Home
  About Us
What We Do

Therapeutic Areas

Related Links

Careers

Contact us
   
 
  India
1) Central Drugs Standard Control
Organization (CDSCO)
2) Indian Council of Medical Research
(ICMR)
3) Department of Biotechnology (DBT)
  International
1) U.S. FDA
2) Center watch
3) International Conference on
Harmonization (ICH)
   
Therapeutic Areas
  Endocrinology/Metabolism | Oncology | Gynecology | Cardiology | Infectious Diseases | Neurology  
  Pain and Rheumatology | Psychiatry | Gastroenterology | Ophthalmology | Dermatology | Medical Devic  
 


Medical Devices


A medical device is an object which is useful for diagnostic or therapeutic purposes. Examples of medical devices include medical thermometers, blood sugar meters, and X-ray machines.

List of medical devices

High risk devices
High risk devices are life supports, critical monitoring, energy emitting and other devices whose failure or misuse is reasonably likely to seriously injure patient or staff. Examples includes

  • Anesthesia ventilators
  • Anesthesia units
  • Apnea monitors
  • Argon enhanced coagulation units
  • Aspirators
  • Auto transfusion units
  • Invasive Blood pressure units
  • Fetal monitors
  • Electrosurgical units
  • Incubators
  • Infusion pump
  • Pulse oximeters
  • External pacemaker
  • Heart Lung Machine

Medium risk devices

These are devices including many diagnostic instruments whose misuse, failure or absence (e.g. out of service) with no replacement available would have a significant impact on patient care, but would not be likely to cause direct serious injury. Examples are

  • ECG
  • EEG
  • Treadmills
  • Ultrasound sensors
  • Phototherapy units
  • Endoscopes
  • Surgical drill and saws
  • Laparoscopic insufflators
  • Phonocardiographs
  • radiant warmers (Adult)
  • Ansiscope - Diabetic diagnostic Device
  • Zoophagous agents (e.g., medicinal leeches; medicinal maggots)
  • Lytic Bacteriophages

Low risk devices
Devices in this category are those whose failure or misuse is unlikely to result in serious consequences. Some examples for such equipments include

  • Electronic thermometer,
  • Breast pumps
  • Surgical microscope
  • Ultrasonic nebulizers
  • Sphygmomanometers
  • Surgical table
  • Surgical lights.
  • Temperature monitor
  • Aspirators
  • X-rays diagnostic equipment

 
Copyright © 2009 Arête Clinical Research Consulting Service Inc