Regulatory Open Forum

Dear All,
Can I have your opinion on the use of new symbol - Single patient multiple uses? 

We have a disposable device intended to be used on a single patient for a maximum of 3 times. The device will run out of battery after these three uses and patients are suggested to complete full three sessions to achieve the best result. We use the Single-Use symbol under ISO15223-1: 2016 as the treatment sessions all together can be considered as a single procedure and there is no need to reprocess the device between each use. 

Reference: MHRA Single-Use Medical Devices Leaflet

However, under the draft of the latest version of ISO15223-1, there is a symbol called Single Patient Multiple Use. in the symbol table, it is explained that "the symbol Indicates a medical device that may be used multiple times (multiple procedures) on a single patient" and "a single patient multiple-use medical device or accessory may require processing between uses". I am not sure which symbol is the best in our case but I guess these are all down to the definition of "procedure". Do we have any references to explain this word? 

Reference: ISO15223-1_2020

Thanks,




------------------------------
Ning Wang
RA Manager
Abingdon
United Kingdom
------------------------------

Hello Ning,

I would imagine for your device being used by a single patient up to 3 times (based on battery life) then Single-Patient Use symbol would be more appropriate.  If you use the Singe-Use Only symbol with the 1 crossed out, this would assume the device should be used only one time, by one patient.  In fact, if you have validated use to be <3 then having the Single-Use Patient symbol and could also "create" a symbol with a "4" crossed out indicating the device can be used up to 3 times and not a fourth time.  To me there is too much emphasis put on 'processing' or 'reprocessing' before use on multiple-use devices.  In some cases, processing/re-processing might just be resetting the device or doing a quick cleaning.​

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 19-Mar-2021 14:46
From: Ning Wang
Subject: Single use and Single patient multiple use symbols

Dear All,
Can I have your opinion on the use of new symbol - Single patient multiple uses?

We have a disposable device intended to be used on a single patient for a maximum of 3 times. The device will run out of battery after these three uses and patients are suggested to complete full three sessions to achieve the best result. We use the Single-Use symbol under ISO15223-1: 2016 as the treatment sessions all together can be considered as a single procedure and there is no need to reprocess the device between each use.

Reference: MHRA Single-Use Medical Devices Leaflet

However, under the draft of the latest version of ISO15223-1, there is a symbol called Single Patient Multiple Use. in the symbol table, it is explained that "the symbol Indicates a medical device that may be used multiple times (multiple procedures) on a single patient" and "a single patient multiple-use medical device or accessory may require processing between uses". I am not sure which symbol is the best in our case but I guess these are all down to the definition of "procedure". Do we have any references to explain this word? 

Reference: ISO15223-1_2020

Thanks,




------------------------------
Ning Wang
RA Manager
Abingdon
United Kingdom
------------------------------

Hi Ning,
we had a sinmilar discussion regarding this symbol. Our endovascular thrombectomy device ("pipe cleaner" for clotted brain arteries -> stroke) can be brought into the stroke region, do some declotting, taken out, rinsed, and (after inspection) be used again up to three times in the same intervention. We went finally for single use only, because all time uses are in the same intervention, patient does not leave surgery in between.

------------------------------
Britta Cyron
Bochum
Germany
------------------------------

Original Message:
Sent: 19-Mar-2021 14:46
From: Ning Wang
Subject: Single use and Single patient multiple use symbols

Dear All,
Can I have your opinion on the use of new symbol - Single patient multiple uses?

We have a disposable device intended to be used on a single patient for a maximum of 3 times. The device will run out of battery after these three uses and patients are suggested to complete full three sessions to achieve the best result. We use the Single-Use symbol under ISO15223-1: 2016 as the treatment sessions all together can be considered as a single procedure and there is no need to reprocess the device between each use.

Reference: MHRA Single-Use Medical Devices Leaflet

However, under the draft of the latest version of ISO15223-1, there is a symbol called Single Patient Multiple Use. in the symbol table, it is explained that "the symbol Indicates a medical device that may be used multiple times (multiple procedures) on a single patient" and "a single patient multiple-use medical device or accessory may require processing between uses". I am not sure which symbol is the best in our case but I guess these are all down to the definition of "procedure". Do we have any references to explain this word? 

