LivaNova Stöckert 3T Heater-Cooler Device - Risk of Mycobacterium chimaera Infections

Starting date:
February 17, 2017
Posting date:
February 17, 2017
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals, General Public
Identification number:
RA-62252

Audience

Healthcare facilities (acute care hospitals) and healthcare providers who use the LivaNova (formerly Sorin)  Stöckert 3T heater-cooler device: hospital staff who are responsible for operating and maintaining these devices, infection control professionals, infectious disease physicians, medical microbiologists, microbiology laboratory managers, cardiovascular and thoracic surgeons, anaesthesiologists, perfusionists.

Key messages

  • Stöckert 3T heater-cooler devices (3T HCDs) manufactured by LivaNova prior to September 2014 are at an increased risk of contamination with Mycobacterium chimaera, a type of nontuberculous mycobacterium, and should be removed from service.
  • If it is not possible to remove these devices from service, facilities should consider interim risk mitigation measures, such as positioning the device as far as possible from the surgical field or sending the devices to the manufacturer for deep disinfection.
  • To date, cases of M. chimaera infection in Canada and internationally have been reported only with 3T HCDs manufactured by LivaNova before September 2014. Health Canada is not aware of any cases of M. chimaera infection with 3T HCDs manufactured after this date.
  • The currently available testing methods to detect M. chimaera in water samples collected from HCDs are not reliable. The benefit of routine testing has not been established at this time.
  • The cleaning and disinfection procedures recommended by LivaNova should be strictly followed for all 3T HCDs.

       

Issue

Health Canada is aware of Canadian and international reports of nontuberculous mycobacteria (NTM) infections associated with the HCDs used in cardiothoracic surgery. In addressing this issue, on October 21, 2016, Health Canada issued a safety alert titled: “Important Safety Information on Heater-Cooler Devices - Risk of Nontuberculous Mycobacteria Infections”.Footnote 1

Since that time, Health Canada has continued to review available information and to work with the manufacturers of all HCDs licensed in Canada to develop strategies to further mitigate the risk of NTM infections. Evidence reviewed suggests that 3T HCDs manufactured by LivaNova prior to September 2014 are at an increased risk of contamination with M. chimaera, a type of NTM.Footnote 2 To date, cases of M. chimaera infection associated with the use of HCDs in Canada and internationally have only been reported for 3T HCDs manufactured prior to September 2014.Footnote 2

Products affected

Stöckert 3T heater-cooler devices, manufactured by LivaNova (formerly Sorin) prior to September 2014.

Background information

Evidence has shown that the LivaNova manufacturing site for 3T HCDs in Germany was likely a source of M. chimaera contamination for devices manufactured prior to September 2014, suggesting a point-source of contamination.Footnote 3,Footnote 4,Footnote 5 LivaNova has implemented changes to their manufacturing processes to reduce the risk of NTM contamination of 3T HCDs released after September 2014.Footnote 2

Routine cleaning recommended by the manufacturer is intended to prevent bacterial contamination, but it is insufficient once the devices have been contaminated for a long period of time (due to biofilm formation).Footnote 6 A deep-disinfection procedure was implemented by LivaNova to allow facilities to return their contaminated 3T HCDs for a full cleaning, disinfection and replacement of connectors and tubing. Information from the manufacturer suggests that the deep disinfection process is a means to eliminate M. chimaera contamination in the HCDs.

With regard to routine monthly testing to detect M. chimaera in water samples collected from HCDs, the Canadian Public Health Laboratory Network (CPHLN) has identified multiple limitations impacting the accuracy and reliability of results.  In particular, these limitations include the lack of standardized and validated methods for sample collection, processing and detection of M. Chimaera. As a result, the value of routine monthly device testing is limited as a reliable means to determine the status of M. chimaera contamination in HCDs.

Who is affected

Information for consumers

The 3T heater-cooler devices affected by this risk communication are sold directly to healthcare facilities and are commonly used during cardiothoracic surgery. There have been reports of patients becoming infected following the use of 3T HCDs during cardiothoracic surgery. In some cases, the infection appeared months or years after the surgery.  The type of bacterium found to cause infection is not typically harmful or highly infectious. However, in cases where the bacterium contaminates open surgical wounds or implanted devices (for example, heart valves) it can cause infections that are difficult to treat.

Patients who have undergone cardiothoracic surgery and who have questions or health concerns regarding the risk of infection are encouraged to contact a healthcare professional or the operating physician for more information.

Information for healthcare facilities

To reduce the risk of patient infection, healthcare facilities are encouraged to follow the recommendations listed below.

