Medical equipment is regulated in the US by the FDA. These regulations cover medical device and equipment manufacturing procedures by requiring certain quality assurance steps and documentation. These QA procedures are known as “controls,” and the type of controls is determined by the risk of the equipment to the patient or operator.
Medical Equipment: Three Classifications
The first class is known as “General Controls.” Most of the devices in this category require very little monitoring by the FDA because they are generally safe to use with patients. Medical equipment included in this class would include tongue depressors, bandages, bedpans, and most hand-held surgical tools.
The second class of medical equipment is labeled “General Controls with Special Controls.” These devices require more quality monitoring by the FDA because they have the potential to develop or cause problems if they are not functioning correctly. In general these devices are not highly invasive, but have the potential to cause damage or infection. Medical equipment included in this class would be X-ray machines and infusion kits. Special labeling as well as manufacturing controls apply to this class.
The third class of medical equipment is “General Controls and Premarket Approval.” The quality of these devices must be high because the risk to patients if the equipment malfunctions is great. In general this class of device is used in invasive procedures, and may be chronically indwelling. A premarket review is required before this type of device is approved for sale. Examples of medical equipment included in this class are artificial heart valves, pacemakers, and breast implants.
Medical Equipment at Home
As technology costs decrease, the trend of creating medical equipment for home use has grown. These medical devices are normally for prevention purposes and are usually recommended by physicians as a way for individuals to be more aware of their own health.
Blood sugar and blood pressure monitoring medical equipment are two of the most common examples of devices which are made for home use. As the trend continues, additional devices are expected to hit the market and the equipment will become even easier for individuals to use.
To learn more about medical equipment, visit Medical Equipment Financing.