DURING THE SUMMER 3 CASES OF ENDOCARDITIC WERE FOUND IN (B)(6). THE CAUSATIVE AGENTS WERE STAPHYLOCOCCUS AND STREPTOCOCCUS. THE HOSPITAL TRIED TO FIND OUT THE CAUSE OF THESE AGENTS. AS A CONTROL THEY DID A SCRAPING FROM THE LI-7 BEFORE USING IT IN THE IMPLANTATION PROCEDURE. THEY ALSO ASSESSED A PROLONGED CULTIVATION. AFTER THE IMPLANTATION THE LI-7 WAS THROWN AWAY. THE RESULT OF THE SCRAPING WAS NEGATIVE; THE RESULT OF THE PROLONGED CULTIVATION WAS POSITIVE ON BACTERIA ESCHERICHIA COLI. HOSPITAL LAB REPORT: DAY 1 - MATERIAL WAS INOCULATED AND PLACED INTO MULTIPLICATION BROTH. DAY 2 - PRIMARY CULTURE NEGATIVE; INCUBATED ANOTHER 24 HOURS THEN THE BROTH WAS INOCULATED TO SOLID MEDIA. DAY 3 - PRIMARY CULTURE EVALUATED AS NEGATIVE; "MEIDAM" WAS ISOLATED TO A :"BIOCHEMISTRY WEDGE". DAY 4 - GROWTH ON WEDGE WAS PRELIMINARILY EVALUATED AS E. COLI. SENSITIVITY WAS STARTED. DAY 6 - THE STRAIN WAS FINALLY DETERMINED AS E. COLI, AND SENSITIVITY WAS REPEATED.
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Patient 1
EVALUATION METHOD: RECORD REVIEW. CONCLUSIONS: BACKGROUND: AS PART OF THE HOSPITAL'S INVESTIGATION INTO 3 CASES OF ENDOCARDITIS (UNRELATED TO THIS DEVICE), THE HOSPITAL BEGAN A SURVEY OF VARIOUS PRODUCTS USED IN THE FACILITY. THE SUBJECT DEVICE WAS SAMPLED PRIOR TO USE ON THE PT (TEST METHOD UNK) AND TESTED FOR GROWTH. INITIAL RESULTS WERE NEGATIVE, BUT PROLONGED CULTIVATION TESTED POSITIVE FOR E. COLI. THE PT ON WHICH THE DEVICE WAS SUBSEQUENTLY USED DID NOT EXHIBIT ANY INFECTIONS OR ADVERSE HEALTH IMPACT. INVESTIGATION: THE MANUFACTURING RECORDS REVEALED NO ABNORMALITIES DURING MANUFACTURING OR STERILIZATION. AS A NON-SPOREFORMER, E. COLI HAS MUCH LESS RESISTANCE/THEREFORE EASIER TO KILL THAN THE STERILIZATION PROCESS CHALLENGE DEVICE AND WOULD NOT BE EXPECTED TO SURVIVE THE VALIDATED EO STERILIZATION CYCLE. THERE WAS NO PT INJURY ASSOCIATED WITH THE GALT DEVICE. CONCLUSIONS: THE MANUFACTURING PROCESS INVESTIGATION AND SUBSEQUENT USER DISCUSSIONS LED TO THE CONCLUSION THAT THE RECOVERY OF E. COLI WAS DUE TO CLINICAL LABORATORY CONTAMINATION AS MICROBIAL GROWTH WAS ONLY FOUND AFTER EXTENDED INCUBATION OF THE SWAB USED TO TEST THE LI-7.