  • Remove 3T HCDs manufactured before September 2014 from service.
  • The emergency nature of surgeries that involve HCDs use may preclude removal of the devices from service. In such situations, there is a series of mitigation strategies that can be put in place, including:
    • Consider sending 3T HCDs manufactured before September 2014 to LivaNova for deep disinfection. LivaNova has implemented a loaner program to provide users with a loaner device to continue surgical procedures while their devices are undergoing deep disinfection. Facilities are encouraged to contact LivaNova regarding criteria to qualify for the loaner program (including NTM infection contamination status) and  availability of loaner devices;
    • Strictly follow the cleaning and disinfection procedures recommended by LivaNova for all 3T HCDsFootnote 7,Footnote 8,Footnote 9 and be aware of any additional safety measures issued by the manufacturer  or posted on the Healthy Canadians website;
    • Place 3T HCDs outside of the operating room or, if not feasible, as far as possible from the sterile surgical field with the exhaust directed away from the field and toward the operating room exhaust Footnote 10,Footnote 11,Footnote 12;
    • Use new accessories, tubing and connectors to prevent recontamination of the HCDs.

In addition, LivaNova has informed Health Canada that they are working on HCD design modifications to limit aerosolisation and prevent transmission. Timelines for review and implementation have not been finalized, but the design fixes by LivaNova could be deployed in Canada in the next two to three months.

Information for healthcare professionals

It is recommended that healthcare professionals consider requesting testing for the detection and identification of NTM to the species level in ill patients where there is concern for NTM infection and who have a history of cardiothoracic surgery. The CPHLN issued an interim guidance for the detection of NTM infections in post-operative patients exposed to HCD.Footnote 13 It needs to be reminded that:

  • infections can take several months to years to develop and cause symptoms, which can include,  but not limited to unexplained and persistent night sweats, weight loss, fatigue or fever;
  • patients with NTM infection following cardiothoracic surgery may experience various clinical presentations, including, but not limited to endocarditis, surgical site infection including abscess and bacteremia; and
  • consultation with an infectious disease specialist may be warranted for patients with a history of cardiothoracic surgery who test positive for NTM, including M. chimaera.

Any case of patient infection associated with the use of HCDs should be reported to Health Canada.

Action taken by Health Canada

Health Canada is continuing to work with LivaNova and other manufacturers of HCDs to review available information and will take further action as deemed necessary.

Health Canada is communicating this important safety information to consumers, healthcare facilities 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 health product inquiries related to this communication, 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

References

References:

Footnote 1

Health Canada Risk Communication. Heater-Cooler Devices - Risk of Nontuberculous Mycobacteria Infections October 21, 2016.

Return to footnote 1 referrer

Footnote 2

FDA Safety Communication UPDATE: Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T Heater-Cooler System, October 13, 2016.

Return to footnote 2 referrer

Footnote 3

Haller S, Höller C, Jacobshagen A, Hamouda O, 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):pii=30215. doi: http://dx.doi.org/10.2807/1560-7917.ES.2016.21.17.30215.

Return to footnote 3 referrer

Footnote 4

US Food and Drug Administration. Mycobacterium chimaera infections associated with Sorin Group Deutschland GmbH Stöckert 3T Heater-Cooler System: FDA safety communication. 2016 Jun 1 [cited 2016 Jun 1].

Return to footnote 4 referrer

Footnote 5

Perkins KM, Lawsin A, Hasan N et al. Notes from the Field: Mycobacterium chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery — United States. MMWR Morb Mortal Wkly Rep. 2016;65(40);1117-8.

Return to footnote 5 referrer

Footnote 6

Garvey MI, Ashford R, Bradley CW, et al. Decontamination of heater-cooler units associated with contamination by atypical mycobacteria. J Hosp Infect. 2016;93: 229-34.

Return to footnote 6 referrer

Footnote 7

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 7 referrer

Footnote 8

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 8 referrer

Footnote 9

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 9 referrer

Footnote 10

Sommerstein R, Rüegg C, Kohler P, et al. Transmission of Mycobacterium chimaera from Heater–Cooler Units during Cardiac Surgery despite an Ultraclean Air Ventilation System. Emerg Infect Dis. 2016;22(6):1008-13.

Return to footnote 10 referrer

Footnote 11

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 11 referrer

Footnote 12

Kohler P, Kuster SP, Bloemberg G, et al. Healthcare-associated prosthetic heart valve, aortic vascular graft, and disseminated Mycobacterium chimaera infections subsequent to open heart surgery. Eur Heart J. 2015;36(40):2745-53. doi: https://doi.org/10.1093/eurheartj/ehv342

Return to footnote 12 referrer

Footnote 13

Public Health Agency of Canada: Interim Laboratory Testing Guidance For The Detection Of Non-Tuberculous Mycobacteria (NTM) Infections In Post Operative Patients Exposed To Heater-Cooler Units. November 18, 2016. http://www.phac-aspc.gc.ca/tbpc-latb/pubs/ntm-mnt-guide/index-eng.php.

Return to footnote 13 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.