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.