Top 2018 Blogs Pt. 1

Top Novo Surgical Blogs From 2018 (Part I) The primary goal of every healthcare professional is to improve patient outcomes and reduce patient risk. The challenges that you and your facility will face in achieving those goals in 2019 will be similar to many of the challenges you faced in 2018. Given that reality, it makes sense to take a brief look back at some of the most important blogs from 2018 in order to prepare for the New Year. In January we started a four part series on the FDA’s List of “Greater Risk” Medical Devices and Validated IFUs. In this series we discussed the fact that the FDA has identified a subset of medical devices that pose a greater likelihood of microbial transmission after reprocessing and represent a high risk of infection (subclinical or clinical) if they are not, or simply cannot be, adequately decontaminated, cleaned and sterilized.¹ So how does the FDA list of “Greater Risk” medical devices apply to you, to your healthcare facility and to your patients as we enter 2019? 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. In light of this FDA list, and as recent lawsuits have shown, healthcare facilities have a responsibility to demand validated IFUs from all of their surgical instrument and reusable medical device suppliers. In March, we started a three part series on the FDA’s March, 2015 mandate that all reusable medical device manufacturers provide validated instructions for successfully reprocessing their devices (IFUs). “FDA interprets these regulations to require manufacturers to validate the design, including reprocessing instructions, of reusable devices to ensure that the device can be effectively reprocessed and safely reused over its use life, as intended.”² It is vital for your patients’ safety to remember that the FDA’s new, ridged requirements for the ‘validation’ of cleaning instructions for use only applies to new products that have been approved since April, 2015. The vast majority (over 98%) of the reusable medical devices and instruments that you use on your patients everyday have never had their cleaning IFUs validated. Accordingly, it is up to healthcare facilities to request ‘validated’ cleaning IFUs from all of reusable device and instrument suppliers. During June we examined a new report that cited biofilms as the probable cause of the contaminated surgical instruments that shutdown all surgeries for a week at a Colorado hospital. Health officials determined that the infection control breach there was due to human error that occurred during "a gap" in the manual pre-cleaning phase — before the instruments underwent heat sterilization. Staff had wiped down, soaked and scrubbed certain spine and orthopedic instruments, but apparently not well enough. The instruments still contained bioburden when they were sent along for automated cleaning and sterilization.³ Biofilm consists of an accumulated biomass of bacteria and extracellular material that is tightly adhered to a surface and cannot be removed easily. Biofilm has the effect of protecting microorganisms from attempts to remove them by ordinary cleaning methods used in the sterile processing area and of preventing antimicrobial agents, such as sterilants, disinfectants, and antibiotics, from reaching the microbial cells. Biofilm can form on many surfaces but is particularly problematic in devices with lumens. Once biofilm forms on a surface, direct friction and/or oxidizing chemicals are required to remove the biofilm.⁴ When it comes to preventing the formation of biofilms on devices and instruments, the current AAMI guidelines state: 6.3.1 Handling of instruments during surgical procedure Throughout the surgical or invasive procedure,

1. a) Instruments should be wiped, as needed, with sterile moistened surgical sponges to remove gross soil; and
2. b) Cannulated instruments or instruments with lumens should be irrigated with sterile water, as needed, without creating aerosols.⁵

According to some manufacturers of modular instruments that come apart, their major benefit is that once they've been disassembled, you can 'visualize' the bioburden and biofilm inside of the lumen of the instrument and manually remove it. In August we began a two part series on modular surgical instruments. In that series we learned that being able to 'visualize' the inside of an instrument does NOT ensure a clean, sterile, moisture-free instrument (assuming that reprocessing personnel even remember to take the time to disassemble, thoroughly clean it and then properly reassemble the instrument). The series documented the fact that the only way to ensure clean surgical instruments on every reprocessing cycle is to only use instruments whose cleaning IFUs have been validated. 1. FDA publication “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” June 9, 2017 Appendix E 2. FDA Report “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” March 17, 2015 3. Outpatient Surgery, June 5, 2018, Combat Biofilm, Margaret Wasserman 4. AAMI Standards, aami.org/standards 5. Cite.