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Vickie Brown, MPH, RN, CICJuly 14-15, 2016
Outbreaks of bacterial infection associated with endoscopes are often attributed to improperly reprocessed endoscopes.
Endoscope reprocessing is highly complex and technical with many potential risks for error
HICPAC formed an Endoscopy Reprocessing Workgroup
Workgroup Update provided to HICPAC March 2016
Goal – Healthcare facilities should have a reliable, high quality system for endoscope reprocessing which minimizes infection risks.
Workgroup charge – Identify the elements necessary to achieve this goal including risk assessment tools, training and competencies, measurement, management. Deliver these draft elements/recommendations to HICPAC for deliberation and input to produce recommendations from HICPAC to CDC.
HICPAC Members◦ Vickie Brown, RN, MPH◦ Lisa Maragakis, MD, MPH
Organization Representatives◦ AAAHC- Accreditation Association for
Ambulatory Health Care; Naomi Kuznets, PhD
◦ AAMI-Association for the Advancement of Medical Instrumentation;
Mary Ann Drosnock, MS, CIC, CFER, RM◦ AGA-American Gastroenterological
Association; Michael L Kochman, MD, AGAF, FASGE
◦ ASGE-American Society for Gastrointestinal Endoscopy;
Glenn Eisen, MD, MPH, FASGEBarbara Connell, CAE, CMPEden Essex
◦ AORN-Association of Perioperative Registered Nurses;
Sharon A Van Wicklin, MSN, RN, CNOR◦ APIC-Association for Professionals in
Infection Control and Epidemiology; Michael Anne Preas, RN, BSN, CIC
◦ Deborah Yokoe, MD, MPH◦ Michael Tapper, MD
◦ CSTE-Council of State and Territorial Epidemiologists;
Rachel Stricof, MPH ◦ DNV Healthcare
Linda L Spaulding, RN, CIC ◦ IAHCSMM-International Association of
Healthcare Central Service Material Management;
Natalie Lind◦ PHAC-Public Health Agency of Canada;
Laurie O’Neil, RN, BN ◦ SGNA-Society of Gastroenterology Nurses
and Associates; Betty McGinty, MS, HAS, CGRN, BSHA, RN
◦ SHEA-Society for Healthcare Epidemiology of America;
Zachary Rubin, MD◦ The Joint Commission
Lisa Waldowski MS, APRN, CIC
Federal Organization Representatives◦ CMS-Centers for Medicare & Medicaid Services
Sharon Roberson, RNKaren Hoffman, RN, BSN, MS FSHEA
◦ FDA-Food and Drug Administration Elizabeth Claverie-Williams, MS
CDC Technical Experts◦ Carolyn Gould, MD, MSCR◦ Alex Kallen, MD, MPH◦ Todd Weber, MD◦ Joe Perz, DrPH, MA◦ Melissa Schaefer, MD◦ Lynne Sehulster, PhD◦ Jeff Hageman, MHS◦ Erin Stone, MS
Biweekly conference calls Identifying gaps and priorities Conceptualizing the final product of the
workgroup Refining the Essential Elements of Flexible
Endoscope Reprocessing document Creating and refining Toolkit Document
Examples
Pre-clean flexible endoscopes and reusable accessories by following the device manufacturer’s instructions for use (IFU). Perform pre-cleaning immediately following completion of the endoscope procedure to prevent the formation of biofilm.
For endoscopes that require leak testing, perform the leak test using manufacturer’s IFU after each use and prior to manual cleaning.
Perform meticulous manual cleaning including brushing and flushing channels and ports consistent with the manufacturer’s IFU before performing high-level disinfection (HLD) or sterilization. Perform manual cleaning within the timeframe specified in the manufacturer’s IFU.
After manual cleaning, visually inspect the endoscope and its accessories.
Following cleaning and visual inspection perform HLD or sterilization in accordance with the manufacturer’s IFU.
After reprocessing is complete, store endoscopes and accessories in a manner that prevents recontamination, protects the equipment from damage, and promotes drying. Store processed flexible endoscopes in a cabinet that is either of sufficient height, width, and depth to allow flexible endoscopes to hang vertically without coiling and without touching the bottom of the cabinet or designed and intended by the manufacturer for horizontal storage of flexible endoscopes.
Maintain documentation of adherence to these essential steps each time an endoscope is reprocessed.
