with different eye trays; however, you can put systems in place to really cut down on your eye instrument flashing and you can probably buy eight additional instruments to have as another available set because it's not a capital expenditure."

But sometimes it's just not that easy, Spry acknowledges. "There's no doubt that the economy is having an impact on hospitals' budgets. There are some facilities that are really desperate and can't buy anything. Then there are those that are either starting new specialties or are renovating sterile processing departments or are building more ORs, so those facilities are going to have the instruments that they need. Any facility that is stable financially ought to be able to have the instruments that are needed, but you must have communication between the sterile processing department and the OR, and you've got to work together. As a simple example, the SPD sends a set to the OR and Dr. X wants a particular instrument, so you get it -- it's not normally in a set but you add it and then there's one more instrument. Then someone else adds another instrument -- trays have a life of their own and they grow without a whole lot of vetting. You can't do it all, but if the OR says put this instrument in, the SPD is going to do it because it's easier than to fight it and because you don't know what's going on upstairs. It really must be a seamless partnership. Departments that are like that are very successful, but there are still a lot of places where it's like a bad marriage."

Immediate-use sterilization has perhaps the greatest meaning for ambulatory surgery centers and other outpatient facilities that lack the resources hospitals do. "Office-based facilities are the most challenged," Spry says. "They are owned and run by physicians so the money comes out of their own pockets. They can be the most reluctant to spend any money, not because they don't want good outcomes for their patients, but because they don't have the margin and they can't borrow from Peter to pay Paul, as a hospital might be able to do."

To that end, the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) makes the following pertinent points regarding immediate-use sterilization:

- Personnel involved in reprocessing should be knowledgeable and capable of exercising critical thinking and judgment, and should implement standardized practices. The supervising organization is responsible for ensuring appropriate training, education, and competency of staff and ensuring that the necessary related resources are provided. (Examples of education and certification resources include the Certification Board for Sterile Processing and Distribution (CBSPD) and the International Association of Healthcare Central Service Materiel Management (IAHCSMM), while examples of standards and practices can be found with AAMI), AORN and the CDC's Healthcare Infection Control Practices Advisory Committee)

- Sterilization personnel should be educated regarding the different types of steam sterilizers (i.e., gravity-displacement and dynamic air removalpre-vacuum, high vacuum, and steam-flush-pressure-pulse sterilizers) and the different types of steam sterilization cycles (i.e., gravity-displacement and dynamic air removal cycles) used in healthcare facilities.

- Sterilization cycles with little or no dry time are efficacious when used in compliance with validated written instructions provided by the device manufacturers, sterilization equipment manufacturers, and (if applicable) container manufacturers and when done in accordance with professional guidelines.

- Cleaning, decontamination, and rinsing are critical and users must follow and complete all required processing steps regardless of the sterilization exposure parameters being used.

- Aseptic transfer from the sterilizer to the point of use is critical to protect items from contamination.

- Only items sterilized and packaged in materials cleared by the FDA for maintenance of sterility can be stored.

- The device manufacturer's written instructions for reprocessing any reusable device must be followed. The cycle parameters required to achieve sterilization are determined by the design of an instrument, the characteristics of the load, the sterilizer capabilities, and the packaging (if used).

- Sterilization process monitoring is essential to ensure that sterilization practices are efficacious (Examples of process monitoring tools are physical indicators, biological indicators and chemical indicators.)

- Instrument inventories should be sufficient to meet anticipated surgical volume and permit the time to complete all critical elements of reprocessing.

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