FW: [ACIPC_Infexion_Connexion] Mycobacterium chimaera update

[Glenys Harrington]

Hi Louise,

If you currently experiencing problems with your Heater cooler Units (i.e. culture positive for Mycobacterium chimaera) you can report it to the TGA using the following link and form.

User Medical Device Incident Report

https://apps.tga.gov.au/prod/mdir/udir03.aspx

Also if you wanted to talk to the Device Vigilance and Monitoring Section of the TGA you the number is on 1800 809 361.

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

Thanks for the information Glenys.

Do we know if the ANZ Society of Cardiothoracic Surgery has taken up this issue here in Australia?

I would have thought this would be the proper avenue for action, similar to the way the Gastroenterologists have taken on board the issues around duodenoscope contamination and the risk of CRE transmission.

Regards,

Irene Wilkinson BSc(Hons) MPH
Manager, Infection Control Service
Communicable Disease Control Branch
System Peformance and Service Delivery
SA Health
Government of South Australia
http://www.sahealth.sa.gov.au/infectionprevention

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Dear All,

Further to below, there is another interesting posting today on Controversies in Hospital Infection Prevention titled:

More data support a common source for the M. chimaera outbreak

http://haicontroversies.blogspot.com.au/2016/04/more-data-support-common-source-for-m.html

The Eurosurveillance publication referred to on the posting notes the following:

Cases had been exposed to HCUs from one single manufacturer during open chest surgery up to five years prior to onset of symptoms. During environmental investigations, M. chimaera was detected in samples from used HCUs from three different countries and samples from new HCUs as well as in the environment at the manufacturing site of one manufacturer in Germany. See link below

Eurosurveillance, Volume 21, Issue 17, 28 April 2016

Surveillance and outbreak report

CONTAMINATION DURING PRODUCTION OF HEATER-COOLER UNITS BY MYCOBACTERIUM CHIMAERA POTENTIAL CAUSE FOR INVASIVE CARDIOVASCULAR INFECTIONS: RESULTS OF AN OUTBREAK INVESTIGATION IN GERMANY, APRIL 2015 TO FEBRUARY 2016

http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId22461

There are more than one manufacturing plant for these devices hence it would be important to know the following:

a) when you HCU was purchased and

b) which manufacturing plant your HCU came from.

The LivaNova group (formerly Sorin Group Deutschland GmbH) should be able to provide this information based on the serial number of your HCU.

See the link to the FDA warning letter to LivaNova

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

This posting on the FDA may also be of interest/use.

http://www.fda.gov/medicaldevices/productsandmedicalprocedures/cardiovasculardevices/heater-coolerdevices/ucm492590.htm

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

Dear All,

For those following the Mycobacterium chimaera heater-cooler units you may find some of the answers you need in the following blog from the Controversies in Hospital Infection Prevention below.

Unfortunately the link to the speakers talk at ECCMID only has the speaker slides.

I have written to the web page contacts to see if an audio is available and will keep you posted.

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

Controversies in Hospital Infection Prevention

_____

Mycobacterium chimaera update: A must listen from ECCMID

Weve posted several times about the horrible M. chimaera outbreak linked to heater-cooler units (HCUs) used during cardiac bypass surgery. As weve addressed the problem here at Iowa, weve become increasingly frustrated (and dumbfounded) at the lack of available information about the clinical and epidemiological features of the outbreak itself, and at the general lack of urgency about this ongoing and grave risk to patients.

Fortunately, Dr. Jakko van Ingen gave an excellent talk at ECCMID that answers several important questions weve had about this outbreak, confirming some of the things weve heard (in confidence, I assume for political or legal reasons) on various conference calls and email strings. I urge you to take 30 minutes of your time to listen to his talk, all the way to the end of the Q&A period.

Aside from being an extremely entertaining speaker, Jakko addresses several key questions, including:

Is this a clonal outbreak? YES. Slide 29 reports whole genome sequencing data that clusters the isolates from Sorin 3T units and infected patients (within just 2-3 SNPs), and further discussion (during Q&A session) confirms that isolates from other European countries are also in this cluster.

Were the HCUs already contaminated prior to being shipped to end users? YES. Listen carefully to the last question and answer.

Does this particular outbreak primarily involve one make/model of HCU? YES. While nontuberculous mycobacteria have been isolated from other types of HCUs, the specific M. chimaera cluster in this case involves Sorin 3T units.

Is the invasive, disseminated, high crude mortality form of the illness restricted to those patients with implants (e.g. valves, grafts)? YES. The life-threatening disseminated infection appears to require some prosthetic material to which the organism can adhere, protecting itself (via biofilm formation) from host defense. According to Dr. van Ingen, case finding in the Netherlands is now limited to those with implants, and does not include standard non-valve, non-implant CABG patients.

Is it possible to mount an effective, rapid national response to this urgent problem? YES. Slide 18 details the Dutch response, which involved discontinuing all non-urgent cardiac surgery until HCUs were placed outside of ORs (which was done within 48 hours). As we learned here when we did the same thing, it is amazing what you can accomplish when you are left with no other option.

Is opening up a Sorin 3T HCU a frightening experience? YES. Im sure Ill have nightmares about these water-stained, biofilm-befouled devices for a long time (see below for one image from Garvey, et al).

What are the implications?

HCUs are not safe to operate in an OR. The air exhausting from the HCU ventilation fan must be physically separated from the air in the OR, and the easiest way to do that is to remove them from the OR (and maintain the OR at positive pressure, of course).

Everyone using Sorin 3T HCUs should assume that they may have exposed patients to M. chimaera, until more is known about the details of the point-source. Contaminated units cannot be disinfected even with the more intensive protocols currently recommended. In addition, only a few labs are capable of properly performing NTM cultures of water samples, so negative water cultures are of limited value and could be falsely reassuring.

A much more active national patient and provider notification is needed. Our experience is similar to that of others: identified cases would never have been found had it not been for aggressive and active case-finding. There are undoubtedly others currently being treated with immunosuppression for sarcoidosis or some other granulomatous process of uncertain etiology who actually have undiagnosed disseminated M. chimaera disease.

Below I’ve pasted an epidemic curve, an underestimate as it involves only those cases reported to FDA from US (blue bars) and abroad (red). This outbreak isn’t over, not by a long shot, and the fact that there are still hospitals performing cardiac surgery with their Sorin 3T HCUs inside of the OR is extremely distressing.

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