The core of sterile processing is the same: remove as much bioburden from instruments as possible, then sterilize properly. The definition of proper and how to achieve it, however, spurs controversy. To the rescue: the updating of the Association for the Advancement of Medical Instrumentation (AAMI)s standards. Many experts think these changes have made sterile processing systems more clear, and in such a fast-paced and vital department, clarity cannot be overrated.
A Dynamic Document
The recommended practices that AAMI publishes through the advice of industry leaders and professional groups have a big impact on the daily lives of staff members in central service or sterile processing departments, says Frank Sizemore, ACSP, BS, manager of central service at Wake Forest University Baptist Medical Center in Winston-Salem, N.C.
The documents are reviewed periodically to keep them current. They contain information about various classifications of chemical indicators, Sizemore says, which include:
- Class 1 (process indicator): chemical indicator intended for use with individual units such as packs and containers, to demonstrate that the unit has been exposed to the sterilization process and to distinguish between processed and unprocessed units
- Class 2 (Bowie-Dick test indicator): chemical indicator designed for use in a specific test procedure
- Class 3 (single-parameter indicator): chemical indicator designed to react to one of the critical parameters of sterilization and to indicate exposure to a sterilization cycle at a stated value of the chosen parameter
- Class 4 (multi-parameter indicator): chemical indicator designed to react to two or more of the critical parameters of sterilization and to indicate exposure to a sterilization cycle at stated values of the chosen parameters
- Class 5 (integrating indicator): chemical indicator designed to react to all critical parameters over a specified range of sterilization cycles
Portions of the updated standards are excellent for several reasons, says Stephen Kovach, director of education at Healthmark. First of all, the standards are in a single document, which makes it more user-friendly.
By placing (them all) in a single document, the overall cost is reduced, making it more affordable for users to purchase, Kovach says. They have made the document a dynamic document and by that I mean it can be updated yearly as new technologies and new regulations and standards require.
The altered standards deal with more than just sterilization and the use of biological and chemical indicators, he says.
Users need to know that it was not just sterilization that was updated, he adds. The decontamination and cleaning section has been expanded. The standard really stresses the importance of having quality systems in place for all processes. It is the implementation of quality systems (including monitoring performance, benchmarking, etc.,) that help organizations manage toward better outcomes.
The newest AAMI standards have several changes of which healthcare workers (HCWs) should be aware, says Charles Hughes, a general manager and educator for SPSmedical Supply Corp.
For example, ANSI/AAMI ST58 now recommends that HCWs monitor high level disinfectants with a chemical indicator before each use, and that STERRAD gas plasma along with the STERIS System 1 peracetic acid processes be biologically monitored at least daily, and preferably in every sterilization cycle, Hughes says.
Biological indicators (BIs) for the STERRAD and System 1 processes have traditionally required from 48 hours to seven days for final results, he says. However, recent advances have reduced incubation times to 24 hours.
ANSI/AAMI ST79 now recommends the use of Class 5 integrating indicators to release nonimplant loads when used within a process challenge device (PCD).
This new standard also recommends including a Class 5 integrating indicator within the BI PCD for monitoring loads with an implant, Hughes says.
Whenever possible, implants should be quarantined until the BI results are available. However, if that is not possible, then HCWs can release the implant based on the results of the Class 5 integrating indicator, he adds.
This is true, but should only be done in documented emergency situations, notes Kovach.
Staff members should refer to "release criteria for implants," on page 87, section 10.6.3 for more information.
Hughes believes that the new standards have already increased awareness of how important proper sterilization is.
(The standards) emphasize sterility assurance from a systems approach involving what happens before, during and after sterilization rather than simply the sterilization cycle itself, Hughes says.
Facility design, personnel attire, training, reprocessing procedures, sterile storage, product testing, quality control and continuous quality improvement are all critical aspects that should be followed.
