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• Identify the impact of standards, guidelines, recommended practices and regulatory agencies on the Central Sterile Department/Sterile Processing Department as it relates to Infection Prevention
• Review the role of the Joint Commission in the Sterile Processing Department (SPD) as it relates to Infection Prevention
• Discuss best practices for monitoring the sterilization process and why biological indicators are considered the most effective method for monitoring the sterilization process
• Understand the importance of procedures for recall of potentially contaminated equipment and supplies
• List three areas of concern in the Sterile Processing Department (SPD) that impacts infection prevention
“The importance of this [SPD] role in the prevention of nosocomial [HAIs] is clear: reusable medical devices improperly handled, disinfected, or sterilized provide a source of contamination and increase the risk of transmission of infection to both patients and the staff involved in reprocessing procedures.”
Pugliese, Gina and Hunstiger. Central Services, Linens and Laundry. In Hospital Infections. Edited by John V. Bennett and Philip S. Brachman. 3rd ed.
Association for Professionals in Infection Control and Prevention (APIC)
• Impact on Sterile Processing• Endorses standards and guidelines through participation on committees such as AAMI and
Healthcare Infection Control Practices Advisory Committee (HICPAC), Centers for Disease Control & Prevention (CDC).
• Development of Position Statements• **Important information for infection preventionists regarding media attention on an outbreak
involving reusable surgical instruments.• “Infection preventionists can play an important role in collaboration with the perioperative team
and the facility’s sterile processing department (SPD)/surgical reprocessing professionals to ensure the proper cleaning and sterilization of surgical instruments.”
• Develops competencies for infection preventionists to ensure a clear understanding and management of risks in department to include the practices in Central Sterile / Sterile Processing• Allows for assessment of practices in this domain
• Supports initiatives that actively promote certification of sterile processing personnel
• Provides a course on “Disinfection and Sterilization: Best Practices in Reprocessing Surgical Instruments”
• Helps healthcare professionals in all settings ensure compliance with regulatory standards for sterile processing and adhere to recommended best practices.
• Ambulatory Surgery• 41% IC.02.02.01 The organization reduces the risk of infections associated with medical
equipment, devices, and supplies.
• 22% IC.01.03.01 The organization identifies risks for acquiring and transmitting infections.
• Office-Based Surgery Practices• 39% IC.02.02.01 The practice reduces the risk of infections associated with medical
equipment, devices, and supplies.
• 19% IC.01.03.01 The practice identifies risks for acquiring and transmitting infections.
• 17% IC.01.04.01 Based on the identified risks, the practice sets goals to minimize the possibility of transmitting infections independent practitioners and staff.
Joint Commission Perspectives®, April 2015, Volume 35, Issue 4
treatment, and services in accordance with licensure requirements, laws and regulations
• LD.04.03.07• Patients with comparable needs
receive the same standard of care, treatment, and services throughout the hospital
• LD.04.04.07
• The hospital considers clinical practice guidelines when designing or improving processes.
• IC.02.02.01 - The organization reduces the risk of infections associated with medical equipment, devices and supplies.
• The hospital implements infection prevention and control activities when doing the following:• EP1- Cleaning and performing low-level
disinfection of medical equipment, devices, and supplies.
• EP2 - The hospital implements infection prevention and control activities when doing the following: Performing intermediate and high-level disinfection and sterilization of medical equipment, devices, and supplies.
The Joint Commission: 2015 Hospital Accreditation Standards
• Evidence-based Guidelines• Standard IC.01.05.01, EP 1 - Lack of having—and/or lack of using—current evidence-
based guidelines for cleaning, disinfection, high-level disinfection, and sterilization practices is a frequently identified issue and includes knowledge of guideline content and accessibility of guidelines (electronic or manual) for staff use.
• Orientation, Training, and Competency• Standard IC.02.02.01 - lack of orientation, training, and competency (initial and ongoing)
of all staff involved in processing or handling semi-critical and critical devices that require high-level disinfection or sterilization.
