M.chimaera in cardiothoracic heater cooler units – FDA moves to halt shipping from device manufacturer linked to patient deaths

[Glenys Harrington]

Dear All,

For those following the issue of cardiothoracic heater cooler units this
article from Beckers Infection Control & Clinical Quality and FDA warning
letter (following inspection at manufacturing plants) may be of interest.

“FDA moves to halt shipping from device manufacturer linked to patient
deaths

The Food and Drug Administration
has issued a warning letter to LivaNova, a London-based medical device
manufacturer, stating the company does not provide adequate cleaning
information to prevent bacteria from accumulating inside its heater-cooler
machines, which were linked to deaths at
WellSpan York (Pa.) Hospital in October and
Penn State Hershey Medical Center in November. Between the two
hospitals, 3,600 patients were notified that they may be at risk from
infections due to the devices.

The heater-cooler devices, used during open heart surgery to regulate
temperature, never come into contact with patients. However, the machines
are at risk of accumulating biofilm, which contains harmful bacteria that
can be transmitted to patients through the air during surgery. Between Penn
State Hershey Medical Center and WellSpan York Hospital, at least six deaths
have been linked to the devices. In addition to finding the
manufacturer-issued device-cleaning protocol to be ineffective, the FDA’s
investigation revealed the devices were misbranded and the company was
operating without an approved application for pre-market approval”.

Beckers Infection Control & Clinical Quality – Written by Max Green |
January 06, 2016

http://www.beckershospitalreview.com/quality/fda-to-halts-shipping-from-devi
ce-manufacturer-linked-to-4-deaths.html

FDA Warning Letter

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm479684.ht
m

LivaNova PLC Provides Update on FDA Warning Letter – LONDON, Jan. 05, 2016

http://www.livanova.com/investor-relations/pressreleases/news_release_212642
9

Regards

Glenys

Glenys Harrington

Consultant

Infection Control Consultancy (ICC)

PO Box 5202

Middle Park

Victoria, 3206

Australia

M: +61 404 816 434

infexion@ozemail.com.au

ABN 47533508426

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