BEST PRACTICES IN REPROCESSING REUSABLE MEDICAL …

1 9/24/2015. SHC 1 SHC 2. Quality Improvement Opportunities best PRACTICES IN. REPROCESSING Every patient undergoing a MEDICAL or surgical procedure has a basic expectation that the environment and REUSABLE MEDICAL DEVICES instruments of care will be clean and safe. Rose Seavey RN, BS, MBA, CNOR, CRCST, CSPDT. Widespread attention in the national media and reports of patients being exposed to improperly reprocessed devices. AAMI. REPROCESSING . 2011 Summit. Priority Issues from the AAMI/FDA MEDICAL SEAVEY HEALTHCARE CONSULTING Device REPROCESSING Summit. STERILE PROCESSING SURGICAL SERVICES.

2 Established in 2003. SHC 3 4. TODAY Investigates: Dirty surgical instruments a Standards, Recommendations and Guidelines growing problem in the OR 2/22/2012. Filthy surgical instruments: The hidden threat in America's operating rooms 2009 rotator cuff repair and 7 other joint surgery patients Arthroscopic shaver & inflow/outflow cannula MFR updated cleaning IFU 10 steps Final step - use a digital scope to visually inspect the insides of handpieces! SHC . 5 6. Retained Human Tissue Tissue and Debris Found in Suction Tips University of Michigan Health System researchers found that surgical suction tubes retain human tissue and other debris SHC.

3 SHC . 1. 9/24/2015. 7 8. Impossible to Clean Tissue and Debris Found in Suction Tips University of Michigan Health System researchers cut this surgical University of Michigan Health System researchers examined the insides suction in half, and found the device packed with debris. of 350 surgery-ready suction tips. All of them contained blood, bone, tissue or rust. SHC SHC . SHC 9 SHC 10. Modern Instruments Revolutionize Surgery Flexible Intramedullary Reamers Proliferation of highly complex surgical instruments, Inadequate device testing by manufacturers, Tiny internal channels and instruments that don't adequately come apart Struggles faced by poorly-paid REPROCESSING staff Under pressure to turn around instruments Insufficient resources space, equipment and tools SHC 11 SHC 12.

4 CDC and FDA Alert Sept. 11, 2015 FDA Safety Communication Sept. 17, 2015. Immediate Need for Healthcare Facilities to Review Procedures for Infections - Reprocessed Flexible Bronchoscopes Cleaning, Disinfecting, and Sterilizing REUSABLE MEDICAL Devices FDA ongoing, comprehensive investigation Arrange for a healthcare professional with expertise in device 500,000 procedures annually REPROCESSING to immediately assess their REPROCESSING procedures. Pose a greater likelihood of microbial transmission and represent a The following actions should be performed: high risk of infection Training Recommendations: Audit and Feedback Strictly adhere to IFU.

5 Infection Control Policies and Procedures Staff competent and understand the importance Implement comprehensive REPROCESSING quality control program. AAMI Standard ST91: Comprehensive guide to flexible and semi-rigid endoscope processing in health care facilities. Published April 2015. 2. 9/24/2015. SHC 13 SHC 14. The Joint Commission TJC National Patient Safety Goals Standard Goal 7: Reduce Risk of HAIs Based on the identified risks the hospital sets goals to minimize the possibility of transmitting infections. Implement evidence-based PRACTICES for preventing surgical site Element of Performance # 4 infections.

6 The hospital's written infection prevention and control goals include Implements policies and PRACTICES aimed at reducing the risk of HAIs. These policies and PRACTICES meet regulatory requirements and are aligned with the following: Limiting the transmission of infections associated with evidence-based guidelines (for example, the Centers for Disease Control and the use of MEDICAL equipment, devices and supplies. Prevention [CDC] and/or professional organization guidelines).. Includes all areas where REPROCESSING takes place Multiple REPROCESSING sites RED flag The Joint Commission: 2014 Hospital Accreditation Standards [HAS].

7 SHC 15 16. Sterilization is a Complex Process Standards & Guidelines AORN Guidelines for Perioperative PRACTICES , 2015. Requires: AAMI ST79 Comprehensive guide to steam sterilization and sterility Environmental controls assurance in health care facilities ANSI/AAMI ST79:2010 & A1:2010. Appropriate equipment and supplies &A2:2011 & A3:2012 &A4:2013. Adequate space AAMI ST58:2013 Chemical sterilization and high-level disinfection in Qualified, competent personnel - ongoing training health care facilities Monitoring for quality assurance AAMI ST41:2008 (R2012) Ethylene Oxide Sterilization In Health Care Facilities: Safety And Effectiveness TJC engineer on site Review environmental concerns such as: AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities Temperature, humidity and traffic controls, ventilation etc.

8 CDC Guideline for Decontamination and Sterilization in Healthcare SHC . Facilities, 2008. SHC 17 SHC 18. AORN Guidelines and Tools for Sterile Processing ST 79 Editions Guidelines Environmental Cleaning, Hand Hygiene, Surgical Attire, Cleaning and Processing Flexible Endoscopes High-Level Disinfection, Cleaning and Care of Surgical Instruments, Selection and Use of Packaging Systems for Sterilization, and Sterilization Competency Verification Tools and Job Descriptions 2006 and A1:2008 & A2:2009 2010 & A1:2010 2010 &A1:2010 & A2:2011 &. A3:2012 & A4:2013.

9 Customizable Policy and Procedure Templates available 3. 9/24/2015. SHC 19 SHC . Most Current ST79 Amendment AAMI ST79 Amendment 3:2012 Examples ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013. The term SPD" revised to "sterile processing area". The design considerations = stronger loaner recommendations Moisture assessment Describes how instruments come to SP Updates to Delicate instruments on top and heavy on bottom Handling and inspection Orderly fashion and Checking for moisture Sharps segregated Instruments requiring repair identified at the point of use New Annex P.

10 Decontam staff have ready access to the device manufacturer's IFU Check list . Workstations should be ergonomic, preferably height adjustable wet packs/loads Anti-fatigue mats are recommended Flow chart Pre-vac sterilization cycles should be used, unless IFU requires gravity ( ). Dietary service items should never be processed in SP area 20. SHC SHC . ANSI/AAMI ST79 Recommended Practice ANSI/AAMI ST79 Recommended Practice If You Have This AAMI What To Purchase What To Download Free Document ANSI/AAMI ST79: 2006 Purchase ANSI/AAMI If You Have This AAMI What To Purchase What To Download Free Document ST79:2010 & A1:2010 &.