Medical Devices Undergo Extensive Safety Testing; Is This Really Necessary?

Product Risk Framework receives NSF STEM Grant

Wellcome Library, London [CC BY 4.0 (], via Wikimedia Commons

As part of ongoing efforts to encourage more physical activity among children, McDonald’s added the “Step it” fitness tracker to Happy Meals.  After only a few days, following reports of skin irritation caused by the wrist worn fitness tracker, McDonald’s decided to remove the fitness tracker from Happy Meals.

In July, 2016, the FDA released the guidance General Wellness: Policy for Low Risk Devices stating the FDA does not intend to examine low-risk general wellness products to determine whether these are actually devices.  Fitness trackers often fit into the FDA’s definition of low-risk general wellness devices.  As such, those companies are not required to perform testing which is required for most medical devices.

When medical device companies develop a product, they are required to perform testing to demonstrate their product is safe and effective.  Examples of testing are cytotoxicity, biocompatibility, and electrical safety per IEC 60601, which are designed to ensure users can safely use your products.

When you design a medical product, you intend it to be safe.  Testing is designed to find unintended safety issues, as well as provide evidence to the FDA that the product is safe.  Examples of safety issues include:

  • Surgeon receiving a mild shock with a new power tool
  • Material leaching from device when it is in constant contact with the skin
  • Skin is abraded as adhesive attached bandage is removed
  • In-home motor scooter gets too hot burning the user
  • Mold release lubricant is toxic even though the device material is safe
  • Screws to mount imaging device failed injuring a patient when it fell

Being efficacious is not enough; you need to provide a safe product for your user.

As reported with the McDonald’s fitness tracker, this may seem to be a minor problem.  However, skin irritation can cause pain and compromise skin integrity leading to other problems such as infection or deeper wounds.  As a medical device company, you need to understand why you need to do required testing.  In the long term, when you prove the safety of a new medical device, even a low-risk device, you forestall negative publicity and future financial liability.