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Sterile Processing
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| Term | Definition |
|---|---|
| ANSI AAMI ST79 Scope IFU Compliance | Follow the device manufacturer instructors for cleaning, rinsing, drying, and sterilization. |
| AAMI ST79 Comprehensive Guide | Comprehensive guide for steam sterilization and processing of reusable medical devices. |
| Spaulding Classification | System grouping devices are critical, semicritical, noncritical to determine processing level. |
| Point of Use Treatment | Immediate removal of grass soil and keeping Instruments moist after use. |
| Safe Transport to decon | Contain and label contaminated items; use rigid, leak resistant, closed container. |
| Decontamination area PPE | Wear glove, gowns, eye and face protection, and other required PPE. |
| Unidirectional workflow | Dirty to clean flow that prevents cross contamination throughout the department. |
| Decon room airflow | Negative pressure relative to adjacent clean areas to control contaminants |
| Decon Temperature range | Maintain Temperature per ST79 guidance to protect staff and process quality. |
| Decon Humidity control | Maintain relative Humidity within ST79 ranges for comfort and safety. |
| Emergency eyewash | Accessible, tepid water eyewash in decontamination areas per safety guidance. |
| Sharps handing | Use puncture resistant containers and do not recap or manipulate needles. |
| Pre Cleaning | Remove visible soil using water and detergent or wipe at point of use. |
| Gross soil removal | Physically remove agents' soil before fine cleaning steps begin. |
| Soaking to prevent drying | Use moistening agents or damp towels to keep soil from drying on devices. |
| Water quality utility | Incoming water used for flushing and cleaning that meets facility specifications. |
| Water quality utility | High purity water for final rinse to minimize residues and spotting. |
| Detergent Selection | Use enzymatic or low foaming detergent compatible with device materials and soil type. |
| Enzymatic detergent use | Apply correct concentration, temperature, and contact time for effective soil breakdown. |
| pH Compatibility | Choose detergent pH that is compatible with instrument materials and water quality. |
| Manual cleaning steps | Follow measured dilution, brushing, flushing, and rinsing per IFU. |
| Brusing Selection | Use appropriately sized, lint free brushing compatible with lumens and surfaces. |
| Lumen brushing | Brush from clean and dirty direction and rinse until clear. |
| Ultrasonic cleaner purpose | Remove soil with cavitation action in hard to reach areas |
| Ultrasonic degassing | Run unit to remove dissolved gasses before processing to improve cavitation. |
| Cavitation test foil | Use aluminum foil test to verify ultrasonic performance as scheduled. |
| Mechanical washer use | Follow cycles validated for load type with proper detergent and settings. |
| Washer rack loading | Do Not overload; ensure spray access and correct orientation for drainage. |
| Spray arm Inspection | Verify spray arms rotate freely, and ports are clear of debris. |
| Instruments articuation | Open hinged instrument to allow contact with cleaning solutions. |
| Complex device IFU | Use dedicated adapters and validated methods for endoscopes and lumened devices. |
| Rinse quality | Use appropriate water quality and through rinsing to remove residues . |
| Drying after cleaning | Use medical compressed air or lint free towels to dry internal and external surfaces. |
| Inspection lighting | Use adequate task lighting and magnification to detect soil and damage. |
| Borescope inspection | Use a borescope to inspect internal lumens when recommended by IFU or policy. |
| Joint and serration check | Inspect box locks, teeth, and serrations for retained soil and damaged. |
| Surface corrosion check | Identify staining, pitting, or corrosion and remove items from service as needed. |
| Function testing | Confirm device moves, locks, and cuts as intended before assembly. |
| Residual soil tests | Use protein, hemoglobin, or carbohydrates test to monitor cleaning effectiveness. |
| Process challenge device | Use device designed to challenge cleaning processes for routine monitoring. |
| Documentation of results | Record cleaning a verification and equipment test per policy and retention times. |
| Corrective Action | Investigate and resolve failure; reprocess affected loads and document actions. |
| Chemical exposure limits | Follow safety data sheets and facility policies for handling chemistries. |
| Detergent storage | Store chemical in labeled, closed containers away from extremes of temperature |
