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March theme: Medical Devices

What is a medical device?

Medical devices come in all shapes and sizes.  A medical device is an instrument, apparatus, implant or similar, that is used to diagnose, prevent or treat disease or other conditions.  It does not achieve its purpose through chemical action within or on the body (which would make it a medicine).  Medicinal products (also called pharmaceuticals) achieve their principle action by pharmacological, metabolic or immunological means.  Medical devices, however, act by other means like physical, mechanical or thermal means.  Medical devices vary greatly in complexity and applications.  Below are examples of medical devices:

  • Tongue depressors
  • Thermometers
  • Blood sugar meters
  • Microchip implants
  • Breast implants
  • Surgical blades


In 2006 the global medical device market was worth around 209 billion US dollars and was expected to grow at an average annual rate of 6 – 9% year on year.


Classification of Medical Devices

The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health.  The MHRA is also responsible for investigation of harmful incidents. 
Medical devices may be classified as Class I, Class IIa, IIb and III, with Class III covering the highest risk products.  The higher the classification the greater the level of assessment required by Notified Bodies.


Classification of a medical device will depend upon a series of factors, including:

  • how long the device is intended to be in continuous use
  • whether or not the device is invasive or surgically invasive
  • whether the device is implantable or active
  • whether or not the device contains a substance, which in its own right is considered to be a medicinal substance and has action ancillary to that of the device


The Medical Devices (Amendment) Regulations 2007 (S.I. No 400) which transpose into UK law the Directive 2005/50/EC which reclassifies hip, knee and shoulder joint replacements as class III medical devices was made on 15 February 2007 and laid before parliament on 16 February 2007. Certain parts of the Regulations came into force on 10 March 2007. Research is continuing to develop new medical devices or instrumentation that improves diagnostic intervention and therapeutic treatments. The Journal of Medical Devices provides articles that support novel devices that allow new surgical strategies, new methods of drug delivery or possible reductions in the complexity, cost or adverse results of health care. 


Home Use Medical Devices
In America a home use medical device is a medical device intended for users in any environment outside of a professional healthcare facility.  This includes devices intended for us in both professional healthcare facilities and homes. A home use medical device is usually supplied to a patient and/or their carer on discharge from hospital or from a clinic. 


Single Use Medical Devices
Many healthcare organisations choose to use single use devices.  A device designated as single use must not be reused.  It should only be used on an individual patient during a single procedure and then discarded.  It is not intended to be processed and used again, even on the same patient. Re-using a single use device can affect their safety and performance and effectiveness which could expose patients and staff to unnecessary risk.

 

Resources:
www.medicaldevice-network.com
http://ASME.org
www.medicaldevicestoday.com
www.mhra.gov.uk

 

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