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         Clinical intelligence for supply chain leadership

 
 

INSIDE THE CURRENT ISSUE

September 2013

CS Connection

 
 


 

Immediate-use sterilization should not be convenient-use practice

by Kara Nadeau Della Vecchia

In recent years the healthcare industry has turned a critical eye toward immediate-use steam sterilization (IUSS) — formerly known as flash sterilization — because its use in inappropriate clinical situations can increase the risk of healthcare-associated infections (HAIs). But the use of IUSS is still prevalent among healthcare facilities, with many using this sterilization practice out of convenience rather than out of necessity as it was intended. If continued use of IUSS is the reality, then how do facilities ensure it is being used appropriately and safely?

IUSS in healthcare today

Numerous healthcare industry associations, including the Association for the Advancement of Medical Instrumentation (AAMI), Association of periOperative Registered Nurses (AORN) and the International Association of Healthcare Central Service Materiel Management (IAHCSMM), have issued guidelines and recommendations on when and how to use IUSS (see sidebar below), but in reality, facilities often use this sterilization method outside these parameters to compensate for limited time, money and staff resources. For example, many turn to IUSS when loaner instrument sets arrive at their facilities without adequate time to reprocess them correctly. IUSS is also frequently used when facilities have insufficient inventory levels to support procedural volume.

Bob Marrs

"When I go into hospitals and look at their sterilization logs, the staff will often tell me they typically utilize immediate-use sterilization for one-of-a-kind instruments that are dropped, but as I dig into their logs I find that this scenario accounts for less than 1 percent of all IUSS cycles," said Bob Marrs, BA, CRCST, CIS, CHL, Director, Consulting Services/Field Operations, Aesculap. "Most facilities are using IUSS for turnover, whether it’s turnover of their own sets, one-of-a-kind instruments where they don’t have enough, or loaner/vendor trays — and all three of those reasons are the wrong reasons."

Lena Burgess

Renee Turmann

Lena Burgess, Clinical Operations Director for Integrated Medical Systems International Inc. (IMS) has seen facilities with an IUSS rate as high as 45-50 percent but she points out that most facilities have a goal that ranges from 3-6 percent. Her colleague, Renee Turmann, BS, CSPDT, CSPM, CFER, Manager of Web Based Education and Compliance for IMS, adds:

"The current ‘word on the street’ is that IUSS is now seen in a negative light. In the past, it was just something one HAD to do to compensate for the lack of inventory. Today it is seen as a failure to uphold the standard of care for all patients."

While most everyone agrees that healthcare organizations must reduce their use of IUSS, the individual facilities themselves face the challenge of getting the necessary resources, policies and procedures in place to achieve this industry-wide goal. According to Martha Page, RN, Clinical Education Specialist for STERIS Corporation, minimizing the use of IUSS could pose a burden to facilities in the short term, but in the long term, it will contribute to both the financial viability of the organizations and the safety of their patients by reducing the risk of HAIs.

"This practice, if improperly used, is now thought to be an associated risk factor for surgical site infections, the reporting of which can have a negative effect on a healthcare facility," said Page. "In addition, healthcare facilities that are already strapped by budget cuts and decreased reimbursement are heeding the recommendations from multiple national professional organizations to reduce the use of IUSS. On the positive side, this acute attention to issues around IUSS has led to an increased awareness by staff of IUSS best practices."

Scott Kaczmarek, Clinical Operations Director for IMS, agrees the benefits of minimizing or eliminating IUSS outweigh the cost and effort.

"Facilities looking to limit — or eliminate completely — the use of IUSS need to commit to the type of investment necessary to succeed," said Kaczmarek. "This is often a fairly substantial financial investment, coupled with extensive staff training and accountability efforts. Ensuring process standardization across the board to improve patient outcomes by lessening the opportunity for deviations of protocol are more than worth the investment in the long run."

