Regulatory Open Forum

Dear all,

Please I need your advise on two points for patient specific implants.

- What expiry date should we put on the label for a non-sterile implant made of titanium? and should we take into account the validity of the CT image used for the manufacturing of the implant to determine the shelf life?

- For a sterile implant device should we put on the label as expiry date the validity of the sterilization method or Should we take into account in addition the validity of the CT image used for the manufacturing of the implant ?

My question is to decline surgeon responsibility (accurate imaging) witch could may be impacte the shelf life the device .

Sorry , but I very confuse on how and from when should determine the shelf life.

Thank you in advance for your reply.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Hello Nadine,

The questions you are asking have a bit more discussion around them which could probably not be answered fully in the foum.

For your first question: typically there is not a shelf life associated with a non-sterile implant product.  If this is a patient-specific made implant, then yes the validity of the CT image for the patient can have an impact on use or implantation of the device, but I would not confuse this with the "shelf life".  In the regulatory world, saying shelf life means something different from what you are referring.  The "validity of use" for the implant (or something like that) should be established between timeframes of CT scan image taken, manufacturing process, and when the physician would actual perform the implant.  This could be established in a "normal" amount of days something like 30 days.  But this information really needs to be conveyed to the physician understanding the risks of implanting a device say a year after CT scan was done because indeed something could have changed with the patient.

The second question is the shelf life is around the sterilisation and packaging integrity of the device.  Now this portion is the typical shelf life which would be expected on the device packaging.  Again, would not confuse this with the "validity of use" as this should be handled or done separately.

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

Original Message:
Sent: 15-Sep-2021 15:58
From: Nadine Adia
Subject: shelf life of patient specific medical device

Dear all,

Please I need your advise on two points for patient specific implants.

- What expiry date should we put on the label for a non-sterile implant made of titanium? and should we take into account the validity of the CT image used for the manufacturing of the implant to determine the shelf life?

- For a sterile implant device should we put on the label as expiry date the validity of the sterilization method or Should we take into account in addition the validity of the CT image used for the manufacturing of the implant ?

My question is to decline surgeon responsibility (accurate imaging) witch could may be impacte the shelf life the device .

Sorry , but I very confuse on how and from when should determine the shelf life.

Thank you in advance for your reply.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

The concept of shelf-life is very important and is not the same as the useful life of product.

Shelf life start at final packaging at the manufacturer until the device is used, i.e.. it is the time the "sits on the shelf" waiting to be used. Some devices have characteristics that change while on the shelf, often some chemical change. When the characteristic goes out of the specification, it is not usable. In the classic definition, this is the shelf life, and the date appears on the label.

To determine the shelf life, understand the characteristic that changes and determine its value over time through testing. In some cases you may be able to accelerate the the time using some environmental attribute, often temperature, that makes the change go faster.

For the sterility case the seal on the sterile barrier can change resulting in loss of integrity. The "bugs" don't grow back.

For a non-sterile titanium implant, I would not expect a shelf-life, so no expiray date. The validity of the CT image does not enter into the shelf life determination.

For the sterile titanium implant the sterilization method doesn't enter into the determination – the bugs don't grow back. The limiting factor the seal on the sterile barrier. Again, the CT image doesn't enter into the determination.

I don't see a mechanism where inaccurate imaging would affect the shelf life. However,, it could affect the use life. For example, if the implant has a waer-out mode, and inaccurate image may result in an implant that wears faster.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 15-Sep-2021 15:58
From: Nadine Adia
Subject: shelf life of patient specific medical device

Dear all,

Please I need your advise on two points for patient specific implants.

- What expiry date should we put on the label for a non-sterile implant made of titanium? and should we take into account the validity of the CT image used for the manufacturing of the implant to determine the shelf life?

- For a sterile implant device should we put on the label as expiry date the validity of the sterilization method or Should we take into account in addition the validity of the CT image used for the manufacturing of the implant ?

My question is to decline surgeon responsibility (accurate imaging) witch could may be impacte the shelf life the device .

Sorry , but I very confuse on how and from when should determine the shelf life.

