9/14/2017. Best Practices in Instrument Cleaning. Objectives. Healthcare-associated Infections

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1 in Instrument Cleaning Crit Fisher, CST, FAST Director, Field Operations Protection1 Services Karl Storz Endoscopy-America, Inc. Objectives Discuss regulations, standards and guidelines of equipment management Identify best practices Identify common errors Importance of partnerships Healthcare-associated Infections On any given day, one in 25 hospital patient has at least one healthcare-associated infection (HAI). There were an estimated 722,000 HAIs in U.S. acute care hospitals. Additionally, about 75,000 patients with HAIs died during their hospitalizations. HAIs cost between $4-5 billion annually. Surgery-originating infections results in a median hospitalization cost of $7,531 per patient. Medicare and most insurance companies do not reimburse for hospital-acquired infections. 1

2 Worst Case: Headline News Monroeville Hospital Urges 200 colonoscopy patients to get checked for hepatitis, HIV - Post-Gazette, Pittsburg, PA VA Colonoscopy Scandal Tied to HIV Case? Equipment used on thousands at three facilities wasn t properly sterilized - Washington Times Kaiser Patients Warned of Possible Hepatitis Exposure Kaiser Permanente has notified 1,331 patients who underwent diagnostic tests at the South Sacramento Medical Center that they may have been exposed to hepatitis. Worst Case: Headline News Houston Methodist Hospital Evidence from the investigation suggests the Methodist infection outbreak was most likely caused by retained tissue, BAMC: Instruments tainted with 'possible human matter' led to surgery cancellations The head of Brooke Army Medical Center said he regrets the inconvenience caused for patients who had surgeriescanceled due to concerns over surgical instruments. State Launches Investigation of Dirty Instruments at DMC The investigation was prompted by a report in the Detroit News showing a pattern of improper cleaning and sterilization at DMC facilities, putting patients at risk for over eleven years. Regulations, Standards and Guidelines The Joint Commission (TJC) Community Health Accreditation Program (CHAP) Accreditation Commission for Health Care (ACHC) Code of Federal Regulations (CFR) Centers for Medicare and Medicaid Services (CMS) American National Standards Institute (ANSI) Association for the Advancement of Medical Instrumentation (AAMI) International Organization for Standards (ISO) 2

3 Regulations, Standards and Guidelines What do these all have in common? Must develop policies and procedures and maintain documentation supporting practice. Recommended practice for a medical equipment management program. Maintenance, inspection and testing frequency and activities for facility and medical equipment. Minimize risk in facility: written plan for managing medical equipment Regulations, Standards and Guidelines CDC issued an official Health Advisory in September of 2015 to healthcare facilities, such as hospitals, ambulatory surgery centers, clinics and doctors offices that utilize reusable medical devices urging them to "immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with current standards and guidelines." Reprocessing Cycle 1. Pre-Cleaning (Soaking to prevent dried protein, removal of gross debris) 2. Cleaning (hand wash, sonic cleaning, automated washer/disinfectors) 3. Inspection (visual / optical) 4. Sterilization or High-level disinfection 5. Storage (important in all steps) 3

4 Definitions Clean absence of visible soil (blood, protein, secretions). Disinfected destruction of vegetative bacteria, fungus and most viruses. Does not destroy all bacterial spores. Sterile absence of microbial life (viruses, bacteria, spores, fungus) Note: Sterility assurance level (SAL) is a term used to describe the probability of a single item being non-sterile after it has been subjected to the sterilization process. Cleaning - Why it is Important? Removal of bio burden and other materials adhering to the device allows the disinfectant or sterilizing agents to work effectively. One can clean without sterilization, but one cannot sterilize without cleaning. In the U.S., instrument reprocessing best practices are detailed in AAMI Standards, AORN Guidelines for Perioperative Practice, along with other documents, such as SGNA which focuses on flexible endoscopes. 4

5 Point of Use Instruments should be kept free of gross soil during surgical procedures as blood, body fluids and saline can damage instruments and if allowed to dry, be difficult to remove during the decontamination process. Transport All instruments opened during a surgical procedure should be considered contaminated and properly contained for transport to prevent damage as well as exposure or injury to personnel and patients. Cleaning and Decontamination Decontamination is the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and are rendered safe for handling, use or disposal. 5

