Instrument Sterilization: What’s the Evidence?

The Joint Commission (TJC) is an important accreditation body that can both help and hurt a hospital or surgical center. Because of this, their rules and regulations are closely scrutinized and followed, sometimes to an extreme.

“People are obviously very concerned about failing their TJC reviews,” said Jonathan Bock, MD, associate professor in the division of laryngology and professional voice at the Medical College of Wisconsin in Milwaukee. “A failed review can affect every aspect of patient care flow through hospitals and clinics. It can become a huge media event if the local hospital does not pass reviews for patient safety.”

It doesn’t take much for people to decide they are going to another nearby hospital. They think they are in danger, even when there is no evidence that not following some TJC protocols impacts patient safety.

Instrument Sterilization

One area of controversy is the requirements for instrument sterilization and packaging. Some TJC inspectors require peel-pack packaging despite the fact that non-sterile use instruments, such as nasal speculums and other tools used in the specialty, seldom come in contact with non-intact mucosa.

These instruments are being autoclaved mostly for convenience. Instead of having a separate place for cleaning, they are being processed along with other instruments requiring higher levels of cleanliness.

The concern is that when you sterilize a nasal speculum because it is easier, the Commission requires you maintain the higher level in packaging and storage. The head and neck is a resilient area in terms of infection issues and the instruments are being used in a relatively non-sterile environment. “According to Spaulding criteria, instruments touching intact mucosa only require ‘high level disinfection,’” said CW David Chang, MD, associate clinical professor of otolaryngology at the University of Missouri in Columbia. “I argue that if you are reprocessing a device at a higher level of disinfection than is needed, you shouldn’t be required to maintain that higher level of disinfection during storage.”

Physicians view peel packing as an added expense that adds more bulk in the drawers that contain the instruments and introduces inefficiency into patient evaluation and care. Such measures are being required largely without compelling evidence of improved value or lessening of demonstrated harm.

Globally, there is a basis for some concern over instrument sterilization. There have been outbreaks of hepatitis C, for example, when colonoscopes were not properly cleaned. However, the structure and use of laryngoscopes make patient-to-patient contamination unlikely. To date, there have been no published articles documenting infection spread through non-channeled flexible laryngoscopes. “It appears that some of these recommendations for non-channeled laryngoscopes may be overly cautious,” said Dr. Bock. “As long as they are sealed, pass leak tests, and the outsides are properly cleaned, there should be no significant risk of passing along infective material.”

Regulations Equal Added Costs

These regulations cause additional costs to the system and to the patient, with little or no evidence of their efficacy. Hospitals and surgery centers often have to obtain additional instruments to treat patients while equipment is being cleaned. More cleaning means additional handling, with increased wear and tear and breakage. Waiting for clean instruments can also mean decreased efficiency for physicians and even increase other quality indicators such as lengthening waiting lists.

“All of these costs are passed along to the patients in increased facility fees,” said Dr. Bock. “These … contribute to the ongoing epidemic increases in national healthcare costs.”

Contaminated instruments have consequences, however. In addition to increased infection rates, having to delay or cancel a procedure due to unsterile instruments leads to delayed treatment and inconvenience to patients and their families, who have rearranged their lives, as well as possibly increased waiting times. “Physicians and surgeons are often unaware of the mission and vision of TJC, which is [to ensure that] ‘all people always experience the safest, highest quality, best-value healthcare across all settings,’” said Julie L. Wei, MD, surgeon-in-chief at Nemours Children’s Hospital in Orlando. “Reviewers for TJC will point out deficiencies that must be corrected to deliver the mission of improving health care and inspiring us to excel to provide safe and effective care of the highest quality and value.

“As a surgeon, I may not agree with or feel inconvenienced by rules and regulations; as a parent, if my own daughter needed surgery, we would only take her to a hospital and healthcare organization whose culture and practice is aligned with TJC’s zero-error aspirational goal,” she said. “Until the day medical errors are no longer the third leading cause of death in the U.S., we simply can’t be vigilant enough.”

As a surgeon, I may not agree with or feel inconvenienced by rules and regulations; as a parent, if my own daughter needed surgery, we would only take her to a hospital and healthcare organization whose culture and practice is aligned with TJC’s zero-error aspirational goal. —Julie L. Wei, MD

Surgical Attire

Another area where there is disagreement with standards is in head-covering regulations issued by the Association of periOperative Registered Nurses (AORN) and adopted by some. They require a bouffant head covering, which impacts a physician’s ability to wear a cloth covering. This is viewed by many as an unwarranted intrusion on a physician’s autonomy, and, ultimately, a contribution to physician burnout.

These concerns led the American Academy of Otolaryngology–Head and Neck Surgery (AAO–HNS) to survey its membership and develop a list of concerns, which they then presented to TJC. While TJC was willing to listen and discuss the concerns, many of the top concerns, such as peel packing, decontamination procedures, and surgical attire, were results of unintended over-interpretations of the guidelines. While there were areas where the Commission said they do not have specific requirements, their surveyors were still handing out citations for “violations” as if these requirements existed.

Due to TJC’s influence, one hospital or clinic being cited for something usually is communicated throughout the industry, and a domino effect occurs. These are then enshrined in hospital policies and procedures and implemented at the local level. “Once one hospital is dinged by TJC surveyors for something, other hospitals are going to revamp their processes in response,” said Dr. Chang. “This propagation of misinterpretation takes off and grows wild.”

Communication

Continued discussions, both within the specialty and with TJC going forward, are important. One of the outcomes of the Academy/TJC talks was the publication of an article in The Joint Commission’s bulletin that included clarifications for surveyors related to the issues discussed (Jt Comm J Qual Patient Saf. 2018;44). TJC also agreed to publish an online FAQ to further communicate these policies and procedures to those in the field.

“We as surgeons like to say that TJC and others don’t have a lot of good evidence for their side,” said Dr. Chang. “The problem is, we don’t often have much high quality evidence supporting our stance either. In the end, both have to recognize that we aren’t going to eliminate every little bug without enduring very large costs. While an ounce of prevention may be worth a pound of cure, is a pound of prevention worth an ounce of cure?”

There are also discussions to be undertaken at individual facilities. Some concerns may be rooted in how hospital administrations interpret TJC requirements. “The perspective and attitude should be to not fight them,” said Dr. Wei. “You need to know who in your system and professional organization you can share feedback with and how your hospital shares that with TJC.”

She also says it is a matter of being prepared. If you are a frontline surgeon, ask your chief and your chair about any concerns. Their awareness and knowledge are key. Understand the requirements and your specific institution’s response to them. Often for TJC, the greater sin is not following the facility’s policies and procedures.

The bottom line is that no physician would argue against an evidence-based requirement, as patient safety remains paramount. “We need to proceed with these decisions using a basis of data as much as possible,” said Dr. Bock. “It often seems they are making these clinic instrument sterilization decisions based on what they think makes sense, but not always based on data.”

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Kurt Ullman is a freelance medical writer based in Indiana.