On Friday 12, 2019, the FDA said that 45 people got infected by superbug and 3 died due to contaminated endoscopes. The director of the Centre of Radiological health and Devices of FDA, Jeffery Shuren said that these light weighted and flexible scopes are necessarily used in the procedures of treatment and diagnosis of the bile duct and pancreatic conditions.
It is difficult to de-contaminate reusable scopes made by Olympus Medical Corporation, Pentax Medicals, and Fujifilm. The contamination occurs due to improper de-contamination and from damaged scopes. In 2015, for conducting a post-market inspection for dealing with this problem, the FDA had the requirement of manufacturers.
On Friday, the FDA agency said that the results of March 2019 are indicating that the estimation is showing higher contamination than expected level. In December, they had said that the safety measures introduced in 2015 are showing results as there is a decline in the cases of contaminated devices and infections.
On Friday, a report issued by safety communication by FDA revealed that their analysis done on infected patients indicated that there was a decline of 62% in the number of medical device infections as it was 250 per year in 2015 and became less than 100 in 2017. The new reports after 2017 have arrived at the end of 2018.
The 205 device reports submitted after October 15 and before March 31 had 45 infection reports, 159 device contamination reports and one person’s report that did not have infection often being exposed to superbug including 3 death reports of 2018 caused due to scopes.
A recent report said that even though there is declination in the cases but there is still a need for improvement in the safety from scopes used.
In the recent safety communication, the FDA agency said that for bringing advance and innovative ways in scope protection they are continuously working with medical experts and device manufacturers.