There are more than 10,000 types of medical devices available today. This range of choices can make it almost impossible for any medical care provider to know which device they need.
Part of the reason for this huge number is that the definition of a medical device is broad. It can refer to any nonbiological means of curing, treating, or preventing a disease.
This covers everything from tongue depressors and stethoscopes to pacemakers and ventilators. Almost anything can be a medical device, which makes categorizing and choosing between them more difficult.
To make it a bit easier, the FDA places devices into different classes based on the potential risk to doctors and patients. This makes regulation easier and lets doctors and everyone in the medical field find the device they need more easily.
The three main options are Class I, Class II, and Class III. Despite similarities, they differ in several ways. Once you understand them all, you can choose the best ones for the needs of your practice and its patients.
Read our comparison guide to learn about the three different classes of medical devices and how to choose between them to provide the best possible care.
Class I
This class contains the most low-risk medical devices. Most are safe for almost anyone to use regardless of ability or age.
These devices also have the least amount of regulation surrounding them. They don’t have to deal with the same regulations that other device classes do.
It takes an average of 3-7 years to bring a medical device to the market for public consumption. Most have to go through a strict approval process, but 95% of class I devices are exempt from normal regulatory procedures.
Class I is the most common medical equipment classification thanks to these stricter regulations and reduced risks. 47% of all medical devices are Class 1.
Class 1 devices can and often are used as hospital equipment, but you probably have a few examples sitting in your home right now. Toothbrushes, bandages, enema kits, and other low-risk devices all fit in this category.
Class I devices are one of the most widely available and affordable types of medical devices on the market. Many types, such as gauze and bandages, are available for a few dollars at grocery stores.
Class II
Devices in this class pose a moderate amount of risk, so they’re subject to more regulations than Class I devices. They have to undergo general and special controls and prove that they’re safe and effective.
A few specific Class II devices are exempt from premarket approval and the normal regulatory process. The laws that determine which specific devices are exempt change frequently, so stay up to date on the current regulations.
Class II devices are relatively common despite the stricter regulations they have to undergo. They make up 42% of medical devices on the market today.
Examples of Class II devices include blood pressure monitors, wheelchairs, pregnancy tests, and other devices that pose a relatively significant level of risk to patients or doctors.
You may have some Class II devices in your home, especially if you have a disability or chronic condition. However, the increased risks make them more common in a hospital or medical facility.
Class II devices are not the least affordable or available of all the different classes of medical devices, but they’re not as easy to get your hands on as a Class I device. Their increased risk makes them pricier and more difficult to find.
Class III
This class contains the most complex and potentially risky medical devices available on the market today. They’re challenging to make and to use. Doing either incorrectly could cause severe harm or even death.
Class III devices have to follow the strictest set of regulations. They must pass general and special controls and premarket approval. They must also demonstrate how safe and effective they are more clearly than devices in other classes.
There are almost no exceptions in the case of Class III medical devices. If it doesn’t meet the requirements of the strict regulation process it must undergo, it won’t get approved and will never be sold to the public.
Stricter regulations make this the least common class of medical devices. They make up only 10% of devices currently on the market.
Class III device examples include heart valves, implants, and defibrillators. They’re used in the most extreme circumstances to sustain life. You’ll almost never see them in the average home.
Class III devices are the most expensive and difficult to find of the three classes. Their complex designs make them harder to mass-produce. This drives up their price and requires you to find a specialized dealer to obtain them.
Whatever type of medical device you choose, there are specific questions you should ask your supplier first. Find out if they offer warranties, use quality shipping methods, have a positive reputation, and are open when you need them.
Where Can I Find All the Different Types of Medical Devices I Need?
A medical device can be almost anything that you use to prevent or treat a disease. A successful practice needs several different types of medical devices to treat a wide range of conditions.
The sheer number of options can feel overwhelming, but the FDA has made it a bit easier by classifying all the medical devices on the market today into three classes based on the level of risk they present.
Approved devices can be either Class I, Class II, or Class III. Knowing the differences between these categories helps you know which one you need for your practice to provide the level of care your patients expect.
Once you’ve decided which types of medical devices you need, it’s time to find a place to purchase them from. Choosing the right supplier is an extremely important choice because it affects the quality of care you can deliver.
We have a range of high-quality medical equipment available from all three classes. View our range of products and contact us for more information today.