There are over 1700 different generic devices on the market today. In order to better regulate these devices, the FDA has divided them up into 16 medical specialties called panels. Each is then classified into Class I, II, or III. Which class a device is class placed into depends on the risk to the patient, which includes additional regulatory controls and exemptions.
Class I – These are the lowest risk. These devices pose little threat to the patient and user when used incorrectly. Almost all of these devices have been exempted from regulatory controls.
Class II- These devices have a greater risk of harm than Class I. If these devices fail, or are used incorrectly, they could pose a risk to both patient and user. They are more regulated in regards to labeling, distributing and manufacturing.
For a list of devices that are exempt of regulatory controls search the database here. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm
Class III- These are risky devices. They can cause harm to patients and technicians if they fail or are used incorrectly. They are all subject to strict regulations, and must follow special controls regarding design, sales and production. The FDA has to approve all class III devices before they are marketed and sold.
To search devices follow the link https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm
Similarly, medical device recalls are separated in to three classes (I, II, III). In the same way that the device classes are based on risk, recall classes are also risk based, but class I poses the most risk to the population.
Here are the descriptions as stated by the FDA:
- Class I – a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
- Class II – a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- Class III – a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
By understanding medical device classes and the associated regulations and risks, as well as the recall classifications and risks you will be able to make better decisions regarding the management of your medical devices. Be sure to keep all your equipment running correctly, especially class III equipment as it’s more likely to cause harm if it malfunctions.