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KSR Publishing, Inc.
Copyright © 2016

         Clinical intelligence for supply chain leadership



January 2010

Central Services


Forward progress

Consultants, vendors outline sterilization best practices – and shortcomings

Accrediting organization surveyors are looking for complete Biological Indicator (BI) records. How can sterile processing professionals do a
better job?

It can be challenging to make sure all staff in a busy sterile processing department takes the time to read BI results and properly complete the required documentation. We hear from customers that completeness of monitoring records is an item about which surveyors are asking. 

To address concerns around this quality control and standards compliance issue, an increasing number of facilities are investing in the best practice of using a sterile processing information system, such as SPM Software with the 3M Attest Monitoring Interface, which provides automatic, real-time documentation of 3M Attest biological indicator results. In addition to providing a centrally located, computer based record that facilitates information retrieval in the event of a recall or when requested by an accrediting organization, the automated, electronic system includes user prompts that increase compliance with recommended practices. For example, the software system reminds an operator building a steam sterilization load to include a BI process challenge device with the first load of the day and with loads containing an implantable device. The system also prompts operators to include a positive control BI in each incubator each day, as recommended in AAMI standards.

~ Susan Flynn, technical service specialist, 3M Sterilization Assurance 

Which aspect of the sterilization process do you believe warrants greater attention from SPD staff?

Reusable medical device manufacturers are responsible for providing complete, validated and comprehensive written instructions for the cleaning and sterilization of their products. Medical device manufacturers must ensure that their devices can be reprocessed using the methods specified in their written instructions. The sterilizer manufacturer must also provide a recommendation for a specific sterilization cycle compatible with that medical device’s written instructions for reprocessing.

The user must ensure that both the sterilizer manufacturer and the reusable medical device manufacturer recommend the same sterilization processes for the specific device to be sterilized. That determination should be made on the basis of comparison of each manufacturer’s written instructions.

Understand, the healthcare personnel using those reusable medical devices are responsible for ensuring that the sterilization methods specified by both the sterilizer manufacturer and the reusable medical device manufacturer can be duplicated in the facilities environment and that the manufacturers written instructions are followed correctly. The healthcare user must demonstrate that they can replicate the specified process exactly, repeatedly and consistently.

This concept may be the least understood and most poorly practiced issue in the field of sterile reprocessing today.

~ Charles Hancock, RAC, president, Charles O. Hancock Associates Inc.

How can Sterile Processing Departments improve their sterilization workflow processes?

For busy SPDs, maximizing the efficiency and integrity of sterilization workflow processes is just as important as having effective sterilization equipment. By looking closely at every logistical step in the reprocessing cycle, SPDs can often find ways to streamline workflow and improve productivity, enabling the facility to reduce turnaround time and serve even more patients. Careful consideration of the optimum workflow design is also helpful for making informed equipment purchasing decisions, such as whether to purchase a sterilization system that produces wrapped sterile instruments for use right away or in the future, or a system that produces unwrapped ‘just-in-time’ instruments for immediate use only.

~Barbara Trattler, RN, MPA, CNOR, CAN, Director of Clinical Education, ASP

What tips of suggestions can you offer regarding proper use of sterilization indicators?

One common challenge is the operating room complaining to SPD about difficulty in finding sterilization indicator(s) inside processed instrument sets. They may question why the SPD can’t just place the indicator in the most convenient location, such as on top of the set?









                   Processed Successfully


                       Processed Failed

It’s important that both OR and SPD staff are aware that, per AAMI and AORN recommendations, internal indicators should be placed in the area of the package considered to be least accessible to sterilant penetration.

OR staff must be educated on best practices, which dictate where sterilization indicators are to be placed – this way, they are aware of what is required of the SPD staff, per hospital policies and procedures, which reference best practices. Usually, this means placing sterilization indicators in the center and/or each layer of an instrument set and/or corners where air can be trapped with rigid containers. Use the cooking analogy: when cooking a large roast, where do you place the meat thermometer to see if it is cooked and safe to eat? The answer is in the center or densest part of the roast. The same is true with heavy and/or layered instrument sets. It is important to place the indicator(s) in the most difficult to reach area(s), to show that the entire set was processed. After all, sterilization is indeed a patient safety issue!

~ Chuck Hughes, general manager, educator, SPSmedical Supply Corp.

Where do you believe the greatest progress has been made regarding sterilization, and what tips can you offer to further aide this critical process?

Great strides have been made in the recent and not so recent past in ensuring that sterility assurance is a reality in healthcare settings. Improved training of staff, certification programs, and the synthesis of the best practices in the industry in AAMI’s ST79, "Comprehensive guide to steam sterilization and sterility assurance in health care facilities," and ST41, "Ethylene oxide sterilization in health care facilities: Safety and effectiveness," have all contributed to improved outcomes in instrument reprocessing. However, if one follows the recommendations of these standards and maintains staff training, there is still more to be done.

Much of the progress in ensuring good reprocessing outcomes has come from standardization of processes and materials used. Also, to give credit to the FDA, the bar for sterilizer and washer-disinfector performance has been raised, which has increased the ability of processes to render instruments clean and/or sterile, even under suboptimal reprocessing conditions. Washer/disinfectors and sterilizers now on the market, especially newer-technology sterilizers, have a much greater margin of safety than products made 20 years ago. The key to this progress has been improved monitoring of cleaning, disinfection and sterilization. A new unit that is cleared by the FDA for use in a healthcare setting has passed stringent tests to achieve that clearance. But, does it work in your facility? Testing of sterilizers per ST79, ST41, and the manufacturer’s recommendations is required and routine. Testing of washers is becoming more commonplace, but no standards exist for this in the US yet. Similarly, ultrasonics used for precleaning are not routinely tested. Manual precleaning itself varys greatly from location to location, and does not always comport with the device manufacturer’s supplied IFU. Finally, steam quality for sterilizers is only now beginning to be recognized as a possible critical variable in sterilization.

