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FA 2016

Editor’s Note:

I received this email from Bryan Lich, President of Perfusion.com, and I felt it was important enough to disseminate to the readership and hopefully together we can work to solve this issue.  The content of the letter is below in it’s entirety.

Below is a survey to try to gather a consensus on current strategies as well as gathering new ideas on what is plausible, and what is only an impractical theory to implement.

I encourage all of you to take this survey, the issue at hand is primarily for the purpose of patient protection FIRST, and and how we adjust to it is obviously reactionary- but must be proactive and simply cannot be ignored or sidestepped with a mantra of “this has existed for a long time”.  The first step, is getting on board with “what we don’t know”. After that we can formulate a game plan.

Survey Live Form

https://docs.google.com/forms/d/e/1FAIpQLSfcAGSSlPvchyuRKaSjWY6Dj8huyIA_eCHPhP-WQVoENONRRw/viewform

Survey Results

https://docs.google.com/forms/d/185WNye2Ml44WzKzSz9doK61Qf9WBKkiZhseX9JADSGA/viewanalytics

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IMPORTANT SAFETY NOTICE
17080 Safety Street, Suite 109
Fort Myers, Florida 33908
October 17, 2016
RE: Sorin/LivaNova 3T Heater Cooler Risk Management

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To whom it may concern,

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Please be advised that the FDA has updated its June 1, 2016 Safety Communication to provide new information about Mycobacterium chimaera (M. chimaera) infections associated with the use of the 3T in U.S. patients who have undergone cardiothoracic surgeries. This communication also contains updated recommendations to help prevent the spread of infection related to the use of these devices.
Please take a moment to review the summary guidelines from the FDA provided concisely below.

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If your facility uses 3T devices, you should:

1. Immediately remove from service any heater-cooler devices, accessories, tubing, and connectors that have tested positive for M. chimaera or have been associated with known M. chimaera patient infections at your facility.
2. Use new accessories, tubing, and connectors to prevent recontamination when using a different heater-cooler device.
3. Direct and channel the heater-cooler exhaust away from the patient, e.g., to the operating room exhaust vent.
4. Be aware that device contamination also may occur from other sources such as environmental contamination or device contact with contaminated accessories.
5. Review the recommendations in CDC’s Health Advisory.
6. Be aware that heater-cooler devices are important in patient care. In appropriately selected patients, the benefits of temperature control during open chest cardiothoracic procedures generally outweigh the risk of infection transmission associated with the use of these devices.
If your facility has 3T devices manufactured prior to September 2014, you should:
1. Strongly consider transitioning away from the use of these devices for open-chest cardiac surgery until the manufacturer has implemented strategies for these devices to mitigate the risks of patient infection.
2. Use of these devices should be limited to emergent and/or life-threatening situations if no other heater cooler devices are available.
3. Follow the FDA’s earlier recommendations to help mitigate the risks of patient infection.
4. Be aware that testing of heater-cooler devices to identify units contaminated with M. chimaera presents technical challenges related to sample collection, the long culture time, and the high rate of false negative tests. Therefore, it is not recommended at this time.

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If your facility has 3T devices manufactured after September 2014, you should:

1. Follow the FDA’s earlier recommendations to help mitigate the risks of patient infection.
2. Be aware that testing of heater-cooler devices to identify units contaminated with M. chimaera presents technical challenges related to sample collection, the long culture time, and the high rate of false negative tests. Therefore, it is not recommended at this time.
Please know that Perfusion.com’s management team has been in ongoing communication with LivaNova on this matter and has conveyed the recommendations as they have evolved to our perfusionists in the field. As a result, our clinicians have been incorporating most of the recommendations for quite some time now.
We also wanted to provide you with some additional resources so your administrative and risk-management team can make the best choices for your organization.

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Alternative Heater Cooler Units:

1. CardioQuip MCH-1000(i)™
2. Cincinnati Sub-Zero Hemotherm® 400CE Dual Reservoir Cooler/Heater
Note: Keep in mind the 3T comprises 60% of the US market, so there is not enough capacity to replace all the 3T units currently. It will likely take months to get a replacement if you begin today. If you buy the CSZ unit, please make sure you get the optional remote. If you buy the CardioQuip unit, please make sure you buy the optional Cardioplegia module.
LivaNova’s 3T Replacement Program:
To help bridge the gap, LivaNova has decided to re-allocate all of their new 3T units to a loaner program. Each hospital may request one (1) new 3T loaner unit at no charge. This program will be available to those units made before Sept 2014.
For a loaner request or additional questions please call the 3T Hotline at 1-888-570-1653. Keep in mind that loaners will likely NOT be immediately available.

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Additional Recommendations from PDC Management:

1. Consider adding the risk of NTM infection to the patient’s informed consent.
2. For all heater cooler units: Direct and channel the heater-cooler exhaust away from the patient, e.g., to the operating room exhaust vent.
3. Setup a committee within your organization to evaluate risk and make any necessary recommendations/changes.
4. If you have a 3T made after September 2014, you should use it instead of any older 3T devices when possible.
5. Consider scheduling manufacturer preventative maintenance service on your existing heater/cooler units as soon as it is feasible to do so.
6. Make sure you follow the manufacturer’s cleaning and service maintenance protocols to the letter.
a. Hemotherm 400MR
b. Hemotherm 400CE
c. MAQUET HCU30
d. Sarns TCM2
e. Sarns Dual Cooler Heater
f. Stockert 3T

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References:

1. Mycobacterium chimaera Infections Associated with Sorin Group Deutschland GmbH Stӧckert 3T Heater-Cooler System: FDA Safety Communication
2. Contaminated Devices Putting Open-Heart Surgery Patients at Risk
3. UPDATE: Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler System: FDA Safety Communication
4. Sorin/LivaNova 3T Field Safety Notice Dated 10/13/2016
5. Sorin/LivaNova 3T link with document downloads including the new FSN and FAQ documents
6. Nontuberculous Mycobacteria (NTM) & Heater-Coolers Video

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Contact

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If you should have any questions, please feel free to contact our main office at 888-499-5672 ext. 101.
Sincerely,
Bryan v. Lich, CCP, LP
President
Perfusion.com, Inc.
239-243-9171 ext. 101

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