"Single Patient Use" Terminology Confusion

Mark Meer

Trusted Information Resource
I've sometimes seen the common ISO symbol for "Do not reuse" (aka "Single Use Only") - a crossed out number "2" - referred to as "Single Patient Use".

I think this is a bit of a confusing term, and should be avoided, because it can easily be interpreted as "Do not share between users", and not the intended "Use only once".

Is there some guidance or standardized terms/symbols for indicating "single-patient use" in the "Do not share" sense? (e.g. like your toothbrush or underwear, were they medical devices).
 

somashekar

Leader
Admin
I've sometimes seen the common ISO symbol for "Do not reuse" (aka "Single Use Only") - a crossed out number "2" - referred to as "Single Patient Use".

I think this is a bit of a confusing term, and should be avoided, because it can easily be interpreted as "Do not share between users", and not the intended "Use only once".

Is there some guidance or standardized terms/symbols for indicating "single-patient use" in the "Do not share" sense? (e.g. like your toothbrush or underwear, were they medical devices).
The EU MDD specifically asks for this in the essential requirements. The manufacturer is expected to detail potential risks within the IFU, if a single use device were to be re-used.

From M5 of 13.6 (h)., ANNEX I - MDD
If the device bears an indication that the device is for single use,
information on known characteristics and technical factors known
to the manufacturer that could pose a risk if the device were to be
re-used. If in accordance with Section 13.1 no instructions for use
are needed, the information must be made available to the user
upon request;

For medical devices, it is also generally accepted that single use means ‘for use on a single patient’. Guidance from the MHRA suggests that single use devices should only be used for a single procedure, however the term ‘procedure’ is not defined.

Some more in THIS thread ...

My examples...
1. Syringe for injection: Single use (1 procedure) Single patient, 10 injections at various intervals, use 10 new syringe (Each is a procedure)
2. Disposable SpO2 sensor: Single patient use. Must be applied at different location once every 4 hours per the IFU to avoid possible skin burn. We provide additional tapes for this in the packaging. Here Single patient use is 1 procedure.
 
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Mark Meer

Trusted Information Resource
For medical devices, it is also generally accepted that single use means ‘for use on a single patient’. Guidance from the MHRA suggests that single use devices should only be used for a single procedure, however the term ‘procedure’ is not defined.

This is the source of my confusion - that the two terms are pretty much used interchangeably.

Is there a difference between "Single Use" and "Single Patient Use"? I would think there should be. In my opinion "Single Use" should refer to use in a single procedure, whereas "Single Patient Use" should mean use by a single patient.
 

somashekar

Leader
Admin
This is the source of my confusion - that the two terms are pretty much used interchangeably.

Is there a difference between "Single Use" and "Single Patient Use"? I would think there should be. In my opinion "Single Use" should refer to use in a single procedure, whereas "Single Patient Use" should mean use by a single patient.
The answer to the confusion is in good risk management .....
 

pkost

Trusted Information Resource
The proposed medical device regulation in Europe uses the following definition:

‘single-use device’ means a device that is intended to be used on an individual
patient during a single procedure.
The single procedure may involve several uses or prolonged use on the same
patient;

This is subject to change, but is clearer on the issue
 

Mark Meer

Trusted Information Resource
The single procedure may involve several uses or prolonged use on the same
patient;

...So my toothbrush (were it a medical device) could be considered a "single use device" if I were to define 2-months of twice daily use as a single cleaning regiment (or "procedure")? ...and it would then be appropriate to label it with the "single use device" symbol? :notme:

Unless they also make a better definition of "procedure", I still don't think "Single Use" (or "Single Patient Use") is very well defined.

I think that a distinction needs to be made somewhere between:

(actual) "Single Use" - intended to be used once - e.g. condoms, band-aids...

and

"Single Patient Use" - intended to be used only by one person. This may or may not involve multiple-uses and/or reprocessing between uses.
 

pkost

Trusted Information Resource
To brush your teeth one evening is one procedure, the next morning is a separate procedure.

Multiple use in a single procedure would be something like using a scalpel for an incision, putting it down for suction, then making another incision with the same blade

I think the term procedure is well defined in the medical world.
 

Ronen E

Problem Solver
Moderator
Mark,

IMO, it's actually a good question with no good answer at the moment. It *is* ambiguous and the current rules / guidance I'm aware of don't fully clarify it. Somashekar is right - when in doubt, manage the risk.

My personal inclination is to be conservative - whenever there is doubt I assume "single procedure use" (usually with a conservative interpretation excluding "multiple sites on a single patient in a single procedure"). I also assume the authorities would take the conservative path, unless otherwise clearly stated by them. When I'm involved in a case where the intention is "single patient use" (implying multiple procedure use), I make sure that this is clearly spelled out in all relevant labeling.

Cheers,
Ronen.
 
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