Thank you in advance for your reply.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Hello Nadine,

The FDA guidance on additive manufacturing addresses this issue. It describes the validity of the CT scan that is the basis of the implant design as being relevant to the expiration date of the device. Both the validity of the imaging and the sterility validation should be considered, although the imaging issue may be able to be addressed using warnings/ precautions.

"Many implantable devices and their patient-matched accessories depend on the patient's anatomy to be clinically accurate representations of the recorded images in order for the device to function as intended. Specifically, when the device is intended to match a patient's anatomy, and that anatomy can change over time (e.g., with disease progression), the time that can elapse between when the patient is imaged and when the final device is used may need to be reflected in the expiration date of the device (see Section VII Labeling). You should consider such potential time constraints associated with producing an AM device based on the intended use of your device."

-Technical Considerations for Additive Manufactured Medical Devices, issued on December 15, 2017

------------------------------
Christopher Sims
Mahwah NJ
United States
------------------------------

Original Message:
Sent: 15-Sep-2021 15:58
From: Nadine Adia
Subject: shelf life of patient specific medical device

Dear all,

Please I need your advise on two points for patient specific implants.

- What expiry date should we put on the label for a non-sterile implant made of titanium? and should we take into account the validity of the CT image used for the manufacturing of the implant to determine the shelf life?

- For a sterile implant device should we put on the label as expiry date the validity of the sterilization method or Should we take into account in addition the validity of the CT image used for the manufacturing of the implant ?

My question is to decline surgeon responsibility (accurate imaging) witch could may be impacte the shelf life the device .

Sorry , but I very confuse on how and from when should determine the shelf life.

Thank you in advance for your reply.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Christopher,

Very good point !  I completely just blanked out on the Additive Manufacturing guidance which speaks about this topic - thanks for raising this point.

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

Original Message:
Sent: 16-Sep-2021 17:02
From: Christopher Sims
Subject: shelf life of patient specific medical device

Hello Nadine,

The FDA guidance on additive manufacturing addresses this issue. It describes the validity of the CT scan that is the basis of the implant design as being relevant to the expiration date of the device. Both the validity of the imaging and the sterility validation should be considered, although the imaging issue may be able to be addressed using warnings/ precautions.

"Many implantable devices and their patient-matched accessories depend on the patient's anatomy to be clinically accurate representations of the recorded images in order for the device to function as intended. Specifically, when the device is intended to match a patient's anatomy, and that anatomy can change over time (e.g., with disease progression), the time that can elapse between when the patient is imaged and when the final device is used may need to be reflected in the expiration date of the device (see Section VII Labeling). You should consider such potential time constraints associated with producing an AM device based on the intended use of your device."

-Technical Considerations for Additive Manufactured Medical Devices, issued on December 15, 2017

------------------------------
Christopher Sims
Mahwah NJ
United States

Original Message:
Sent: 15-Sep-2021 15:58
From: Nadine Adia
Subject: shelf life of patient specific medical device

Dear all,

Please I need your advise on two points for patient specific implants.

- What expiry date should we put on the label for a non-sterile implant made of titanium? and should we take into account the validity of the CT image used for the manufacturing of the implant to determine the shelf life?

- For a sterile implant device should we put on the label as expiry date the validity of the sterilization method or Should we take into account in addition the validity of the CT image used for the manufacturing of the implant ?

My question is to decline surgeon responsibility (accurate imaging) witch could may be impacte the shelf life the device .

Sorry , but I very confuse on how and from when should determine the shelf life.

Thank you in advance for your reply.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Perfect, thank you all ( @Richard Vincins, @Dan O'Leary, @Christopher Sims) for these excellent and useful replies.
Much appreciated.​​​​

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Original Message:
Sent: 17-Sep-2021 03:37
From: Richard Vincins
Subject: shelf life of patient specific medical device

Christopher,

Very good point !  I completely just blanked out on the Additive Manufacturing guidance which speaks about this topic - thanks for raising this point.

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

Original Message:
Sent: 16-Sep-2021 17:02
From: Christopher Sims
Subject: shelf life of patient specific medical device

Hello Nadine,

The FDA guidance on additive manufacturing addresses this issue. It describes the validity of the CT scan that is the basis of the implant design as being relevant to the expiration date of the device. Both the validity of the imaging and the sterility validation should be considered, although the imaging issue may be able to be addressed using warnings/ precautions.