Best practices for safe and effective IUSS

We looked to industry associations, experts and representatives to provide the following IUSS best practices.

Policies and procedures

Martha Page

Having a solid policy in place that states under which conditions IUSS is permitted and what procedures must be followed when using IUSS enables a hospital to rein in the practice so that it is used only as intended. Page provides her recommendations on what factors facilities should include in their IUSS policies:

  • Statements of purpose

  • Specific decontamination instructions

  • Steps for choosing the correct sterility monitoring device

  • Selection of the proper sterilization cycle (which must be recommended and validated by the manufacturer of the instrument)

  • Transport steps to the point of use

  • Proper documentation of the IUSS cycle

Rose Seavey

In addition to an overall IUSS policy, Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT, President and CEO, Seavey Healthcare Consulting LLC., urges healthcare facilities to have in place policies and procedures specific to loaner instrumentation. While Seavey notes that many facilities require vendors to deliver sets to decontamination 24 to 48 hours prior to a case, IAHCSMM recommends an even longer lead time — at least two working days (48 hours) for existing loaner sets and three working days (72 hours) for new sets.1

"A facility must have a good strong loaner instrumentation policy in place backed by all the powers that be, including administration, infection prevention and control, quality and safety, to ensure those items arrive in time for testing and sterilization," said Seavey.

Education and training

The multi-society IUSS position statement, published by AAMI and endorsed by numerous healthcare industry organizations (AAMI, AAAHC, AORN, APIC, ASC Quality Collaboration, IAHCSMM), emphasizes the need for sterile processing department (SPD) personnel to have thorough education and training around sterilization to ensure IUSS is performed in compliance with hospital and industry guidelines. The statement reads:

"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."2

Seavey agrees: "Staff training is number one," she states. "Anybody who sterilizes instruments should have critical thinking skills and understand that sterilization is a complex process. It’s a lot more than just putting items into a sterilizer and pushing a button. Staff members have to ensure that instruments are cleaned and sterilized appropriately. In many instances with IUSS, they are in such a hurry that they may skip steps and risk contamination."

Page stresses that education and training are of the "utmost importance," and suggests that training for all staff involved in the process of IUSS include the following topics:

  • Steam sterilization

  • Manufacturers’ instructions for use

  • The purpose and proper use of sterility assurance products

  • The care and handling of rigid container systems validated for IUSS

  • Proper cleaning and decontamination of instruments prior to IUSS

  • Techniques to transport items from the sterilizer to the point of use

Dorothy Larson

"Overall there seems to be a better understanding of IUSS across the healthcare industry," adds Dorothy Larson, 3M Sterilization Technical Service Representative. "Through certification, staff members become knowledgeable of the recommended practices and guidelines. Hospitals should also require that annual competencies include training on the current recommended best practices around IUSS."

Documentation

A critical step to reducing or eliminating IUSS is determining when and why a healthcare facility is using IUSS outside of its intended use. With the Joint Commission placing greater scrutiny on product sterilization, facilities are being driven to better document their sterilization practices and can use this knowledge to help identify gaps in processes and resources that contribute to the inappropriate use of IUSS.

Multi-Society IUSS position statement

The IUSS position statement published by AAMI and endorsed by numerous healthcare industry organizations (AAMI, AAAHC, AORN, APIC, ASC Quality Collaboration, IAHCSMM) defines IUSS as:

"The shortest possible time between a sterilized item’s removal from the sterilizer and its aseptic transfer to the sterile field. Immediacy implies that a sterilized item is used during the procedure for which it was sterilized and in a manner that minimizes its exposure to air and other environmental contaminants. A sterilized item intended for immediate-use is not stored for future use, nor held from one case to another."1


AAMI’s ST79 Landmark Recommended Practice for Hospital Steam Sterilization states that IUSS can be performed when deemed appropriate and when all of the following conditions are met2:

• The device manufacturer’s written instructions on cycle times, exposure times, temperature and dry times are followed.

