Medical Devices

A medical device is intended for use in:

• the diagnosis of disease or other conditions, or
• in the cure, mitigation, treatment, or prevention of disease,
• intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

A pump for continuous subcutaneous insulin infusion, an example of a biomedical engineering application of electrical engineering to medical equipment.

Some examples include pacemakers, infusion pumps, the heart-lung machine, dialysis machines, artificial organs, implants, artificial limbs, corrective lenses, cochlear implants, ocular prosthetics, facial prosthetics, somato prosthetics, and dental implants.

Stereolithography is a practical example on how medical modeling can be used to create physical objects. Beyond modeling organs and the human body, emerging engineering techniques are also currently used in the research and development of new devices for innovative therapies, treatments, patient monitoring, and early diagnosis of complex diseases.

Medical devices can be regulated and classified (in the US) as shown below:

1. Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Devices in this category include tongue depressors, bedpans, elastic bandages, examination gloves, and hand-held surgical instruments and other similar types of common equipment.
2. Class II devices are subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance. Devices in this class are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps, and surgical drapes.
3. Class III devices require premarket approval, a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I. Examples include replacement heart valves, silicone gel-filled breast implants, implanted cerebellar stimulators, implantable pacemaker pulse generators and endosseous (intra-bone) implants.