Nontuberculous Mycobacterium (NTM) Infections Associated with Heater-Cooler Devices (HCD) – FDA Executive Summary, June 2 -3, 2016 meeting of the Circulatory Devices Panel of the Medical Devices Advisory Committee

[Glenys Harrington]

Dear All,

For those involved or interested in the above issue find attached the FDA
Executive Summary, prepared for the June 2 -3, 2016 meeting of the
Circulatory Devices Panel of the Medical Devices Advisory Committee in
relation to Nontuberculous Mycobacterium (NTM) Infections Associated with
Heater-Cooler Devices (HCD) during Cardiothoracic Surgery.

In addition attached is the Brief Summary of the Circulatory System Devices
Panel Meeting – Heater-Cooler Devices June 2-3, 2016 – which includes
recommendations.

http://www.fda.gov/advisorycommittees/committeesmeetingmaterials/medicaldevi
ces/medicaldevicesadvisorycommittee/circulatorysystemdevicespanel/ucm485091.
htm

There were a number of presentations at the meeting and these are available
at the FDA web page (see links below).

The images and information in these presentations (note: some are from the
manufacturers in addition to those in Europe and USA who have had case/s)
will be useful in assisting your investigation of these devices in
Australia.

FDA PRESENTATION

Suzanne Schwartz, MD, MBA Associate Director for Science and Strategic
Partnerships Emergency Preparedness/Operations & Medical Countermeasures
(EMCM) Director (Acting) Food & Drug Administration Center for Devices &
Radiological Health June 2, 2016

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/M
edicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/
UCM504026.pdf

NON FDA PRESENTATIONS

June 2-3, 2016: Meeting Materials Non-FDA Generated

.
Presentation: Joseph O. Falkinham, III (PDF – 308KB)

.
Presentation: CSZ (PDF – 771KB)

.
Presentation: Hugo Sax, MD (PDF – 22.5MB)

.
Presentation: Joseph Perz, DrPH MA (PDF – 214KB)

.
Presentation: CardioQuip (PDF – 3.5MB)

.
Presentation: Jeffrey R. Miller, MD, MPH (PPTX – 5.4MB)

.
Presentation: LivaNova (PDF – 545KB)

.
Presentation: L. Silvia Munoz-Price, M.D., Ph.D. (PDF –
3.1MB)

.
Presentation: Charles L. Daley, MD (PDF – 710KB)

.
Presentation: Michael Strong, Ph.D. (PDF – 1.1MB)

.
Presentation: Daniel Diekema (PDF – 715KB)

There is also a good summary by David Wiseman a business news reporter for
the “Yorkdispatch” – “FDA discusses devices linked to infections in York”

http://www.yorkdispatch.com/story/news/health/2016/06/15/fda-discusses-devic
es-linked-infections-york/85821866/

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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