In this new year, more central service (CS) community members will become familiar with two sterilization standards that were updated in late 2006, and will also find help from another update that is expected any time in January 2008.
Perhaps most important is ST79, a directive from the Association for the Advancement of Medical Instrumentation (AAMI) that deals with steam sterilization and sterility assurance in healthcare facilities. The standard was released in late 2006 and many in the industry hail it as an important update and compilation of past standards.
Another AAMI standard (ST77) was also released in late 2006 and is getting increased attention. ST77 deals with containment devices for reusable medical device sterilization.
And on top of it all, a Centers for Disease Control and Prevention (CDC) committee is expected to release a long-awaited update of disinfection and sterilization standards in January 2008. Members of the CS and environmental service (ES) communities have anxiously awaited the HICPAC guidelines since June 2007.
Plus, new products are hitting the marketplace and some will make lives easier for personnel from CS, ES and infection control.
AAMI members develop medical device safety and performance standards, publish technical documents and offer guidance on practices, sterilizers, wraps, containers and weight limitations. AAMI guidelines are extremely useful, says Cynthia Spry, RN, MA, MSN, CNOR. Spry served as a perioperative nurse for more than 25 years and is an independent consultant.
Following AAMI guidelines contributes to patient safety and can save lives, Spry says. Standards are continually updated, and personnel responsible for sterile processing should keep up with the changes even though they are voluntary.
ST79 is more complete and explicit than its predecessor and has been very helpful to the staff of Intermountain Valley View Medical Center in Cedar City, Utah, says Danny Adams, a central processing manager there. The new standard requires a little adjustment, however, which is why Adams staff has received ongoing training regarding the standard.
Overall, I believe ST79 is better and more inclusive of the ever-changing world of CS, Adams says. But it does require having someone who knows the field well to explain to the team what is being required of them. Some healthcare facilities even call AAMI standards the bible, says Becki Jenkins, CST, CRCST, FCS. Jenkins has 25 years experience in sterile processing and is president of the central Indiana chapter of the International Association of Healthcare Central Service Material Management (IAHCSMM).
ST79 is useful and can save lives, and the fact that all sterilization standards can be viewed at one time is an amazing plus, Jenkins says. Most of the professionals I have either encountered over the years or am currently working with are very happy to see the updates, the format that the updates are in and the fact that they are all in one place. One-stop reference shop fantastic! Because ST79 is comprehensive there is less likelihood of missing an important standard because you either could not find it or did not know it existed.
In future updates, however, there is one section that Jenkins says needs more attention: the treatment of variant Creutzfeld-Jacobs Disease (vCJD).
This (section) really needs to be spelled out step-by-step in such a way that any healthcare professional dealing with it can feel confident about handling a situation where vCJD is present, Jenkins says. This should cover everything from documentation to waste removal, she says.
ST79, the Lowdown
- ST79 comes in a 3-ring binder, or PDF format and replaces the following information:
- ST46, steam sterilization and sterility assurance
- ST37, flash sterilization ST42, table top sterilization
- ST33, guidelines for rigid reusable containers
- ST35, safe handling biological decontamination
One section of the document deals with recalls and suggests ways to prevent them through quality monitoring in the form of physical, biological and chemical indicators. Recalls should be avoided at all costs since they can be expensive, make departments look inept, lead to schedule delays, etc.
ST79s monitoring section divides the routine sterilizer efficacy monitoring and qualification testing in two sections and includes segments about table top sterilizers, flash sterilization cycles and sterilizers that are bigger than two-cubic feet.¹
The chemical indicators section (10.5.2.1) states that chemical indicators are designed to respond with a chemical or physical change to one or more of the physical conditions within the sterilization chamber, Spry says. There are five classes listed in the document and each has a specified performance requirement.
Class 1 distinguishes between a processed and an unprocessed package and includes information on tape and labeling. ST79 says external indicators should be used on the outside of every package. Class 3, 4, and 5 enzyme indicators are for use inside the package. Class 2 refers to daily air removal tests (for vacuum and flush-pressure-pulse sterilizers), and to Bowie Dick tests. It covers inadequate air removal, inadequate steam penetration and the presence of non-condensable gasses such as air or gas from boiler activity.¹
Class 3 monitors parameter and temperature tubes and class 4 refers to a reaction of two or more parameters at specified values. Class 5 is an integrating indicator and reacts to all critical parameters over a specified range of sterilization cycles. Class 6, emulating indicator, is mentioned but is not thoroughly addressed in ST79, Spry says. The reason for this is that it is new to the U.S. market.
