News / August 27, 2020
The cleaning of surgical instruments is defined as the process of removing foreign material (e.g., bioburden, biofilm) from the instruments and is usually accomplished using water with detergents or enzymatic products that are suitable for use. As we mentioned in Part I of this series on cleaning, surgical instruments must be thoroughly cleaned before high-level disinfection and sterilization. In the absence of thorough cleaning, inorganic and organic materials that remain on the surfaces of instruments will interfere with the effectiveness of these processes. When it comes to surgical instrument reprocessing, you must always remember that “If it’s not clean, it can’t be safe!”
Part II of ‘How to Properly Clean Surgical Instruments’ concluded with information on how to remove microorganisms and biofilms from the surfaces of surgical instruments. In Part III we will continue our discussion on how to efficiently and thoroughly remove microorganisms and biofilms from surgical instruments.
Although the effectiveness of high-level disinfection and sterilization mandates effective cleaning, no “real-time” tests exist that can be employed in a clinical setting to verify cleaning. If such tests were commercially available they could be used to ensure an adequate level of cleaning (1, 2).
There are only two ways of ensuring that your surgical instruments are completely clean after reprocessing. The first method is to conduct a reprocessing verification test (e.g., microbiologic sampling), but this is not routinely recommended due to the time, labor and expense of conducting the verification tests.3 The second method is to only use surgical instruments that have had their cleaning Instructions for Use (IFUs) validated by an independent testing laboratory using AAMI and FDA testing protocols. Without validated cleaning IFUs, you and your team can be doing everything right according the manufacturer’s Cleaning IFUs and still not have the assurance of sending clean, sterile, moisture-free instruments back to surgery.
In order to scientifically validate an instrument’s cleaning IFUs, the validation testing must be done in a laboratory-testing environment. Validation of the cleaning processes in a laboratory-testing program is possible by microorganism detection, chemical detection for organic contaminants, radionuclide tagging, and chemical detection for specific ions (4, 5).
When considering the purchase of new surgical instruments, you must ask the supplier for a copy of their cleaning IFU validation report that documents their laboratory-testing program. The same holds true when it comes to validating the manual or automated cleaning process.
During the past few years, data have been published describing use of an artificial soil, protein, endotoxin, X-ray contrast medium, or blood to verify the manual or automated cleaning process (6 – 11) and adenosine triphosphate bioluminescence and microbiologic sampling to evaluate the effectiveness of environmental surface cleaning (12, 13). Regardless of which type or brand of product you chose, always make your choice based on testing data that proves the efficacy of the product. You need more than just the verbal claims made by the supplier; you need to see the documentation that validates those claims.
In an earlier blog (Elmed blog #5 “The Costs Associated With A Surgical Infection”), we pointed out that one of the more important ‘investments’ a hospital can make to help reduce their patients’ risk of a surgical site infection (SSI) is to invest in surgical instruments whose cleaning IFUs have been validated to provide clean, sterile, moisture-free instruments on every reprocessing cycle.
Given all of the documented costs associated with SSIs, the time has come for hospitals to require all of their surgical instrument suppliers to provide them with the instrument manufacturers’ cleaning IFU validation test results that were conducted by an independent laboratory. Without this level of documented, validated testing of the surgical instrument manufacturers’ cleaning IFUs, it is difficult, if not impossible, to ensure clean, sterile, moisture-free instruments for all of your patients on every reprocessing cycle.
Elmed Incorporated is an American* manufacturer and distributor providing the medical industry and its many specialties with quality products.
Elmed Incorporated is a wholly owned American company and is not associated with any other “Elmed” company based outside the United States.