Have you ever received a gift that you didn’t really want? Was it an ugly sweater from Great Aunt Margie, or a holiday pillow that didn’t quite match with your décor? People always say, it’s the thought that counts… but if that was the case, gift receipts would not be so important, and return lines at Kohl’s would not be so long the day after Christmas. A bad gift is not the end of the world; we just grin and bear it, and learn to craft a more detailed wish list the next year to avoid any room for ‘interpretation’.

But sometimes, you really don’t know what you need, so you rely on others to make decisions for you. Think of healthcare for example. If you knew what was wrong every time you got sick, there would be no need to go to the doctor. But we need to rely on the expert judgment of doctors to analyze our health and prescribe the best treatment for us.

I recently read an article about a cardiology center in Western Pennsylvania that was fined $2 million for unnecessary stenting. The article discusses that surgeons, who are no longer with the practice, had administered angioplasty and stenting operations to patients that did not have sufficient plaque buildup to warrant the procedure.

These patients received something that they didn’t quite want or need. This medical device is something that didn’t come with a gift receipt, and is not that easy to return. Unfortunately, it’s difficult to know what each individual person needs, and sometimes, it is even difficult for the care-provider to select the best treatment route for a patient.

Unwanted ‘gifts’ in the medical device industry may be more hazardous than an ill-fitting sweater… but there are some things manufacturers of medical devices can do. Manufacturers can help by carefully crafting the ‘intended use’ statement for a device and ensuring proper labeling and instructions for use. Developing a strong risk assessment can also uncover any possible hazards and harms of proper and improper use of the device, and help your team determine how to mitigate and control those identified risks.

Happy holidays!

- Sherri

We are passionate about your success. Tell us more about your regulatory and quality needs to learn about how we can help.

Book a Consultation


To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!