Description of Event or Problem · 0
ON (B)(6) 2023: THE OBSERVATION WAS BROUGHT TO MY ATTENTION, BY (B)(4), THAT THE HARDY VAL SURFACE SAMPLING MEDIA PLATES (CATALOG # P34) WITH THE LOT# 608163 EXPIRATION: 10/31/2023) SENT VIA UPS OVERNIGHT IN COOLER WAS DELIVERED, BUT THE SAMPLING PLATES LOOKED "DIRTY". UPON ASKING FOR ELABORATION FROM THE LAB TECHNICIAN, SHE STATED THAT IT LOOKED AS IF THE PLATES HAD WATER POURED ON THEM. SHE STATED THAT OVER THE LAST 6 MONTHS, THE MEDIA PLATES FROM HARDY VAL DIAGNOSTIC HAD SHOWN INCREASED CONDENSATION IN THEIR PACKAGING, AND WHEN SHE CALLED TO QUESTION IT, HARDY VAL TOLD HER IT SHOULD NOT BE A PROBLEM SINCE THE PLATES ARE MADE UNDER STERILE CONDITIONS. THE LAB TECHNICIAN, WHO IS IN (B)(6), AND I, WHO LIVES IN (B)(6), DISCUSSED THE CHANGES WE NOTICED IN THE PRODUCT OVER THE LAST FEW MONTHS. FROM WHAT SHE CAN DISCERN, THE PLATES SWEAT AND EVEN THOUGH, THEY ARE PACKAGED, THE CONDENSATION POURS INTO TOP PLATES, DRIPPING DOWN INTO THE LOWER PLATES. THE PACKAGING HAS ALSO BECOME MUCH FLIMSIER. THE CONDENSATION IS MUCH GREATER IN THE PACKAGING EVEN AS IT ARRIVES VIA FEDEX OR UPS, DEPENDING ON WHO DELIVERS TO THE FACILITY. MY CONCERN IS THAT WITH NEW USP 797 GUIDELINES GOING INTO EFFECT ON NOVEMBER 1, 2023, ANY LAPSE IN QUALITY OF STERILE MEDIA IS A FAILURE OF THE INDUSTRY AS WELL AS A BREACH OF TRUST BETWEEN MANUFACTURERS AND HOSPITALS THAT ARE REQUIRED TO TEST SO [INVALID]NTLY. UNTIL 6 MONTHS AGO, IT WAS RARE TO HAVE ANY GROWTH ON A MONTHLY SURFACE SAMPLE SINCE CLEANING MEASURES ARE ENFORCED SO STRICTLY. HOWEVER, UPON FURTHER DISCUSSION WITH THE (B)(4) ANALYTICAL LAB TECHNICIAN, SHE STATED SHE HAD NOTICED AN INCREASE IN GROWTH FROM ALL FACILITIES ACROSS THE COUNTRY THAT THEY INCUBATE AND READ MEDIA. THIS IS CAUSE FOR CONCERN AS THE INDUSTRY IS CONTINUING TO INCREASE FREQUENCY OF TESTING, AS WELL AS TYPES OF TESTING, IE. MONTHLY SURFACE SAMPLING. HARDY VAL IS A LEADER IN THE MEDICAL INDUSTRY FOR SUPPLYING STERILE MEDIA, BUT TO SEE A DECREASE IN QUALITY, AND NOW, POSSIBLY QUESTIONABLE CONTAMINATION FROM THE MEDIA MANUFACTURING LOCATION GIVES EXTREME CAUSE FOR CONCERN. MANUFACTURE DATE: 8/2/2023. OUR FACILITY IS CONCERNED THAT IF MULTIPLE NATIONAL FACILITIES ARE HAVING GROWTH, EVEN IF IT'S BELOW THRESHOLD, IS IT TRULY GROWTH FROM THE FACILITIES OR ARE THE PLATES ALREADY CONTAMINATED? HAS THE MANUFACTURER PRODUCED A PRODUCT WITH DECREASED QUALITY TO KEEP UP WITH DEMAND? IS THE HUMAN ELEMENT, IN THE ATTEMPT TO FILL INCREASED ORDER VOLUME, STAYING STERILE DURING MANUFACTURING?