FDA weighs in on improper cleaning of medical equipment at Bayst - Western Mass News - WGGB/WSHM

FDA weighs in on improper cleaning of medical equipment at Baystate Medical Center

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(Western Mass News photo) (Western Mass News photo)

Baystate Medical Center has warned dozens of patients that they could be at risk for illness following the possible improper cleaning of medical equipment.

The hospital reported nearly 50 patients are at risk for illness due to medical equipment that may not have been cleaned properly.

A Spokesperson for the Food and Drug Administration told Western Mass News the responsibility to report this kind of malfunction falls onto the manufacturer, but it’s not clear when this mishap took place. 
It’s the second time in two years that Baystate Health is dealing with the possibility of colonoscope equipment not getting cleaned properly.

“My wife was really upset, and I was really upset. I was 69 at the time. I’m retired, I’m 71 now but if you’re older, the stress for some of these people, they can’t handle it," said Westfield resident Robert Corchinski. 
Robert Corchinski received one of the letters.
He said his results came back clean, but after what happened to him and this new announcement, he said he’d never go back there for a colonoscopy again.

The manufacturer of that colonoscope would have 30 days to report the malfunction, according to a Spokesperson with the FDA. 

A Spokesperson for Baystate Medical Center would not confirm the name of the manufacturer, so a search through the FDA database didn’t clear much up.

“To ensure that users can understand the reprocessing instructions and correctly follow them, the guidance lists six criteria that should be addressed in the instructions for use with every reusable device," a FDA Spokesperson wrote. 
A search in the database for the months of December 2017 and January 2018, shows dozens of ‘malfunctions’ with colonoscopes, but it’s unclear if any of these are related to Baystate’s announcement.
The FDA Spokesperson said U.S. hospitals are only required to report to the FDA if there is death or serious injury.

It’s the manufacturer’s job to report it,  so she said it’s possible this happens more often than we hear about.

Copyright 2018 Western Mass News (Meredith Corporation). All rights reserved. 

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