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Medical Equipment

 

Definitions

A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).[1] Whereas medicinal products (also called pharmaceuticals) achieve their principal action by pharmacological, metabolic or immunological means, medical devices act by other means like physical, mechanical, or thermal means. wikipedia


Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • Investigation, replacement, modification, or support of the anatomy or of a physiological process,
  • Supporting or sustaining life,
  • Control of conception,
  • Disinfection of medical devices,
  • Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body.  wikipedia


A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:


  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes." US-FDA

A Medical Device (MD)
is defined in Directive (93/42/EEC) as: Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of :
  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • investigation, replacement or modification of the anatomy or of a physiological process,
  • control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means. CE Marking

Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other 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 purpose(s) of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
  • investigation, replacement, modification, or support of the anatomy or of a physiological process,
  • supporting or sustaining life,
  • control of conception,
  • disinfection of medical devices
  • providing information by means of in vitro examination of specimens derived from the human body;

and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. WHO

Medical Device References

Several Medical Equipment descriptions and references can be find at EBME site


80 lead 3D ECG

Action Potential Stimulation

Anaesthesia Inhalation Agents and reactions with absorbents

Anaesthetic agents

Anaesthetic Gas Scavenging Systems (AGSS)

Apnoea Alarms

Audiometric Testing

Automatic External Defibrillation - A.E.D.

Baby Incubation

Biphasic Cuirass Ventilation

Biphasic Defibrillation

Bispectral index (BIS) monitoring

Blood Tests and Point Of Care diagnostics

Breath Hydrogen (H2) Monitoring

Capnometry / Capnography

Carbon Dioxide Monitoring

Carbon Monoxide (CO) Monitoring

Cardiac catheterisation

Cardiac Monitoring.

Cardiac Output

Cardiology

Cardiopulmonary bypass machine - CPB

Cardiotocography (CTG)

Computed tomography angiography

CRT v flat screen monitors for medical stack systems

Dynamic Volume Computed Tomography

Echocardiogram (Echo)

Electro Convulsive Therapy (ECT)

Electromagnetic Compatibility (EMC)

Electromyography (EMG)

Endoscope Design and Assembly

Endoscopy

Extracorporeal Membrane Oxygenation (ECMO)

Feeding Therapy

Foetal monitoring

Functional Magnetic Resonance Imaging [fMRI]

Fundamentals of Ventilation

Haemodynamics

Helping burns victims in the 21st century

High-Intensity Focused Ultrasound (HIFU)

Hyfrecation

Implanted devices

Impulse Oscillometry (Lung Function) Systems - IOS

Infusion Devices A Bleeding Vein Of Clinical Negligence?

Infusion Devices Training Tutorial

Infusion pumps

Intense Pulsed Light (IPL) treatment

Internal Defibrillator / Cardioverter

Internal Pacing

Intra-operative Cell Salvage

Intraosseous infusion devices

Intravascular ultrasound (IVUS)

Introduction to Anaesthesia

Introduction to Cold Phaco

Introduction to EEG

Introduction to Radiology

Invasive Arterial Blood Pressure Measurement

Killing Super-bugs with Ultra-violet light

Light Sources

Lithotripsy

Magnetic Particle Imaging (MPI)

Magnetic Resonance Imaging (MRI)

Magnetoencephalography

Medical Laser Systems

Medical Thermography

Mercury hazards

Microstream Capnography

Nerve Conduction Velocity (NCV) Test

Nerve Stimulators

Noninvasive blood pressure measurement

Noninvasive ventilation

Occlusion tests - Why bother?

Photothermal Therapy (PTT)

Positron Emission Tomography Scanning

Pressure Relieving Mattresses

Principles of fluorescence cystoscopy.

Pulse Oximetry

Pulse Oximetry - in depth

Q Switch laser removal of tattoos

Radio Frequency Identification Technology

Renal Dialysis

Rigid and flexible scopes

Robotic-Assisted Surgery

Sequential Compression Devices

Sigmoidoscopy

Soda lime production

Spirometry

Stereoscopic digital mammography

Stereotactic surgery

Temperature Measurement

The Harmonic Scalpel

The Microscope

Therapeutic ultrasound

Tonometry

Total intravenous anaesthesia (TIVA)

Transcranial Magnetic Stimulation of the Brain

Transcutaneous electrical nerve stimulation (TENS)

Ultrasonic Coagulation and Cutting Devices

Urology

Vacuum Assisted Wound Dressings

Vascular Infusion Systems

Vascular Ultrasound

Venous Ablation

Why we warm patients.