Description of Event or Problem · 0
PB980 VENTILATOR COMPONENT, EXHALATION FLOW SENSOR (EVQ) HAD PREVIOUS RECOMMENDATIONS FOR HIGH LEVEL DISINFECTION. ON (B)(6) 2017 WE RECEIVED A LETTER THAT MEDTRONIC RECEIVED 510K FOOD & DRUG ADMINISTRATION CLEARANCE WHICH REMOVED THE REQUIREMENT TO CLEAN THIS COMPONENT BETWEEN PATIENT USE (K162738). DURING AN INVESTIGATION INTO A BURKHOLDERIA CEPACIA OUTBREAK WE STARTED LOOKING AT OUR VENTILATOR CLEANING PROCESS WHICH INCLUDED THIS COMPONENT. THE NEW MANUAL WAS NOT UPDATED ON THE MANUFACTURERS SITE WHICH PROMPTED A CONVERSATION WITH THE COMPANY TO ENSURE WE WERE FOLLOWING THE HLD REQUIREMENT (WHICH WE WEREN'T). THEY PROVIDED US WITH THE 501K LETTER, BUT I WAS STILL CONCERNED WITH THE POTENTIAL FOR CROSS CONTAMINATION SINCE OUR STAFF WERE CLEANING THIS PIECE WITH A LOW-LEVEL DISINFECTANT. THE COMPANY TOLD ME THAT BECAUSE THE N100 FILTER PRECEDES THIS COMPONENT IT SHOULD CAPTURE ANY BACTERIA OR VIRUSES THAT COME FROM THE PATIENT. I WASN'T SURE THIS WAS THE CASE AND CULTURED THE COMPONENT DIRECTLY FROM A PATIENT ON FILTER DAY 13. THE COMPONENT I CULTURED GENOTYPICALLY MATCHED THE PATIENTS' BACTERIA. I HAVE CONCERNS THAT THE FILTER MAY NOT BE PROVIDING ADEQUATE PROTECTION OF THE VENTILATOR COMPONENT AND SUBSEQUENTLY CAN CAUSE CROSS CONTAMINATION/TRANSMISSION TO OTHER PATIENTS. THE SAMPLES WERE INOCULATED TO BLOOD/CHOCOLATE/MACCONKEY AGARS AND ENRICHED THIOGLYCOLATE BROTH. THE MEDIA WAS INCUBATED FOR 6 DAYS AT 35° - 37°C IN CO2 ATMOSPHERE. THE ISOLATE GREW OUT OF THE THIO ONLY.