According to FDA, “Medical device is an apparatus, implement, machine, appliance, implant, reagent for in-vitro use, software, material or another similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purposes of: diagnosis, prevention, monitoring, treatment or alleviation of or compensation for an injury, etc.
Medical devices vary according to their intended use and indications. Examples range from basic technical tools to tongue depressors, medical thermometers, and disposable gloves.
Examples of electronic radiation-emitting devices having medical applications and claims that also meet the definition of a medical device include diagnostic ultrasound products, x-ray equipment, and medical lasers.
Medical equipment also includes general-purpose lab supplies, reagents, and test kits that are used for in vitro diagnosis.
The FDA (Food and Drug Administration) categorizes medical devices into three groups based on the level of control required to assure the device's safety and effectiveness, as well as the risk associated with its usage in a patient.
FDA Medical Device Classifications:
Class I: A medical device with low to moderate risk that requires general controls.
Class II: A medical device with a moderate to high risk that requires general control plus special controls.
Class III: A medical device with a high risk that requires general control plus special control plus premarket approval.
Examples as per classification:
Class I examples include tongue depressors, telescopes, sunglasses, stretches, mechanical wheelchairs, syringes, gloves, bandages, simple surgical devices, stethoscopes, etc.
Class II includes contact lenses, electrically operated wheelchairs, needles, infusion pumps, X-ray machines, MRI machines, catheters, pregnancy test kits, surgical needles, and spinal or dental implants.
Class III includes implanted pacemakers, brain stimulators, silicon implants, and hip and bone joints.
Some of the criteria used to classify medical equipment include:
Duration: the duration is the amount of time the patient uses the device.
Invasiveness: whether or not the device is invasive would be determined to establish its criticality.
Active/Implantable: Is the device active or implantable? Medical devices are classified into two types: active devices and non-active devices. Active devices required external power sources for operation.
Medicinal substances: this is to determine whether or not the medical equipment includes medicinal substances, as well as the risk involved in the operation.
Some examples of medical devices and their purpose:
Stethoscope: A stethoscope is a tool used largely by doctors and other healthcare professionals to listen to the internal noises produced by the heart, lungs, and intestinal tract. Additionally, blood pressure is checked with it.
Thermometer: A thermometer is a tool that allows you to measure your body's temperature or the gradient of temperature.
Glucometer: The amount of sugar in a blood sample is measured using a small instrument known as a glucose meter or glucometer.
Otoscope: A medical instrument called an otoscope is used to examine the ears. Otoscopes are used by doctors to examine ear complaints and check for sickness during routine checkups. A view of the ear canal and tympanic membrane or eardrum may be obtained with an otoscope.
Pulse oximeter: An electronic instrument called a pulse oximeter, often known as a Pulse Ox, detects the saturation of oxygen transported by your red blood cells.
Sphygmomanometer: Your doctor uses a device known as a sphygmomanometer, sometimes known as a blood pressure cuff, to test blood pressure. Your upper arm is wrapped in the cuff, which is then inflated to stop the blood flow through your artery.
Nebulizer machine: The liquid medication is turned into a mist using a nebulizer, which is then inhaled through a mouthpiece or a mask. Nebulizers are occasionally used to provide asthma medications. Used to treat coughs and other symptoms brought on by respiratory infections since medicine easily reaches the lungs.
Echocardiogram machine: Certain heart diseases can be identified and monitored with the aid of echocardiography. It examines the heart's structure and the blood arteries around it, analyzing its blood flow and evaluating the heart's pumping chambers.
Cardiac monitors: Cardiac monitors can be used in clinics and hospitals to track patient parameters. The ECG, HR, NIBP, temperature, EtCO2, and other data are recorded and displayed by the cardiac monitor.
ECG: the heart's electrical activity.
HR: Heart rate; an adult's typical resting heart rate is between 60 and 100 beats per minute.
Noninvasive blood pressure (NIBP): The noninvasive blood pressure parameter gives the heart rate as well as the data for the systolic, diastolic, and mean arterial pressures.
The amount of carbon dioxide emitted at the end of an exhaled breath is known as end-tidal carbon dioxide (EtCO2). It displays how well the blood transports carbon dioxide (CO2) back to the lungs for exhalation.
Defibrillator machine: An electrical device that provides a shock to the heart when there is a life-threatening arrhythmia.
X-ray machine: Used to take images of the tissue, organs, bones, or teeth.
Dialysis machine: Used to filter patient's blood to remove excess water and waste products.
Suction machine: The main purpose of a suction machine, commonly referred to as an aspirator, is to clear obstructions from a person's airway, such as mucus, saliva, blood, or secretions.
Spirometer: A spirometer is a device used to measure how much air is taken in and exhaled by the lungs. Ventilation, or the movement of air into and out of the lungs, is measured with a spirometer. Obstructive and restrictive abnormal ventilation patterns are the two categories that the spirometer will detect.
Conclusion:
A medical device is equipment, machine, software, material, or other similar or related product intended by the manufacturer for diagnosing, preventing, or treating patients with various diseases. Based on risks, medical devices are in three categories, used to treat or monitor oneself for several medical conditions in clinics, hospitals, or at home.
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