While I have heard some people state they feel the new standards are too strict and do not have to be followed because they are only voluntary, I wonder if they would feel the same way if they had a loved one lying in a hospital bed awaiting surgery in a weakened state, Hughes says. With hospital acquired infections running rampant, it is important that every healthcare facility commit to meet or exceed best practices as established by our ANSI/AAMI national standards.
Challenges of the Job
Sterile processing presents several challenges, the biggest of which is that every step must be done right every time.
Human beings make mistakes, equipment malfunctions, the unexpected happens, Kovach says. This is why a process must include feedback loops steps in the process where staff and management get information on how they are performing. Are instruments clean when they reach the sterilizer? Are the instruments properly arranged and all present within the instrument set? Is the washer, the sterilizer, etc., loaded properly? Is the equipment performing to specifications? The best information is that which is provided real time (such as a sterilizer print-out).
Real-time information is not always possible, and when its not its important to compensate by implementing audit systems, and periodically monitoring process outcomes.
That is what so many of the new AAMI documents are stressing understanding your processes and how to monitor and verify various aspects of the system and its processes, Kovach says. This can only be done with having good processes that you have verified. Equipment used for cleaning and the manual process can be independently verified to improve the visual inspection process and improve the outcome.
Furthermore, equipment often fails and visual inspection does not always pick up on these failures, he says. The consequences of such oversight are paramount.
If instruments reach the sterilizer dirty, for instance, no amount of sterilization will render the instruments safe for use, Kovach says. If this is not discovered until the surgical site or worse yet not at all we have a complete and expensive failure of the sterilization process. If a sterilizer is overloaded and sterilization conditions are not reached inside of instrument sets and this is not discovered until the surgical site we have another expensive failure of the system.
According to Hughes, effective recognition of cleaning procedures is the main challenge in determining sterility assurance.
Chemical and biological indicators are designed to show that proper sterilization parameters have been achieved, however, they do not know if the instruments have been properly cleaned, Hughes says.
The phrase you can clean without sterilization, but you cannot sterilize without cleaning has been said many times, but bears repeating, he adds. I visit a large number of healthcare facilities each year and feel a greater importance should be placed on decontamination and the people performing this critical task.
Another big challenge is the design of instruments and equipment, says Bob Marrs, BA, CRCST, CHL, director of sterile processing at St. Davids Medical Center in Austin, Texas.
They (are being made with) more nooks and crannies and they just arent user friendly, Marrs says. Weve actually had some hip trays that have come back that we in sterile processing didnt know how to dissemble. I had seen this tray maybe four years ago from when I was still scrubbing and I took the device apart and sure enough on the inside it was just disgusting It seems like the engineers when they design the devices for the companies only take functionality (of surgeon use) into consideration and they dont think at all about the cleaning process.
Many people in the industry are working hard to assure that products are designed better, but Marrs thinks more needs to be done.
It seems like until we get some governmental involvement through the U.S. Food and Drug Administration or the Centers for Disease Control and Prevention, I dont know how to impact this. However, AAMI is working closely with some vendor groups and I think theyre hopefully going to be able to start making some changes here really soon.
Sterile processing staffs nationwide are learning more about how to use biological indicators and chemical indicators and integrators, Kovach says.
This is a direct result, Kovach adds, of people like Nancy Chobin (RN, CSPDT, CASSPT, CSIP, CSPDS, CSPDM, executive director of the Certification Board for Sterile Processing and Distribution CBSPD), Martha Young (CSPDT, international liaison representative for CBSPD), Natalie Lind (educational director for the International Association of Healthcare Central Service Materials Management IAHCSMM) and Chuck Hughes, to name a few people who are trying to educate medical facilities' staff on the proper use of these products.
Staff members are responding well, he says. There is still a long way to go, however, and the way to get there is certification.
I strongly believe that a key part in improving the general process is mandatory certification for central service staff, Kovach says. This will help raise the level of understanding and knowledge. This is a mustSterile reprocessing is a critical and complicated process. Certification at least sets a minimum bar that all should attain. This should no longer be an issue it needs to take place as soon as possible.