Reference: ISO15223-1_2020

Thanks,




------------------------------
Ning Wang
RA Manager
Abingdon
United Kingdom
------------------------------

Hello again,

Very interesting device use Britta ... can definitely see how would go with the single use only symbol.  I think this just shows how depending on the device there is just no one "right way" to apply regulatory requirements.  Definitely recommend documenting any reason or justification for symbols used especially when there are situations which has been presented as there may not always be one clear specific reason.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 22-Mar-2021 03:11
From: Britta Cyron
Subject: Single use and Single patient multiple use symbols

Hi Ning,
we had a sinmilar discussion regarding this symbol. Our endovascular thrombectomy device ("pipe cleaner" for clotted brain arteries -> stroke) can be brought into the stroke region, do some declotting, taken out, rinsed, and (after inspection) be used again up to three times in the same intervention. We went finally for single use only, because all time uses are in the same intervention, patient does not leave surgery in between.

------------------------------
Britta Cyron
Bochum
Germany

Original Message:
Sent: 19-Mar-2021 14:46
From: Ning Wang
Subject: Single use and Single patient multiple use symbols

Dear All,
Can I have your opinion on the use of new symbol - Single patient multiple uses?

We have a disposable device intended to be used on a single patient for a maximum of 3 times. The device will run out of battery after these three uses and patients are suggested to complete full three sessions to achieve the best result. We use the Single-Use symbol under ISO15223-1: 2016 as the treatment sessions all together can be considered as a single procedure and there is no need to reprocess the device between each use.

Reference: MHRA Single-Use Medical Devices Leaflet

However, under the draft of the latest version of ISO15223-1, there is a symbol called Single Patient Multiple Use. in the symbol table, it is explained that "the symbol Indicates a medical device that may be used multiple times (multiple procedures) on a single patient" and "a single patient multiple-use medical device or accessory may require processing between uses". I am not sure which symbol is the best in our case but I guess these are all down to the definition of "procedure". Do we have any references to explain this word? 

Reference: ISO15223-1_2020

Thanks,




------------------------------
Ning Wang
RA Manager
Abingdon
United Kingdom
------------------------------

Hello Ning,

I would consider the use time and how long it is interrupted.

Let me  pick two example to illustrate the approach.
For me, a implantable peacemaker is a single patient single use device with a use time of multiple years.
At the other side, a body worn insulin pump may be assessed as a single patient multiple use device (used as a system with single patient single use disposables).

------------------------------
Uwe Zeller | Regulatory Affairs / Risk Management Consultant
Biberach an der Riß, Germany
------------------------------

Original Message:
Sent: 22-Mar-2021 03:11
From: Britta Cyron
Subject: Single use and Single patient multiple use symbols

Hi Ning,
we had a sinmilar discussion regarding this symbol. Our endovascular thrombectomy device ("pipe cleaner" for clotted brain arteries -> stroke) can be brought into the stroke region, do some declotting, taken out, rinsed, and (after inspection) be used again up to three times in the same intervention. We went finally for single use only, because all time uses are in the same intervention, patient does not leave surgery in between.

------------------------------
Britta Cyron
Bochum
Germany

Original Message:
Sent: 19-Mar-2021 14:46
From: Ning Wang
Subject: Single use and Single patient multiple use symbols

Dear All,
Can I have your opinion on the use of new symbol - Single patient multiple uses?

We have a disposable device intended to be used on a single patient for a maximum of 3 times. The device will run out of battery after these three uses and patients are suggested to complete full three sessions to achieve the best result. We use the Single-Use symbol under ISO15223-1: 2016 as the treatment sessions all together can be considered as a single procedure and there is no need to reprocess the device between each use.

Reference: MHRA Single-Use Medical Devices Leaflet

However, under the draft of the latest version of ISO15223-1, there is a symbol called Single Patient Multiple Use. in the symbol table, it is explained that "the symbol Indicates a medical device that may be used multiple times (multiple procedures) on a single patient" and "a single patient multiple-use medical device or accessory may require processing between uses". I am not sure which symbol is the best in our case but I guess these are all down to the definition of "procedure". Do we have any references to explain this word? 

Reference: ISO15223-1_2020

Thanks,




------------------------------
Ning Wang
RA Manager
Abingdon
United Kingdom
------------------------------