Medical devices are used in a day to day basis for injury and disease diagnosis and treatments.
Medical devices are not to be mistaken for medical products for their main features are to work on several different levels: chemical, physical or even mechanical.
On the other hand, medical products are commonly known as drugs or pharmaceuticals. Their role is to make changes only on metabolic and immunological levels.
Medical devices have no association with chemical products, as they are simply machines used for treatment, but they are often used at the same time with medical products in order to better and more effectively treat diseases.
For instance, a thermometer is a medical device which is frequently used when a diagnosis is set. As the research of medical scientist has quickly evolved, nowadays there are also more complex medical devices that can improve the quality of our health.
For example, many hospitals and doctors now use artificial hearts, heart-lung machines or neurovascular embolization kits.
What are Medical Devices used for?
In most cases, these types of devices are used to fight diseases, from the most common ones to the most complicated.
Whether it’s about minor illnesses or serious diseases, they both have certain causes that interfere with the normal functions of the body.
Medical devices have a major role in detecting the causes, setting a diagnosis, giving a suitable treatment and even monitoring and preventing future disorders.
As diseases evolve, so do medical devices. Every day it seems that more and more disorders come to light and therefore the scientist work continuously to develop more useful medical devices that can totally treat or just improve the health of millions of people who are in suffering.
Medical devices have a large range of use. Whether it`s about routine investigations or replacing body parts, they are frequently aiding the medical field. In the case of inserted devices, they are used for smaller or larger periods of time, depending on the disease at hand.
They are also designed to sustain life as external devices powered by electricity and not by the human body or gravity, as some regulations require.
Another type of medical devices are used for disinfection purposes or for examining samples of tissue or entire body parts.
To sum up, medical devices can be described as: test kits, medical equipment, medical implants, medical tools, medical machines (hardware), medical software, reagents or calibrators.
Regulations on the Manufacture of Medical Devices
Depending on the complexity, features, levels of use and damage, there are different requirements that medical devices have to fulfill in order to be approved for medical use.
There are also cases in which different parts of the same device are subject of different regulations concerning manufacturing or performance.
When it comes to certain specialist skills, medical devices are frequently manufactured by companies that are well aware of national and international regulations.
In the US, medical devices and their parts are under the regulations of the FDA. They need to be strictly tested and their production and distribution needs to be looked for closely. In the EU all medical devices need to have a certificate of conformity.
The EU and the European Free Trade Association are working together in order to ensure a safe usage of medical devices.