Duodenoscope Culture Methods Update

Transcription

1 Duodenoscope Culture Methods Update Angela Coulliette-Salmond, Ph.D. Division of Healthcare Quality and Promotion, Clinical and Environmental Microbiology Branch HICPAC, Session on Medical Device Reprocessing July 16, 2015 National Center for Emerging and Zoonotic Infectious Diseases U.S. Centers for Disease Control and Prevention

2 CEMB Organization Matt Arduino, DrPH Branch chief Brandi Limbago, PhD Deputy Branch Chief Lee Lam, PMO Sigrid McAllister, Quality Manager Advanced Molecular Detection Judith Noble-Wang, PhD Lead, Environmental & Applied Microbiology J. Kamile Rasheed, PhD Lead, Antimicrobial Resistance & Characterization Laboratory Biofilm laboratory Reference laboratory Outbreak support Gram-negative surveillance Healthcare Environment research Gram-positive surveillance

3 Environmental and Applied Microbiology Laboratory

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5 Timeline N M J M J 2015 F

6 CEMB Duodenoscope Activities Protocol development IL and WA outbreak response Literature review, SME feedback Stakeholder engagement Discussions with facilities, societies, federal agencies Feedback to CDC INFO Amended protocols, developed Frequently Asked Questions (FAQs)

7 Protocol development IL Outbreak Response 39 case patients: NDM-producing E. coli Initial protocols used to extract bacteria from duodenoscope Devices were sent to the CDC CEMB laboratory More rigorous methods: broth, brushes, sonication Recovered from duodenoscope: KPC+ K. pneumonia, NDM-producing E. coli Epstein et al. 2015, JAMA, 312(14):1447

8 Protocol development WA outbreak response 32 case patient and 4 of 8 duodenoscopes: multidrug resistant E. coli (hyper ampc) EIS Officers deployed, targeted protocol refined for facilities in mind Methods: targeted individual samples, PBST, sterile water, swab/brush combination, samples shipped to the CDC CEMB laboratory Study, only detected gram-positive bacteria Ross et al. 2015, Gasto Endoscopy, Article in Press

9 Protocol Development Historic Literature 1970 Flushing channels with sterile saline or water to culture was common practice Bond and Moncada (1978) used swab to sample the distal end and other endoscope surfaces 1980 First published validated procedure for sampling endoscopes was published, used flush and swab samples (Hanson et al. 1989, 1990) 1990 Alfa et al. (1991) utilized the Hanson et al. model for sampling duodenoscopes to assess drying Approach was adjusted to passing a brush up/down the channels and sterile water flush (Alfa et al. 1999)

10 Protocol Development Literature Review Sampling location Channel (20 studies), elevator guide wire (3 studies), distal end (3 studies) Sampling technique Flush (16 studies) Brush (8 studies) or swab (2 studies) Combined (2 studies) Sampling media sterile/ro/di water (9 studies) and saline (7 studies)

11 Protocol Development Literature Review Concentration of samples to detect low numbers, centrifugation (3 studies) or membrane filtration (2 studies) Plating/ Culture media Blood (16 studies), MacConkey (9 studies) Counted (CFU) (15 studies) or presence (pos/neg)(4 studies) Common bacteria detected Majority: Pseudomonas (14 studies), Staphylococcus (15 studies) Klebsiella, Acinetobacter (7 studies)

12 I. Sampling Protocol Development Current Status II. Culturing - Agitated, concentrated - Cultured - Focused on high-concern organisms III. Algorithm - Interpretation/Remedial Actions - Criterion for low-concern, action level >10 CFU per scope - Criterion for high-concern, 0 CFU

