TONOMETRY
Received May 8, 2015
Report MW5042726 · MDR key 4777241
Device
Generic name
Tonometry
Product problems
- Device Reprocessing Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
(B)(6). I WOULD LIKE TO REPORT THAT TONOMETRY DEVICES CANNOT BE PROPERLY DISINFECTED. IT HAS BEEN DOCUMENTED THAT EBOLA CAN REMAIN LIVE IN PATIENT'S EYE. THERE IS NO WAY BECAUSE OF THE DESIGN OF THE TONOMETRY DEVICE THAT IT CAN BE PROPERLY DISINFECTED. IT HAS DIRECT CONTACT WITH PATIENT'S BODY FLUIDS, AND IS USED MULTIPLE TIMES A DAY WITHOUT PROPER DISINFECTING. I KNOW THAT THE FDA IS ACTIVELY INVOLVED IN REPRODUCING REUSABLE MEDICAL DEVICE ISSUES, AND WOULD RECOMMEND THAT THIS DEVICE ALSO BE EVALUATED. YOU WILL NOTICE IN THE PHOTOGRAPHS THAT THE OPHTHALMOLOGIST WAS NOT WEARING GLOVES WHILE EXAMINING THE PATIENT AND WOULD POTENTIALLY TOUCH BODY FLUIDS FROM PATIENTS' EYES. INSTRUMENT TOUCHES PATIENT'S EYE AS WELL WHICH HAD ACTIVE EBOLA VIRUS IN IT.