Just Because An Instrument Is ‘Sterile’ Doesn’t Mean It Is ‘Safe!’

According to the CDC, over 30,000 patients die every year in the U.S. from a surgical infection. Among hospital acquired infections (HAIs), surgical site infections (SSIs) are associated with greater increases in hospital stays and costs as compared to all other HAIs. Deep organ SSIs involving organs or spaces, as opposed to SSIs confined to the incision, have an even greater impact on patient morbidity and mortality.1 A leading cause of surgical infections has long been, and continues to be, instruments that remain contaminated with organic debris after decontamination, cleaning and ‘visual’ inspection. Instruments that remain contaminated after cleaning are then sterilized and returned to surgery. Even though these instruments are ‘sterile’ they are certainly not ‘Safe!’ As Bertha Linsky used to famously say during her seminars on surgical infections “A contaminated instrument is like a loaded gun in the operating room!” So what steps can you and your staff take to reduce the risk of a ‘sterile’ instrument that remains contaminated with organic debris being returned to surgery and causing a surgical infection? The first step is to recognize that certain types/categories of instruments create the greatest decontamination and cleaning challenges for you and your staff. The good news is that you and your staff don’t have to try and identify those instruments that cause the greatest challenges. The FDA has already identified a subset of medical devices that pose a greater likelihood of microbial transmission and represent a high risk of infection (subclinical or clinical) if they are not adequately decontaminated, cleaned and reprocessed.2 According to the FDA report, these are some of the products or design features which pose a greater risk to patient safety and thus require validated reprocessing instructions: Arthroscopes; Laparoscopic Instruments; Electrosurgical Instruments, and their Respective Accessories; Lumens (especially lumens of flexible design, multiple internal lumens, lumens that are not freely accessible, bifurcated lumens, lumens with internal surfaces that are not smooth); Hinges, depressions, joints with gaps, overlapping or butted joints that result in acute angles, or ribbed or otherwise “roughened” surfaces (e.g., jaws); Interior device channels (e.g., the “I” beam and channel inside of a Kerrison Rongeur); Shafts within lumens (e.g., the operating shaft inside of a laparoscopic instrument); Adjacent device surfaces between which debris can be forced or caught during use; Crevices; Junctions between insulating sheaths and activating mechanisms (as in certain laparoscopic instruments that are insulated with plastic ‘shrink-type’ insulation);  Instruments that have dead-ended chambers (e.g., the distal end of a laparoscopic instrument). In the future this list may be updated by the FDA as additional information regarding reprocessing medical devices becomes available.3 The second and most important step that you and your staff can take to reduce the risk of a contaminated instrument being returned to surgery is to only use instruments whose cleaning and sterilization IFUs have been validated by independent laboratory testing. Unless a surgical instrument manufacturer has validated that its decontamination and cleaning process removes the bioload from the instrument, you and your staff have no assurance that you are sending a clean, sterile and Safe instrument back to surgery. You and your staff can follow every step of a manufacturer’s non-validated set of IFUs perfectly and still be returning a contaminated instrument back to surgery where it can cause patient harm. You must insist that your instrument suppliers provide your facility with validated cleaning IFUs. In order for the IFUs to be validated, the validation testing had to have been conducted by an independent laboratory using AAMI and FDA testing protocols. In light of this FDA report, and as recent lawsuits have shown, healthcare facilities have an ethical, moral, financial and legal responsibility to demand validated IFUs from all of their surgical instrument and reusable medical device suppliers. 1 CDC Publication “Guideline For The Prevention Of Surgical Site Infection”   2 FDA publication “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” June 9, 2017 Appendix E 3 Op. Cite.