Heater-Cooler Devices - Risk of Nontuberculous Mycobacteria Infections

Starting date:
October 21, 2016
Posting date:
October 21, 2016
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Hospitals
Identification number:
RA-60662

Audience

Healthcare facilities and healthcare providers who use heater-cooler devices, hospital staff who are responsible for operating and maintaining devices, infection control professionals, infectious disease physicians, medical microbiologists, surgeons (cardiothoracic surgeons, cardiovascular surgeons, thoracic surgeons), anaesthesiologists, perfusionists, microbiology laboratory managers.

Key messages

  • There are international reports of nontuberculous mycobacteria (NTM) infections associated with heater-cooler devices used in cardiothoracic surgery; a small number of possible Canadian cases are under investigation.
  • The infection could result from the transfer via aerosolization of   NTM-contaminated water contained in the heater-cooler devices into the operating room and into patients during surgery.
  • NTM infections potentially associated with heater-cooler devices have been diagnosed months to years after cardiothoracic surgery.
  • Healthcare professionals should consider testing for NTM in ill patients with signs of infection who have a history of cardiothoracic surgery.
  • At this time, Health Canada is reminding healthcare facilities to strictly follow the cleaning and disinfection procedures recommended by the manufacturers of the devices.
  • Health Canada is working with heater-cooler device manufacturers to determine additional measures to further mitigate the risk of NTM infections.

   

Issue

Health Canada is aware of international reports of nontuberculous mycobacteria (NTM) infections that have been confirmed to be associated with the heater-cooler devices used in cardiothoracic surgery.Footnote 1

Recently, Health Canada has received Canadian reports of possible NTM infections in patients with a history of cardiothoracic surgery involving the use of heater-cooler devices. The root causes for these cases are under investigation.

Products affected

All heater-cooler devices licensed in Canada are currently under investigation.

heater-cooler devices
Device Name License Number Manufacturer
Paratherm, Heater/Cooler 97427 Chalice Medical Limited
Hemotherm Cooler/Heater 26798 Cincinnati Sub-Zero Products
Heater Cooler Unit 30 system
Heater Unit HU 35
Heater Cooler Unit HCU 40
HL-20 Perfusion System – Heater-Cooler System
28031
85350
90785
24031
Maquet Cardiopulmonary GMBH
BIO-CAL 370 Blood Temperature Control Module 14986 Medtronic Inc.
Flextherm Heater Cooler System

SIII Heart lung Machine Modular System: Heater Cooler System

Stockert Heater Cooler System 3T
93837

6989


71196
LivaNova/SORIN GROUP DEUTSCHLAND GMBH
SARNS Temperature Control Device 14302 Terumo Cardiovascular System Corporation
Deltastream HC
Novatherm
96066
96067
Xenios AG, MI

Background information

Heater-cooler devices are non-sterile devices used in the operating room to control the patient’s blood temperature during cardiothoracic surgeries, as well as other medical and surgical procedures when heating and cooling of blood is desired. Heater-cooler devices include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. The water circuits are physically separated and not intended to come in contact with the patient’s blood circuits. However, recent studies have suggested that there is a potential for bacteria contaminated water contained in the device to be transferred via aerosolization into the operating room environment and ultimately into the patient during open-chest heart surgery.

The reported cases were infections with Mycobacterium chimaera, a slow growing NTM that is a member of the Mycobacterium avium complex, which is widespread in nature and can be found in soil and water, including drinking water sources. This type of mycobacterium was isolated from heater-cooler devices used in some hospitals and in the manufacturing process.Footnote 2 In rare cases, these nontuberculous mycobacteria may cause serious and potentially life-threatening infections in patients.

Although the potential risk of NTM infections exists with all heater-cooler devices, the vast majority of reported cases were associated with the Stockert Heater Cooler System 3T manufactured by LivaNova/Sorin. Following the report of these cases, some manufacturers have taken actions in Canada to reduce the risk of patient infection.Footnote 3 Footnote 4 Footnote 5 Footnote 6

Health Canada is monitoring this issue and currently working with the manufacturers of heater-cooler devices to investigate the issue and determine additional measures to further mitigate the risk of infection.