6 Instructions For Use (IFU) It is critical to follow the instrument MFR s instructions for use (IFU) with regards to water temperature, cleaning solution, brush type, and cleaning procedures. For complex devices, specific times will be validated for the soaking, ultrasonic cleaning and/or rinsing. Exercise in Communication 6

7 Inspection It is important to carefully inspect and assemble surgical instruments prior to packaging. A dirty or non-functioning instrument is a patient safety issue and should never be used. Sterilization / High-Level Disinfection Following the MFRs regarding the recommended modality for sterilization or high-level disinfection is vital. Also the intended final use of the instrument will dictate is the pathway the surgical instrument will take. Spaulding Risk Classification High Risk / Critical Sterile tissues, non-intact membranes, vascular Intermediate Risk / Semi-critical Contact with nonintact skin, mucous membranes (non-penetrating) Low Risk / Non-critical No contact or contact with intact skin 7

8 Storage The correct storage of processed instruments is important to protect them from environmental contamination. Common Errors Point of Use and Transport Failure to wipe off gross soil and/or flush lumens with sterile water Delay in transporting soiled (and opened) items to the decontamination area Failure to use a pre-soak solution on soiled items prior to transport Transporting items without using a closed container Common Errors 8

9 Common Errors Cleaning and Decontamination Not having enough or the wrong sinks to soak-wash-rinse Stacking and storage Not having all the written IFUs Not following all the written IFUs Common Errors Sterilization and Storage Not inspecting 100% of instruments Incorrect sterilization mode and/or parameters Not storing sterile items in a separate, controlled area Stacking wrapped trays which causes compression Be A Detective Keep your eyes open for easy opportunities to improve your care and handling. 9

10 It is easy to rely on the SPD staff in the hospital, but what happens when you are the SPD Staff in the office? Education: Online courses and seminars Sales/Service representatives Professional organizations Reprocessing Area Separate hand washing facilities. Adequate bench space. Smooth surfaces without crevices. Good lighting. Efficient ventilation. Adequate storage space for materials and equipment. Bins or other containers for disposal of waste. Non-slip flooring. Sink suitable for the disposal of liquid waste. Cleaning sinks. Drying facilities. Work surfaces made of non-porous materials which allow for efficient cleaning. Directed traffic flow from reception to final distribution of clean products. Cleaning and Reprocessing Cleaning Agents: Cleaning agents shall be used to remove residual soil and organic matter from instruments and equipment. Only those intended by the manufacturer for use in cleaning medical devices shall be used. Manual Cleaning: Thorough cleaning of all instruments and equipment is an essential prerequisite in disinfection and sterilization processes. The effectiveness of sterilization is dependent on a low bioburden; therefore care shall be taken to ensure that the cleaning process does not add to the bioburden. 10

11 Cleaning and Reprocessing Cleaning Methods: Cleaning methods shall be appropriate to the design of the instruments and equipment being cleaned. Ultrasonic Cleaners: Ultrasonic cleaners may be used to effectively clean jointed and serrated stainless steel instruments. Cannulated instruments may be cleaned in an ultrasonic cleaner provided that the manufacturer s instructions are followed. Leak Testing: Leak testing is one of the most important steps when deal with flexible endoscopes. Cleaning and Reprocessing Time: Some cleaners have a specific time that the instrumentation should be exposed too. (1 Hour) Cleaning and Reprocessing Rinsing: Where manual cleaning methods are used, thorough rinsing in clean, running, warm to hot water is required to ensure that instruments and equipment are free from detergent residues after the cleaning process. 11

12 Cleaning and Reprocessing (Advanced Instrumentation) Do not immerse the handpiece. Wipe the handpiece and cable with neutral detergent applied to a clean, non-abrasive cloth. Manually rinse the handpiece, cable, and tubing management clips with running tap water to remove all visible soil from the device. Hold the handpiece with collet end down when rinsing and run stream of water through the suction port. Cleaning and Reprocessing (Advanced Instrumentation) Apply a small amount of silicone spray into the front-end collet and outside of the handpiece. Sterilize the handpiece immediately after cleaning. How To Control Your Costs Having good processes Hold yourself and staff accountable Follow manufacturers IFUs Investigative detective Document Good/Bad Practices Increase quality and efficiency 12