BATTELLE DECONTAMINATION FOR N95 MASKS EUGENE OREGON

Description of Event or Problem

(B)(4). HI (B)(6), MY EMPLOYER IS UTILIZING THE BATTELLE DECONTAMINATION SYSTEM IN (B)(4) FOR THE N95 MASKS THAT I WEAR ON A DAILY BASIS TO PROVIDE PATIENT TREATMENT AS A DENTAL HYGIENIST IN (B)(6). RECENTLY, I COMMENTED TO THE PRACTICE MANAGER, (B)(6), THAT A LARGE NUMBER OF N95 MASKS WERE DISCARDED IN THE DECEMBER 2020 SHIPMENT OF USED MASKS SENT FOR DECONTAMINATION TO THE BATTELLE DECONTAMINATION UNIT IN (B)(4). FOR YOUR REFERENCE; PROCESS CODE: (B)(6) AND BOX CODE: (B)(6). MY EMPLOYER THEN REPLIED TO ME WITH AN EMAIL RESPONSE ON JANUARY 21, 2021 WHICH INCLUDED A FORWARD OF THE INFORMATION YOU HAD PROVIDED TO OFFICES UTILIZING THE BATTELLE DECONTAMINATION UNIT REGARDING A HIGH DISCARD RATE DUE TO RECEIPT OF A HIGH NUMBER OF N95 MASKS WITH CONTAMINANTS AND IN PARTICULAR FACIAL COSMETICS AT THE (B)(4) BATTELLE DECONTAMINATION SYSTEM SITE. I AM CONTACTING YOU AS I AM CONCERNED I HAVE RECEIVED N95 MASKS SENT TO YOU, DECONTAMINATED AND RETURNED WITH WHAT MAY BE RESIDUAL COSMETIC CONTAMINATION. SINCE THIS IS THE FIRST TIME, I HAVE BEEN A PARTICIPANT IN RECEIVING DECONTAMINATED N95 MASKS, AT FIRST GLANCE I ASSUMED IT WAS RELATED TO THE IDENTIFICATION INK FADING IN THE BATTELLE DECONTAMINATION PROCESS? THEN, UPON RECEIVING YOUR FORWARDED BATTELLE EMAIL FROM MY EMPLOYER ABOUT THE RECENT HIGH RATE OF COSMETIC CONTAMINATION THAT RESULTED IN MANY N95 MASKS BEING DISCARDED, I AM CONCERNED I HAVE RECEIVED MASKS THAT WERE RETURNED WITH COSMETIC CONTAMINATION? EVEN MORE CONCERNING, IS THAT ASIDE FROM CONTINUED DAILY MORNING APPLICATION OF FACIAL SEBA MED MOISTURIZING CREAM FOR SENSITIVE SKIN, I DO NOT USE OR WEAR ANY FACIAL COSMETICS. NONE. YOU MAY UNDERSTAND HOW IT IS THAT I AM DEEPLY CONCERNED WITH WHAT APPEARS TO BE THE PRESENCE OF FACIAL COSMETICS ON THE N95 MASKS RETURNED FOR USE AFTER DECONTAMINATION. I HAVE PROVIDED IMAGES FOR YOUR REVIEW. PRIOR TO THIS, IN UTILIZING THE BATTELLE DECONTAMINATION SYSTEM FOR MY N95 MASKS, THERE HAS NOT BEEN ANY SUCH DISCOLORATION APPARENT WITH THE MASKS THAT WERE RETURNED AFTER DECONTAMINATION. THANK YOU, (B)(6). HAVE IMAGES OF THE MASKS SENT TO BATTELLE DECONTAMINATION UNIT IN (B)(4) THAT WERE DECONTAMINATED AND RETURNED FOR USE WITH WHAT APPEARS TO BE RESIDUAL COSMETIC CONTAMINATION. UNFORTUNATELY, I AM UNABLE TO FIGURE OUT HOW TO CREATE FILES AND ATTACH THE IMAGES FROM MY (B)(6) TO THIS SUBMISSION. IN THE EMAILS OF INQUIRY/CONCERN SENT TO BATTELLE, I INCLUDED THE IMAGES AS ATTACHMENT. I HAVE NOT RECEIVED A RESPONSE FROM BATTELLE REGARDING MY CONCERN. THANK YOU, (B)(6) FDA SAFETY REPORT ID # (B)(4).