6 Handling, collection, and transport of contaminated items General rationale Separation of waste and reusable items at point of

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1 Contents Glossary of equivalent standards... ix Committee representation... xi Acknowledgments...xiii Background on Amendment 1...xiii Foreword... xiv Introduction: Need for the recommended practice Scope General Inclusions Exclusions Definitions and abbreviations Design considerations General rationale Work area design and functional workflow Definitions of work areas Design criteria Functional workflow patterns Traffic control Physical facilities Space requirements Mechanical systems Electrical systems Steam for sterile processing Utility monitoring and alarm systems General area requirements Special area requirements and restrictions Emergency eyewash/shower equipment Housekeeping procedures Personnel considerations General rationale Qualifications Supervisory personnel Sterile processing personnel Training and continuing education Sterile processing personnel Service personnel Other personnel Health and personal hygiene Attire General considerations Decontamination area Sterilization area (flash sterilization) Service personnel Standard/transmission-based (enhanced) precautions Receiving General rationale Receiving of purchased or loaner items General considerations Newly purchased reusable items and repaired reusable items Rigid sterilization container systems Disposable items Disposition of sterile items (issued but not used)...37

2 6 Handling, collection, and transport of contaminated items General rationale Separation of waste and reusable items at point of use Care and handling of contaminated reusable items at point of use Containment Transport Transportation scheduling and routes Transportation equipment Hand transport Dedicated lifts Transport between buildings Off-site transportation Cleaning and other decontamination processes General rationale Policies, procedures, and manufacturers instructions Policies and procedures Manufacturers instructions Presoaking Disassembly Sorting and disassembly of instrumentation Disassembly of rigid sterilization container systems Cleaning General considerations Cleaning agents Methods of cleaning Rinsing Verification of the cleaning process Cleaning of instruments Utensils Reusable textiles Rigid sterilization container systems Microbicidal processes General considerations Processes to decontaminate devices so that they are safe to handle Terminal sterilization processes to prepare devices for the next patient use Servicing and repair of devices in the health care facility General considerations Potential for exposure Protective measures for service personnel Postexposure program Devices that cannot be repaired in-house Packaging, preparation, and sterilization General rationale Selection of packaging materials Package configurations and preparation General considerations Package labels Package closures Paper plastic pouches Textile packs Basins and basin sets Surgical supplies Devices with lumens Preparation and assembly of surgical instrumentation General considerations Weight and density of sets Inspection Instrument placement Use of tray liners or containment devices Loading the sterilizer General considerations...67

3 8.5.2 Paper-plastic pouches Instrument sets Textile packs Utensils and glassware Rigid sterilization container systems Liquids and solutions Powders and oils Sterilization parameters Sterilization parameters for wrapped or containerized items Flash sterilization parameters Specialty instruments Monitoring sterilization cycles Unloading the sterilizer Large-chamber sterilizers Table-top sterilizers Open-tray flash cycles Flash cycles with single wrappers or other textile packaging Flash cycles with sealed containment devices Handling and inspection Sterile storage Sterility maintenance covers Storage facilities Shelf life Distribution (general) Handling and inspection Distribution containers Transport of sterile packaged items General considerations Tables and carts (open or closed) Hand transport Dedicated lifts Off-site transportation Policies and procedures Aseptic presentation Opening sterile packages Removing items from sterile packaging and transferring them to the sterile field Installation, care, and maintenance of sterilizers General rationale Instruction manuals Installation Routine care Preventive maintenance General considerations Scheduled maintenance Calibration Record-keeping Quality control General rationale Monitoring of mechanical cleaning equipment Product identification and traceability Lot control numbers Sterilizer records Expiration dating Overview of sterilization process monitoring Sterilization process monitoring devices Physical monitors Chemical indicators (CIs) Biological indicators Process challenge devices (PCDs) Routine load release Process monitoring devices Release criteria for nonimplants...91

