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Patient 1
SERIAL NUMBER, MANUFACTURE DATE AND EXPIRY ARE NOT AVAILABLE PER THE CUSTOMER. INVESTIGATION: DURING FOLLOW-UP WITH THE AUTHOR OF THE JOURNAL ARTICLE, IT WAS DETERMINED THAT NO ADDITIONAL INFORMATION OR INDIVIDUAL PATIENT/DONOR INFORMATION WILL BE PROVIDED TO TERUMO BCT. THE AUTHOR DECLINED TO PROVIDE FURTHER DETAILS CONCERNING THESE EVENTS, AND THEREFORE, PER SECTION 4.16.2 OF THE MEDICAL DEVICE REPORTING FOR MANUFACTURERS: GUIDANCE FOR INDUSTRY AND DRUG ADMINISTRATION STATION DOCUMENT ISSUES JULY 9, 2013 ONE MDR WILL BE SUBMITTED FOR EACH IDENTIFIED DEVICE AND FAILURE MODE. PER THE AUTHOR OF THE ARTICLE TERUMO BCT DEVICES ARE NOT BEING SUSPECTED OF CONTRIBUTING TO THE BACTERIAL CONTAMINATION, PATIENT REACTIONS OR DEATHS. THE TERUMO BCT PRODUCTS WERE USED SOLELY AS A MEANS OF COLLECTING PRODUCT FOR THE STUDY. THE NHSBT IN ENGLAND INTRODUCED DIVERSION NATIONALLY IN 2003 AND IMPROVED ARM DISINFECTION IN 2007. IN 2011, NHSBT INTRODUCED SCREENING OF ALL PLATELET COMPONENTS FOR BACTERIA AS A FURTHER RISK REDUCTION MEASURE. THE ARTICLE REPRESENTS THE FIRST 4 YEARS AND 7 MONTHS (FEBRUARY 2011 TO SEPTEMBER 2015) OF THE SCREENING PROGRAM USING AN AUTOMATED MICROBIAL DETECTION SYSTEM. THE ARTICLE CONCLUDED THAT 'IMPLEMENTATION OF BACTERIAL SCREENING OF PLT COMPONENTS WITH THE NHSBT BACT/ ALERT PROTOCOL WAS AN EFFECTIVE RISK REDUCTION MEASURE AND INCREASED THE SAFETY OF THE BLOOD SUPPLY'. ALL SAMPLED PLT PRODUCTS MEET THE STUDY SPECIFICATION OF 2.4X10^11 OR GREATER AND THE WHITE BLOOD COUNT (WBC) IN EACH PRODUCT WAS BELOW 5X10^6. RESULTS PER THE ARTICLE: ACCORDING TO MCDONALD ET AL, FROM 'FEBRUARY 2011 TO SEPTEMBER 2015, A TOTAL OF 1,239,029 PLT COMPONENTS WERE SCREENED. INITIAL-REACTIVE, CONFIRMED-POSITIVE, AND FALSE-POSITIVE RATES WERE 0.37, 0.03, AND 0.19%, RESPECTIVELY. FALSE- NEGATIVE CULTURES, ALL WITH STAPHYLOCOCCUS AUREUS, OCCURRED ON FOUR OCCASIONS; THREE WERE VISUALLY DETECTED BEFORE TRANSFUSION AND ONE CONFIRMED TRANSMISSION RESULTED IN PATIENT MORBIDITY. THE NHSBT SCREENING PROTOCOL EFFECTIVELY REDUCED THE NUMBER OF CLINICALLY ADVERSE TRANSFUSION TRANSMISSIONS BY 90%IN THIS REPORTING PERIOD, COMPARED TO A SIMILAR TIME PERIOD BEFORE IMPLEMENTATION. DELAYED TESTING OF 4515 TIME- EXPIRED PLT UNITS AFTER SCREENING REVEALED NO POSITIVES. PRIOR TO INOCULATION, THE PROTOCOL AT THE CUSTOMER SITE WAS, WHILE THE OPERATOR WORE NON-STERILE GLOVES, TO WIPE THE SEPTUM OF THE BOTTLE WITH AN ALCOHOL WIPE. THE COMPONENTS WERE HELD FOR36-48 HOURS POST