An Industry Waits in Anticipation

Members of the infection control community have expected the official release of an updated set of guidelines on disinfection and sterilization since June 2007, but an ostensibly innocuous-looking formula has stalled the progress of this Centers for Disease Control and Prevention (CDC) document.

The formula in question is: 45 minutes at 25 degrees C for >2 percent glutaraldehyde. This recommendation contradicts a label claim made by the Food and Drug Administration (FDA), and has therefore caused confusion.

The matter and some others are being cleared up, however, and CDC spokespersons estimate that the guidelines will be released in late summer or early fall of 2007. The document will likely be called Guideline for Disinfection and Sterilization in Healthcare Facilities, they say.

The guidelines are from the Healthcare Infection Control Practices Advisory Committee (HICPAC), a federal committee operated by the CDC.

HICPAC is made up of 14 infection control experts who provide infection control, surveillance and prevention strategies to the CDC and the secretary of the Department of Health and Human Services. HICPAC members also provide guidelines and recommendations for the reduction of healthcare-acquired illnesses.

Infection control practitioners are anxiously awaiting the release of the guideline, 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; professor of medicine at the UNC School of Medicine, and director of a state-wide infection control and epidemiology program operated by the UNC School of Medicine.

ICPs are regularly asking when the guideline will be published, as it has been over 20 years since the last CDC guideline on disinfection and sterilization, Rutala says.

According to the CDC, the last related document was published in 1985 and was called the Guideline for Handwashing and Hospital Environmental Control, and included a section on cleaning, disinfecting and sterilizing equipment.

The primary issue delaying the publication of the 2007 guidelines has been the recommended exposure time for achieving high-level disinfection with >2 percent glutaraldehyde, Rutala says.

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, he says.

Rutala points out that the following groups and others recommend 20 minutes and 20 degrees C for >2 percent glutaraldehyde: Joint Commission, Society for Healthcare Epidemiology of America (SHEA), Association for Professionals in Infection Control and Epidemiology (APIC), Association of periOperative Registered Nurses (AORN), American Society for Gastrointestinal Endoscopy (ASGE), American College for Gastroenterology (ACG), American Gastroenterological Association (AGA) Rutala explains that this disagreement persists even though the guideline states that if the user selects exposure conditions that differ from those in the FDA-cleared labeling for high-level disinfection, the user assumes liability for any injuries resulting from off-label use.

In addition, because the FDA-cleared label claim is based on a test that does not allow cleaning, is conducted in the presence of horse serum (i.e., protein load), and uses an extremely high number of mycobacteria (100,000 to 1 million), an extended immersion time and elevated temperature are necessary to inactivate 100 percent of the mycobacteria, Rutala says.

When cleaning is performed, the time to achieve high-level disinfection is reduced, he adds. While this issue of glutaraldehyde use at 20/20 was supposed to have been resolved on several occasions, it remains the reason why the guideline (had not been) published.

The controversy that has resulted from this formula is only one matter that has held up the guidelines release, says Michael Bell, MD, associate director for infection control at the Division of Healthcare Quality Promotion of the CDC.

For the last five years or longer there have been expectations that the disinfection and sterilization guidelines would be released.

There are evolving issues though that keep this from being published until those things can be resolved, Bell says. Its more a matter of interpreting intermediate data. If you look at the evidence, for example, for disinfection and sterilization thats available for prions, the evidence is not rock solid in one direction or another. We want to make sure the guideline is as pertinent as possible, and correct as possible. So were trying to make certain that all these issues get ironed between all the experts before it goes to press.

The matter of the glutaraldehyde recommendations is not the whole picture.

Thats less of a big deal, Bell says. Were working with the FDA to make certain that the guidelines dont directly contradict another health and human service departments requirements. Its not helpful to anyone if theres an FDA regulation and then we come and make a recommendation thats completely at odds with that. Were trying to provide language in the guidelines so that users will understand that there is a concrete requirement by the FDA, and what Dr. Rutala is pointing out is that there may be an alternative and understanding (of) why those things might be different in a way that doesnt step on either groups toes.