| Instrument set weight | Keep set weight within ST79 recommended limits to allow effective cleaning. |
| Mixed metal avoidance | Avoid mixing dissimilar metals that could cause galvanic corrosion during cleaning. |
| Water temperature control | Use recommended temperatures to avoid protein coagulation and improve soil removal |
| Hardness and TDS monitoring | Monitor water hardness and total dissolved solids to protect devices and equipment. |
| Equipment maintenance | Follow preventive and calibration schedules for cleaning equipment. |
| Staff competency | Provide initial and ongoing competencies for cleaning processes and equipment |
| Quality audits | Conduct internal audits to verify compliance with ST79 cleaning requirements |
| Washer disinfector validation | Confirms washer meets performance standards using cleaning indicators and biological tests. |
| Washers daily testing | Run mechanical and chemical indicators to ensure proper function each day |
| Ultrasonic cleaner maintenance | Changes solution at least daily and clean tank per manufacturer instructions |
| Decontamination room separation | Maintain Physical separation between dirty and clean areas |
| Decon hand hygiene | Washing hands before leaving the decontamination area |
| Instrument tracking | Use system to trace devices from use through reprocessing to patient |
| Load documentation | Record load contents, operator, date, and cycle parameters. |
| Work surface material | Use smooth, nonporous, corrosion resistant surfaces in decon areas. |
| Chemical dilution verification | Confirm detergent concentration with test strips or refractometer. |
| Rinse water conductivity | Monitor and document conductivity to verify final rinse purity |
| Compressed air quality | Filter dry air to prevent oil and water contamination |
| Cleaning equipment calibration | Calibration instrument like thermometer and timers per schedule |
| Ultrasonic basket placement | Ensure devices are fully submerged but not touching tank sides. |
| Soil test control | Run positive and negative controls with cleaning tests for validation. |
| Detergent expiration | Check and do not use chemicals beyond expiration or stability date. |
| Device labeling after decon | Apply clean tags or indicators to identify items ready for assembly. |
| Transport after decon | Move clean items in covered, dedicated carts to prep and pack |
| Prep and pack environment | Maintain positive air pressure, controlled temperature, and humidity. |
| Instrument set assembly | Assemble sets according to count sheets and manufacturer instructions. |
| Count Sheet verification | Ensure items match sheet are functional before packaging |
| Indicator placement | Place internal chemical indicators in each package tray |
| External indicator | Process indicator used externally to show exposure to sterilization process |
| Package labeling | include load number, date, sterilizer, and operator initials |
| Peel pouch sealing | Seal using validated equipment and inspect for defects |
| Tray liner use | Use lint free liners when recommended by the devices IFU |
| Instrument protection | Use tip guards or holders to prevent puncture and maintain function |
| Lubrication | Apply Instruments milk as directed and allow drain before sterilization |
| Sterilizer type identification | Know the specific sterilizer type and parameters for each cycle |
| Steam sterilization principle | Kills microorganisms through heat and moisture under pressure |
| Air removal phase | Remove air using gravity displacement or dynamic air removal methods |
| Exposure phase | Maintain required temperature and time for sterilization |
| Drying phase | Use drying phase to remove moisture and prevent recontamination |
| Bowie Dick test | Daily test for air removal efficiency in pre vacuum sterilizers |
| Leak test | Check chamber integrity to detect vacuum leaks before daily use. |
| Chemical indicator classes | Indicators range from class 1 to class 6 based on performance and response |
| Class 1 indicator | Adhesive strip showing exposure to specific temperature threshold |
| Class 5 indicator | Responds to all critical parameters of sterilizer cycle |
| Biological indicator | Contains live spores used to confirm sterilization process efficacy |
| Sterilization load record | Documents cycle parameters, operator, indicators, and BI results |
| Sterilizer maintenace | Perform manufacturer recommended inspections and maintenance regularly |
| Steam quality | Steam should be dry saturated and free of contaminated for proper sterilization |
| Cycle parameter monitoring | Record temperature, pressure, and time for every sterilization cycle |
