AAMI News December 2019

Tech World: Environmental Challenges in Sterile Processing

Hank BalchWeston “Hank” Balch, CRCST, CER, CIS, CHL, is president and founder of Beyond Clean in San Antonio, TX, and host of the Beyond Clean Podcast.


Debates are raging in the medical device processing industry around the definitions of “clean.” Simultaneously, tremendous innovations are occurring around our ability to ensure “sterility” of packaged surgical instrumentation.

However, lurking in the background of these high-profile discussions and technological advances is the proverbial elephant in the room. What is the status of our sterile processing departments (SPDs) themselves? Are our cleanrooms actually clean rooms? Is there anything truly sterile about our sterile storage areas?

Despite the environmental challenges of sterile processing being some of the most difficult aspects for our SPDs to control, they are critical to our ability to prevent contamination of our devices and infection in our patients. Without success in this area, nothing else that we do really matters.

It’s no secret that sterile processing teams deal with some of the highest risk of blood-borne pathogen exposure in all of healthcare. Even with appropriate personal protective equipment (PPE) during the decontamination phase, including gowns, gloves, face masks, eye protection, and shoe covers, the environment itself is often uncontrolled.

Professional recommendations and standards call for regular, daily cleaning of decontamination areas. However, this type of cleaning in SPDs typically happens far less than daily. The result is a gradual increase in overall contamination of our decontamination rooms, to the point that many of these rooms can go weeks and even years without adequate cleaning.

The challenges do not stop as we move across the workflow to the packaging and assembly area. This part of the SPD is where the detailed inspection, assembly, and packaging of surgical devices occurs. Unfortunately, it also is a prime source for re- and cross-contamination of the very instruments that were decontaminated previously.

Perhaps the most striking potential for contamination in this area has to do with the practice of using forced–air hoses to dry lumens, power devices, and low-temperature instrument loads. While understandable in theory, the practice of blowing forced air through a blind lumen or cannulated device on the “clean side” can easily cause all manner of aerosolized contaminants into the air and completely undermine the one-way flow of instruments from dirty to clean.

Our packaging rooms are clean(er) than the decontamination area; however, they still hold a very real potential for recontamination of surgical trays. Knowing this danger should prompt us to uphold higher standards of environmental cleaning of workstations and related surfaces, enact PPE requirements that guard against hair transfer, and follow protocols that reduce potential for aerosolization of contaminants.

The last step of the instrument processing workflow should be sterile storage. Sterile storage has high amounts of foot traffic from SPD personnel, operating room (OR) staff, and vendors retrieving instruments for their cases. This foot traffic, combined with the constant handling and touching of bins, racks, and instrument sets, creates a perfect storm for external contamination of device packaging.

Two factors further jeopardize this potentially unsterile storage context. First, the industry recognizes an expected failure rate for device packaging. Second, various industry surveys of OR staff have shown that as many as 8% of respondents report having noticed breaks in sterile technique that could lead to infection or postsurgical complications. All of this amounts to a scenario where the simple cross-contamination of the outer packaging could undermine the entire sterilization process and introduce pathogens to the patient.

There is no easy fix for the multitude of environmental and infection control challenges that exist across the sterile processing workflow. More effective PPE and terminal cleaning of decontamination areas will help, as will higher standards for our cleanrooms and tighter protocols for instrument drying practices. Innovations around how we store sterilized packages can even further reduce the potential infection risk to patients.

Regardless of the final answer, advancement in this area will take a commitment from all of us to continuously question the status quo of what we consider dirty, clean, and sterile—and how we keep each of them firmly in their place.


To read Balch’s complete discussion of challenges across the sterile processing workflow, look in the November/December issue of BI&T (Biomedical Information & Technology).