I think were getting very close for that part and then were working on some other aspects, which is pinning down some language for the prion section, Bell adds.

As for releasing the guidelines in late summer, Bell says it is his most earnest hope that this can be accomplished.

In terms of getting the language clarified I think that will happen within a few weeks, he says. Thereafter it needs to go to press and finish getting edited. All together it will probably be in the summer.

HICPACs guidelines are vitally important to sterile processing teams, says Bob Marrs, BA, CRCST, CHL director of sterile processing at St. Davids Medical Center in Austin, Texas.

The prevention of nosocomial infections is what we are about, Marrs says. Any document or organization that will help CS/SPD (central/service sterile processing department) professionals achieve fewer nosocomial infections is of great benefit. This document looks specifically at prevention of pneumonias and other severe respiratory tract infections. Both of these can be a trouble spot for CS/SPD departments if respiratory equipment is not cleaned and disinfected according to manufacturers instructions.

The new HICPAC recommendations also discuss educating healthcare workers about prevention, control, reporting and person-to-person transmission, Marrs adds. Knowledge in all of these areas is vital to excellent patient care. Having said this, it is also just as important for the CS/SPD department to have a great working relationship with the facility ICP. The ICP and CS/SPD leaders should be able to discuss tough issues facing healthcare workers and work to solve these issues for the benefit of our patients.

An important piece to this relationship is CS/SPD leadership having an active role on the facility infection control committee.

This allows CS/SPD and infection control to work hand in hand to fight these bugs that are so very detrimental to patient care, Marrs says. Without this working relationship, the new HICPAC recommendations are just a piece of paper.

A piece of paper that many people are waiting to get their hands on, that is. Bells office has received several inquiries from people who want to know when the guidelines are going to be released.

I dont think its caused any problems but its certainly making a lot of people anxious, Bell says. I think everyone is interested in the next version of this document because it is one of the main documents that people use for infection control policies.

In addition to updated recommendations, some new topics will make their debut, Rutala says. They include the following:

  • inactivation of antibiotic-resistant organisms such as the Creutzfeldt-Jakob disease agent, bioterrorist agents, emerging pathogens and bloodborne pathogens

  • toxicological, environmental and occupational concerns associated with disinfection and sterilization practices 

  • disinfection of patient-care equipment used in ambulatory settings and home care 

  • new sterilization processes such as hydrogen peroxide gas plasma and liquid peracetic acid 

  • disinfection of complex medical instruments such as endoscopes 

Also, the guideline provides performance measures to help healthcare facilities monitor their success, Rutala says.

The references for the guideline were updated in September 2006, so the reference list is relatively current, he adds. In regard to the recommendations, no advance in disinfection and sterilization has altered the recommendations that were approved by HICPAC in February 2003.

The updated version of the guidelines will indeed be different from the old copy, according to Bell.

What the updated guidelines bring is the last ten years of publications and data that reflect the more current level of science that can back up some of the things that we do, so from that perspective I think it will be a very helpful update, Bell says.

HICPACs disinfection and sterilization guidelines are vital to the infection control community, but the guidelines influence is far broader than that.

I think its not just in the infection control community but in safe healthcare in general, Bell says. There are certain instruments and devices that need to be sterilized or disinfected so that they dont become sources of infection transmission. So clearly from that perspective, making sure that we have effective guidelines that prevent that kind of transmission is essential.

As Marrs stated, guidelines alone are not enough, Rutala says. They are useless if team members do not properly apply them.

The guideline provides evidence-based recommendations on the preferred methods for cleaning, disinfection, and sterilization of patient-care medical devices and for cleaning and disinfecting the healthcare environment, Rutala says.

When properly used, these cleaning, disinfection, and sterilization processes can reduce the risk of infection associated with the use of invasive and non-invasive medical and surgical devices, he adds. However, for these processes to be effective, healthcare workers should strictly adhere to the cleaning, disinfection and sterilization recommendations in the guideline.