COLLECTION, A 16ML SAMPLE WAS TAKEN FROM THE SAMPLING POUCH THAT WAS ATTACHED USING THE TSCD II DEVICE. ALL UNITS WERE TREATED THE SAME APART FROM PEDIATRIC UNITS WHICH WERE POOLED TOGETHER. ALL NEGATIVE RESULTS WERE ADDED THE NHSBT COMPUTER SYSTEM. POSITIVE INITIAL REACTIVE RESULTS FROM THE BACT/ALERT SYSTEM RESULTED IN A HOLD OR RECALL OF THE PRODUCT. ADDITIONAL INVESTIGATION WAS MADE ON THE UNITS THAT WERE ALREADY UNDERTAKEN AT A FACILITY. IT WAS DETERMINED THAT THE SOURCE OF THE CONTAMINATION BASED ON THE SPECIES DISTRIBUTION, WAS SKIN FLORA. PER THE ARTICLE, "AT THE BEGINNING OF THE SCREENING PROCESS, THE PLT PRODUCTS WERE MANUFACTURED AT A RATIO OF 80% APHERESIS TO 20% OF POOLED UNITS (BUFFY COAT DERIVED FROM FOUR DONATIONS), MOVING TO 60% APHERESIS AND 40% POOLED UNITS IN 2015. INITIALLY, ALL PLT PRODUCTS WERE SUSPENDED IN 100% PLASMA, BUT FROM FEBRUARY 2015, THE USE OF PLT ADDITIVE SOLUTION (PAS; SSP1, MACOPHARMA) FOR POOLED UNITS WAS PHASED IN AND ALL MANUFACTURING CENTERS PRODUCED POOLED PLTS SUSPENDED IN 65%:35% (PAS:PLASMA) AS OF JULY 2015. ALL REPORTED MOTHER BAGS WERE SPLIT INTO THERAPEUTIC DOSES AT 3 TO 4 HOURS POST COLLECTION. BUFFY COAT?POOLED PLTS WERE PREPARED FROM FOUR DONATIONS.""AMONG CONFIRMED POSITIVE POOLED PLT COMPONENTS IN WHICH ALL COMPONENTS (INCLUDING ASSOCIATED RBC UNITS) WERE RETURNED FOR TESTING, 58.2% WERE POSITIVE IN THE INDEX UNIT ALONE AND 33.7% IN BOTH INDEX AND RBC UNITS. IN ALL CASES, BACTERIA WERE DETECTED IN ONLY ONE OF THE FOUR RBC UNITS UNDER TEST. FOR POOLED PLT COMPONENTS WHERE THE INDEX PLT UNIT WAS NOT AVAILABLE FOR TESTING, 78 (40.2%) INCIDENTS OF BACTERIAL CONTAMINATION WERE CONFIRMED BY TESTING OF THE RBC UNITS ALONE."THE DEVICE SERIAL NUMBERS WERE NOT PROVIDED; THEREFORE, ONE YEAR OF SERVICE HISTORY COULD NOTBE REVIEWED. ALL DEVICES MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. BASED ON THE BACTERIAL IDENTIFICATION RESULTS OF THE CONTAMINATED UNITS (74.7% SKIN FLORA, 16.4%OROPHARYNGEAL FLORA, AND 8.9% GUT AND OTHER FLORA), AS WELL AS REVIEW OF THE SPECIES, POSSIBLE SOURCES OF CONTAMINATION INCLUDE INADEQUATE DONOR ARM DISINFECTION PRIOR TO VENIPUNCTURE, POOR MANUFACTURING LABORATORY HYGIENE STANDARDS, INCREASED TIME REQUIREMENTS FOR APHERESIS DONATIONS, THE COMMON PRACTICE OF APHERESIS DONORS CONSUMING SNACKS DURING A COLLECTION, AND UNDERLYING PATHOLOGIES IN ASYMPTOMATIC DONORS. INVESTIGATION IS IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED. CITATION:CARL MCDONALD, JENNIFER ALLEN, SUSAN BRAILSFORD, ANJANA ROY, JOANNE BALL...