Top 2018 Blogs Pt. 2

Top Novo Surgical Blogs From 2018 (Part II) In order to help you and your facility achieve these goals in 2019 we are taking a brief look back at some of the most important blog topics from 2018 to help ensure your success. This is part two of our 2018 blog review. We concluded Part I of this blog with a discussion on the difficulty of removing microscopic bioburden and biofilms. To help you and your staff with this difficult task we reviewed AAMI’s pre-cleaning and decontamination recommendations. Residual microscopic bioburden and biofilms that remain on surgical instruments can be a significant cause of surgical infections. Data from the Centers for Disease Control and Prevention (CDC) indicate that over 30,000 patients die annually from surgical infections. Many of these surgical infections are caused by surgical instruments that remain contaminated with bioburden and/or biofilm after reprocessing. Even more troubling is the fact that when patients died from a surgical infection “77% of the deaths were reported to be related to the infection, and the majority (93%) was serious infections involving organs or spaces accessed during the operation.”¹ The CDC’s “Guideline for the Prevention of Surgical Site Infection” points out that “Microbial contamination of the surgical site is a necessary precursor of a surgical infection.”² When dead, sterile bioburden and/or biofilm gets deposited into a patient’s body from a contaminated instrument during a surgical case, the foreign, organic material begins to decompose inside the body and is attacked by phagocytes. This process is frequently seen in a post-surgical patient who presents with a fever of unknown origin and an elevated white blood cell count within 24 to 48 hours of a surgical case. Any and all steps taken by healthcare facilities to remove bioburden and biofilm from reusable medical devices will go a long way in reducing patients’ risk of a surgical infection caused by a contaminated instrument. The first step in reducing patients’ risk is the thorough removal of dangerous organic debris (microscopic bioburden and biofilm) from surgical instruments. To further help with the difficult task of removing dangerous organic debris from surgical instruments, we did a three-part series on the increased emphasis being placed on pre-cleaning surgical instruments at the point-of-use. The goal is to ensure pre-cleaning of instruments immediately after use and prior to transport to sterile reprocessing to minimize the adhesion of bioburden and biofilm to reusable medical devices. This new, increased emphasis on pre-cleaning is coming from many sources and organizations, including AAMI, AORN, FDA and the Joint Commission. Pre-cleaning is the removal of visible soil (e.g., organic and inorganic material) from reusable medical devices at the point-of-use. This should be done immediately after use and prior to transport to reprocessing. It is normally accomplished manually using sterile water; water with an FDA approved detergent, or an enzymatic product with a neutral pH (7 or lower). Given the importance of pre-cleaning at the point-of-use combined with all of the new emphasis on the procedure in both hospitals and ambulatory surgery centers, what steps should be taken? A good starting point is to consult the instrument manufacturers’ IFUs for their recommendations and requirements. To ensure clean, sterile, moisture-free instruments on every reprocessing cycle, only use instruments whose IFUs have been validated by an independent laboratory using AAMI and FDA testing protocols. The first step in every instrument manufacturers’ IFU for reprocessing surgical instruments or reusable devices should be to pre-clean the device at the point-of-use. In addition to manufacturers’ IFUs, you should also consult the Association of Surgical Technologists (AST) publication “Standards of Practice for the Decontamination of Surgical Instruments.” This publication is the industry standard for the safe, thorough and effective decontamination of surgical instruments and reusable medical devices.³ There are fourteen “Standards of Practice” listed in the AST publication and each one plays an important role in the complete and thorough pre-cleaning, decontamination, cleaning and sterilization of surgical instruments and reusable medical devices.⁴ If your facility does not have a copy of this publication, make it a New Year’s resolution to get a copy of this great resource to use in your battle against contaminated surgical instruments. Regretfully, the greatest threat to your patients from reusable medical devices in 2019 will continue to be reusable medical scopes. This is because new data in 2018 from three major hospitals documented the fact that seventy-one percent (71%) of their reusable medical scopes deemed ready for use on patients after reprocessing tested positive for bacteria according to a new study.⁵ This alarming study was published in March of 2018 in the American Journal of Infection Control and it underscores the infection risk posed by a wide range of endoscopes. The study documents a lack of progress by manufacturers, reprocessing personnel and regulators in reducing patient risk caused by scopes that remain contaminated after reprocessing. To help address this critical patient safety issue, the FDA in March of 2018 ordered all duodenoscope manufacturers to conduct two postmarket surveillance studies. These studies are designed to determine whether or not healthcare facilities can properly clean and disinfect the scopes using the manufacturers’ current IFUs. You and your staff can access the FDA’s safety communications on scopes and their recommendations for healthcare facilities and the staff responsible for reprocessing the scopes here. Improving patient outcomes and reducing patients’ risk of contracting a surgical infection are important goals for you and your facility in 2019. All of us at Novo Surgical are committed to helping you and your staff achieve those goals by continuing to provide the highest quality surgical instruments whose IFUs have been validated! 1.“Guideline For The Prevention Of Surgical Site Infection” Center For Disease Control (CDC) 2. Op cite. 3. “Standards of Practice for the Decontamination of Surgical Instruments” Association of   Surgical Technologists (AST) April 2009 4. Op cite. 5. “Residual moisture and waterborne pathogens inside flexible endoscopes: Evidence from a multisite study of endoscope drying effectiveness” Cori L. Ofstead, MSPH, Otis L. Heymann, BA, Mariah R. Quick, MPH, John E. Eiland, RN, MS, Harry P. Wetzler, MD, MSPH. American Journal of Infection Control, March, 2018.