1. Duodenal Scope Culturing Ann Hayes RN BSN, CGRN Gastroenterology Interventional and Diagnostic Center Veterans Affairs Medical Center San Francisco, CA

2. Culturing Endoscopes A most difficult and controversial area

3. FDA Monitors Medical Device Reports From January 2013 through December 2014 Received 75 MDR encompassing 135 patient Related to infections transmission with duodenal scopes: Olympus, Pentax and Fujifilm Possible all infections not reported to FDA

4. Outbreaks involve CRE CRE = carbapenem-resistant Enterobacteriaceae - Group of bacteria that have grown to be multidrug resistant organisms (MDRO) - carbapenamase producers - Can be detected by a lab test of stool

5. Known CRE These bacteria have mutated to MDROs - Klebsiella - E coli Other CRE out side the U.S.

6. On the Edge of 2 epidemics First by E coli; community acquired Second by Klebsiella pneumonia CRE was rare before 2000 Mortality from invasive CRE infection reaches 40%

7. Investigations Found No breaches in scope reprocessing identified Yet contaminated duodenal scopes were found Disinfections protocol for duodenal scopes inadequate and have been revised

8. Other Findings One center sent duodenal scope back to manufacturer 4 required critical repairs despite lack of malfunction 3 of these scopes had cultured positive for E coli Should duodenal scope be sent for inspections on a routine bases?

9. ERCP Important life saving procedure 500,000 performed annually Possible infection risk; yet the benefits of ERCP outweigh the risk, if reprocessing guidelines followed

10. Countries that culture scope Australia (1995), New Zealand, Germany, Canada, French and Asia ESGE and ESGENA have published guidelines on scope culturing As of this date: No recommendations from professional societies in USA

11. Centers for Disease Control and Prevention (CDC) Publications Duodenal scope surveillance Duodenal scope sampling method Duodenal scope culture method All on CDC web site

12. San Francisco VA GIDC Decided to do duodenal scope culturing Lessons learned

13. Need a team approach Do not go alone: hospital committee – GI nurse and tech; knows area and equipment – Infection control: knowledge and influence – Sterile processing – Laboratory: makes up culturing kit and does the test

14. CDC guidelines Caused more questions then solutions – only be culturing duodenal scopes? – when to culture: from AER or closet? – why cleaning scope with alcohol pad? – will we not look for other organisms? – why place scope on a sterile field ? – what brush to use to get sample?

15. Answering questions Only be culturing duodenal scopes? – Will start with only duodenal scope – What about EUS scope that has elevator?

16. When to culture: from AER or closet? Australia recommends culture after 12 days of scope hanging Olympus recommends culture immediately after reprocessing – Evaluates efficacy of reprocessing and removal of bioburden

17. Why cleaning scope with alcohol pad? CDC recommends “sanitize scope with alcohol wipe” - We omitted alcohol wipe – We will be taking scope straight from AER and doing culture

18. Why place scope on the sterile field ? We decided to take scope from AER and Aid holds scope, culture is complete – Takes less than 2 -3 minutes – Eliminated need for more equipment and preparation time such as sterile field

19. CDC suggests sterile gowns No other guidelines recommends sterile gowns – Not Australia ( 20 years of experience) – Not ESGE or ESGENA – We chose not to use sterile gowns

20. Will we look for other organisms? CRE is not present in hospital at this time Lab will look for any organism – Culturing is validating cleaning process

21. What brush to use to get sample? CDC recommends brush similar to Olympus – MH-507

22. Problem with brush Want brush to be sterile Olympus brush : green handle shows it is autoclavable But first sterilization process flatten brush bristles Need tip protector to prevent bristle flattening

23. Other problem with brush Tip prevents good sample: 5 mm long tip prevents good access

24. Finding a brush No company makes sterile brush for culturing Most brushes bristles too small in diameter or have tip which prevent good access Decided to try cleaning brush – Would it hold up to autoclave?

25. Cleaning Brush Could it be autoclaved?

26. Autoclaving a brush Yes, but not without a bristle protector

27. Brush ready for Autoclaving

28. Need to Validate If you invent a sterile brush you need to prove it is sterile After brush is sterilized sent two to lab for culture

29. Finish Product Sterile brush ready to culture

30. Our Lab is the greatest Makes these kits for us: sterile water & PBST

31. Equipment needed Face mask, gown, hair cover and sterile gloves Lab kit, sterile channel brush, sterile bowel, sterile 60 cc syringe and small sterile field. Make lab slip and specimen labels

33. Next steps Take specimen to the lab Clean scope and remove from service until lab result: 48 hours This step depend on how many scopes available

34. Ideas for Change Most guidelines including CDC: – Pre-moisten culture brush then insert into upper elevator channel, rotate several times, then repeat with elevator up into lower elevator and then lens – My questions: same brush for 3 separate area?

35. What if culture positive? If it is the brush, which area was not cleaned? – Upper elevator, lower elevator or lens? Suggest each of the three have separate brush for culture

36. Three brushes: one wash

37. Ultrasound Scopes These have much smaller elevators Cannot use same brush

38. Ideas to make it easier Make copies of lab slips; then add serial number at the time of culture

39. Labels for culture bottles Make ahead and add scope serial number

40. Joint Commission JC arrived while doing scope culture = OMG Explained the process and showed SOP Sited for “best practiced” and requested to write up for publication in The Joint Commission Journal on Quality and Patient Safety