03/08/2023
Medical Devices
It may surprise you to learn that you use a medical device everyday. If I asked you to name 3 medical devices, you likely wouldn’t name household products. This blog asks you to challenge your idea of what a medical device is and investigate how common they are.
What is a medical device?
Let’s start by defining the scope of a medical device.
The FDA defines a medical device as “any instrument, machine, contrivance, implant, in vitro reagent that’s intended to treat, cure, prevent, mitigate, diagnose disease in man”
That’s a lot of legal jargon for a product that works mechanically to help people with diseases at any stage. Medical devices are also grouped into one of three ‘classes’. You can read more about medical device classes here.
In short, it all comes down to the claims. Is the product claiming to prevent or solve a medical issue? If so, it is likely classed as a medical device. If there are no pharmacological, immunological, or metabolic means for the mechanism of the device, then it is likely a medical device.
Now that we have a grip on what a medical device is, let’s dive into medical devices you have lying around at home.
Toothbrush
A toothbrush. A prime example of a universal medical device. This is an item that you have (hopefully) incorporated into your daily routine. A toothbrush scratches and wipes a high-density bacteria area mechanically.
Toothbrushes are an important tool for maintaining good oral health. They help to remove plaque, which can cause tooth decay and gum disease. Brushing your teeth twice a day for two minutes is the best way to prevent these problems. Dental problems may be more extreme than you realise. Take care of your teeth and gums to lower your future dental bills.
Toothpaste
If you guessed this would go hand in hand with toothbrushes, you were right! Your toothpaste may be a medical device. It depends on the way the product works. Is your toothpaste addressing cosmetic concerns or health issues? If your toothpaste helps prevent gum disease, reduce sensitivity or in other ways helps your oral health, it might be a medical device!
Tampons
The FDA is trying to do better to regulate tampons. They are Class II medical devices. Devices in this category are medium to high-risk to a patient.
Tampons are invasive, so regulation is key. Especially as menstruating individuals are dependent on these products, month after month.
Contacts
Contact lenses are surprisingly harmful. Misuse can lead to several serious issues. The severity can range from eye infections to blindness. This is why they are regulated by the FDA to ensure they are safe and effective. In fact, contact lenses are Class II medical devices.
Condoms
Yes. You read that right. Condoms are Class II medical devices. The FDA ensures they are effective in preventing pregnancy and sexually transmitted infections. This medical device is key to reducing the chances of the spread of an STD breakout. It also helps with population control and planned parenthood.
Q-Tips
Perhaps one of the more obvious objects on the list. The same Q-tips you use to perfect your eyeshadow is a medical device. They were originally used to apply ointment. Today, consumers erroneously use Q-tips to clean their ears. In fact, the Washington Post wrote an article about it.
What isn’t a Medical Device?
What about common products that people may mistake for medical devices?
There are a few products like this in the market. Many people might believe that a FitBit or Apple Watch are medical devices. Unfortunately, these devices do not prevent diseases like obesity or accurately mitigate others. These watches have motivated people to keep their steps up. However, there isn’t long-term data proving consumers lost weight or managed their blood pressure. Not as a direct result of wearing the watch, at least.
Next on the list; infant head-shaping pillows are dangerous products. The FDA released a statement warning parents from purchasing these products. These pillow companies claim their product can ‘fix’ flat head syndrome, but that isn’t true. Head-shaping pillows can induce suffocation, craniosynostosis, and even lead to death. This product should not be mistaken for a medical device.
Conclusion
As you can see, there are many common household objects that are actually medical devices. It is important to be aware of this so that you can use them safely and effectively. If you have any questions about a medical device, you can always consult with your doctor or a medical professional.
