Insulin Pumps Linked To More Reports Of Injury And Death Than Any Other Medical Device, Records Show
- Nov 28, 2018 -

Cutting costs

The problem isn't unique to Canada. In the U.K., a 2013 coroner's inquiry into the sudden death of another insulin pump user expressed concern about a "lack of analysis of medical devices post-mortem," especially since insulin pumps had become so popular.

However, in 2010, Health Canada actually closed its Bureau of Medical Devices labs to cut costs.

Briefing notes sent to Health Minister Leona Aglukkaq at the time, and obtained by CBC News, show the department was under pressure to approve licences for a growing number of medical devices. To pay for that work, cuts had to be made to "lab research in low-impact or non-critical areas."

In a statement to CBC, Health Canada said lab testing is now done by device manufacturers themselves or outsourced to third parties.

"This is more cost-effective and allows the department to access state-of-the-art facilities across all areas, rather than maintain lab capacity related only to specific scientific domains."

Health Canada also said because of "recent post-market concerns" with all infusion pumps, including insulin pumps, it now requires manufacturers to submit evidence of more rigorous testing on their devices before they can be approved for sale.

In a written statement to the International Consortium of Investigative Journalists, Medtronic said "numerous clinical studies" have shown its insulin pumps "improve blood glucose control in patients with diabetes."

The company also points out that adverse event reports sent to Health Canada do not establish whether a medical device actually caused an injury or death.