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Medical Devices, Their Examples, and How the FDA Defines Them

Over the past decade, the advances in medical science have really progressed in leaps and bounds. Many diseases and illnesses that may have gone uncured before have become treatable and curable now saving many lives. While the advancement is largely attributed to new medicines and medical processes, one cannot discount that new medical devices have had a great contribution in improving the overall health and wellness of people around the world.

But what are medical devices? What are some examples of it? How does the FDA look at them and define these medical devices? We’ll take a look at all of this and learn more about how they help the medical field.

What are Medical Devices?

According to the Food and Drug Administration (FDA) and the Department of Health (DOH), any instrument, equipment, implement, machine, appliance, implant, in vitro reagent or calibrator, software, substance, or other comparable or related object is referred to as a medical device.

It is intended for it to be used, alone or in combination, for human beings for one or more of the following particular purposes:

  • Disease diagnosis, prevention, monitoring, treatment, or relief
  • An injury’s diagnosis, monitoring, treatment, relief, or compensation
  • Anatomy or a physiological process is investigated, replaced, modified, or supported
  • supporting or sustaining life
  • control of conception
  • disinfection of medical devices
  • in-vitro examination of specimens produced from the human body to provide information for medical or diagnostic purposes;
  • and which, while not achieving its primary intended action in or on the human body through pharmacological, immunological, or metabolic means, may be aided in performing its intended function by such means.

To elaborate, medical devices range in complexity from a simple tongue depressor to an oxygen concentrator or even a complex MRI scanner. Condoms, pieces of cotton, test tubes, and other medical instruments were also provided. Medical devices also include in-vitro diagnostic equipment and self-test tubes.

What Are Some Examples of Medical Devices?

There are several types of medical devices that you may see at a clinic, hospital or may even be seen at home. Here are some examples:

  • Medical imaging machines are examples of diagnostic equipment. They are used to aid in diagnosis. Ultrasound and MRI machines, PET and CT scanners, and x-ray machines are examples.
  • Infusion pumps, medical lasers, and LASIK surgical machines are among the treatment equipment.
  • The purpose of life support equipment is to keep a patient’s bodily functions going. Medical ventilators, incubators, anesthetic machines, heart-lung machines, ECMO, and dialysis devices are all examples of this.
  • Medical monitors allow medical personnel to assess a patient’s health. Patient vital signs and other parameters such as ECG, EEG, and blood pressure may be measured using monitors.
  • Blood, urine, DNA, and dissolved gases in the blood are all analyzed using medical laboratory equipment.
  • Diagnostic medical equipment can also be utilized at home for some purposes, such as diabetes management.
  • Physical therapy equipment, such as continuous passive range of motion (CPM) devices, are used for therapeutic purposes.