Description of Event or Problem · 1
THE FOLLOWING IS THE CONTENT OF THE SUMMARY WE HAVE SUBMITTED TO VAPOTHERM, INC., OF OUR INVESTIGATION OF RALSTONIA MANNITOLILYTICA INFECTION AND CONTAMINATION ASSOCIATED WITH THE VAPOTHERM 2000I DEVICE AT THE (B)(6) MEDICAL CENTER. THE EVENT BEGAN WITH A REFRACTORY BLOODSTREAM INFECTION IN A (B)(6) FEMALE PREMATURE NEONATE, IN (B)(6) 2011. (B)(6) MEDICAL CENTER COMPRISES 2 HOSPITALS, A LARGE TERTIARY CARE FACILITY AT (B)(6) AND A SMALLER ONE AT (B)(6). BOTH HOSPITALS HAVE PREMATURE CARE UNITS, THOUGH THE MAIN UNIT AND DEPARTMENT ARE LOCATED AT (B)(6). THE INDEX PT WAS LOCATED AT (B)(6). REPORT OF THE INVESTIGATION FOLLOWING A CASE OF RALSTONIA MANNITOLILYTICA BLOODSTREAM INFECTION IN A PREMATURE BABY. THIS INVESTIGATION WAS UNDERTAKEN AFTER RALSTONIA MANNITOLILYTICA WAS ISOLATED FROM REPEATED BLOOD CULTURES FROM A PREMATURE INFANT, WHO HAD BEEN TREATED WITH A VAPOTHERM 2000I UNIT, DURING (B)(6) 2011 AND IN VIEW OF THE OUTBREAK OF THIS ORGANISM EXPERIENCED IN THE (B)(6) IN 2005. AS A RESULT OF THAT OUTBREAK, THE VAPOTHERM 2000 WAS RECALLED IN JANUARY 2006 AND REINTRODUCED IN EARLY 2007 AFTER REVISION OF THE DISINFECTION PROTOCOL AND INTRODUCTION OF STERILIZED VAPOR TRANSFER CARTRIDGES. ON IDENTIFICATION OF THE ORGANISM AT OUR INSTITUTION, THE VAPOTHERM 2000I UNITS WERE REMOVED FROM SERVICE. CULTURES: CULTURES WERE TAKEN FROM THE NARES AND ORAL CAVITY OF THE 15 PREMATURE INFANTS IN THE PREMATURE UNIT AT (B)(6) HOSP AT THE TIME, FROM THE VAPOTHERM DELIVERY TUBE IN USE ON THE INDEX CASE, FROM ALL SIX CARTRIDGES IN USE AT THE TIME (4 FROM (B)(6) HOSP, 2 FROM (B)(6)) AND FROM ONE UNOPENED CARTRIDGE. THE CULTURE METHODS WERE BASED ON THOSE USED BY THE (B)(6) IN THE PREVIOUS INVESTIGATION. BRIEFLY FLUSHING ASEPTICALLY WITH 45 ML VOLUMES; FILTRATION OF THE FLUSHED FLUID THROUGH STERILE 0.45 MICROMETER PORE-SIZE MILLIPORE MEMBRANES. IN OUR STUDY, STERILE WATER WAS USED FOR FLUSHING THE CARTRIDGES AND THE GAS LINE OF THE DELIVERY TUBE. FOR THE WATER-JACKET OF THE DELIVERY TUBE, THE ENTIRE RETAINED VOLUME OF WATER WAS FILTERED. MEMBRANES WERE ASEPTICALLY PLACED ON TRYPTIC SOY AGAR FOR INCUBATION. THE STERILE WATER USED FOR FLUSHING WAS CHECKED FOR STERILITY. EXTERNAL SURFACES OF THE VAPOTHERM 2000I UNITS WERE NOT SAMPLED. AS REPORTED TO VAPOTHERM PREVIOUSLY, R. MANNITOLILYTICA WAS ISOLATED FROM THE NARES OR ORAL CAVITY OF 2 PTS, INCLUDING THE INDEX CASE AND ONE ASYMPTOMATIC CHILD WHO HAD ALSO RECEIVED VAPOTHERM THERAPY, FROM 5 OF THE 6 USED CARTRIDGES AND FROM THE DELIVERY TUBE. THE STERILE SUPPLY WATER MANUFACTURED BY THE (B)(4) WAS SAMPLED ON TWO SEPARATE OCCASIONS AND CULTURES WERE NEGATIVE. INVESTIGATION OF THE CLEANING PROCEDURE FOR THE VAPOTHERM 2000I EQUIPMENT: REPROCESSING OF THE