A verification of proper function has been the route to success for all of the processes that are now considered to be reliable and robust in healthcare instrument reprocessing. These verifications ensure that the process is under control and doing what is expected of it. The next steps in successful sterilization strategies will come from looking at reprocessing with a process control viewpoint. This viewpoint includes:

• Thoroughly verifying the function and performance of a newly-installed device, creating a baseline and ensuring that the unit is working properly

• Re-verifying the device’s performance on a periodic basis, going beyond routine testing

• Verifying the condition of the utilities provided to the device, e.g., steam quality, water and air pressures, water quality

• following applicable standards, or creating valid SOP’s where there are no standards

There is currently no requirement to implement a full qualification program for a device used in reprocessing to ensure proper function, as is required of medical device manufacturers for production equipment, for example. To ensure proper reprocessing and reduce the number of cleaning, disinfection, and sterilization process failures, qualification and periodic requalification of processes and machines used in reprocessing is a must. A thorough Installation Qualification, Operational Qualification, and Performance Qualification as mentioned in ST79 will tell you not only that the units work properly, but will also identify non-optimal situations and set a baseline for proper performance. This approach falls under the quality assurance requirements of ST79 and is an integral part of improved outcomes in sterile processing.

~ Jonathan A. Wilder, Ph.D., president, H & W Technology, LLC,
SteriCert Co.

How can SPDs reduce damage to flexible endoscopes?

The lifespan of an endoscope may be five to eight years if appropriately handled and maintained;1 However, that often is not the case. In fact, a high percentage of endoscope damage can be attributed to improper handling practices1, and the resulting damage can lead to compromised patient safety, as well as significant repair bills. As a result, safely transporting fragile and expensive endoscopes is imperative. The good news is that an estimated 70–90 percent of that damage is preventable. In fact, proper care and handling can dramatically improve the useful life of an endoscope1.

Guidelines from AORN and SGNA include:

• Transport endoscopes in enclosed containers—when transporting a scope to the reprocessing area, an enclosed container will prevent escape of airborne and droplet contaminants. It is important to consider both the protection of the apparatus and the environment during transport2,3.

• Avoid over-coiling insertion tubes as this may lead to buckling and scope leaks.2-4

• Avoid stacking endoscopes with other accessories or transporting multiple endoscopes simultaneously as this "…increases component contact and leads to an increased risk of puncture damage."3

1. Dilulio R. Service solutions: protecting your endoscope investment. 24X7. October 2006; Available at: http://www.24X7mag.com/issues/articles/2006-10_05.asp. Accessed June 26, 2008.

2. Standards of infection control in reprocessing of flexible gastrointestinal endoscopes. Gastroenterol Nurs. Mar-Apr 2006;29(2):142-148.

3. Thomas LA. Transporting the endoscope. Gastroenterol Nurs. Mar-Apr 2005;28(2):145-146.

~Barbara Trattler, RN, MPA, CNOR, CAN, Director of Clinical Education, ASP

What tips or suggestions would you offer to help facilities drive best practices in sterilization?

Here are seven best practices for proper instrument sterilization and decontamination. Tip #1: Use Flash Sterilization Appropriately. Flash sterilization was designed to immediately sterilize a one-of-a-kind device that was dropped or contaminated in the operating room. However, flash sterilization today is more often used to sterilize instruments quickly because of insufficient instrument inventories and increased procedure volume. This is especially true for Orthopedics and Ophthalmology cases.

Flash sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method. Flash sterilization should not be used as a substitute for insufficient instrument inventory. Tip #2: Weigh cost of instruments vs. patient safety. Although instrument sets can be a significant cost for facilities, the cost pales in comparison to the detriment associated with declining patient safety and contamination. Not only does this put the patient at risk, but also the facility’s reputation, risk of lawsuits and Joint Commission accreditation. Tip #3: Establish guidelines. Define the rules for flash sterilization by your facility and establish appropriate guidelines for everyone to follow. A flash sterilization log must be used. Tip #4: If you are going to flash, do it right. Use closed sterilization containers, such as Case Medical’s FlashTite or the Flash-Guard system, so instruments are protected from contamination from autoclave to point of use. These sterilization containers are easy to use, sterilization is fully validated and instruments can be transported safely and within guidelines through non-sterile areas. Tip #5: Build more efficient instrument sets. Inventory the instruments and determine those that are most frequently used. Streamlined instrument sets should be built to only include those instruments. Fewer instruments in the sets allow for faster processing. With streamlined sets, money isn’t wasted on instruments that are rarely used. Find an instrument vendor who can help you. Tip #6: Dedicate someone for instrument reprocessing. Ensure all instruments are properly processed and sterilized by dedicating someone to this responsibility. Patient safety is an important measure for all facilities and reprocessing instruments is a key part of ensuring a sterile and safe environment. Tip # 7 Seek outside support. If your budget or systems can not keep up with demands, seek outside help. There are several companies which provide outsourced sterilization services and even companies who can provide sterile instruments on a just-in-time and charge-by-use basis.

~ Robert Edelstein, president, Millennium Surgical Corp.


Interdepartmental links priceless for sterilization success

Forward progress: Consultants, vendors outline sterilization best practices – and shortcomings

Driving sterilization best practice starts with proper instrument cleaning