| BI Incubation | Incubate biological indicators at proper temperature and duration |
| Positive BI result | Indicates sterilization failure; quarantine and investigate load. |
| Load recall Procedure | Identify and remove affected items from service following a failed test. |
| Sterilization record rentation | Maintain records according to facility policy and regulatory requirements |
| Sterile Storage conditions | Store sterilized items in clean, temperature and humidity controlled area |
| Event related sterility | Sterility maintained until packaging is compromised or item is used |
| Stock rotation | Use first in first out method to ensure oldest items used first |
| Storage shelf height | Keep sterile item at least 8 to 10 inches from floor and 18 inches from ceiling or sprinklers |
| Transport of sterile items | Use clean, covered carts to prevent contamination during transfer |
| Package inspection | Check for tears, moisture, seal integrity before distributing sterile packs |
| Dust covers | Use transparent covers if extended storage is required; apply only after cooling |
| Return of opened items | Don't return opened or dropped sterile item to inventory |
| Distribution Documentation | Record data and recipient department for traceability |
| Sterility breach | Any compromise to package that may allow microorganism entry |
| Temperature monitoring | Use calibrated thermometers to record ambient temperature in storage areas |
| Humidity monitoring | Maintain relative humidity within recommended ST79 ranges |
| Handing sterile packs | Avoid bending, crushing, or compressed packages to maintain sterility |
| Expiration Labeling | Use event related or time related dating based on facility policy |
| Sterile field setup | opened packages must be used immediately under aseptic conditions |
| Immediate use steam sterilization | For emergency reprocessing when no replacement item is available |
| IUSS load documentation | Document reason, cycle parameters, and indicators for every IUSS cycle. |
| IUSS container system | Use validated rigid containers with filters or valves per manufacturer IFU |
| IUSS verification testing | Include biological and chemical indicators per policy |
| Drying before storage | Ensure items are completely dry before storage to prevent microbial growth |
| Cooling before handling | Allow packages to cool on sterilizer cart before handing to avoid wicking |
| Sterile barrier system | Combination of materials that maintain sterility of contents |
| Packaging validation | Material must be test for compatibility with sterilization process |
| Seal integrity test | Verify pouch seals through peel tests or dye penetration |
| Label legibility | Labels must remain readable after sterilization and handling |
| Sterile storage traffic | Restrict access and minimize dust generating activities in storage rooms. |
| Environmental cleaning | Clean storage areas on routine schedule using approved agents |
| Humidity data log | Maintain electronic or manual humidity records for compliance verification |
| Temperature alarm | Set alarm threshold for deviations beyond recommended storage range |
| Sterility assurance level | Probability of a non-sterile item being present after sterilization, typically 10^-6 |
| Bioburden | Number of microorganisms on an item before sterilization |
| D value | Time required to reduce microbial population by 90 percent under specific conditions |
| Z value | Temperature change needed to change D value by one log |
| F value | Equivalent sterilization time at specific reference temperature |
| Cycle Qualification | Process used to demonstrate sterilizer performance and load compatibility |
| Load Qualification | Specific arrangement of items within sterilizer validated for use |
| Wet pack | Package with visible moisture after sterilization; must be considered nonsterile |
| Overloading | Placing too many items in sterilizer, impeding air removal and steam contact |
| Sterilant Penetration | Ability of sterilant to reach all surfaces and lumens within the load |
| Drain strainer cleaning | Clean chamber surfaces per schedule to remove residue and scale |
| Gasket Inspection | Inspect door gaskets for cracks or wear that may cause leaks |
| Cycle record printer | Verify cycle data prints correctly and matches control settings |
| Sterilizer chart recorder | Record temperature and pressure graphs for permanent documentation |
| Preventive maintenance logs | Maintain service records as part of quality assurance programs |
| Sterilizer downtime | Report and log any unplanned outages and corrective actions |
| Utility monitoring | Monitor steam supply, water quality, and electrical stability |