There are several new additions to ST79, including:
- A Bowie Dick test should run after a biological indicator (BI) test for qualification, installation and major repair.
- The routine load release section states that all data should be evaluated by experienced people, and that a load should not be distributed if any part of the data suggests failure.
- New BI information is that enzyme-based BIs may be used for non-implant load release in PCD (process challenge device), sterilizer efficacy in PCD, implant load in PCD, product testing and sterilizer qualification testing. Class 5 integrators cannot be used to release implant loads.
ImplantsImplants are defined as any device that is intended to stay inside a body for more than 30 days. ST79 states that releasing implants before biological results are known is unacceptable. Furthermore, representatives of infection control, surgery and risk management should get together and determine what they consider to be emergency exceptions and should put those definitions in writing, Spry says.
A reigning rule of medical devices, particularly implants, is that they should always be traceable to the patient who received them. Implant exception forms should include reasons for the release, the name of the implant, the surgeon, the patient, and the patient record number.¹ Only biological indicator results can be used to release implants, and flash sterilization for implants is not recommended. Implants should be wrapped and quarantined until biological results are read.¹ As for pouches, paper and plastic pouches should not be used in wrapped sets or containers. Positioning does not ensure adequate air removal, steam contact or drying.
The Skinny on ST77
Another great resource is AAMIs ST77, Jenkins says. Containment devices for reusable medical device sterilization is by far the new standard I am most excited about, Jenkins says. The standard has given end-users a renewed understanding, she adds.
(It is) a document that can be used to develop policies and recommendations to purchasing agents departments where sterilization of instruments in these devices are employed, she adds. Overall in the healthcare setting, this is the new standard that has empowered us to make educated proper choices in the use of containment devices for reusable medical device sterilization. This was a standard hard-earned and definitely another feather in AAMIs cap for patient safety.
HICPAC Sterilization Guidelines
An update of disinfection and sterilization guidelines from the Healthcare Infection Control Practices Advisory Committee (HICPAC), is likely to be released any time in January 2008. It will be published in the CDC publication, Morbidity and Mortality Weekly Reports (MMWR), CDC spokespersons claim.
HICPAC is a federal advisory committee that includes 14 infection control experts. The group provides healthcare infection control advice to the CDC and provides strategies for surveillance and prevention in American healthcare facilities.
A vital function of the committee is to issue recommendations, guidelines, resolutions and informal communication on the topic of healthcare-acquired infection (HAI) reduction. The document will probably be called the Guideline for Disinfection and Sterilization in Healthcare Facilities.
One of the reasons the release was stalled was because of controversy over a formula. It is: 45 minutes at 25 degrees C for >2 percent glutaraldehyde. This recommendation contradicts with a label claim made by the Food and Drug Administration (FDA), and has therefore caused confusion, says William Rutala, PhD, MPH, director of hospital epidemiology for the occupational health and safety program at the University of North Carolina (UNC) Health Care System.
This delay has occurred even though the CDC guidelines are evidence- based and there are greater than 30 peer-reviewed publications that demonstrate the effectiveness of >2 percent glutaraldehyde at 20 minutes and 20 degrees Celsius, provided cleaning precedes disinfection, Rutala says.
Healthcare professionals have regularly inquired about the status of the document. This is in part because the last CDC guideline on disinfection and sterilization was released more than 20 years ago.
New Products for a New Year
Some products and practices making their way around the market are exciting, says Charles Chuck Hughes, general manager and educator with SPSmedical Supply Corp. He is especially glad to see people using Class 5 integrating indicators inside every package they process in steam sterilization.
SPSmedicals STEAMPlus Integrator is now being used in thousands of healthcare facilities, after years of trying to get users to spend the money to upgrade from Class 4 indicators, Hughes says. The new AAMI ST79 standard does a good job of explaining the importance of Class 5 indicators, recommending to release routine loads with them providing they are processed inside a challenge test pack.
Hughes says many people are realizing that Class 5 indicators are particularly helpful in complex, multi-layer trays. This is the only feasible way to show adequate sterilization has taken place, especially when so many of these trays now require extended cycles, Hughes says.
