How to minimize risk of surgical instruments contaminated with organic debris
In Part I of this two-part series, we pointed out that the primary goal of surgical instrument processing is to minimize the risk of a dangerous, painful and costly surgical infections caused by an instrument that remains contaminated with organic debris after processing. Minimizing patient risk of a surgical infection begins with pre-cleaning instruments at point-of-use and prior to transport. The practice of pre-cleaning instruments has long-been recommended by the FDA, AORN, IAHCSMM, AAMI and The Joint Commission (TJC).
The responsibility to minimize patient harm from a contaminated surgical instrument is made even more difficult when it comes to processing complex surgical instruments e.g., ?instruments with lumens, corners, dead-spaces, etc.). This is because even with enhanced visualization methods, it is impossible to see inside of these complex devices, much less see microscopic bioburden and/or biofilm.
Any and all steps taken by you and your staff to reduce the risk of an instrument contaminated with organic debris being returned to surgery will help reduce the risk of a patient contracting a surgical infection, especially a deep-organ surgical infection. The first step in reducing the risk of a surgical infection caused by a contaminated instrument involves a thorough review of instrument manufacturers’ cleaning instructions for use (IFUs).
Almost all surgical instrument manufacturers’ cleaning IFUs call for a ”visual inspection” of the instrument after cleaning to ensure that the instrument is free of bioburden and/or biofilm. “The problem with this ‘visual inspection’ requirement in their IFU is that microscopic bioburden and biofilm are invisible to the human eye, which makes the task physically impossible.” (1)
When dealing with surgical instruments whose cleaning IFUs rely on visual inspection to detect organic debris, sterile processing professionals need additional help and technologies to see what is not visible by the human eye alone. AAMI’s “Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities,” states in AAMI ST79:2017 that, “The use of methods that are able to measure organic residues that are not detectable using visual inspection should be considered in facility cleaning policy and procedures.” (2)
The most commonly used method to solve the visual inspection ”problem” is to provide each and every processing workstation with a lighted magnifying glass. To deal with more complex instruments, Central Service (CS)/Sterile Processing & Distribution (SPD) departments also should invest in a borescope or flexible camera that can be used to look down the lumens and into the channels of complex instruments (e.g., laparoscopic instruments, trocars, etc.).?
The International Association of Healthcare Central Service Materiel Management (IAHCSMM) points out in its CRCST Self-Study Lesson Plan, Understanding Biofilm, “Even with the use of most visual enhancing tools, microorganisms will still not be seen.” (3) Therefore, “other tests have been developed to help verify that cleaning quality standards have been attained.” These include protein tests and adenosine triphosphate (ATP) bioluminescence tests, both of which test for residual soils and which might also be suggestive of biofilm formation. (4)
“There are products that test beyond what you can see visually and are particularly helpful for lumens and other devices that are difficult or impossible to visually inspect,” said Ralph Basile [Vice President, Healthmark]. “For example, we have reagent tests that test for protein and hemoglobin, and another 3-in-1 test for lumen devices that test for blood, protein and carbohydrate all at the same time.” (5)
A less costly, more efficient solution to ensure the elimination of invisible residues is only to use surgical instruments whose cleaning IFUs have been validated. To be reliable, such validation testing must be conducted by an independent testing laboratory using AAMI and FDA validation testing protocols. The validation testing must use soils that are relevant to the clinical use conditions of the instruments and should include the FDA’s worst-case (least rigorous) implementation and execution of the cleaning process. (6)
In the absence of validated IFUs, it’s impossible for you and your staff to provide clean, sterile, moisture-free instruments on every processing cycle. “You and your staff can follow every step of a manufacturer’s non-validated set of IFUs perfectly and still be returning a contaminated device back to surgery where it can cause patient harm. This is why it is so critical that you and your staff insist that your surgical instrument manufacturers provide your facility with validated cleaning and sterilization IFUs.” (7)
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If an instrument manufacturer can’t -- or won’t -- provide you with IFUs that have been independently validated using AAMI and FDA validation testing protocols, then you need to look for another manufacturer who can -- and will -- provide you with a copy of their validated IFUs.
It’s important to remember that just because an instrument is sterilized there’s no guarantee that it can't harm a patient if it still contains residual bioburden and/or biofilm after cleaning. When it comes to instrument cleaning and reprocessing, always remember that "If it isn't clean, it can't be safe!" The best way to ensure safe instruments on every reprocessing cycle is to only use instruments whose cleaning IFUs have been validated. Your patients are counting on you.
4. Ibid “IAHCSMM”
5. “Validated, It’s Complicated” Kara Nadeau, Healthcare Purchasing News, April 2017
6. FDA Publication “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”
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Prior to his retirement in December 2018, James Schneiter had been the founder, owner and president of?America’s MedSource Inc.,?which designed, developed, licensed and marketed a variety of implantable vascular devices, laparoscopic devices and neurosurgical instruments. Schneiter has nearly five decades of experience in medical device design and production and is a recognized expert in the area of instructions for use (IFU) and independent laboratory IFU validation studies. Schneiter can be reached at [email protected].