| Load release procedure | Verify indicator results before releasing sterile load of use |
| Quality control program | Systemic activities ensuring compliance with cleaning and sterilization standards. |
| Accreditation compliance | Meet requirements of agencies such as joint commission or DNV |
| Regulatory Refernces | Follow CDC, FDAM and AAMI guidelines for sterile processing operations |
| Staff safety training | Annual review of PPE, chemical handling, and ergonomics safety |
| Competency Assessment | Evaluate staff skills and knowledge in cleaning and sterilization processes |
| Policy and procedure manual | Comprehensive guide detailing reprocessing methods and responsibilities |
| Risk Assessment | Identify potential hazards in processing and develop mitigation compliance |
| Continuous quality improvement | Ongoing effort to enhance processing performance and compliance |
| Internal audit | Scheduled review to verify adherence to ST79 and facility policy |
| External audit | Third party evaluation to assess compliance with regulations and standards |
| Corrective and preventive action | Processes to identify root causes and prevent recurrence of nonconformities |
| Root cause analysis | Investigate source of process deviation to prevent recurrence |
| Incident Reporting | Document events that deviate from standards processing practices |
| Risk Communication | Shares information on risks with affected staff and department |
| Equipment validation | Documented process confirming equipment performs as intended |
| Performance qualifications | Evidence demonstrating equipment consistently meet performance criteria |
| Installation quailification | Verification equipment is installed and operating to manufacturer specifications |
| Operational qualifications | Testing to confirm proper operation within defined limits |
| Calibration | Adjust instruments to ensure accurate and traceable measurements |
| Cycle load challenge device | Used to evaluate sterilizer performance with a simulated load |
| Documentation control | Manage revision and distribution of controlled process documents |
| Records retention | Maintain processing and test records for specified time periods |
| Traceability | Ability to track devices through each reprocessing step back to the patient |
| Batch control | System for identify and monitoring reprocessed items in groups or load |
| Deviation Management | Process for identifying documenting, and resolving non-conforming events |
| Competency checklist | List of tasks skills evaluated for each staff member |
| Continuing Education | Regular learning opportunities to maintain current knowledge and certification |
| Certification Maintenance | Ongoing renewal of CRCST or similar credential through CE credits |
| Requalification | Re validation required when major changes occur in eqiupment or process |
| Change control | Formal process for evaluating and approving procedural changes |
| Environmental monitoring | Test air, surfaces, or water for microbial contamination |
| Endoscope cleaning | Manual and automated cleaning pre manufacturer IFU using approved detergents |
| Leak testing | Performed before manual cleaning to detect damage in endoscopes channels |
| Channel flushing | Rinse and flush internal channels with appropriate solutions after use |
| High Level disinfection | Process using liquid chemical sterilant to destroy all microorganisms except spores |
| Reprocessing room separation | Maintain physical barriers between dirty and clean endoscopes areas |
| Drying Cabinet | Used to dry and store flexible endoscopes areas |
| HLD documentation | Record disinfectant type, contact time, temperature, and test results |
| Disinfectants testing | Check minimum effective concentration before each use with test strips |
| Rinsing after disinfection | Use sterile or filtered water to remove residual disinfectant |
| Storage of endoscopes | Hang vertically with distal tip not touching the bottom surface |
| Endoscopes storage duration | Maximum time scope may remain stored before reprocessing again |
| Bioburden reduction | Cleaning process removes most microorganisms before sterilization or disinfection |
| Drying verification | Ensure lumens are dry to prevent microbial growth during storage |
| Aseptic handling | Avoid recontamination after disinfection or sterilization |
| Labeling of reprocessed devices | including reprocessing date, operator, and expiration when applicable |
| Endoscopes reprocessing competency | Validate technician skills specific to flexible endoscopes reprocessing |
| Documentation accuracy | Ensure entries are complete, legible, and signed by responsible staff |