VAPOR TRANSFER CARTRIDGE AND WATER CIRCUIT WAS CARRIED OUT ACCORDING TO THE INSTRUCTIONS RECEIVED IN (B)(6) FROM (B)(4) USING THE CK-101 CLEANING KIT, WHICH WAS SUPPLIED WITH CONTROL III DISINFECTANT (A MIXTURE OF QACS). THE PROCEDURE INCLUDED DECONTAMINATION OF THE CARTRIDGES USING THIS DISINFECTANT. CARTRIDGES SUPPLIED TO (B)(6) MEDICAL CENTERS WERE NOT MARKED AS PRE-STERILIZED OR FOR SINGLE-USE. CHARACTERIZATION OF THE RALSTONIA MANNITOLILYTICA ISOLATES: ALL NINE ISOLATES RECOVERED DURING THE INVESTIGATION WERE SUBMITTED TO THE MOLECULAR BIOLOGY LABORATORY OF THE (B)(6) MINISTRY OF HEALTH IN (B)(6). PULSED FIELD GEL ELECTROPHORESIS (PFGE) WAS PERFORMED AFTER DIGESTION WITH SPE1, ACCORDING TO A PROTOCOL COMPATIBLE WITH PULSENET, WHICH ALLOWS COMPARISON OF RESULTS BETWEEN LABORATORIES. ALL THE ISOLATES FROM BOTH HOSPITALS PROVED TO BE INDISTINGUISHABLE BY PFGE. IN VIEW OF THE PREVIOUS EXPERIENCE IN THE (B)(6), DR (B)(6) OF THE (B)(6) IN (B)(6) WAS CONTACTED WITH A VIEW TO CONDUCTING A COMPARISON OF OUR STRAINS' PULSOTYPES WITH THOSE OF THE UNITED STATES OUTBREAK, WHICH WERE PUBLISHED IN PEDIATRIC IN 2007. THE COMPARISON WAS CONDUCTED COLLABORATIVELY BY DR (B)(6) AT THE (B)(6) MINISTRY OF HEALTH IN (B)(6) AND DR (B)(6) AT THE (B)(6). IT WAS FOUND THAT THE (B)(6) ISOLATES AND THE OUTBREAK-ASSOCIATED ISOLATES FROM THE USA WERE INDISTINGUISHABLE. ASSESSMENT: THE CONCLUSION TO BE DERIVED FROM THESE FINDINGS IS THAT THE ISOLATES OF RALSTONIA MANNITOLILYTICA RECOVERED FROM THE DEVICES IN USE AT (B)(6) HOSPITAL AND DURING THE OUTBREAK IN 2005 IN THE UNTIED STATES SHARED A COMMON SOURCE. IT CAN BE NOTED FROM APPENDIX 3 THAT THE VAPOR TRANSFER CARTRIDGES EXAMINED INCLUDED LOTS THAT WERE MFG IN 2005 (CONTEMPORANEOUSLY WITH THE US OUTBREAK), IN 2009 AND IN 2010. THERE IS NO WAY TO DETERMINE WHETHER ANY OF THESE LOTS CONSTITUTED THE SOURCE OF THE CONTAMINATION BY RALSTONIA MANNITOLILYTICA OR WHETHER THE CONTAMINATION ORIGINATED EARLIER IN CARTRIDGES OF A DIFFERENT LOT -OR LOTS- OR EVEN FROM DIFFERENT ITEMS OF EQUIPMENT. IT IS POSSIBLE THAT LOCAL LAPSES IN PROCEDURE AND CLEANING TECHNIQUE MAY HAVE CONTRIBUTED TO THE FAILURE TO INTERRUPT THIS CONTAMINATION, BUT IT IS CLEARLY EVIDENT THAT THE PRINCIPLES OF THE CLEANING PROCEDURE PROVIDED TO (B)(6) HAD BEEN UNEQUIVOCALLY FOUND WANTING DURING THE US OUTBREAK. THIS INVESTIGATION WAS CONDUCTED BY STAFF OF THE DEPT OF CLINICAL MICROBIOLOGY AND INFECTIOUS DISEASE (INCLUDING THE INFECTION CONTROL SERVICE AND THE CLINICAL MICROBIOLOGY UNIT), THE STAFF OF THE PREMATURE UNIT IN THE DEPT OF NEONATOLOGY AT (B)(6) HOSP AT (B)(6) AND THE RESPIRATORY THERAPY SVC IN THE DIV OF ANESTHESIOLOGY, WITH SUPPORT FROM THE (B)(6) MINISTRY OF HEALTH AND THE CENTERS FOR DISEASE CONTROL AND PREVENTION, (B)(6).