Authors: ASSOCIATED PRESS and MARY KEKATOS HEALTH REPORTER FOR DAILYMAIL.COM
PUBLISHED: 27 November 2018
“Many medical device companies and experts say insulin pumps are safe and can help diabetics lead more normal lives. They blame user error for most reported problems, noting that the pumps are complicated devices requiring special training for patients. Lawsuits related to insulin pumps often blame malfunctions for causing injuries or deaths.
But over the last decade, insulin pumps and pump parts made by Medtronic Inc were subject to 20 manufacturer recalls and about 100 lawsuits alleging pump malfunctions.In the more than 150,000 reports of deaths or injuries, the AP found that Medtronic offered ‘no conclusion can be drawn at this time’ as the cause in more than 80 percent of the reports. The second most common phrase: ‘Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.’The FDA’s data offers no explanation for why the devices have so many adverse events. Many of the reports filed by doctors, manufacturers and patients lack critical information – a reporting failure the FDA acknowledges across all devices. In a statement, Medtronic said it monitors the safety of its products through clinical trials and observational studies, and that ‘data supports both the safety and efficacy of our insulin pumps, which have helped hundreds of thousands of patients manage their diabetes.’ Polly Varnado’s nine-year-old daughter was diagnosed with Type 1 diabetes in September 2012 and, when it came time to buy an insulin pump, her daughter selected a Medtronic purple one – her favorite color. Over the next seven months, she was hospitalized four times in a medical center in McComb, Mississippi, with high blood sugar” (Associated Press, 2018)
Insulin pumps are used by all ages because they are a necessary device of life for some individuals. They provide the critical insulin that individuals need to stabilize their blood sugar and stay healthy. A decline in a patient’s state can happen quickly with a malfunctioning pump. As we can see in the article, it’s a life or death scenario. The reality that Medtronic and even doctors are caulking this evidence-based claim up to user error is concerning and disappointing.
This issue calls to light the capitalist society we live in. Organizations will overlook the personal, care impact to ensure the lucrative and marketable wellbeing of their products and services. When designing my capstone project product, thinking about the real patients that are using this product will be top priority. There are actual people that are in need of this product and could be harmed from it if certain deficiencies are neglected.
Reference
Associated Press, & Kekatos, M. (2018, November 27). Insulin pumps caused more than 150,000 deaths or injuries in the last 10 years – more than any other device in America, report reveals. Daily Mail Online. https://www.dailymail.co.uk/health/article-6435103/Insulin-pumps-cause-injuries-device-study-reveals.html
