Whether you are dealing with injuries or diseases, medical devices are becoming more commonplace in everyday medical diagnosis and treatments. A medical device is technically distinct from a medical product because they are units which operate on a physical, mechanical or chemical level. Medical Products on the other hand operate on using metabolic, immunological or pharmacological means and are more commonly referred to as pharmaceuticals. Devices are never associated directly with chemical reactions within the body but quite often medical devices will be used in unison with medical products to achieve the desired effect.
The simplest example of a medical device would be the use of a thermometer to assists with diagnosis. Complex units such as artificial hearts, neurovascular embolization kits and heart-lung machines are developing at a rapid pace and regulatory bodies have created a vast array of definitions to preside over the quality of medical engineering practises.
Uses of Medical Devices
Many devices are engineered to combat different aspects of disease in humans. Diseases may result from known or unknown causes and are characterised by any interruption of or deviation from normal bodily functions of structure. Devices are used to diagnose, treat, monitor and prevent disease.
The care of human injuries (physical traumas of which the cause is often known) is also influencing new developments in medical engineering. Diagnosing, treating, monitoring and compensating for injuries challenges health care professionals every day and provides opportunities for better quality of live to millions of patients worldwide.
In terms of anatomical issues relating to the body's structure medical devices are used to investigate, support, replace or modify structures and issues. Concerns relating to the physiological functioning of the body are similarly aided by medical technologies. Implantable devices are intended to stay totally or partially inserted into the human body for 30 days or more after a medical procedure.
Units used for life support or sustenance are only defined as active devices if they use electricity or other energy sources to operate. Some regulations exclude units powered by the human body or gravity.
The last three main uses of medical devices include those used to direct human conception, used for disinfecting other medical devices or units used to examine specimens taken from human bodies. From all the uses described it is easier to summarise what typically constitutes a medical device: Implants, appliances, instrumentation, machinery, materials, software, calibrators, lab equipment, reagents, test kits, and related items.
Regulations Governing Medical Device Manufacture:
Regulations distinguish different devices based on their levels of prospective damage if misused, the complexity of the design and main characteristics. Sometimes different components of the same device will be governed by different manufacturing and performance requirements. Specialist skills such as micro welding will often be outsourced to contract manufacturers with an in-depth knowledge of national and international requirements.
In the US the manufacture of units and components is regulated by the FDA and the requirements include a strict set of testing, production and distribution mandates (premarketing and postmarketing). In the EU a certificate of conformity needs to accompany all medical devices and the European Union and the European Free Trade Association (EFTA) work in conjunction to setup safety and performance requirements for the region.