The Joint Commission Perspectives February 2014
The Joint Commission – Issues with High-Level Disinfection (HLD)
Findings from non-complying organizations include:• Mistaken belief that the risk of passing bloodborne pathogens or bacterial agents to patients is low• Staff lack the knowledge or training required to properly sterilize or high-level disinfect equipment• Staff do not have access to or lack knowledge of evidence-based guidelines• Lack of leadership support• Frequent leadership and staff turnover makes sterilization or high-level disinfection of equipment a
low priority• Lack of a culture of safety that supports the reporting of safety risks• Processes for sterilization or high-level disinfection are not followed (i.e., staff take short-cuts)• Time frames for proper sterilization or high-level disinfection of equipment are not followed• No dedicated staff person to oversee the proper sterilization or high-level disinfection of equipment
• Facility design or space issues prevent proper sterilization or high-level disinfection of equipment (e.g., processing takes place in a small room that is also used for storage)
• Lack of monitoring or documentation of sterilization or high-level disinfection of equipment, which makes it difficult to track the use of equipment on a specific patient, complicating the patient notification process when an outbreak occurs
• Equipment is spread throughout the facility and may be processed or stored in numerous locations, making it difficult to track the equipment for documentation purposes.
• EC.02.05.01 The hospital manages risks associated with its utility systems
• EP 6: In areas designed to control airborne contaminants (such as biological agents, gases, fumes, dust), the ventilation system provides appropriate pressure relationships, air exchange rates and filtration efficiencies
“The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are alerting healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices. Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety. Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics, and doctors’ offices) that utilize reusable medical devices are urged 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.
http://emergency.cdc.gov/han/han00383.asp September 11, 2015, 12:15 EDT (12:15 PM EDT) CDCHAN-00382
“The sterilization risk analysis should be part of the overall infection prevention and control risk analysis in accordance with accreditation agency requirements.”
• Risk assessment (FMEA)
• Risk management (ANSI/AAMI ST79, Root cause analysis)
• Risk communication (Recall procedure)
“It should be performed annually and should be reevaluated whenever significant changes occur.”
• “To be rendered safe to handle, some medical devices require only thorough cleaning; others, because of occupational exposure considerations, must be cleaned and subjected to a microbicidal process. Some devices can be prepared for patient reuse following the decontamination process, whereas others must be prepared and subjected to terminal sterilization (e.g., steam sterilization of surgical instruments).” (Clause 7.1)
• “The type of decontamination required for a particular contaminated device depends on the biohazard that the device presents.” (Clause 7.1)
• “The written [instructions for use] IFU of the device manufacturer should always be followed.” (Clause 7.2.2)
• “Surgical instruments and other items composed of more than one part or piece (e.g., metal tracheostomy tubes, procedure needles, dental handpieces, laparoscopic instrumentation, trumpet valves) should be disassembled to expose all surfaces to the cleaning process.” (Clause 7.4.1)
Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Sec. 7.1 & 7.2.2 & 7.4.1
“For all reusable, the first and most important step in decontamination is thorough cleaning and rinsing.” (Clause 7.5.1) Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause 7.5.1
How do you monitor the cleanliness of instruments after the decontamination process?a. Visual inspection onlyb. Visual inspection plus a cleaning monitoring productc. We do not monitor the cleaning process
“The primary functions of a package containing a medical item are to allow the sterilization of the contents, to maintain the sterility of the contents until the package is opened, and to provide for the removal of the contents without contamination.”
Paper-Plastic Pouches – “The plastic laminate used in paper–plastic pouches is impervious to the sterilant and, therefore, might prevent the sterilant from reaching the surface of anything with which the plastic side is in physical contact. Therefore, paper–plastic pouches should not be used within wrapped sets or containment devices unless the practice has been validated by the packaging manufacturer and verified by product testing in the health care facility.”
• ANSI/AAMI ST77:2013 Rigid Container Systems (Manufacturer Standard)
• Ergonomic issue• “The combined weight of the containment
device, the instruments, and any accessories or wrappers shall not exceed 25 pounds…”
• When containment devices, including their contents and any accessories or wrappers, are too heavy, sterilization and/or drying could be compromised in commonly available hospital sterilization cycles.
• Monitoring and verifying the cleaning process• Sterilization process monitoring
• monitoring of every package and sterilization load • routine monitoring of sterilizer efficacy • qualification testing of the sterilizer after installation,
relocation, sterilizer malfunction, major repairs, and sterilization process failures
• Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
• “Biological indicators are recognized by most authorities as being closest to the ideal monitors of the sterilization process because they measure the sterilization process directly by using the most resistant organisms (i.e., Bacillus spores) and not by merely testing the physical and chemical conditions necessary for sterilization.”