13 EIN Duodenoscope Survey March 30 to April 22, /699 physicians responded (Infection Control, SHEA members) 31% - no cultures, surveillance cultures, clinical cultures Number of respondents Culture method 17 Interim CDC Recommendations (March 2015) 4 Other methods: (a) Flush-Brush-Flush (Aumeran C, et al. Endoscopy 2010, 42(11):895-9); (b) Clinical Micro Procedures Handbook by HD Isenberg; (c) modified Australian procedure 2 Virginia Mason Protocol 26 Flushed fluid down the channels and cultured fluid 6 Various methods from brushing, swabbing elevator, to flushing channels

14 Stakeholder Engagement Regulator/ Standards FDA, CMS, AAMI Healthcare Patients, MD s, Nurses Device ERCP Manufacturer s Olympus, FUJI, Pentax Agencies/Societies ASGE, SGNA, AGA, APIC, ASM CDC DHQP, CEMB lab Reprocessing Nurses, Technicians, Infection Control Clinical laboratories

15 Stakeholder Engagement Regulator/ Standards FDA, CMS, AAMI Healthcare Patients, MD s, Nurses CDC INFO, Device FAQs ERCP Manufacturer s Olympus, FUJI, Pentax Agencies/Societies ASGE, SGNA, AGA, APIC, ASM Update protocols CDC DHQP, CEMB lab Reprocessing Nurses, Technicians, Infection Control Clinical laboratories

16 Stakeholder Engagement Regulator/ Standards FDA, CMS, AAMI Healthcare Patients, MD s, Nurses Agencies/Societies ASGE, SGNA, AGA, APIC, ASM Device ERCP Duodenoscope surveillance experience and pilot study interests CDC DHQP, CEMB lab Manufacturer s Olympus, FUJI, Pentax Reprocessing Nurses, Technicians, Infection Control Clinical laboratories

17 Stakeholder Engagement Regulator/ Standards FDA, CMS, AAMI Healthcare Patients, MD s, Nurses ID and assist Agencies/Societies facilities with ASGE, handling SGNA, AGA, transmission APIC, ASM clusters Device ERCP CDC DHQP, CEMB lab Manufacturer s Olympus, FUJI, Pentax Reprocessing Nurses, Technicians, Infection Control Clinical laboratories

18 Stakeholder Engagement Healthcare Patients, MD s, Nurses Agencies/Societies ASGE, SGNA, AGA, APIC, ASM Regulator/ Standards FDA, CMS, AAMI Device ERCP CDC DHQP, CEMB lab Provide Manufacturer s environmental Olympus, laboratory FUJI, assistance Pentax Reprocessing Nurses, Technicians, Infection Control Clinical laboratories

19 Coming Soon Amended protocols, developed FAQs

20 Moving Forward FDA (March 2015), recommendations for the formulations and scientific validation of reprocessing instructions for reusable medical devices Quality control issues Limitations validation, unknown baseline, cost, notification FDA-led duodenoscope working group FDA, March 2015: Olympus, March 2015:

21 For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA Telephone, CDC-INFO ( )/TTY: Web: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

22 References 1. Moses, F.M. and J. Lee Am J Gastroenterol. 98(1): Chiu et al Hepato-Gastroenterol. 57: Bordas et al Hepato-Gastroenterol. 52: Brock et al Gastrointest Endosc. In Press Chiu et al BMC Gasterenterol. 12: Ingram et al Gastroenterol Nurs. 36(2): Pang et al Gastrointest Endosc. 56(3): Vergis et al Endoscopy. 39: Alfa M.J. and D.L. Sitter J Hosp Infect. 19: Alfa et al Infect Cont Hosp Ep. 23(4): Alfa et al Am J Infect Control. 40: Grandval et al J Hosp Infect. 84: Osborne et al Endosc. 39: Kim et al Clin Endosc. 44: Bisset et al Am J Infect Control. 34: Deva et al J Hosp Infect. 39: Alfa et al Am J Infect Control. 42:e1-e5. 18.Riley et al Gastroenterol Nurs. 25(3): Gillespie et al J Gasteroenterol Hepato. 23: Hanson et al Gut. 31: Alfa et al Am J Infect Control. 40: Queensland Health,