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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.
The link to the presentation by Dr. Jakko van Ingen at ECCMID is well worth looking at – see link below.
Regards
Glenys
Glenys Harrington
Consultant
Infection Control Consultancy (ICC)
PO Box 5202
Middle Park
Victoria, 3206
Australia
M: +61 404 816 434
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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Thank you for sharing this information Glenys
Does anyone know how the TGA recognises and responds to these types of overseas reports of equipment cleaning failures which have resulted in a number of adverse event outcomes and subsequently offers advice response to the Australian community? Is this the responsibility of another national body?
Regards
Louise Hobbs PhD | Manager Infection Prevention and Surveillance Service
Melbourne Health | Royal Melbourne Hospital – City Campus | Level 9 Royal Melbourne Hospital
Grattan Street, Parkville Victoria 3052
T: + 61 3 9342 8328 | F: + 61 3 9342 7277 | e: louise.hobbs@mh.org.au
[cid:image001.png@01D1A164.7D89F610]From: ACIPC Infexion Connexion [mailto:AICALIST@AICALIST.ORG.AU] On Behalf Of Glenys Harrington
Sent: Thursday, 28 April 2016 2:34 PM
To: AICALIST@AICALIST.ORG.AU
Subject: [ACIPC_Infexion_Connexion] FW: Mycobacterium chimaera update: A must listen from ECCMID [WARNING: SPF validation unavailable]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.
The link to the presentation by Dr. Jakko van Ingen at ECCMID is well worth looking at – see link below.
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 47533508426From: noreply+feedproxy@google.com [mailto:noreply+feedproxy@google.com]
Sent: 15 April, 2016 4:21 PM
To: infexion@ozemail.com.au
Subject: Controversies in Hospital Infection PreventionControversies in Hospital Infection Prevention
________________________________
Mycobacterium chimaera update: A must listen from ECCMID
Posted: 14 Apr 2016 06:33 PM PDT
[https://2.bp.blogspot.com/-nSG7E3FIOUI/VxA6EVJ7aOI/AAAAAAAABPc/yxCsKjr02FI703yFHoldb2azHpKcIXGSQCLcB/s640/cover%2Bphoto%2Bfor%2Bblog.jpg]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).
[https://3.bp.blogspot.com/-nrOmoURm3NQ/VxA6HaCEksI/AAAAAAAABPk/fpT7TpyENfcB4jxnEW8LZ1_qKBzRIO7LQCKgB/s640/Screen%2BShot%2B2016-04-14%2Bat%2B7.32.56%2BPM.png]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.
[https://1.bp.blogspot.com/-C2f_g5YW_rM/VxA-j-6qAhI/AAAAAAAABP8/9EgqZ6WlqZcrrCfOjH_F-Bo3m34JiCndwCLcB/s640/Screen%2BShot%2B2016-04-14%2Bat%2B8.05.55%2BPM.png]You are subscribed to email updates from Controversies in Hospital Infection Prevention.
To stop receiving these emails, you may unsubscribe now.Email delivery powered by Google
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MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.
The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.
Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.
Replies to this message will be directed back to the list. To create a new message send an email to aicalist@aicalist.org.au
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________________________________
WARNING: This message originated from outside the Northern/Melbourne/Western Health e-mail network. The sender cannot be validated. Caution is advised. Contact IT Services (+61 3 ) 9342 8888 for more information.MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.
The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.
Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.
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Hi Louise
My understanding is that TGA and equivalent regulatory bodies in the US (FDA) and parts of Europe have an agreement between them to monitor these types of events. FDA has an impressive registry of all sorts of reports including incidents from devices etc.
Also any sponsors of devices or equipment ie. manufacturers or distributors are typically well informed of problems with their devices and are typically diligent in taking remedial action regardless of TGA involvement. It is in their better interest to mitigate risk.
Of course this all depends on the classification of a device/ machine according to TGA requirements as not every device used in healthcare is automatically required to be registered.
When I see informal notices like this on listservers like ACIPCs I think of them as early informal notifications. As well its always good to keep a watching on eye on reports from literature and grey sources.
Hope this helps Louise.
