Device Classification Flashcards
What is the criteria for classifying a medical device?
Does it touch the patient?
Does it store/channel/modify biological or chemical compositions?
Is it in contact with broken skin?
Is it invasive or non-invasive?
Is it an active device?
What are the risk groups that help classify medical devices?
Class I - low risk
Class IIa - low-medium risk
Class IIb - medium-high risk
Class III - high risk
What are the Class I subtypes?
Class Is (marketed in sterile condition)
Class Im (feature measuring function)
Class Ir (reusable surgical instruments)
Give examples of Class I medical devices
Stethoscope, ECG/EEG electrodes, thermometer, ultrasound gel
When are Class I medical devices considered invasive?
Intention of channeling/storing blood, body fluids, cells, tissues, liquids, gases;
Intention of modifying biological or chemical composition of human tissues/cells;
Maintaining injured skin/mucus membrane beyond acting as a mechanical barrier
When are invasive devices considered Class I?
Short-term use;
Procedure is carried out through an opening (nostril) for short distance
Describe Class IIa medical devices, giving examples
Short-term use (60 mins - 30 days);
Non-invasive;
Some surgically invasive if short-term;
Channeling and storing blood, body fluids, cells, tissues, liquids, gases;
Purpose of eventual infusion, administration or introduction into the body;
Intention of managing micro-environment of injured skin or mucus membrane
E.g ultrasound equipment, diagnostic software
When are short-term surgically invasive devices not considered Class IIa?
Directly control, diagnose, monitor, protect a heart defect or that of the circulatory system;
Direct contact with vital systems;
Reusable surgical instruments;
Administering medicinal products through delivery system
Describe Class IIb medical devices giving examples
Long-term use (30+ days);
Some implantable devices;
Some long-term surgically invasive devices;
Used for injuries to skin breaching dermis or mucus membrane that can only heal by secondary intent;
Supply energy in form of ionising radiation;
E.g equipment for intraoperative monitoring (catheters), x-rays, radiotherapy cancer treatment
Describe Class III medical devices giving examples
High risk;
Critical to patient’s management or life;
Used to control/maintain the condition of viral organs;
E.g stent, pacemaker, defibrillator
What is an active medical device?
Any device that is dependent on an energy source other than that of the human body
What classification are active medical devices?
Class IIa with the intention of diagnosis or monitoring, unless they alter the energy;
Class IIb if they emit ionising radiation or control such devices;
Class III when controlling/monitoring/influencing implantable devices
What classification are software devices?
Class IIa when providing information related to diagnosis or therapeutic purposes;
Class IIb when related to the deterioration of a person’s health or surgical intervention;
Class III when related to the irreversible deterioration of a person’s health or their death
What are the 4 rules for classifying non-invasive medical devices?
- Does not touch the patient or is in contact with intact skin (I)
- Channels/stores blood, body liquids, cells, tissues, liquids, gases for eventual infusion/administration/introduction into the body (mainly I)
- Modifies biological/chemical composition of human tissues/cells/blood/liquids for implantation/administration into body (mainly IIb)
- Contacts injured skin or mucus membrane (mainly IIa)