• Items are disassembled and thoroughly cleaned with detergent and water to remove soil, blood, body fats, and other substances

• Lumens are brushed and flushed under the water with cleaning solution and rinsed thoroughly.

• Items are placed in a closed sterilization container or tray, validated for immediate-use sterilization, in a manner that allows steam contact and aseptic transfer to the operating room.


In regards to when IUSS is appropriate to use, the American Association of periOperative Registered Nurses (AORN) states3:

• IUSS should be kept to a minimum and should be used only in selected clinical situations and in a controlled manner.

• Immediate-use steam sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization.

• Regarding implants, there is an exception that IUSS can be used in defined emergencies when no other option is available.


The multi-society IUSS position statement notes that IUSS should NOT be performed on the following devices1:

• Implants, except in a documented emergency situation when no other option is available

• Post-procedure decontamination of instruments used on patients who may have Creutzfeldt-Jakob disease (CJD) or similar disorders

• Devices or loads that have not been validated with the specific cycle employed

• Devices that are sold sterile and intended for single-use only

----------------------------------------------------- 

1. Immediate-Use Steam Sterilization Position Statement http://www.aami.org/publications/standards/
ST79_Immediate_Use_Statement.pdf

2. ST79: AAMI’s Landmark Recommended Practice for Hospital Steam Sterilization, http://www.aami.org/
publications/standards/st79.html

3. Recommended Practices for Sterilization in the Perioperative Practice Setting, American Association of periOperative Registered Nurses (AORN), http://www.aorn.org

"Documentation can help a facility determine if its IUSS usage is related to inadequate inventory, scheduling conflicts or some other issues," said Seavey. "For example, a facility might pinpoint that it’s using IUSS frequently on a certain day of the week and uncover the issue where OR staff is scheduling all of its total knee cases on that day and doesn’t have enough instruments to turn around. Or maybe they are scheduling 20 eye cases in one day with only two sets of instruments — that’s not OK."

"Facilities have started monitoring sterilization more closely to meet Joint Commission requirements but they could do a better job of what they are tracking," said Marrs. "When we look at an IUSS sterilization log it will often state something like ‘item sterilized, Dr. Jones.’ I’ll ask the hospital how Dr. Jones is feeling, they’ll ask me why and I’ll point out that their log indicates that Dr. Jones was sterilized that morning. Although I’m making a joke, it drives home the critical point that having Dr. Jones on the log doesn’t help. A facility needs to be specific about the items being flashed."

AAMI’s Landmark Recommended Practice for Hospital Steam Sterilization (AAMI ST:79) states specifically that a facility should track; a) the assigned lot number, including sterilizer identification and cycle number, b)the general contents of the load, c) the duration and temperature of the exposure phase of the cycle, d) the signature or other identification of the operator; and e) the date and time of the cycle.3

Inventory management

The multi-society IUSS position statement states that healthcare facilities should have "instrument inventories (that are) sufficient to meet anticipated surgical volume and permit the time to complete all critical elements of reprocessing."2 With many facilities using IUSS to compensate for inadequate inventories, this is an area that warrants greater scrutiny by healthcare organizations.

To help healthcare facilities better manage existing inventory, Marrs recommends they standardize their surgical instrumentation to help staff identify and assemble sets more quickly and correctly. He also suggests they optimize their instrument sets to reduce the number of instruments in the tray.

"I often find twenty different manufacturers or more in a single instrument set. This adds to confusion with assembly and increases surgeon dissatisfaction as they are forced to deal with pattern inconsistency," said Marrs. "Standardizing and optimizing instrument sets decreases turnover time and counting in the operating rooms."

Communication and collaboration

Communication and collaboration among multiple internal stakeholders, including the SPD, operating room (OR), infection control, materials management and administration, as well as external vendors, is critical to reducing the use of IUSS by ensuring a healthcare facility has the necessary resources and processes in place to perform proper sterilization.