• Routine sterilizer efficacy monitoring• Establishing a regular pattern of testing the
efficacy of the sterilization process for both gravity and dynamic air-removal testing.
• BI PCD• Every load • Daily plus every implant load• Weekly plus every implant load
• BD type test• Daily
• Immediate Use Steam Sterilizer (IUSS)• BI PCD representative of tray
routinely processed• Each type of tray configuration in
routine use should be tested separately• Perforated, mesh bottom, open surgical tray• Rigid sterilization container system• Protective organizing case• Single-wrapped surgical tray • Empty load on bottom shelf over drain
What is an Implant?According to FDA, “device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. FDA may, in order to protect public health, determine that devices placed in subjects for shorter periods are also ‘implants.’ ” 21 CFR 812.3(d)
•Only BI results can be used to release implants
•“BIs within a PCD should be used to monitor every load containing implants (see 10.6.1).”•The PCD should include a Class 5 integrating CI
•“The load should be quarantined until the results of the BI testing are available (CDC, 2008).”
• Bowie-Dick type test –run three consecutive cycles in an empty chamber, one right after the other, with the each test result demonstrating sufficient air removal
• Table-top sterilizers• BI PCD representative
of package or tray routinely processed and most difficult to sterilize
• BI PCD should contain items normally present during routine sterilization
• Full load in cold point (check with sterilizer manufacturer)
• Three consecutive cycles
• For both gravity-displacement and dynamic-air-removal sterilizers
• Steam sterilizer installation, relocation, or repaired and the time it is released for use in the health care facility.
• Three consecutive cycles should be run, one right after the other, with a BI PCD
• Sterilizer and load records Load contents Date and time of cycle Exposure time and temperature Initials of operator Biological results Chemical indicator results
• Records of sterilizer repair, maintenance and calibration• Maintain records for time determined by risk manager
Recall Procedures• Written policies and procedures for the
recall of items from issued or stored loads should be developed in cooperation with the infection prevention and control committee and risk management of the individual health care facility.
• These policies and procedures should be documented, and records should be maintained.
• If cause of failure immediately identified and confined to one load or item
– e.g., using incorrect sterilization cycle
– No recall, correct problem and reprocess load
•If cause of failure not identified•Quarantine load, recall all items processed since last negative BI
Areas of Concerns that Impact Infection Prevention
• Processing of endoscope• Inadequate processing
• Culturing of endoscope
• Cleaning verification • How clean is visibly clean?
• Immediate Use Steam Sterilization
• Toxic Anterior Segment Syndrome (TASS)• “Most cases of TASS appear to result from
inadequate instrument cleaning and sterilization”
• Loaner instrumentation• Timelines not met to allow for proper
processing
• Product testing• Product testing should always be performed
when major changes are made in packaging, wraps, or load configuration, such as dimensional changes, weight changes, or changes in the type or material of packaging or wrapper.”
• Infection Preventionist collaboration with the Sterile Processing Department (SPD) is key
• Include SPD in your Joint Commission tracer and rounding activities
• Ensure that all policies and procedures are evidence-based and up to date
• Quality does not automatically translate into patient safety
• Monitoring of the sterilization process is necessity for maintaining patient safety
• Be aware of publications in the media that impacts patient safety, healthcare environment and perioperative setting including the Sterile Processing Department
• Conduct regular risk assessments of the various processes and potential problems using tools such as FMEA and RCA when issues arise that impact patient safety
• Reprinted from ANSI/AAMI ST79:2010, A1:2010, & A2:2011 & A3:2012 & A4:2013 with permission of Association for the Advancement of Medical Instrumentation, Inc. (C) 2011 AAMI www.aami.org. All rights reserved. Further reproduction or distribution prohibited.
AAMI Sterilization Standards• ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities, 2nd edition (Incorporates Amendment
1:2010, A2,2011, A3:2012, and A4:2013)
• ST58 Chemical sterilization and high-level disinfection in health care facilities, 3rd edition
• ST91 Flexible and semi-rigid endoscope processing in health care facilities
• ST40 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities, 2nd edition
• TIR34 Water for the reprocessing of medical devices
• ST41 Ethylene oxide sterilization in health care facilities: Safety and effectiveness, 4th edition (Incorporates 2010 Erratum).
