MEDICAL EQUIPMENT CLASSIFICATION

As the health care system uses a large variety of electronic equipment, it can be grouped into three major classifications:

A, B, and C.

Classification A includes medical equipment/devices that are directly and immediatelyresponsible for the patient’s life or may become so in emergencies. Morespecifically, when this type of equipment fails, there is seldom sufficient time forrepair. Therefore, this equipment must always operate at the moment of need. Itmust have high reliability. Some examples of the Classification A equipment are cardiac pacemakers, cardiac defibrillators, respirators, and electro-cardiographicmonitors.

Classification B contains a vast majority of medical equipment used for routineor semi-emergency diagnostic or therapeutic purposes. Failure of such equipmentdoes not result in the same emergency as in the case of Classification A equipmentbecause there is time for repair. Some of the devices that fall under this classificationare ultrasound equipment, spectrophotometers, electrocardiograph andelectroencephalographrecorders and monitors, gas analyzers, colorimeters, and diathermyequipment.
Classification C contains equipment that is not critical to a patient’s life orwelfare but simply serves as a convenience equipment. Two examples of the ClassificationC equipment are wheelchairs andbedside television sets.

All in all, there could be some overlap between these three classifications ofequipment, particularly between Classifications A and B.After the passage of the Medical Device Amendments of 1976, the FDA classifieddevices marketed prior to 1976 into the following three categories:

Category I
This contained devices in which general controls such as
good manufacturing practices were considered satisfactory with respect
to safety and efficacy.

Category II
This contained devices in which general controls were
considered insufficient with respect to safety and efficacy and in which
performancestandards could be established.Medical Device Reliability and Associated Areas

Category III
This contained devices in which the manufacturer isrequired to submit evidence of safety and efficacy with the aid of welldesignedstudies. More specifically, the devices included in this categorysupport life, prevent health impairment, or present an unreasonable riskof injury or illness and need FDA approval prior to their marketing.