In my opinion, the most important tip I would offer for improving the general process of sterility assurance would be staff certification, he says. Todays healthcare facilities are reprocessing complicated medical devices in complex sterilization equipment that requires expertise unlike any we have known in previous years. Sterile processing certification demonstrates a level of competency has been achieved that the department and facility can rely upon.
Certification coupled with frequent continuing education is the ultimate combination and both are making gains, Marrs believes.
I think staff and management are becoming more up to date and in tune with the changes that are happening, thanks to education, Marrs says.
At industry conferences he used to frequently come across people who didnt know what AAMI was or who had received very little continuing education. Such instances are much less common now, he says.
There are folks out there who not only dont have an AAMI standards manual in their facility, but who also just dont know what theyre supposed to be doing, Marrs says. Fortunately there are guys like Chuck (Hughes) who are willing to travel around (and educate). Hes able to make a huge difference and affect a lot of people that way.
The industry is making constant changes, Kovach says, and many are improvements. He claims that ANSI/AAMI ST79-2006; ANSI/AAMI TIR12-2005; the Joint Commissions EC6.20- 2005, and ASTM D 7225 have led to stronger programs. A few products have too, Kovach says. He points toward Class 6 indicators, process challenge devices and cleaning verification tests and says they will continue to play an important role.
Sterility assurance is going to get more attention, Hughes believes, and product lines will be part of that.
Medical device manufacturers will continue to develop more and more complicated devices (such as) robotics that will require specialized training in order to properly clean, package, and sterilize, Hughes says. Gone are the days when an instrument was either steamed or gassed based on whether or not it would melt in the autoclave.
Staffs are likely to improve, according to Marrs, and that is long overdue.
Its frightening to think about (what sub-par staff members at some facilities) do, he says. I feel really luck here because I have a great staff that is willing to put up with me being anal about this stuff.
Its an AAMI requirement to follow manufacturers cleaning instructions. The Catch-22, though, is that several devices have very poor directions, Marrs says.
One thing that we do here very much is we pressure the sales reps for inservice and training for the staff, he says. Whenever they bring a device in, not only do they bring sterilization and cleaning instructions, they also set up a time when they work with my staff to clean and sterilize the device.
If that doesnt work, Marrs calls the company and tries to get in touch with the engineering department. Every once in a while they are unable to help him and his staff is forced to compare the devices to similar models for which they have directions, and get answers that way.
Some vendors are paying attention to this problem, Kovach claims.
Many vendors are now giving users more detailed instructions on cleaning and sterilization, Kovach says. Vendors are now telling users they need to monitor their process. He adds that two vendors who are doing this well are Smith & Nephew, and Getinge.
Poorly designed trays, especially heavy ones, are the bane of Marrs existence. He believes that AAMI standards are an improvement over the old ones, but that they should be more strict and less ambiguous when it comes to vendors, especially of trays.
Any tray over 25 pounds is ergonomically unhealthy, and is difficult to handle and lift, Marrs says. And yet, several trays weigh more than 40 pounds. Also, most trays are not validated for the sterilization process at weights higher than (25 pounds), Marrs adds. There used to be a weight standard of 17 pounds many moons ago. Then they went away with the weight standard and trays have kind of gone crazy.
Recent improvements have been made, Hughes says. For example, ANSI/AAMI ST77 recently limited the weight of instrument sets/trays to no more than 25 pounds, he says. This was a direct result of users letting the industry know their concerns regarding ergonomics and sterilization efficiencyFurthermore, heavy trays can cause the manufacturer to validate extended sterilization times that the HCW is unaware of or has difficulty complying with.
As important as trays are, they make up only a small part of a multi-tiered and complex department. It is wise for staff members to flow-chart their processes so they can visualize all the steps, Kovach says. The sterilization system consists of many processes (cleaning, assembly, handling) that interact and depend on each other to provide a clean, functioning product that is sterilized and used on a patient, he says.