4 Release criteria for implants Sterilization process failures Routine sterilizer efficacy monitoring General considerations Routine biological monitoring of sterilizers larger than 2 cubic feet Routine biological monitoring of table-top sterilizers Routine biological monitoring of flash sterilization cycles Positive BI results Routine Bowie-Dick testing of dynamic-air-removal sterilizers Qualification testing General considerations Qualification testing of sterilizers larger than 2 cubic feet Qualification testing of table-top sterilizers Qualification testing of flash sterilization cycles Periodic product quality assurance testing of routinely processed items Periodic product quality assurance testing of rigid sterilization container systems General considerations Responsibilities of the manufacturer User responsibilities Product recalls General considerations Recall procedure Recall order Recall report Quality process improvement General rationale Quality process General considerations Decontamination Rigid sterilization container systems Flash sterilization Functional areas for product and process improvements Workplace design Processing policies and procedures Product use Implementing product and process improvements Annexes A Examples of workplace design B Infection transmission C D E F G Processing CJD-contaminated patient care equipment and environmental surfaces User verification of cleaning processes Selection and use of chemical disinfectants Thermal disinfection Devices returned to the manufacturer H Occupational exposure to blood-borne pathogens (29 CFR Part ) I J Development of a prepurchase evaluation protocol for rigid sterilization container systems Effect of containerized packaging on load heat-up time K Development and qualification of the 16 towel PCD (biological-indicator challenge test pack) L Example of documentation of premature release of implants M Steam quality N Toxic anterior segment syndrome (TASS) and the processing of intraocular surgical instruments O Bibliography...192

5 Tables 1 Saturated steam pressure conversion units at sea level Typical limiting values of contaminants of steam and/or water in contact with product and/or product packaging Ventilation requirements for functional areas IES-recommended illuminance levels for work environments Minimum cycle times for gravity-displacement steam sterilization cycles Minimum cycle times for dynamic-air-removal steam sterilization cycles Sterilization process monitoring recommendations Types and applications for use of sterilization monitoring devices Summary of test configurations for prepurchase evaluation of rigid sterilization container systems D.1 In-use tests available to assess efficacy of cleaning of medical devices D.2 In-use tests available to assess efficacy of washer-disinfectors used for medical device reprocessing E.1 Levels of disinfection according to type of microorganism E.2 Occupational exposure limits for some chemical sterilants and disinfectants K.1 16 towel pack survey K.2 Biological-indicator results from 121 C (250 F) gravity cycle K.3 Biological-indicator results from 132 C (270 F) deep-vacuum cycle K.4 Biological-indicator results from 132 C (270 F) pulsing vacuum cycle K.5 Comparison of the 16 towel pack with the inch pack by Most Probable Number and sterility assessment of spore strips (121 C [250 F] gravity cycle) K.6 Fraction-negative results in a 121 C (250 F) gravity cycle K.7 Biological-indicator results from 121 C (250 F) steam-flush pressure-pulse cycle K.8 Biological-indicator results from 132 C (270 F) steam-flush pressure-pulse cycle Figures 1 Functional work areas of a sterile processing department Workflow Microbicidal processes and use of PPE Sequential double-wrapping: envelope fold Sequential double-wrapping: square fold Simultaneous double-wrapping: envelope fold Simultaneous double-wrapping: square fold Example of single- and double-packaging with paper/plastic pouches Loading the sterilizer Preparation of the 16 towel PCD (BI challenge test pack) Placement of the 16 towel PCD (BI challenge test pack) for routine biological monitoring of sterilizers larger than 2 cubic feet Composition of the Bowie-Dick test pack Placement of the Bowie-Dick test pack...100

6 14 Placement of the 16 towel PCD (BI challenge test pack) for qualification testing Test rigid sterilization container system A.1 Example of a work area design and workflow pattern for a sterile processing department in a typical small hospital A.2 Example of a work area design and workflow pattern for a sterile processing department in a typical medium-sized hospital A.3 Example of a work area design and workflow pattern for a sterile processing department in a typical regional processing center A.4 Example of a work area design and workflow pattern for a sterile processing department A.5 Example of a work area design and workflow pattern for a sterile processing department A.6 Example of a work area design and workflow pattern for a sterile processing department A.7 Example of an ambulatory surgery facility A.8 Example of a dental facility B.1 The chain of infection, components of the infectious disease process B.2 Blood-borne pathogen strike-through conversion chart J.1 Typical rigid sterilization container system processed in a gravity-displacement cycle at 121 C (250 F) J.2 Muslin-wrapped, 16-pound instrument set processed in a gravity-displacement cycle at 121 C (250 F) J.3 Typical rigid sterilization container system processed in a prevacuum cycle at 132 C (270 F) K.1 Temperature profiles for two different configurations of inch packs in a 121 C (250 F) gravity cycle K.2 Temperature profiles for huck and absorbent 16 towel packs in a 121 C (250 F) gravity cycle K.3 Average temperature profile for the 16 towel pack in a 121 C (250 F) gravity cycle L.1 Implantable devices load record L.2 Exception form for premature release of implantable device/tray...186