Medical Devices

Medical Device FAQs

Your questions on medical device safety answered.

What is a medical device?

According to the U.S. Food & Drug Administration – which regulates the use and marketing of medical devices – a medical device is basically anything that is used to diagnose, cure, treat, or prevent a disease or other medical condition in humans or animals, or which affects the structure or function of a human or animal body. The FDA’s definition excludes chemicals, which are classified as pharmaceuticals (drugs).

What are some examples of a medical device?

Medical devices can come in all forms, sizes, and shapes. They can be include devices used only by physicians or other medical staff in a doctor’s office or hospital, devices used at home by individuals or their caregivers, and even devices that are implanted in the body.

The word “device” can be misleading, as it may imply a complex piece of technology. However, according to the FDA, a device can include even simple first aid items like bandages or gauze.

Here are some examples of the different types of medical devices that exist:

  • Hospital beds
  • Pacemakers
  • Examination gloves
  • Magnetic Resonance Imaging (MRI) equipment
  • Oxygen masks
  • Sutures/stitches
  • Dental fillings
  • Orthopedic pins
  • Joint implants (like artificial knees or hips)

This is just a short list of examples. There are many other types of medical devices on the market. As is seen by this list, the definition of a medical device covers a broad range of objects.

How are medical devices categorized?

The FDA uses a tiered classification system to categorize all medical devices. Each of these classes have to meet general controls; however, Class II and Class III have additional regulatory standards that must be met.

Class I: Lowest risk devices. Includes things like gauze, absorbent pads, thermometers, stethoscopes, tongue-depressors, and non-powered, handheld surgical equipment.

Class II: Medium-risk devices that require special controls (labeling, performance standards, postmarket surveillance, etc.). Includes things like X-ray machines, needles (surgical, acupuncture, etc.), and pumps.

Class III: High-risk devices that are complex or may be used to support or sustain life, and therefore require the strictest standards. Includes things like pacemakers, breast implants,

What questions should I ask my doctor about medical devices?

Depending on the type of device, it may be necessary for you or a caregiver to know how the device operates. Some questions you can ask are:

  • What is this device for?
  • When/how often should I used the device?
  • What could go wrong if I use it incorrectly?
  • How does the device work?
  • Does the device ever need to be replaced?
  • What happens if it stops working?
  • What are the dangers of using this device?
  • Who makes the device?
  • Does the device have a warranty?
  • How will this device help me?
  • How will this device affect my body?

There may be additional questions you will want to ask based on the specific device being used. Always feel free to ask your doctor about any device that is being used as a part of your treatment. Don’t be afraid to be persistent if the doctor doesn’t answer the question to your satisfaction.

Does the FDA review all medical devices?

Class I devices are typically not included in the regulatory review process overseen by the FDA. These types of devices include things that are least likely to harm users, and they include things like hot water bottles and elastic bandages. According to the FDA, about 95% of Class I devices are exempted from the regulatory process.

All Class II and Class III medical devices undergo a rigorous premarket notification process, also called a 510(k) due to the section of the Food, Drug and Cosmetic Act where the regulation appears.

Who makes medical devices?

Medical devices are primarily made by private companies throughout the world. Some of the biggest international corporations are medical device makers, including:

  • Johnson & Johnson
  • GE Healthcare (General Electric)
  • Siemens AG
  • Medtronic Inc.
  • Philips Healthcare
  • Baxter International Inc.
  • Fresenius Medical Care
  • Covidien PLC
  • Novartis
  • Cardinal Health Inc.
  • Stryker Corp.

There are many other smaller medical device makers as well, including companies that contract with these larger corporations to make parts or provide services related to medical devices.

Are medical devices safe?

In general, medical devices are safe if they meet all the following conditions:

  • Approved by the FDA (when necessary)
  • Manufactured following all safety-related rules, regulations, and best practices
  • Used properly in accordance with their directions

Unfortunately, sometimes products make it onto the market without meeting the proper conditions. Manufacturers may make mistakes during production, or they may deceive regulators and consumers about the safety of their devices. Other times, inaccurate directions, warnings, or other label information may be printed on the device, causing individuals to use it incorrectly or in an unintended manner.

In the best cases, defective and dangerous devices will be recalled and either removed from the marketplace or replaced with safe versions of the device. However, sometimes unsafe devices can sometimes lead to injuries or even death. In such cases, consumers may have legal rights that they can pursue to receive compensation for the injuries caused to them or their loved ones.

Can people die from a medical device?

While most FDA-approved medical devices are safe to use for their indicated purposes, there are still some dangers tied to certain medical devices. The FDA classes some devices as “significant risk devices,” which includes:

  • Implanted devices that can potentially cause serious risks to the health, safety, and welfare of the patient
  • Life-support devices
  • Otherwise provide