Administrative◦ Accountable leadership Resources and infrastructure Authority Ensuring essential elements are followed and ensuring endoscopes are
reprocessed according to manufacturer’s IFU◦ Policies Multidisciplinary input Address selection, use, transport, reprocessing, storage in compliance with
manufacturer’s IFUs; training, competency assessment, documentation, and quality assurance methods
Address “loaner” endoscopes not owned by healthcare facility Assess condition and reprocess prior to use
Consistent with all regulatory requirements, accrediting organizations, and standards and recommendations from professional organizations
Administrative◦ Management Ensure reprocessing policies are in place and regularly updated Ensure single use devices are not reprocessed Ensure occupational health protections are addressed Ensure scheduling and staffing allows adequate time for reprocessing Provide access to infection prevention knowledge and expertise Ensure adequate, ongoing training, education, and certification
Including competency for each type of endoscope used in facility Certification is encouraged but does not negate ongoing competency
assessment Ensure water quality meets standards set by manufacturers’ IFU
Professional society guidelines recommending more stringent water quality standards can be considered
Ensure appropriate documentation is kept
Documentation◦ Requirements may vary depending upon method, germicide, etc.◦ Endoscope and patient identifiers for traceability◦ Times for each step should be included, including pre-cleaning◦ Fluid tests of efficacy, concentration, expiration◦ Preventive maintenance and repair◦ Include investigation of potential critical events◦ Retain documentation of endoscopes (including retired ones) as well as
AERs, sterilizers Inventory◦ Identify all endoscopes (make; model; location of use, IFUs, and
reprocessing; reprocessing equipment and personnel; condition◦ Ensure each scope has a unique identifier for tracking
Physical Setting◦ Separate, dedicated space for reprocessing◦ One-way workflow that separates clean from dirty spaces◦ Negative airflow for separate room if manual cleaning is employed◦ Ensure proper heating, ventilation, and air conditioning parameters◦ Provide a clean hand washing sink with eyewash separate from
reprocessing sink(s)◦ Two sinks or a divided sink for washing and rinsing endoscopes◦ Ensure manufacturer’s IFUs for endoscopes, AERs, and chemicals are
available on site◦ Provide dedicated space for IFU binders & safety data or enable access to
computer
Training and Competencies◦ Include the rationale for the reprocessing steps Model-specific training and competency assessment based upon IFUs and
equipment used Posting of visual education aids and SOP
◦ Address reprocessing of reusable accessories that break the mucosal barrier (e.g. biopsy forceps)
◦ Trainers and supervisors must be competent to reprocess endoscopes in order to train and assess the frontline staff
◦ Assessment of staff competency: On hire and at least annually and direct observation of reprocessing is
recommended When new equipment or chemicals are purchased and used Whenever manufacturer’s IFUs change Include all steps of the process (preclean to storage) Include review of manual reprocessing Include how to perform rapid verifications tests when used by the facility
◦ Certification does not mitigate the need for orientation, ongoing education/ training, and competency assessments
Quality Assurance◦ Comprehensive gap analysis, including Verification of staff competencies Sufficient reprocessing personnel for all contingencies Manufacturer’s IFU are available and followed Adequate physical space HVAC parameters are monitored and controlled Documentation is maintained
◦ Risk assessment when IFUs allow for intermediate reprocessing and use of a sheath
◦ If AER is used, assess for documentation verifying compatibility of endoscope and endoscope component use with AER.
◦ Periodic audits of documentation and observations of reprocessing◦ Repeated gap analysis and risk assessment periodically and when new
equipment is purchased, IFUs change, or new recommendations and guidance are issued
Disinfection/ Sterilization Failure◦ Multi-disciplinary review of each event to determine
corrective steps and need for patient notification◦ Team use of available resources to assist in breach
evaluation and guide evaluation◦ Notify FDA through MedWatch if persistent bacterial
contamination is suspected
Unresolved Issues◦ Supplemental Measures◦ Endoscope Storage Interval◦ Endoscope storage Space◦ Replacement of Endoscopes
Gap analysis (annually) Audit tool (monthly or quarterly) Inventory template (annually) Competency verification checklist (upon hire and
at least annually) Policy template (reviewed at least every 3 years)
1. Is the Essential Elements document missing any important points?
2. Are there elements in the document that require further refinement?
3. Should water quality for the final post high level disinfection rinse in manual flexible endoscope reprocessing be described as tap, filtered, or sterile or a combination of all three?
4. Are there areas the document should highlight where additional research/ data is needed?
5. Are any sample documents missing from the toolkit?6. Are any of the toolkit sample documents missing any
important points?
1. Is the Essential Elements document missing any important points?
2. Are there elements in the document that require further refinement?
3. Should water quality for the final post high level disinfection rinse in manual flexible endoscope reprocessing be described as tap, filtered, or sterile or a combination of all three?
4. Are there areas the document should highlight where additional research/ data is needed?
5. Are any sample documents missing from the toolkit?6. Are any of the toolkit sample documents missing any
important points?
1. Is the Essential Elements document missing any important points?
2. Are there elements in the document that require further refinement?
3. Should water quality for the final post high level disinfection rinse in manual flexible endoscope reprocessing be described as tap, filtered, or sterile or a combination of all three?
4. Are there areas the document should highlight where additional research/ data is needed?
5. Are any sample documents missing from the toolkit?6. Are any of the toolkit sample documents missing any
important points?
1. Is the Essential Elements document missing any important points?
2. Are there elements in the document that require further refinement?
3. Should water quality for the final post high level disinfection rinse in manual flexible endoscope reprocessing be described as tap, filtered, or sterile or a combination of all three?
4. Are there areas the document should highlight where additional research/ data is needed?
5. Are any sample documents missing from the toolkit?6. Are any of the toolkit sample documents missing any
important points?
1. Is the Essential Elements document missing any important points?
2. Are there elements in the document that require further refinement?
3. Should water quality for the final post high level disinfection rinse in manual flexible endoscope reprocessing be described as tap, filtered, or sterile or a combination of all three?
4. Are there areas the document should highlight where additional research/ data is needed?
5. Are any sample documents missing from the toolkit?6. Are any of the toolkit sample documents missing any
important points?
1. Is the Essential Elements document missing any important points?
2. Are there elements in the document that require further refinement?
3. Should water quality for the final post high level disinfection rinse in manual flexible endoscope reprocessing be described as tap, filtered, or sterile or a combination of all three?
4. Are there areas the document should highlight where additional research/ data is needed?
5. Are any sample documents missing from the toolkit?6. Are any of the toolkit sample documents missing any
important points?
1. Is the Essential Elements document missing any important points?
2. Are there elements in the document that require further refinement?
3. Should water quality for the final post high level disinfection rinse in manual flexible endoscope reprocessing be described as tap, filtered, or sterile or a combination of all three?
4. Are there areas the document should highlight where additional research/ data is needed?
5. Are any sample documents missing from the toolkit?6. Are any of the toolkit sample documents missing any
important points?
