Low Temperature Processing. An Update on Guidelines, Standards and Requirements

Transcription

1 Low Temperature Processing An Update on Guidelines, Standards and Requirements

2 Continuing Education Contact Hours Participants must complete the entire presentation/seminar to achieve successful completion and receive contact hour credit. Partial credit will not be given. All of the presenters are employees of STERIS Corporation and receive no direct compensation other than their normal salaries for participation in this activity. STERIS Corporation is an approved provider of continuing nursing education by the California Board of Registered Nursing, provider number CEP for 1 contact hour along with IAHCSMM and CBSPD. STERIS Corporation is providing the speakers and contact hours for this activity. However, products referred to or seen during this presentation do not constitute a commercial support by the speakers.

3 Objectives Differentiate between guidelines, standards and requirements in low temperature processing. Provide an overview of the current low temperature processing guidelines and standards. Understand the modern requirements for choosing low temperature processing solutions to include safety, sustainability and cost of ownership.

4 Why is this important? Healthcare facilities are being held accountable Increased auditing Greater demand for interpretation and support We play an important role in the development of standards and best practices in our profession Our credibility, your credibility, and ultimately patient safety is at stake

5 Definitions Regulations A rule or directive made and maintained by an authority Mandatory Standards Provide requirements and specifications that can be used to ensure consistency and fit for purpose National and International (often the same, often not) Voluntary, but can become mandatory Act of legislation New Jersey adoption of standards published by Association for the Advancement of Medical Instrumentation (AAMI) If you claim compliance

6 Definitions Guidelines, Recommended Practices, Technical Information reports Technical guidance, information or preferred procedures regarding a given topic e.g., AAMI TIRs, AORN Guidelines for Peri-operative Practice Voluntary but with interpretation

7 Examples of agencies that provide regulations and mandatory standards

8 Examples of groups that provide standards and guidelines

9 AAMI Document Types Standard Primarily for device manufacturers Recommendations for labeling, safety, performance criteria and test methods to assess compliance Interaction with ISO e.g., AAMI ISO or ISO Recommended practice Primarily for healthcare personnel, often considered standards Guidance on the use, care, evaluation or processing of devices e.g., AAMI ST79, ST58 or ST91

10 AAMI Document Types Technical Information Report Review of important technical issues relevant to a particular technology and a statement of expert opinion Often developed when there is not sufficient information to develop standard or when consensus can not be reached e.g., TIR30 or TIR34

11 AAMI: The Essential Customer List Standards AAMI/ANSI ST79. Steam sterilization, 2nd edition (Incorporates Amendment 1:2010, A2,2011, A3:2012, and A4:2013) AAMI/ANSI ST58. Chemical sterilization and high-level disinfection. 3rd edition (2013) AAMI/ANSI ST41. Ethylene oxide sterilization 4th edition (2010) ANSI/AAMI ST 91: Flexible and semirigid endoscope processing in health care facilities

12 AAMI: The Essential Customer List Guidelines AAMI TIR34 Water for the reprocessing AAMI TIR12 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers, 3rd edition AAMI TIR30 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices (2nd edition )

13 But there are others AORN Guidelines for perioperative practice (2016) CDC Guideline for decontamination and sterilization in healthcare facilities (2008) ASGE/SGNA (and others) Multisociety guideline on reprocessing flexible gastrointestinal endoscopes (2011) IAHCSMM Central service technical manual, 7 th edition

14 Examples of agencies that provide accreditation services

15 AAMI/ANSI ST58 Chemical sterilization and highlevel disinfection in healthcare facilities Guidelines for the selection and use of liquid chemical sterilants (LCSs)/high-level disinfectants (HLDs) and gaseous chemical sterilizers Updated in 2013 Essential for HCFs in parallel with ST79 (steam sterilization)

16 AAMI/ANSI ST58 Sections include: Work area design Personnel considerations Criteria for selection Decontamination (cleaning) and Preparation Safe and effective use Storage and transport Quality control Quality process improvement Informational Annexes

