Endoscope Reprocessing: Are your patients at risk

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Endoscope Reprocessing Are your patients at risk?

• Laura Strohmeyer, RN, CGRN
• GI Clinical Director, Division III, AmSurg

3rd Annual NTSGNA Lone Star Roundup November 14,
2009
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News Headlines

• 12/22/08 VA Safety Alert Improper reprocessing
  of flexible endoscope tubing
• 2/9/09 VA Offers Tennessee Valley Patients Free
  Screening
• 3/23/09 Veterans face HIV risk from Hospital
  Pumps, Miami Herald
• 3/24/00 Miami VA Flooded with Calls about HIV
• 4/19/09 VA 3 Patients HIV-Positive after
  Clinic Mistakes
• 5/14/09 VA/Endoscopy Controversy Spreads to
  Transplant World
• MIAMI    A Veterans Affairs hospital here has
  notified thousands of patients that their
  colonoscopies were performed with improperly
  sterilized equipment, officials said Monday.
• The hospital urged about 3,260 patients who had
  colonoscopies between May 2004 and March 12 of
  this year to get tests for HIV, hepatitis and
  other diseases.

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Doctor HIV will Never be Traced to VA

• Five patients have tested positive for HIV and 33
  have tested positive for hepatitis since
  February, when the VA started notifying more than
  11,000 people treated at three VA medical centers
  to get follow-up blood checks because they could
  have been exposed to infectious body fluids. The
  hospitals are in Miami, Murfreesboro, Tenn., and
  Augusta, Ga.
• Fox News 5/9/09

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• The Department of Veterans Affairs, Office of
  the Inspector General Use and reprocessing of
  flexible fiber-optic endoscopes at VA medical
  facilities. 6/16/09
• http//www.va.gov/oig/54/reports/VAOIG-09-01784-14
  6.pdf

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Memo from Secretary of Health

• VHA facilities have not complied with management
  directives regarding scope reprocessing.
• Standardized approach
• Monitor continuously
• Random site visits
• Annual Competencies
• Standard Operating Procedure reviewed annually
• Quality assurance monitored
• Standardize equipment

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http//www.asge.org/reprocessing.aspx

• ASGE Endoscope Reprocessing- Safety and Risk
  Management
• Packet of Materials to facilitate the
  notification and tracking of patients when a
  reprocessing failure occurs
• Notification worksheet
• Letter for notification of patients
• Letter for referring physicians
• Script for notification of patients by telephone
• Letter to patients failing to comply with tests
• Letter to patients failing to comply with
  follow-up testing

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Lessons Learned

• AER Settings
• HLD usage
• TJC Mock Survey
• Ongoing Education
• Annual Competencies
• Frequently Monitor Compliance

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Scope Reprocessing Observations

• Bedside Pre-Cleaning
• Transportation to cleaning room
• Leak Testing
• MEC testing and documentation
• HLD changing and documentation
• Alcohol flush
• Water bottles
• Flushing pumps
• Re-use single use items

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Resources Available

• Guidelines
• SGNA Standards of Infection Control in
  Reprocessing of Flexible Gastrointestinal
  Endoscopes
• The Multi-Society Guideline for Reprocessing
  Gastrointestinal Flexible Endoscopes 2003
• SGNA Guideline for the use of High-Level
  Disinfectants and Sterilants for Reprocessing GI
  Endoscopes
• Manufacturers Instructions/product labels
• Vendor representatives

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Attention can be a good thing

• Enforces importance of scope reprocessing
• Identifies risks if guidelines are not followed
• Justifies training and expense to physicians
• Provides opportunities for training and education
• Validates why we do what we do
• To take better care of our patients

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Hand Hygiene

• When washing hands with soap and water, wet hands
  first with water, apply an amount of product
  recommended by the manufacturer to hands, and rub
  hands together vigorously for at least 15
  seconds, covering all surfaces of the hands and
  fingers. Rinse hands with water and dry
  thoroughly with a disposable towel. Use towel to
  turn off the faucet.
• CDC Guideline for Hand Hygiene in Health-Care
  Settings 2002

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How can we reprocess GI Endoscopes when we cant
wash our hands correctly?
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Are your patients at risk?

• Take the test and evaluate your facilities
  current scope reprocessing

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Question 1 10 points

• Documentation
• There should be documentation of which scope(s)
  are used for every procedure. Nurses notes,
  electronic procedure reporting, patient log.
• Needed to investigate a breech in infection
  control or equipment malfunctioning.
• If this is done at your facility, 10 points
• If this is not done at your facility, -10 points

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Question 2 10 points

• Water Bottles
• High Level Disinfection (HLD) or sterilization
  daily
• Filled with sterile water
• No additives such as mylicon drops
• Pentax recommends sterilization only EPK-I
• If this is done at your facility, 10 points
• If this is not done at your facility, -10 points

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Question 3 10 points

• Bedside Cleaning
• PPE- Gown, gloves, goggles, mask
• Performed immediately following procedure
• Use freshly prepared enzymatic solution
• Wipe down insertion tube
• Flush air/water channels
• Transport in container with lid
• If this is done at your facility, 10 points
• If this is not done at your facility, -10 points

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Question 4 10 points

• Leak Testing
• PPE- Gown, gloves, goggles, mask
• Test for air flow, connect to scope
• Prepare sink of freshly prepared, plain water
• Pressurize scope before submersing in water
• 90 seconds, check entire scope, angulate bending
  section.
• Follow procedure to disinfect with a positive
  leak
• If this is done at your facility, 10 points
• If this is not done at your facility, -10 points

