Over the River And Through The Wood: Healthcare Observations Post-Thanksgiving

Coach is Right ^ | 12/2/15 | Michael D. Shaw

[Oldpuppymax]

Many of us remember at least this first line from Lydia Maria Child’s “The New-England Boy’s Song About Thanksgiving Day” (1844). Child was an ardent abolitionist, advocate of women’s rights, and spoke out about the mistreatment of Indians. Were she to return today, I suspect that Ms. Child would have a few things to say about our healthcare system.

Here are two disturbing current events:

1. Duodenoscopes, AERs, and the FDA

This one just seems to stay in the news. In fact, it gets worse and more convoluted as 2015 races into the history books.

The latest wrinkle occurred on November 12th. In a five-page letter from the FDA, Custom Ultrasonics, Inc.—a manufacturer of Automated Endoscope Reprocessors (used to clean and disinfect duodenoscopes and other endoscopes)—was ordered to recall all of its System 83 Plus AERs. In accordance with a consent decree issued in 2007, FDA permitted Custom Ultrasonics to resume operations on a limited basis, only as to the System 83 Plus.

Oddly, a recall for these same products was issued to Custom in September, 2012, but was apparently not rigorously enforced. One suspects that the agency got more serious, in light of multiple outbreaks of superbug CRE (carbapenem-resistant Enterobacteriaceae), which have been linked to contaminated duodenoscopes and bronchoscopes.

Among other things, Custom had not provided validation data to prove that its AERs can adequately wash and disinfect endoscopes. Readers may be surprised to discover that FDA’s coveted 510(k) clearance—required to market a medical device—is often issued, as it was in this case, with the manufacturer merely asserting that it has the validation data.

Given that as many as 2,800 of these recalled devices are currently in use in U.S. hospitals and outpatient clinics, what does the FDA suggest that affected facilities do? From its November 13th...

[massgopguy]

If you go over the river and through the woods. You are crossing Rte. 16 in Medford, MA on you way to “grandfather’s house” on Governor’s Ave,

[Larry Lucido]

(Excerpt) Read more at coachisright.com ...

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