Across the globe, the medical equipment and supplies industry reports revenues totaling upwards of $273 billion. In the United States alone over 18,000 businesses realized $151 billion in sales in 2015. The federal government works to ensure the health and safety of both patients and physicians.

Medical Equipment Monitored by FDA

The Food and Drug Administration oversees medical devices both pre and post marketing to ensure that labeling, promotion of the product and its primary intended use of the product is met.

A medical device according to its purest definition can be as basic as a tongue depressor, or as complex as a laser surgical device.

According to the FDA, the definition of a medical device must fit the following criteria:

An instrument, part, or component that is:

• Listed in the National Formulary, or United States Pharmacopoeia.
• Designed to diagnose, treat, cure, or prevent disease, or other condition in the human body or in animals.
• Created to affect the body’s function or structure.
• Does not depend on a chemical action, or metabolic activity in or on the body.

Medical Device Companies—Who Get’s Regulated

The FDA’s Center for Devices and Radiological Health regulates any company that:

• designs
• manufactures
• repackages
• re-labels
• imports

medical devices within or into the U.S. The Food and Drug Administration does not oversee the practice of medicine, or the way in which medical personnel use a device.

In 1976, the FDA began to regulate medical devices, ensuring safety and effectiveness for consumers and patients.

At this time the regulatory body required that medical devices must be specifically defined, categorized into one of three classes, and monitored through the marketing phase. Advisory panels were also established and clinical investigations were required.

The Three-Class System

To ensure the safety and effectiveness of medical devices for patients and consumers, each device is placed in a class, depending on the degree of regulatory control needed.

Class I — These medical devices present the lowest safety risk to users. Examples may include, hearing aids, exam gloves, arm slings, bandages, manual breast pumps, and microbial analyzers.

Class II — Devices in this class are more complex and must meet performance standards. Labeling, guidance, tracking and design must be monitored post marketing. Contact lens products, powered wheelchairs, and CT scanners fall into this category.

Class III — Class III devices incur the most regulatory control because they are used to sustain/support life, are implanted in the body, or may present the risk of illness or injury. These require pre market approval as well. Examples of these devices include pacemakers, cochlear implants, breast implants, weight loss devices, and medical imaging analyzers.

Health Insurance/Medicare—Is your medical device covered?

If your doctor deems certain medical equipment necessary for either the treatment of (or prevention of) a diagnosed medical condition, private healthcare insurance and/or Medicare will generally cover some of the purchase or rental cost. Most plans require that equipment qualify under the guidelines of Durable Medical Equipment. There may also be a co-pay involved, depending on the type of insurance and plan in use.

DME (Durable Medical Equipment) Coverage

Durable medical equipment refers to re-usable, long lasting, equipment to be used at home for the daily function of an individual. This also includes wheelchairs, hospital beds, ventilators, nebulizers, blood and glucose monitors, handrails, and commodes. While an individual without a doctor’s prescription may purchase most durable or home medical equipment, it is helpful in order to get private healthcare plans or Medicare to pay for it. In cases where a prescription is not obtained a Justification Statement of Medical Necessity may be submitted to the insurance company in lieu of one.

Further DME criteria states that equipment must be:

• For use by someone who is either sick or injured
• Used in the home
• Able to last for a period of at least 3 years

Currently Medicare Part B covers a number medical devices including:

• Air-fluidized beds
• Blood sugar monitors
• Blood sugar test strips
• Canes
• Commode chairs
• Continuous passive motion (CPM) machine
• Crutches
• Hospital beds
• Infusion pumps and supplies
• Manual wheelchairs/power mobility devices
• Nebulizers
• Oxygen equipment
• Patient lifts
• Continuous Positive Airway Pressure (CPAP) devices
• Suction pumps
• Traction equipment
• Walkers

Medical Supplies Defined

Medical supplies differ from durable medical equipment in that they are generally disposable and are only for use by one individual.

Examples of medical supplies covered by private healthcare insurance companies or Medicare may include:

• Antiseptic
• Bandages
• Batteries
• Blood monitoring test strips
• Braces
• Belts
• Ostomy supplies
• Syringes/needles
• Urological supplies
• Adult diapers

Medical supply companies may either provide supplies to hospitals and physicians, or for retail sale.