| Product recall | Procedure for identifying and retrieving items from use due to defects |
| Patient safety event | Incident involving potential of actual patient harm related to reprocessing failure |
| Incident investigation | Systemic review to identify contributing factors and corrective actions |
| Communication with infection control | Coordinate with infection prevention team regarding failures or exposures |
| Annual policy review | Ensure all procedures are updated with latest ST79 revisions and best practices. |
| Competency retraining | Re eduate staff when deficiencies or new technologies and identified |
| Ergonomic workstation design | Adjustable tables and tools to reduce strain during cleaning and assembly |
| Lighting requirements | Provide 500 lux more task lighting in inspection areas |
| Noise control | Maintain safe noise levels in processing areas to prevent hearing damage |
| Chemical spill response | Follow spill kit procedures and report incidents pr facility policy |
| Sharps injury prevention | Use safety devices and proper handling to prevent punctures and cuts |
| Chemical Labeling | Ensure secondary containers are labeling with contents and hazards warnings |
| Safety data sheet | Document providing chemical hazards and handling information |
| Emergency exit routes | Cleary marked and unobstructed paths from decontamination and prep areas |
| Fire Safety | Maintain extinguishers and train staff on fire response procedures |
| Eye Protection | Use safety glasses or face shields during all cleaning activities |
| Glove integrity | Inspect gloves for damage before use and replace if compromised |
| Chemical resistant gloves | Use when handling detergents or disinfectant per SDS recommendations |
| Hearing protection | Required when noise levels exceed OSHA limits in works area |
| Respiratory Protection | Use masks or respirators if required for chemical or aerosol exposure |
| Hand hygiene moments | Before and after glove use, after contact with contaminated surfaces |
| Infection prevention | Implement procedures or minimize transmission or infectious agents |
| Biohazard wasta disposal | Dispose of contaminated materials in red biohazard bags or containers |
| Spill containment | Use absorbent materials to contain spills and prevent spreading |
| Safety committee | Team responsible for reviewing incidents and recommending safety improvements |
| Annual safety training | Mandatory education covering PPE, chemical safety, emergency response |
| Utility system failure | Plan for loss power, water, or steam with defined contingency procedures |
| Label printer calibration | Verify label legibility and adhesion for traceability compliance |
| Barcode tracking | Use barcode scanning to ensure complete device traceability |
| Software validation | Confirm electronic tracking systems perform accurately and securely |
| Cybersecurity compliance | Protect reprocessing system data per HIPAA and facility IT policy |
| Sterilizer cycle verification | Compare printed or digital cycle data with indicator results for consistency |
| Autoclave chamber capacity | Do not exceed validated load volume to maintain cycle performance |
| Steam quality testing | Perform non condensable gas and dryness fraction tests per standard |
| Condensate drain inspection | Ensure free flow of condensate to prevent wet packs |
| Air filter replacement | Replace HEPA filters in prep and pack areas per schedule |
| Temperature mapping | Conduct validation of sterilizer chamber temperature distribution |
| Pressure gauge calibration | Confirm accuracy of sterilizer pressure reading per maintenance plan |
| Steam piping calibration | Insulate pipes to maintain steam temperature and reduce condensation |
| Ventilation monitoring | Verify airflow direction and pressure differentials monthly |
| Environmental separation | Dirty, clean, sterile zones physically divided by walls or barriers |
| Pass through window use | Transfer clean item through interlocking windows to avoid cross contamination |
| Intercom communication | Use voice communication system between areas to maintain separation |
| Instrument marking | Use laser etching or approved labels for permanent identification |
| Marking verification | Ensure marks do not compromise device surface integrity |
| Instrument lifecycle | Track total uses, repairs, and replacements for asset management |
| Repair vendor management | Ensure outside repair companies comply with facility decontamination policies |
| Loaner tray processing | Process loaned instruments per same standards before and after use |
| Loaner tray documentation | Record arrival, processing, and return information for traceability |
