The company that manufactures the approved tubes for blood collection in Canada has made some massive changes to their blood tubes. This will undoubtedly have an impact on DUI cases in Canada.
BD Life Sciences has made several changes to its Vacutainer® Fluoride Blood Collection Tubes. The company has received FDA clearance in the United States for an expanded indication for use, which now includes lactate testing for the Sodium Fluoride/KOx tube. This is the grey-stoppered forensic tube, used to collect blood samples for drug and alcohol analysis in DUI cases.
The changes do not impact the design, form, or fit of the products. But they do impact the laws and regulations that apply to blood drug and alcohol testing in Canada.
Effective April 5, 2024, BD has implemented a new electronic Instructions for Use (eIFU) for these tubes. Key updates include a revised Intended Use Statement, the addition of an Analytical Equivalency section, and the transition from physical copies of product inserts to eIFUs. The new intended use statement clarifies that these tubes are intended for the collection, containment, preservation, transportation, and centrifugation of venous blood specimens for in vitro diagnostic testing by trained healthcare professionals.
AKA – they are not meant to be used for forensic analysis.
The updates also provide information about the within-tube stability of glucose and lactate in the tubes, with recommendations for testing timelines.
Why does the ability to test for glucose and lactate matter in forensic blood tests? Because these substances can interfere with the results of certain blood tests for alcohol.
Additionally, the shelf-life for the 6.0mL BD Vacutainer® Fluoride Blood Collection Tube will be reduced from 17 months to 15 months. This shelf-life change is based on data available at the time of the FDA’s 510(k) clearance and is not due to a product performance issue.
Effective October 2024, three BD Vacutainer® Fluoride Blood Collection Tubes have also been discontinued. Suggested alternate products have been provided, but customers should determine the clinical appropriateness of the suggested alternatives based on their specific circumstances, clinical requirements, and intended use.
But in Canada, for RCMP testing in blood demand cases, only certain blood tubes are “approved” under the Criminal Code for use. If a non-approved container is used, there are some additional evidentiary hurdles for the Crown. With the discontinuation of some blood tubes and changes to the chemical makeup of the ingredients and preservatives in the tubes, the so-called approved tubes may no longer reflect the underlying scientific rationale for the approval.
This opens the door for possible legal challenges to whether blood tubes used in the case were approved and, in the case of samples seized from the hospital, whether the blood tubes were in fact discontinued and ought not to have been used.
Interested in learning more about how these changes could impact your case? Feel free to get in touch for further information or assistance with DUI-related legal matters.
