| Health care provider notification and education (11,12,28,32) |
Cases have been detected via provider notification. Earliest implicated surgery was performed in 2007. Maintain high clinical suspicion for M. chimaera or other NTM infection in patients (who underwent surgery involving CPB with use of HCDs from 2007 to implementation of risk mitigation measures). |
| Patient notification (8,12,28,32) |
To date, no cases have been identified via patient notification. Testing is not recommended for asymptomatic exposed individuals. Until effective risk mitigation measures are implemented, information regarding potential exposure should be provided to patients prior to surgery. |
| Enhanced prospective NTM surveillance (9,21) |
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| Ensure traceability of HCDs in use (12) |
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| Remove potentially contaminated HCDs from service (12,15,27) |
Where possible, all Stöckert 3T HCDs manufactured by LivaNova prior to September 2014 should be removed from service. In some settings, risk of deferring surgery exceeds risk of surgery with use of proven or suspect contaminated HCD. |
| Replace contaminated HCDs, plus accessories, tubing and connectors, to prevent recontamination (13,15,27,35) |
LivaNova implemented a program to, in some circumstances, provide users with a loaner device to continue surgical procedures while their devices are undergoing deep disinfection. International demands for replacement of HCDs may result in a backlog in supply.
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| Use manufacturer’s operation protocol including updated cleaning and disinfection procedures (3,9,12,15,27,28,35) |
Maintain log of cleaning and disinfection of HCDs. Regularly check manufacturer’s website for relevant updates. Current decontamination protocols are yet to be validated. Studies have challenged the effectiveness of these protocols, suggesting a systematic decontamination failure. Biofilm removal is essential for effective decontamination of HCDs. |
| Routine microbiological testing of HCDs in use (12,15,17,25,27,36) |
This is not widely adopted because of the high rate of false negative results and the lack of standardized and validated methods for sample collection, processing and detection of M. chimaera. The Canadian Public Health Laboratory Network and the US FDA advise against obtaining routine environmental cultures from HCDs for M. chimaera. |
| Apply engineering solutions to enable reliable separation of HCD exhaust air from operating room air (4,5,12,13,15,18,25,26,37) |
Options include:
Place the HCD outside the operating room with tubing connected through an opening in the wall (ensuring operating room positive air pressure is maintained). Although this is the most reliable solution, the unintended consequences of this solution (e.g., possibly altered airflow in operating rooms and a longer distance between the HCD and surgical field) are unknown. Encase the HCD in custom-made housing with separate ventilation (e.g., connected to the operating room exhaust conduit). Attachments to the HCD may need to be approved by the manufacturer. The unintended consequences of this solution (e.g., effects of custom-made housing on how well the device functions) are unknown. If unable to reliably separate HCD exhaust air from operating room air, move the HCD as far as possible (preferably more than five metres) from the surgical field with the vent exhaust directed away from both the patient and the exposed instruments, and if possible, place the HCD close to the room air exhaust. Smoke dispersal experiments demonstrated that exhaust air from HCDs was propelled to merge with ultraclean airflow near the ceiling of the operating room. As a result, it is unclear whether this approach is useful in separating HCD exhaust air from operating room air (4).
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