Overview of Medical Devices

Broadly speaking, medical devices are any apparatus or material used in diagnosing, monitoring, and treating an individual’s illness or injury. They can vary from something as simple as a tongue depressor to computerized implants or prostheses. Designing medical devices is a considerable portion of the biomedical engineering industry.

Regulations and Classifications

In the United States, the Food and Drug Administration approves or denies new medical devices to help protect the public. They recognize three classes of medical devices based on the level of control required to assure they are safe and effective.

Class I Devices

Class I devices are subject to the least control, and these devices are not intended to support or sustain life. Devices included in Class I are items such as bandages, hand-held surgical instruments, and examination gloves.

Class II Devices

Class II devices may be subject to some special controls such as labeling requirements, ongoing surveillance after the device has gone to market, and mandatory performance standards. These devices are held to a higher standard than those Class I devices, and they are designed not to harm or injure a patient when used as indicated, such as acupuncture needles, infusion pumps, powered wheelchairs, and surgical drapes.

Class III Devices

This final class of medical devices are for items that support or sustain human life, are critically important in preventing an impairment in one’s health, or devices that present an unreasonable risk of illness or injury. Class III devices require premarket approval, which is a scientific review to ensure the device is safe and effective. Devices in this class include pacemakers, automated external defibrillators, and implants.

Technology Improvements

As technology advances, medical devices continue to be at the forefront of new development. Medical devices are getting smaller, more technologically advanced, and offer a broader range of preventative features. The human body is one of the most demanding environments, and it is critical that implanted medical devices are adequately protected so they can continue to operate correctly and protect the patient for whom the device was inserted. One way devices are protected is through a parylene coating, which you can read more about here.

In Closing

Medical devices have been around in one way or another for thousands of years. Technology and manufacturing improvements are continually improving functionality and design to enhance patient care.