Data from the Centers for Disease Control and Prevention (CDC) indicate that surgical infections cause more than 8,000 patient deaths annually.1 A significant number of these infections are caused by surgical instruments that are difficult, if not impossible, to thoroughly decontaminate, clean and sterilize. Contaminated surgical instruments have always been and continue to be a significant cause of surgical infections.
To reduce the risk of a surgical infection caused by a difficult- to-clean surgical instrument, a number of surgical instrument companies began to introduce ”modular” instruments that could be disassembled for cleaning internal surfaces during processing. Two of the more common modular instruments are laparoscopic instruments that were introduced more than 25 years ago and modular Kerrison Rongeurs that were introduced more than 10 years ago.
According to the manufacturers’ claims of modular instruments that can be disassembled to help decontaminate and clean, their major benefit is that once they’ve been disassembled, you can “visualize” the bioburden and debris inside of the instrument and manually remove it. Regretfully, the human eye is NOT capable of seeing microscopic bacteria and biofilm on the surface of a surgical instrument.
During a recent discussion with a surgeon about modular instruments, he made a very interesting observation. His comment was that “Modular instruments were supposed to be easier to clean, which in turn would reduce the rate of surgical infections. Where are all of the studies and clinicals that prove that modular instruments have reduced surgical infections over the last decade? If they really did reduce the number of contaminated instruments being returned to the O.R. after reprocessing, the manufacturers would have the studies plastered on the walls in every surgeons lounge in the country.”
The simple answer to the surgeon’s question is that modular instruments have not reduced the frequency, nor the rate of surgical infections caused by contaminated instruments. Being able to ‘visualize’ the inside of a modular instrument does NOT ensure a clean, sterile, moisture-free instrument (assuming that the processing personnel know how, or even remember to take the time to disassemble, thoroughly clean it and then properly reassemble the instrument).
“A major limitation of many manufacturers’ IFUs is that they require a CS/SPD professional to visually inspect an instrument after cleaning for bioburden and/or biofilm prior to sterilization. For some complex instruments that means disassembling them to both clean and inspect. But the dirty little secret is that this residue is invisible to the naked eye — making the task physically impossible.” 2
Logic dictates that if modular instruments were truly effective in reducing surgical infections, we would have seen a reduction in surgical infections. However, according to the CDC, “Advances in infection control practices include improved operating room ventilation, sterilization methods, barriers, surgical technique, and availability of antimicrobial prophylaxis. Despite these activities, surgical infections remain a substantial cause of morbidity and mortality among hospitalized patients.”3
The only way to ensure clean surgical instruments on every reprocessing cycle is to use instruments whose cleaning and sterilization IFUs have been validated. Such validation must be done in accordance with U.S. Food and Drug Administration (FDA)-mandated validation testing protocols described in 21 CFR 820.3(k) “Validation of Reprocessing Methods in Accordance with the Quality System Regulation.”
Unlike reusable surgical instruments whose cleaning IFUs may have been validated by independent laboratory testing, no brand, make or style of modular instruments have ever had their cleaning IFUs validated. In fact, no manufacturer of modular instruments has ever even attempted to validate the cleaning IFUs on their modular instruments because no two people can or will clean an instrument the same way on every reprocessing cycle.
Key point: There is simply no way to ensure “repeatability” of cleaning results with a reusable surgical instrument that relies on manual disassembly and cleaning to remove bioburden, especially microscopic bioburden and biofilm that is NOT visible to the human eye. Conversely, even the most inexperienced processing person can consistently flush a ”flushable” reusable surgical instrument whose cleaning IFUs have been validated with a syringe in less than 10 seconds and be assured of a clean, sterile, moisture-free instrument on every processing cycle.
So how does the lack of validation of cleaning IFUs for modular surgical instruments impact you, your healthcare facility and most importantly, your patients? Unless a surgical instrument manufacturer has validated that its cleaning process removes the bioload from the instrument, you have no assurance that you are sending a clean, sterile and safe instrument back to the OR. You and your healthcare facility have an ethical, moral, financial and legal responsibility to demand validated IFUs from all your surgical instrument and reusable medical device suppliers.
References
1. Joint Commission Center for Transforming Healthcare: Surgical Site Infections, https://www.centerfortransforminghealthcare.org/improvement-topics/surgical-site-infections/
2. “Validated? It’s complicated” by Kara Nadeau, Healthcare Purchasing News, April 2017
3. CDC publication, “Guideline For Prevention Of Surgical Infection”
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, is a recognized expert in instructions for use (IFU) and independent laboratory IFU validation studies and is a co-founder of #IFUcan, an online community that examines and explores the world of manufacturer IFUs. Schneiter can be reached at [email protected].