17 Definitions High level disinfectant Expected to kill all microbial pathogens, except large numbers of bacterial spores, when used according to labeling Often a liquid chemical sterilant (LCS) used for a shorter exposure time than that required to pass an FDA-defined spore inactivation test Disinfection and rinsing controlled

18 Key Points with Disinfection Label claims can vary Safety, preparation, contact time, numbers or rinsing etc Request specifics from manufacturers (e.g., rinse thoroughly ) Single use or multiple use Use of solution test strips to verify minimum recommended concentration (MRC) Multiple use disinfectants Closely follow label claims, including maximum reuse life NO topping off All surfaces of the device should be in contact Rinsing Correct water quality (bacteria-free; AAMI TIR34) Fresh water for every rinse (by immersion) Correct number of rinses

19 Definitions Liquid chemical sterilant Product validated to provide microbial kill adequate to obtain FDA clearance for a sterilization label claim (often at longer exposure times) Sterilization Validated process used to render a product free from viable microorganisms, including bacterial spores. Liquid or gaseous process

20 High Level Disinfectant/Sterilant Examples Chemicals Sterilant High Level Disinfection Notes 3.4% glutaraldehyde 20.1% isopropanol 8 hours at 20 o C 10 mins at 20 o C Requires activation 3 rinses following exposure 2% hydrogen peroxide 6 hours at 20 o C 8 mins at 20 o C No activation 1 rinse 0.575% OPA No claim (passes sporicidal test at 32 hours at 20 o C) 10 mins at 20 o C No activation 3 rinses 2.4% glutaraldehyde 10 hours at 25 o C 45 mins at 25 o C Requires activation 3 rinses following exposure 3.4% glutaraldehyde 10 hours at 25 o C 90 mins at 25 o C Requires activation Thoroughly rinse following exposure

21 Effectiveness of Reprocessing Contaminated Cleaned Disinfection Sterilization

22 High Level Disinfection Steps Preparation (if applicable, e.g., activation) Immersion/Flow (ensure all parts/lumens exposed) Remove Device, Purge all Lumens Rinsing (each rinse timed and repeated as necessary in fresh water)

23 Manual Automated

24 Automated Endoscope Reprocessors Review claims and instructions for use FDA clearance Automate and standardize processing steps Reduced chemical exposure Defined flow of lumens Specific design-dependant Pre-cleaning still required Flow connector design Filtered tap water Correct use dependant on operators

25 Automated Endoscope Reprocessors Note limitations Disinfection of connector contact sites Device preparation Flushing capabilities for all lumens Drying capabilities Correct use of cleaning detergents (when applicable) and disinfectants Rinse water control Routine maintenance

26 Flexible Endoscope Reprocessing Wate AAMI TIR 34: Utility water: Rinsing following cleaning Critical water: Rinsing following disinfection Some systems provide extensively treated water Control of any water storage or distribution systems are essentia Biofilm development and cross-contamination AAMI TIR34 (2014)

27 Low Temperature Liquid/Gaseous Sterilization Options

28 Sterilization Essentials Cleaning, rinsing, device preparation Drying Packaging requirements (if applicable) Claims are product specific Not just the active (e.g., ETO ) Controlled processes Correct equipment installation, maintenance Monitoring required for all systems Correct handling including storage Device inspection prior to use

29 Two sterilization options for most semicritical flexible endoscopes used in GI Reprocessing Modality Type Notes Uses Toxic gas. Large Inventory Required. 60 minute Cycle, 12 hour Traditional Sterilization / EtO aeration. Known for leaving residuals. May damage devices after long term use. Liquid Chemical Sterilization 23 minute cycle. Less inventory needed. Oxidative, non fixative chemistry that is safe for the user and patient. No toxic residuals

30 Ethylene Oxide Sterilization Ensure devices are clean and dry ETO is sensitive to the presence of residual soil and water Low pressure (vacuum) systems Venting cap required Sterilization parameters should be validated by endoscope manufacturer Conditioning, sterilization and aeration Post-sterilization aeration is essential Processing time typically >15 hours Endoscopes may have a limited number of cycles before requiring extensive repair