Hughes is also excited to see more healthcare facilities move from wrapped to rigid packaging systems. During the many facility sterilization audits I perform annually, I routinely see non-compliance in the proper storage of sterile products, primarily in the area of shelf cleanliness and temperature control, Hughes says. Also, rigid containers protect processed items far better than wrappers when non-compliance issues arise.
Hughes adds that rigid containers dont tear, are easier to carry since they have handles, and can be stacked in sterile storage whereas wrappers should not be.
Some other recent products, such as those from Metrex, will also be useful. Enzymatic pre-cleaner Metrex EmPower® dual-enzymatic detergent dissolves protein, is mild in pH, and is easily rinsed from instruments, company representatives say. As anyone in CS knows, inadequate cleaning of flexible endoscopes can transmit infection. Cleaning of endoscopes prior to disinfection includes purging the air/water channel and using an enzymatic pre-cleaner, such as Metrex EmPower®.
Other new products from Metrex include MetriCide OPA Plus Solution, and MetriCide OPA Plus Solution test strips. MetriCide OPA Plus Solution has comparable compositions and properties to competing products, but less of it is required. Therefore, it can save facilities money over time, company representatives say. The MetriCide OPA Plus Solution test strips were developed to indicate when the minimum recommended concentration of OPA in Metricide OPA Plus Solution has been reached during the reuse process.
Looking into 2008
The coming year will hopefully bring more attention to CS, since that department is integral to infection control, Jenkins says.
When dealing with patient safety and infection control directives, CS should be the driving force in the beginning, end, and everywhere in between, Jenkins says. No one department directly deals with all aspects of the infection control process like CS Infection control is not just washing your hands anymore. Infection control departments are starting to see that there are vast more opportunities for prevention that exist and can evolve right in the middle of it all, in CS.
Hughes echoes the importance of CS, and is glad that so many professionals in that industry are increasing their standards.
I am excited to see so many CS chapters around the country embracing mandatory CS certification and taking up this important cause, Hughes says. Local chapters are banning together to form state organizations to bring this fight to their state health department and/or legislative branch of the government. Mandatory CS certification is being aggressively pursued in my state of New York, and soon will be in others, such as Florida, Connecticut, Ohio, Texas and California, to name a few.
Guidelines for Guidelines
Some guidelines are more useful than others, Adams says. They must be practical and written in a way that everyone can understand.
Overall, guidelines are definitely helpful, says Adams colleague, Janet Malachowski, an infection control and employee health nurse at Intermountain Valley View Medical Center. Plopping down and reading them isnt enough, however.
I believe it is often more useful for the infection control person to collaborate with the education department to provide annual training on these guidelines, Malachowski says. Without it, the guidelines have the potential to just become words on paper. Visual demonstrations concerning the spread of germs and clear explanations of the chain of infection will assist in memorization and facilitation of the guidelines.
Going Beyond Instructions
Guidelines for CS are fantastic, but CS workers also need education, certification, adequate resources and a facility-wide understanding that what they are doing contributes to infection prevention and control, Jenkins says.
If there was a thorough understanding of how important CS is to the overall infection control process, every healthcare facility in every state would require education and certification of all employees in CS, she says.
Yes, the awareness has been heightened, she adds. Yet you can still find CS departments ran by managers with no formal education on the subject and employee line staff with no formal education. Healthcare facilities will gladly pay less for the uneducated right-off-the-street employee than pay rightly more for the opposite.
The average CS employee could benefit from continuing education and applicable documents, magazines and Web sites, Adams says. Most CS workers know they are linked to infection control.
CS staff sees what comes to them on the instrumentation after surgery or other procedures and know how this can affect other personnel or patients who come in contact with the instrumentation and supplies after contact from others, Adams says.
Infection control nurses should be available for questions from CS, according to Malachowski. She says presentations are also helpful.
CS departments generally need more resources, Jenkins says.
Though it is getting better, this is still not a high priority for many healthcare facilities, Jenkins adds. The tide is turning. We have a long way to go in getting every healthcare facility all over this great nation on board. First, in understanding how important following standards of practice rather than common practice isIf we truly believe that our patients come first, lets prove it, lets get this done.
Hopefully, new standards, products and practices will help achieve that goal.
1. Spry C. Whats new in sterilization standards? Managing Todays OR Suite handout. Oct. 2007.