Health Canada Designates Devices That Deliver Drugs Via Smoking as Class II
Health Canada has ruled that a medical device that delivers a drug to a patient via smoking (including medical cannabis) is a Class II device.
The regulator notes that a device used for smoking drugs for therapeutic use is considered an active device, because the operation of the device depends on a source of energy other than energy generated by the human body or gravity.
As an active device, a medical license is required to sell such a product in Canada.
UK Coroner Blames Teenager’s Death on Inadequate EpiPen
A UK coroner who examined the body of a 15-year old girl who died of anaphylaxis attributed her death to an inadequate dose of adrenaline delivered by an EpiPen needle that was too short.
Natasha Ednan-Laperouse had an anaphylactic attack on an airplane to Nice, France after consuming a bagel that contained sesame. The coroner’s report noted the EpiPen needle that delivered the adrenaline was 16 mm, but said the preferred length is 25 mm for adrenaline injectors to access muscle in most individuals.
“I heard during expert evidence that EpiPen needle length was 16 mm — suitable according to the UK Resuscitation Council for pre-term or very small infants,” the coroner said. “The combination of what my expert told me was an inadequate dose of adrenaline for anaphylaxis and an inadequate length needle raises serious safety concerns,” he added.