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Question 5 10 points

• Manual Cleaning
• Freshly prepared enzymatic/detergent solution
  according to manufacturers instructions
• Wipe entire scope
• Submerse in solution,
• Flush all channels using channel irrigator
• Brush all channels and flush again
• Soak for recommended time per instructions
• Rinse all channels, dry scope
• If this is done at your facility, 10 points
• If this is not done at your facility, -10 points

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Question 6 10 points

• HLD Potency Testing
• Test strip bottle dated when opened
• Quality Control performed when bottle opened and
  documented
• Check Minimum Effective Concentration prior to
  each use
• Submerse test strip recommended time
• Read at recommended time, use timer
• Document results
• If this is done at your facility, 10 points
• If this is not done at your facility, -10 points

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Question 7 10 points

• High Level Disinfectants
• Use approved HLD or sterilant
• AER Automated Endoscope Reprocessor
• Connected as recommended
• Verify exposure time, temp
• Documentation of Patient, instrument
• Manual Reprocessing
• Flush all channels, remove channel irrigator
• Set Timer starting with the last item placed in
  basin
• If this is done at your facility, 10 points
• If this is not done at your facility, -10 points

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Question 8 10 points

• Rinse
• Freshly prepared rinse water
• One scope at a time
• Flush all channels with alcohol
• Alcohol stored in closed container between uses
• Done after every reprocessing cycle
• Purge all channels with air
• Dry scope
• If this is done at your facility, 10 points
• If this is not done at your facility, -10 points

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Question 9 10 points

• Storage
• Hang scope vertically in well-ventilated, dust
  free area
• Distal tip hanging freely
• Scopes are not stored in cases
• Scopes returned from repair are reprocessed
• AORN 2009 Scopes should be reprocessed before
  use if unused for more than 5 days
• If this is done at your facility, 10 points
• If this is not done at your facility, -10 points

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Question 10 10 points

• Items labels Single-use are not reused
• Bite blocks
• Inflation devices and syringes
• Cleaning brushes
• Cleaning sponges
• Specimen containers
• Specimen traps
• Polyp traps
• If this is done at your facility, 10 points
• If this is not done at your facility, -10 points

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Bonus Question 1 10 points

• Olympus Flushing Pumps
• OFP filter and irrigation tubing are sterilized
  before use
• OFP Water container filled with sterile water
  without mylicon
• Reprocess MAJ-855 with scope after each use
• OFP filter and irrigation tubing must be
  discarded at the end of each day
• OFP water container sterilized daily
• If this is done correctly at your facility, 10
  points

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Bonus Question 2 10 points

• HLD Accessories
• Should use a separate bin of HLD
• Do not put water bottles or biopsy forceps in AER
• Soak recommended time
• If this is done correctly at your facility, 10
  points

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Bonus Question 3 10 points

• Forceps- Critical devices
• Use disposable forceps one time only
• OR
• Reprocess re-usable forceps
• Cleaning in ultrasonic cleaner
• Sterilize by autoclave
• Perform required autoclave testing, maintenance
  and documentation
• If this is done correctly at your facility, 10
  points

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Test Results
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Test Results
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Other Recommendations

• Label water bottles sterile water only
• Label bins for scope transport dirty scopes
  only
• Develop a step-by-step policy and procedure for
  scope reprocessing
• Include all models of scopes used
• Initial and annual competency
• One person (administration) accountable
• Monitor scope reprocessing regularly

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Glutaraldehyde Label

• Recommends a 45-minute exposure at 25C for HLD
  because the current federal labeling regulation
  assumes no cleaning of the medical device prior
  to chemical exposure.

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Glutaraldehyde Label (continued)

• SGNA, ASGE, AGA and APIC adopted the
  Multi-society Guideline for Reprocessing Flexible
  Gastrointestinal Endoscopes in 2003.
• HLD is achievable with a 20-minute exposure
• This recommendation differs from the label
  because the current federal labeling regulation
  assumes no cleaning of the medical device prior
  to chemical exposure.

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Breech in Scope Re-processing

• Stop reprocessing error immediately
• Inform Risk Manager, Infection Control
  Coordinator, Medical Director, PI Chair
• Identify extent of breech
• Length of time
• Patients at risk
• Number of patients affected
• Independent Biomed Representative
• Contact malpractice carrier, infection control
  specialists

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Breech in Scope Re-processing

• Report to health department, authorities as
  required
• Inform patients
• ASGE templates
• Phone script
• Patient letter
• Develop a media plan
• Prepare for unannounced survey
• Follow-up as recommended

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Training

• SGNA Endoscope Cleaning and High-Level
  Disinfection Module
• Learning Guide with post-test
• Instructional DVD
• Wall Chart
• IMS Online learning- www.imsready.com
• Care and handling of flexible endoscopes
• Preventing fluid damage in flexible endoscopes
• Care and handling of small diameter flexible
  endoscopes
• Competency validations

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MyEndoSite.com

• Your site for infection control and scope
  reprocessing news
• Q-Net newsletters
• News Headlines
• How to reprocess
• Guidelines and documents
• Product labels, manuals and information

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BE PROACTIVE

• Dont wait for disease transmission to occur
  before putting an effective quality assurance
  program in place.
• Speak up if correct practices are not followed.
• Patient care is everyones job

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Questions?

• Laura Strohmeyer, RN, CGRN
• LStrohmeyer_at_AmSurg.com
• 214-406-3623