• ST81 Information to be provided by the manufacturer for the processing of resterilizable medical devices, 1st edition
• TIR12 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers, 3rd edition
• TIR30 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, 2nd edition
• TIR55 Human factors engineering for processing medical devices
• TIR63 Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
• ST65 Processing of reusable surgical textiles for use in health care facilities, 2nd edition
• PB70 Liquid barrier performance and classification of protective apparel and drapes in health care facilities, 2ed
• TIR11 Selection of surgical gowns and drapes in health care facilities, 2nd edition
References• The Joint Commission: 2015 Accreditation Standards• Joint Commission Perspectives®, April 2015, Volume 35, Issue 4• http://www.jointcommission.org/assets/1/23/Quick_Safety_Issue_Two_May_2014.pdf• CDC Health Advisory Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing
Reusable Medical Devices. CDC Health Alert Network. September 11, 2015, 12:15 EDT (12:15 PM EDT) CDCHAN-00382• Association for the Advancement of Medical Instrumentation (AAMI). Comprehensive guide to steam sterilization and sterility
assurance in healthcare facilities. ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3;2012 & A4:2013• Association for the Advancement of Medical Instrumentation (AAMI). Containment devices for reusable medical device sterilization.
ANSI/AAMI ST77:2013• Recommended Practices for Sterilization in the Perioperative Practice Settings. In: Perioperative Standards and Recommended
Practices. Denver, CO: AORN, Inc, 2015• Rutala, William A, Weber, David J and HICPAC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
• Brachman, Philip S. Epidemiology of Nosocomial Infections. In Hospital Infections 3rd edition, edited by John V. Bennett and Philip s. Brachman. 1992 pp. 3-20.
• IAHCSMM Central Service Technical Manual, 7th Edition.• http://www.iahcsmm.org/current_issues_Joint_paper_loaner_instrumentation.htm• Seavey, Rose. AAMI Sterile Processing In Healthcare Facilities: Preparing for Accreditation Surveys. AAMI 2011.
References• Recommended Practices for Cleaning and Sterilizing Intraocular Surgical Instruments. From the American Society of Cataract and
Refractive Surgery and the American Society of Ophthalmic Registered Nurses. Special Report prepared February 16, 2007.• Occupational Safety and Health Administration. 29 CFR 1910.1030 Occupational Exposure to Bloodborne Pathogens ; Final Rule.
Federal Register December 6, 1991.• Archibald, Lennox K. and Hierholzer, Walter J. Principles of Infectious Diseases Epidemiology. in Hospital Epidemiology and Infection
Control 3rd edition. C. Glen Mayhall, Editor. 2004. Pp.1-17.• Sehulster, Lynn and Schultz, Janet. Central Sterile Supply. In Hospital Epidemiology and Infection Control 3rd edition. C. Glen Mayhall,
Editor. 2004. Pp.1301-1313.• Steam Sterilization – Update on The Joint Commission’s Position. June 16, 2009. • The Joint Commission Perspectives. October 2009 Vol 29 (10)• Reason, James Human error: models and management. BMJ 2000:768-70• Nick Mamalis, MD, Toxic Anterior Segment Syndrome Journal of Cataract and Refractive. Surgery 2006; 32:324-333.• AAMI / FDA Reprocessing Summit. October 2011.
http://www.aami.org/publications/summits/2011_Reprocessing_Summit_publication.pdf• Sterilization and Reprocessing – A Matter of Patient Safety. Horizons Spring 2012• Martha Young (2012) Top 10 Risks in Sterile Processing. Biomedical Instrumentation & Technology: Reprocessing, Vol. 46, No. sp12, pp.
15-19. • Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes. SGNA 2012• Guidelines for Use of High Level Disinfectants and Sterilants for Reprocessing Flexible Gastrointestinal Endoscopes. SGNA 2010• Multiple Society guideline on reprocessing flexible gastrointestinal endoscopes: 2011. American Society for Gastrointestinal Endoscopy
and the Society for Healthcare Epidemiology of America.