Who is affected

Information for consumers

The heater-cooler devices affected by this risk communication are sold directly to healthcare facilities and commonly used during open-chest surgery. There have been reports of patients becoming infected with NTM following the use of heater-cooler devices in open-chest surgery. In some cases, the infection appeared months or years after the surgery.

Nontuberculous mycobacteria are typically not harmful but in rare cases, they can cause infections in very ill patients, including those with compromised immune systems, and chronic diseases or health conditions.

Patients who have undergone cardiac surgery and who have questions or health concerns regarding the risk of infection with NTM are encouraged to contact their healthcare professional for more information.

Information for healthcare professionals

Hospitals performing cardiac surgery should identify and assess which heater-cooler devices are being used in their facility and increase awareness among health care professionals about the risk of infection.

Hospitals should consider organization-specific policies for risk communication.
These infections are difficult to diagnose and require specialized laboratory techniques to identify infection.  Hospitals should review their microbiology laboratory capacity to identify these organisms should an infection occur.

To reduce the risk of patient infection, hospitals are reminded to:

  • Strictly adhere to the most current manufacturer’s instructions for use of the device, particularly the cleaning, disinfection and maintenance procedures.
  • Be aware of additional safety measures issued by the manufacturers of devices and posted on the Healthy Canadian website.Footnote 3 Footnote 4 Footnote 5 Footnote 6
  • Position, when feasible,  heater cooler units as far as possible from the sterile surgical field and the exhaust should be directed away from the field, towards the operating room exhaust.
  • For facilities that have identified Stockert Heater Cooler System 3T devices suspected to be contaminated, the manufacturer is recommending removal of the affected devices from the operating room or, if feasible, from service as soon as practical. Contact LivaNova/Sorin to have the deep-disinfection service performed prior to further use.

Healthcare professionals should consider requesting testing for the detection and identification of NTM to the species level, in ill patients with signs of infection who have a history of cardiothoracic surgery.

  • Infections can take months to years to cause symptoms, which can include unexplained and persistent night sweats, muscle aches, weight loss, fatigue or fever.
  • Patients with NTM infections following a cardiothoracic surgery may experience various clinical presentations including but not limited to endocarditis, surgical site infection, abscess and bacteremia.
  • Healthcare professionals should consider consultation with an infectious disease specialist for patients with a history of cardiothoracic surgery that test positive for NTM, including Mycobacterium chimaera.

Action taken by Health Canada

Health Canada is working with the manufacturers of heater-cooler devices sold in Canada to review available information.  Health Canada continues to monitor the situation and will take further action as deemed necessary.

Health Canada is communicating this important safety information to Hospitals and healthcare professionals via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect e-Notice email notification system.

Report health or safety concerns

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of patient infection or other serious or unexpected side effects associated with the use of heater-cooler devices should be reported to Health Canada.

Any suspected adverse incident can be reported to:
Regulatory and Operations Regions Branch
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline: 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines   can be found on the Health Canada Web site.

For other medical device inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Footnotes

References

Footnote 1

Sax H, Bloemberg G, Hasse B, et al. Prolonged outbreak of Mycobacterium chimaera infection after open-chest heart surgery. Clin Infect Dis. 2015, 61(1):67-75.

Return to footnote 1 referrer

Footnote 2

Haller S, Holler C, Jacobshagen A, et al. 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. Euro Surveill. 2016, 21(17). doi: 10.2807/1560-7917.ES.2016.21.17.30215.

Return to footnote 2 referrer

Footnote 3

Medical Device Recall: Sorin Heater Cooler System 3T. Available: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/54106r-eng.php

Return to footnote 3 referrer

Footnote 4

Medical Device Recall: Adult and Pediatric Oxygenator Brackets. Available: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/59122r-eng.php

Return to footnote 4 referrer

Footnote 5

Medical Device Recall: Heater Cooler System 3T. Available: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/59390r-eng.php

Return to footnote 5 referrer

Footnote 6

Medical Device Recall: Heater Cooler Units. Available: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/60432r-eng.php

Return to footnote 6 referrer

 


For more information

The manufacturer advised Health Canada of the risk associated with this health product. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.