"Facilities can reduce IUSS practices by, most importantly, having a "game plan" in place for their surgical days," said Turmann. "Getting ahead of the ‘known’ events make the ‘unknown’ events easier to deal with. A huge part of achieving this is making sure the SPD and the OR are in constant communication with each other throughout the day with each party making the other aware of any expected shortages in instrumentation or devices. There are several examples of this and one is when the OR lets the SPD know they had to open a duplicate tray or peel pack due to a contamination of the first tray or peel packed item. Sounds simple, but it is easily forgotten when both teams have a hectic day."

Stephen Kovach
Stephen Kovach, Director of Education at Healthmark Industries, points to a specific example of where collaboration among multiple departments within healthcare facilities has improved sterilization practices for certain ophthalmic procedures thereby reducing the risk of a dangerous complication that resulted from inadequate sterilization practices.

"We are seeing more teamwork among OR, SPD, physicians and administrators to reduce IUSS," said Kovach. "One of the best examples of where healthcare facilities have collaborated to ensure proper instrument sterilization is the toxic anterior segment syndrome (TASS) concern. Widespread publicity following recent TASS outbreaks prompted hospitals to evaluate how they schedule cases, their inventory levels, their cleaning processes and the verification of these processes to reduce the occurrences of TASS nationwide."

Adherence to manufacturers’ instructions for use

The multi-society IUSS position statement reads: "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)."2

The document goes on to note that if the manufacturer’s instructions for use (IFU) is not compatible with the sterilizer instructions or the instructions for the container/ wrapper, or if the IFU is "unclear, incomplete, or requires processes or cycles that are not available in the health care facility," then the facility should contact the manufacturer for more guidance. It states: "If differing instructions cannot be resolved and the instrument is urgently needed, the device manufacturer’s instructions must be followed."

"To ensure the IUSS process is both safe and effective, one must first begin with knowing everything there is to know about the product or device that is to be sterilized including whether the product is even approved to go through the IUSS cycle," said Turmann. "A person can obtain this knowledge through the product manufacturer, specifically by reading the manufacturer’s recommendations on the process. The operator should also know everything there is to know about the machine running the IUSS cycle. If they do not, they should have an expert on site to assist them. We have reached a point in healthcare where it is no longer safe to just ‘wing it’. As healthcare workers we must ensure we are following directions."

Moving ahead

It’s clear that while IUSS is becoming less prevalent in some hospitals, it’s here to stay in most — at least for now. In healthcare, as in other complex industries, change doesn’t happen overnight so it’s critical that all stakeholders — clinicians, SPD professionals, clinicians, administrators, vendors and others that impact or are impacted by sterilization practices — come together to ensure IUSS is performed in an effective manner, and only when appropriate, to protect patient safety.

"I believe facilities should be doing everything in their power to reduce or eliminate this practice," said Marrs. "It is true that when performed correctly, it is a safe practice. I also believe that every patient deserves and is entitled to the same standard of care. When patient number one, two and three receive terminally sterilized devices and patient number four, five and six receive the same devices that have been subject to IUSS they are not receiving the same standard of care."

"When we see IUSS in a different light, as a failure in practice, a short cut and a last resort, we will then reduce the national numbers significantly, allowing patients to all receive terminally sterilized surgical instrumentation for their surgical procedures," adds Turmann.

 

References

1. IAHCSMM Position Paper on the Management of Loaner Instrumentation, http://www.iahcsmm.org/pdfs/IAHCSMM_Position_Paper_%20
Management_of_Loaner_Instrumentation_070111.pdf

2. Immediate-Use Steam Sterilization Position Statement http://www.aami.org/publications/standards/ST79_Immediate_Use_Statement.pdf

3. ST79: AAMI’s Landmark Recommended Practice for Hospital Steam Sterilization, http://www.aami.org/publications/standards/st79.html