Re: M.chimaera in cardiothoracic heater cooler units

[Glenys Harrington]

Dear All,

Further to my earlier posting on the issue of M.chimaera in cardiothoracic
heater cooler units this posting on the USA Controversies in Hospital
infection Prevention blog site today may be of interest.

Tuesday, February 2, 2016 – M. chimaera infections associated with
cardiopulmonary bypass

http://haicontroversies.blogspot.com.au/2016/02/m-chimaera-infections-associ
ated-with.html?showComment54495047170#c157092978532341716

You will see in the comments section that I have asked Mike Edmond, the
author, if he is able to provide more details (and perhaps some images)about
how their hospital engineers were able to move the heater-cooler
units/devices out of the operating room.

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

halt shipping from device manufacturer linked to patient deaths

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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