Instrumentation Flashcards
(294 cards)
How many classes of medical devices are there?
4
Class I
Class IIa
Class IIb
Class III
What is the most common class for a medical device?
Class I
Which type of med device is used to maintain control of vital organs?
Class III
Which classes of medical device are commonly installed within the human body?
Class IIa
Class IIb
Class III
Give an example of a Class I device
Thermometer, ultrasound gel…
Give an example of a Class IIa device
Diagnostic software, ultrasound equipment, blood pressure,
Give an example of a Class IIb device
Equipment used for intraoperative monitoring, blood bags, gauze, contact lenses, hearing aids
Give an example of a Class III device
Defibrillator, Pacemake, Vagal Nerve Stimulator
What determines the class of device?
Invasive vs non-invasive
Length of time spent in-vivo: I - not implanted, IIa - 60mins - 30 days, IIb - 30+ days, III - longterm
What is an active medical device?
An active medical device is any medical device that relies on an external source of energy to function, rather than being powered solely by the body or gravity. These devices require electrical or other forms of energy (e.g., mechanical, thermal, or chemical) to operate, excluding energy generated directly by the human body. e.g. pacemaker, infusion pumps, usually IIa
What is a passive medical device?
Passive medical devices (like bandages or stents) do not require an external power source to perform their intended medical function.
4 Rules of Medical Device Classification
Rule 1: Do they touch the patient?
Rule 2 + 3: Do they Store, Channel or modify the biological or chemical composition?
Rule 4: In contact with broken skin?
Bonus: Invasive? Active Device?
If a software device provides info to make decisions, what class of medical device is it?
Class IIa
If a device is responsible for controlling or monitoring an implantable device, what class of medical device is it?
Class III
Probability vs Consequence
(name the 4 levels)
Severity: mild, major, critical, fatal
Is standardisation or specific safety tests designed by regulatory bodies? (pick one)
Standardisation
Standards exists so manufacturers can: (2)
Identify potential hazards
Estimate and evaluate associated risks
Risk classifications (3)
Insignificant/negligible
Investigate risk reduction
Unacceptable
What is resolution?
Smallest differential value that can be measured, useful for images & signals, the devices ability to detect change for a given input
Risk Process (6)
Analysis > Evaluation > Risk Control > Residual Risk > Risk Management Report <> Post-Production
What needs to be considered in the evaluation of a new device? (4)
Accuracy, precision, reliability, reproducibility
Does sensitivity determine the ability to identify True Positive (TP) or True Negative?
True Positive
Does specificity determine the ability to identify True Positive (TP) or True Negative (TN)?
True Negative (TN)
What is used to screen for a disease? (Sensitivity or specificity)
A test with the highest sensitivity