31 Liquid Chemical Sterilization One system cleared as a liquid chemical sterilant processing system cleared through the FDA Liquid chemical sterilization with peracetic acid sterilant Rinsing with extensively treated water Removal of bacteria, viruses, protozoa and fungi Controlled rinsing (non-toxic) Cycle time (23 minutes) Validated flexible endoscope models including ERCP scopes Includes specially designed connectors

32 Hydrogen Peroxide Gas AAMI/ANSI ST58 Processes with and without plasma Vacuum processes require device venting Packaging requirements Claims (lumen length and diameter restrictions) product specific Generally critical flexible endoscopes Some systems include claims for single/multiple lumen devices No GI endoscope claims Typical sterilization time ~30 mins Devices clean and dry before sterilization

33 To protect the public health we must shift endoscope reprocessing from HLD to sterilization. FDA should mandate that GI endoscopes used in healthcare facilities be sterile by 2018 Dr. Bill Rutala, 2015

34 Endoscope Drying Essential to prevent bacterial/fungal growth or biofilm development over time Hanging to dry or drip dry is NOT effective Compressed air Most AERs purge water from the endoscope lumens not dry Air pressure and quality of air Accessories

35 Storage General considerations Prevent coiling or kinking of flexible scopes (hanging preferred) Closed cabinets recommended Tracking and traceability Hang time Importance of risk assessment (facility-specific) Policy and procedure development Liquid chemical disinfection or sterilization Drying is essential Reduce risks of recontamination Transportation to point of use Gaseous sterilization Correct storage conditions/methods (e.g., AAMI/ANSI ST58)

36 Quality Control Quality control is usually thought of only as product and process monitoring. In its broadest sense, however, quality control involves continuous supervision of personnel performance and work practices and ongoing verification of adherence to established policies and procedures AAMI/ANSI ST58 (2013)

37 Quality Control Plan Policies, standards and guidelines They may conflict or be periodically updated Reprocessing policy Facility Reprocessing area design Essential requirements Department Detailed work instructions Safety and essential steps Recalls Staff training and demonstrated competency Periodic auditing of practices Documentation

38 Quality Control Plan Verification points* Physical: exposure times, temperature, volumes, shelf-life, number of uses, etc Chemical: test strips and chemical indicators Biological (when appropriate): spore test strips and biological indicators Standards recommend Monitoring every device/load Routine (equipment) testing Following installation or major repair Periodic (load) testing *Specific for each product/process

39 Quality Control Plan Cleaning Preparation (dilution, temperature) and use (contact time) Visual and another method (e.g., protein, ATP detection) Disinfection Preparation and use (contact time, reuse criteria) Solution test strips (indicators) Sterilization Pressure, temperature, time Chemical, biological and spore test indicators Documentation

40 Quality Control Plan Microbiological Surveillance Testing Limited information for guidance of surveillance cultures Surveillance cultures to assess adequacy of reprocessing Culture results delayed 2-3 days Quarantine endoscopes/accessories/aer? Is there a cutoff to define proper disinfection? What endoscopes are cultured/sampling? Areas cultured? Protocol for culturing correctly Real time testing

41 Risk Analysis and Mitigation Stage 1: Risk identification Stage 2: Risk assessment Stage 3: Risk mitigation Stage 4: Maintenance (quality control) and Quality Process Improvement

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43 Action Plan Review current documents and standards to ensure policies and procedures are consistent with best practices Provide continuing education to staff based on updated information, new endoscope models, equipment and reprocessing methods Perform risk assessment as part of quality improvement

44 Questions

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47 Useful References AAMI/ANSI ST 58. Chemical sterilization and high-level disinfection. 3rd edition (2013) AAMI/ANSI ST91. Flexible and semi-rigid endoscope processing in health care facilities (2015) AAMI/ANSI ST 41. Ethylene oxide sterilization 4th edition (2010) AAMI TIR34 Water for the reprocessing of medical devices (2014) ASGE/SHEA/SGNA/APIC: Multi-society guideline on reprocessing flexible gastrointestinal endoscopes (2011) Kovaleva et al (2014). Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy. Clin Micro Rev 26: McDonnell & Sheard (2012). A Practical guide to decontamination in healthcare. Wiley-Blackwell.