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What is a medical device ?
Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers
Legislation
The regulation of rules for medical devices is importent to ensure the safety of a country's citizens. Most times these regulations are made by a special federal agency of a country. The regulation of medical devices are similar in most countries.
Legislation in the EU
In order to ensure a high level of protection of human health and safety and the smooth functioning o the internal market the EU harmonised rules relating to the safety and performance of medical devices. This happened in the 1990s and was based on the New Approach.
The core directives are:
- Directive 90/385/EEC (regarding active implantable medical devices)
- Directive 93/42/EEC (regarding medical devices)
- Directive 98/79/EC (regarding in vitro diagnostic medical devices)
Over the course of time these 3 core directives has been modified and corrected several times.
On 26 September 2012 these 3 core directives were replaced by a Proposal for a Rgulation of the European Parliament and of the Council on medical devices and a Proposal for a Reglation of the European Parliament and of th Council on in vitro diagnostic medical devices.
Legislation in the United States
All firms related to the production and import of medical devices sold in the United States are regulated by a special department of a federal agency of the United States Department of Health and Human Services named FDA (Food and Drug Administration). FDA's Center for Devices and Radiological Health (CDRH) is also responsible for radiation-emitting electronic products like x-ray systems and lasers.
The US regulates medical devices by classifying them into Class I, II, and III.
Risk Classification of Medical Devices
Medical devices are rated by their potential risk from Class I (low) to Active Implantable Medical Device (AIMD, high). The Regulations require a sponsor to determine the correct risk classification of its medical devices.
Risk Class ---------- Risk Description ------------ Example
Active Implantable Medical Device ----- High ---------- Implantable pacemaker
Class III ----------------------------- High ---------- Drug eluting cardiac stents
Class IIb ----------------------------- Medium-High --- Ventilators, orthopaedic implants
Class IIa ----------------------------- Medium-Low ---- Hypodermic needles, suction equipment
Class I sterile ----------------------- Low ----------- Sterile dressings, non-medicated
Class I measuring --------------------- Low ----------- Volumetric urine bag
Class I basic ------------------------- Low ----------- Reusable surgical instruments
Advantages
Medical technologies benefit the lives of people in many ways. Through the use of such technologies, people can live healthier, more productive and independent lives. Many individuals who previously may have been chronically ill, disabled, or suffering chronic pain can now look forward to leading normal or close-to- normal lives.
Here are just a few examples:
In the treatment of cardiovascular disease, the use of coronary stents - artificial tubes used in cases of coronary heart disease to keep the arteries open – have halved the number of those dying from heart attacks or suffering heart failure. Patients with an Implantable Cardioverter Defibrillator (ICD) – a small device implanted for those at risk of sudden cardiac death – now have a 98% chance of surviving a cardiac arrest, compared with only 5% without the implantable device.
For those who suffer from diabetes– a disease which is becoming increasingly common, and which places a substantial burden on health systems –now have access to very accurate blood glucose monitoring technologies. This means that they can monitor on a daily basis and control their condition much more effectively, sharply reducing the risk of suffering the common but debilitating complications of diabetes, such as blindness and peripheral nerve damage.
Those people undergoing surgical procedures also benefit from the ongoing advances in medical technology. The minimally-invasive surgical techniques which are now used to treat aneurysms can mean a recovery time of around four weeks, compared with over a year for older procedures. Using new medical technologies, endometrial ablation, as an alternative to hysterectomy, has a recovery time of just two to four days; the alternative needed six to eight weeks.
major manufactures of medical engineering equipment/systems
- Siemens ("Siemens Health Care")
- Philips
- General Electric
- Fujitsu
- Hitachi
medical imaging methods (the more modern methods)
- x-ray technology (radiology), also x-ray system or radiographic systems since 1895 (non-invasive, unless an injection of a contrast medium is delivered; an injectioin would be minimally invasive).
- ultrasound: Often used on pregnants to check on the embryo. But it is also used in Lithotripsy. By using concentrated/focused ultrasound to pulverize stones in the body. Also referred as "shockwaves".
This method is non-invasive as it can do without surgery.
- computed/computerized tomography (CT) (non-invasive)
- magneticresonanceimaging (MRT/MRI) (non-invasive). It can deliver a full view on the inner human body including all blood vessels. You can even detect aneurysms or hidden metastases.
- positron emission tomography (PET) (non-invasive)
- patient monitoring systems in critical/intensive care stations/departments (minimally invasive when a needle is inserted and sometimes non-invasive when a clip is attached to a finger). To supervise e.g. heart
activity, respiratory activity, brain activity and blood values)
- electroencephalography (EEG), this method measures electric currents produced by the brain.
- electrocardiography (ECG), this method measures electric currents produced by the heart.
- Endoscopy (works with a camera):
rigid endoscope (for knee joint),
flexible endoscope (for stomach),
capsule endoscope (it has the size if a slightly larger vitamin capsule with a light flash for taking pictures)
It is able to travel through the stomach, the duodenum, the small intestine and the large intestine. Then it is discharged from the body.
Minimally invasive, includes inserting an endoscope through a small cut/incision, but if possible via natural body openings.
Notes and references