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Laboratory Analysis

Medical devices

International reports of infection with Mycobacterium chimaera, one type of Non-Tuberculous Mycobacteria (NTM) have been confirmed to be associated with the heater-cooler devices used in cardiothoracic surgery.

In Canada, The Hospital for Sick Children , hospitals in Quebec , and Alberta Health Services all reported cases where patients who were in contact with heater-cooler units were confirmed to have developed infections.

A heater-cooler machine is routinely used to warm and cool the blood during heart transplant, lung transplant and heart surgeries. The potential risk that is arising from these machines is that the bacterium is adhering to aerosols inside the tank of the Heater-Cooler and is blown into the operating room and reaches the surgical site. Mycobacterium chimaera is a slow-growing bacterium, and the infection is often only detected after many months or years after the operation.

The need arose for a quick turnaround testing solution to determine the contamination of the devices and to confirm disinfection that the traditional culture techniques could not meet. Sporometrics worked closely with manufacturers of these devices to develop rapid analytical testing and standardize methods of sampling heater-cooler units.

Heater-Cooler Unit Bacteria Testing [HCPAC/W]

Our bacterial testing package involves testing for:

Non-Tuberculous Mycobacteria [NTM]

We offer rapid molecular testing for NTM complex and more specifically Mycobacterium chimaera which is the bacterium linked to HCU related infections.

Sample Collection Procedures

  1. Contact Sporometrics for sampling bottles or use own sterile collection bottles.
  2. 500mL of water from the HCU to be tested should be sent to us within 48 hours of sampling for maximum bacterial viability.
  3. DO NOT use ice packs when sending in samples, but samples should be protected from extreme temperatures.
  4. Fill out Sporometrics Chain of Custody/ Sample Submission Form

Service Options

Please contact us for more details regarding medical device services, sampling bottles and pricing.