Cheers
CathPLEASE NOTE OUR NEW MAILING ADDRESS:
Cathryn Murphy RN MPH PhD
Executive Director
Infection Control Plus Pty Ltd
PO Box 3079
Burleigh Town 4219
Queensland
AUSTRALIAE: Cath@infectioncontrolplus.com.au
Ph: +61 428 154154http://www.infectioncontrolplus.com.au
From: ACIPC Infexion Connexion [mailto:AICALIST@AICALIST.ORG.AU] On Behalf Of Hobbs, Louise
Sent: Thursday, 28 April 2016 15:47 PM
To: AICALIST@AICALIST.ORG.AU
Subject: Re: FW: Mycobacterium chimaera update: A must listen from ECCMID [WARNING: SPF validation unavailable]Thank you for sharing this information Glenys
Does anyone know how the TGA recognises and responds to these types of overseas reports of equipment cleaning failures which have resulted in a number of adverse event outcomes and subsequently offers advice response to the Australian community? Is this the responsibility of another national body?
Regards
Louise Hobbs PhD | Manager Infection Prevention and Surveillance Service
Melbourne Health | Royal Melbourne Hospital – City Campus | Level 9 Royal Melbourne Hospital
Grattan Street, Parkville Victoria 3052
T: + 61 3 9342 8328 | F: + 61 3 9342 7277 | e: louise.hobbs@mh.org.au
[Flu-Vax-2015-banner-300px]From: ACIPC Infexion Connexion [mailto:AICALIST@AICALIST.ORG.AU] On Behalf Of Glenys Harrington
Sent: Thursday, 28 April 2016 2:34 PM
To: AICALIST@AICALIST.ORG.AU
Subject: [ACIPC_Infexion_Connexion] FW: Mycobacterium chimaera update: A must listen from ECCMID [WARNING: SPF validation unavailable]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.
The link to the presentation by Dr. Jakko van Ingen at ECCMID is well worth looking at – see link below.
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 47533508426From: noreply+feedproxy@google.com [mailto:noreply+feedproxy@google.com]
Sent: 15 April, 2016 4:21 PM
To: infexion@ozemail.com.au
Subject: Controversies in Hospital Infection PreventionControversies in Hospital Infection Prevention
________________________________
Mycobacterium chimaera update: A must listen from ECCMID
Posted: 14 Apr 2016 06:33 PM PDT
[https://2.bp.blogspot.com/-nSG7E3FIOUI/VxA6EVJ7aOI/AAAAAAAABPc/yxCsKjr02FI703yFHoldb2azHpKcIXGSQCLcB/s640/cover%2Bphoto%2Bfor%2Bblog.jpg]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).
[https://3.bp.blogspot.com/-nrOmoURm3NQ/VxA6HaCEksI/AAAAAAAABPk/fpT7TpyENfcB4jxnEW8LZ1_qKBzRIO7LQCKgB/s640/Screen%2BShot%2B2016-04-14%2Bat%2B7.32.56%2BPM.png]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.
[https://1.bp.blogspot.com/-C2f_g5YW_rM/VxA-j-6qAhI/AAAAAAAABP8/9EgqZ6WlqZcrrCfOjH_F-Bo3m34JiCndwCLcB/s640/Screen%2BShot%2B2016-04-14%2Bat%2B8.05.55%2BPM.png]You are subscribed to email updates from Controversies in Hospital Infection Prevention.
To stop receiving these emails, you may unsubscribe now.Email delivery powered by Google
Google Inc., 1600 Amphitheatre Parkway, Mountain View, CA 94043, United States
MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.
The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.
Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.
Replies to this message will be directed back to the list. To create a new message send an email to aicalist@aicalist.org.au
To send a message to the list administrator send an email to aicalist-request@aicalist.org.au.
You can unsubscribe from this list be sending ‘signoff aicalist’ (without the quotes) to listserv@aicalist.org.au
________________________________
WARNING: This message originated from outside the Northern/Melbourne/Western Health e-mail network. The sender cannot be validated. Caution is advised. Contact IT Services (+61 3 ) 9342 8888 for more information.
MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.
Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.
Replies to this message will be directed back to the list. To create a new message send an email to aicalist@aicalist.org.au
To send a message to the list administrator send an email to aicalist-request@aicalist.org.au.
You can unsubscribe from this list be sending ‘signoff aicalist’ (without the quotes) to listserv@aicalist.org.au
MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.
The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.
Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.
Replies to this message will be directed back to the list. To create a new message send an email to aicalist@aicalist.org.au
To send a message to the list administrator send an email to aicalist-request@aicalist.org.au.
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