You’re not alone – defining Essential Performance is difficult.
F2 Labs is here to help.
What is Essential Performance?
For your medical device to comply with 60601-1, you must conduct a risk assessment according to ISO 14971. Part of your risk assessment will include determining your device’s Essential Performance, defined in the standard as “performance of a clinical function, other than related to BASIC SAFETY, where loss or degradation beyond the limits specified by the MANUFACTURER results in an unacceptable RISK… [it] is most easily understood by considering whether its absence or degradation would result in an unacceptable risk.”
More simply put – you need to look individually at each of your device’s clinical functions (there may be none, one, or many – see below) and identify any functions that, if not performing correctly (or inaccurately, or at all), could result in an unacceptable risk.
How is “Essential Performance” different from “Basic Safety”?
60601-1 defines Basic Safety as “freedom from unacceptable RISK directly caused by physical HAZARDS when [the medical device] is used under NORMAL CONDITION and SINGLE FAULT CONDITION.”
In other words – while Essential Performance and Basic Safety both relate to the safety of your device, Basic Safety doesn’t take into consideration your device’s “clinical function”, whereas Essential Performance tries to ask the question “what is your device supposed to do, and if it doesn’t do that, are you creating an unacceptable risk of harm?”.
Is it possible that my device has no Essential Performance?
Yes. If you determine that your device has no functions the loss or degradation of which would result in an unacceptable risk, you may decide it has no Essential Performance.
Is it possible to have multiple “Essential Performance” functions?
Yes – medical devices often have multiple functions. You need to analyze, for each and every clinical function, whether the loss or degradation of that particular function creates an unacceptable risk. If so, the performance of that function must be defined as “Essential Performance”.
Who determines my device’s Essential Performance? Can F2 Labs help me determine my device’s Essential Performance?
Ultimately, you (as the manufacturer) are responsible for determining your device’s Essential Performance. F2 Labs provides consulting services to customers who want further guidance and can help you conduct this analysis.
At what point in the testing process do I need to tell you my device’s Essential Performance?
Essential Performance can affect the time required for testing, as such, it is best shared during the quoting phase.
Examples of Essential Performance (for illustrative purposes only):
| **Product Description: Electrically powered poolside chair for a handicapped/injured patient going through therapy. | ||
| Clinical Function: | Essential Performance? (Y/N) | Rationale |
| Lowers the patient into the pool | N | Not being able to lower the patient is acceptable and has no risk. |
| Lifts patient out of the pool | Y | Not being able to lift the patient out of the pool could result in serious injury/death; the degradation or loss of this function creates an unacceptable risk. |
| **Product Description: A multifunctional supplemental breathing machine, measuring temperature/heart rate/blood pressure as a secondary function, not to be used for treatment decisions. | ||
| Clinical Function: | Essential Performance? (Y/N) | Rationale |
| Monitors oxygen levels and supplies oxygen to the patient if the breathing slows down to a set limit | Y | If the measurement of the patient’s oxygen levels is degraded or fails, or the device is not able to supply the required level of oxygen to the patient, this could result in direct injury to or death of the patient. |
| Monitors patient’s temperature | N | This is a “secondary” function that does not change any treatment administered by the device to the patient – there is no direct harm to the patient if it does not work properly. |
| Monitors patient’s heart rate | N | This is a “secondary” function that does not change any treatment administered by the device to the patient – there is no direct harm to the patient if it does not work properly. |
| Monitors patient’s blood pressure | N | This is a “secondary” function that does not change any treatment administered by the device to the patient – there is no direct harm to the patient if it does not work properly. |