| IFU availability | Ensure up to date manufacturer instructions are accessible to staff |
| IFU management system | Digital or binder-based system for quick retrieval of validation instructions |
| Translation verification | Confirm IFU language matches device and staff comprehension needs |
| Multilingual labeling | Include required information in languages used by staff as applicable |
| Staff communication board | Post updates, alerts, and reminders for department awareness |
| Safety signage | Display warnings for PPE, chemical handling, restricted access |
| Ergonomic lifting | Use mechanical aids and team lifts for heavy trays or equipment |
| Workload balancing | Distribute tasks evenly to prevent fatigue and improve productivity |
| Shift handoff report | Communicate equipment issues and incomplete loads between shifts |
| Sterilizer cooling racks | Use carts designed to allow proper air circulation during cooldown |
| Moisture detection | Inspect cooled packs for dampness before labeling or storage |
| Instrument inventory audit | Regularly verify that all instruments are accounted for and in serviceable condition |
| Preventive maintenance schedule | Documented calendar for servicing washers, sterilizer, and HVAC systems |
| Electrical safety check | Inspect cards and plugs before use to prevent shock hazards |
| Compressed gas cylinder storage | Secure upright and label cylinders with contents and hazard class |
| Color coding system | Assign colors for workflow zones or instrument categories for clarity |
| Visual management board | Display metrics, schedules, and compliance data for team awareness |
| Workload metrics | Track tray volume, cycle counts, and turnaround times for efficiency monitoring |
| Downtime tracking | Record equipment outages and causes to support preventive actions |
| Backflow Prevention | Install and test devices to prevent reverse water contamination |
| Plumbing maintenance | Inspect drains and supply lines for leaks or obstruction |
| Chemical exposure logs | Maintain logs of staff exposure to hazardous cleaning agents |
| Ventilation testing | Verify airflow rates and direction annually or after maintenance |
| Microbial Surveillance | Periodic surface testing to detect contamination in clean areas |
| Instrument corrosion prevention | Use water treatment and proper drying to prevent rust formation |
| Detergent residue testing | Perform test to confirm all cleaning agents are removed form instruments |
| Surface disinfectant rotation | Roate chemicals to reduce resistance and ensure effectiveness |
| Work instruction | Step by step written procedures for all reprocessing activates |
| Visual aids | Use Photos or diagrams to assist with correct assembly and setup |
| Competency observation | Direct observation or staff performing tasks to verify compliance |
| Audit Checklist | Structured list for assessing process adherence and documentation completeness |
| Corrective training | Targeted retaining after audit findings or process deviations |
| Staff meeting minutes | Document topics, attendance, and follow up actions from team meetings |
| Process improvement plan | Structured approach to enhanced quality and efficiency in workflows |
| Sterilization load recall log | Records all recalls with investigation outcomes and corrective actions |
| Hazard communication training | Educate staff about hazardous chemicals and labeling systems |
| First aid station | Maintain stocked first aid kits accessible in all processing areas |
| Emergency contact list | Display key phone numbers for quick response during incidents |
| Safety inspection checklist | Tool to routinely verify environmental and equipment safety compliance |
| Chemical spill drill | Conduct periodic practice drills to test response procedures |
| Eye wash test logs | Records weekly functions tests and maintenance of eyewash stations |
| Lockout tagout procedure | Ensure equipment is safety de energized before maintenance |
| Equipment cleaning log | Track daily and weekly cleaning of washers, sterilizers, and counters |
| Load labeling standards | Define consistent label format for all reprocessed items |
| Sterile transport vehicle | Dedicated clean vehicle used for moving sterile supplies to department |
| Temperature recording device | Monitor environmental temperature continuously with alarm alerts |
| Sterilizer door safety | check interlock and warning lights before operating sterilizer |
| Flash sterilization prohibition | Avoid IUSS for implants or routine processing |
| Implant load monitoring | Use BI and CI in every implant load and quarantine until BI results known |
Created by:
Wolfylea