F2 Labs has many conversations every week with medical device manufacturers who are struggling to define Essential Performance for their device.
From our experience, the confusion around Essential Performance frequently stems from the fact that what a device manufacturer views as ‘essential performance’, does not align with the definition of ‘Essential Performance’ from IEC 60601-1.
They consider every function described by the product’s specification to be ‘essential’. If the device does not work as intended – what is the point? Who would want to buy or use it? These specifications will need to be proven through bench testing typically performed by the manufacturer, on the manufacturer’s behalf by an accredited laboratory. However – this is not the same as what 60601-1 intends when it defines Essential Performance.
For the purposes of 60601 testing, the definition Essential Performance is this:
Essential Performance: those clinical functions which ‘if degraded or not present, could result in an unacceptable risk’.
Blending the two ideas of essential performance together muddies the waters, and often creates confusion in developing the correct Essential Performance for a device.
Defining Essential Performance can be simplified by breaking it down into manageable pieces as follows:
1. Create a list of your device’s clinical functions (there could be one, none, or many).
2. Review each one individually and ask “If this function is not performing correctly (inaccurately or at all), could it result in an unacceptable risk?”
(a) If the answer is no, that particular function is not Essential Performance.
(b) If the answer is yes, that particular function is Essential Performance.
3. For each item that was answered ‘Yes’, define the exact requirement and define the method of monitoring.
That’s it – you could end up with one, none, or many. The rationale you use for making these decisions should be detailed in your Risk Management File.
Let’s follow the above steps using the simple example of a basic thermometer.
1. List of clinical functions:
(i) Measure temperature accurately.
(ii) Display that measurement on a cell phone app.
2. Review each clinical function individually, and ask the question – is this Essential Performance?
(i) Measure temperature accurately:
Yes – treatment decisions will be made based on this measurement (i.e. administer medication)
(ii) Display that measurement on a cell phone app:
No – if the result is ‘unavailable’, a different thermometer could be used, no treatment decisions would be made, etc.
3. For each item that was answered ‘Yes’, define the exact requirement and define the method of monitoring it.
(i) Measure temperature accurately.
(a) Define the exact requirement(s): measure temperature within +/- 0.10 degrees
(b) Define the method of monitoring/measuring: use a calibrated thermometer or calibrated water bath to verify the measurement accuracy.
In this example, the Essential Performance and Method of Monitoring for this thermometer is:
CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.
Want to discuss your project with us?
You can contact us at this link. Our phone number is 877-405-1580 and we are here to help you.