"Many implantable devices and their patient-matched accessories depend on the patient's anatomy to be clinically accurate representations of the recorded images in order for the device to function as intended. Specifically, when the device is intended to match a patient's anatomy, and that anatomy can change over time (e.g., with disease progression), the time that can elapse between when the patient is imaged and when the final device is used may need to be reflected in the expiration date of the device (see Section VII Labeling). You should consider such potential time constraints associated with producing an AM device based on the intended use of your device."

-Technical Considerations for Additive Manufactured Medical Devices, issued on December 15, 2017

------------------------------
Christopher Sims
Mahwah NJ
United States

Original Message:
Sent: 15-Sep-2021 15:58
From: Nadine Adia
Subject: shelf life of patient specific medical device

Dear all,

Please I need your advise on two points for patient specific implants.

- What expiry date should we put on the label for a non-sterile implant made of titanium? and should we take into account the validity of the CT image used for the manufacturing of the implant to determine the shelf life?

- For a sterile implant device should we put on the label as expiry date the validity of the sterilization method or Should we take into account in addition the validity of the CT image used for the manufacturing of the implant ?

My question is to decline surgeon responsibility (accurate imaging) witch could may be impacte the shelf life the device .

Sorry , but I very confuse on how and from when should determine the shelf life.

Thank you in advance for your reply.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

This message was posted by a user wishing to remain anonymous

Hi Nadine - the shelf life of the patient specific implant is based solely on the validity of the imaging you used to create it. Our reviewer made us set it at 6months. We could not find any literature to refute this. This is the expiry date you must put on the label. 6 months is surprisingly short given that some patients have an old CT before setting a surgery date. They don't want to get a newer one because of time, inconvenience and exposure to more radiation. If you also use X-ray imaging as an input to your design you can key off that date as an alternative. Most doctors/patients are not nearly as reluctant to get new X-rays as they are to CT's.
Original Message:
Sent: 15-Sep-2021 15:58
From: Nadine Adia
Subject: shelf life of patient specific medical device

Dear all,

Please I need your advise on two points for patient specific implants.

- What expiry date should we put on the label for a non-sterile implant made of titanium? and should we take into account the validity of the CT image used for the manufacturing of the implant to determine the shelf life?

- For a sterile implant device should we put on the label as expiry date the validity of the sterilization method or Should we take into account in addition the validity of the CT image used for the manufacturing of the implant ?

My question is to decline surgeon responsibility (accurate imaging) witch could may be impacte the shelf life the device .

Sorry , but I very confuse on how and from when should determine the shelf life.

Thank you in advance for your reply.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Hi Ano,

You've touched on exactly our daily challenge.
Indeed generally we receive some CTs after 5 months and as you said they don't want to get a newer one because of time, inconvenience and exposure to more radiation.
6 monts were fix as shelf life but from my understanding this information is not accurate; if we have an image date from 5 months and the surgery is plan in 2 months. Knowing that anatomy can change over time (e.g., with disease progression), the time that can elapse between when the patient is imaged and when the final device is used
I think that adding the caution as indicated in  FDA guidance and as said above is more realistic.

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------

Original Message:
Sent: 17-Sep-2021 08:16
From: Anonymous Member
Subject: shelf life of patient specific medical device

This message was posted by a user wishing to remain anonymous

Hi Nadine - the shelf life of the patient specific implant is based solely on the validity of the imaging you used to create it. Our reviewer made us set it at 6months. We could not find any literature to refute this. This is the expiry date you must put on the label. 6 months is surprisingly short given that some patients have an old CT before setting a surgery date. They don't want to get a newer one because of time, inconvenience and exposure to more radiation. If you also use X-ray imaging as an input to your design you can key off that date as an alternative. Most doctors/patients are not nearly as reluctant to get new X-rays as they are to CT's.
Original Message:
Sent: 15-Sep-2021 15:58
From: Nadine Adia
Subject: shelf life of patient specific medical device

Dear all,

Please I need your advise on two points for patient specific implants.

- What expiry date should we put on the label for a non-sterile implant made of titanium? and should we take into account the validity of the CT image used for the manufacturing of the implant to determine the shelf life?

- For a sterile implant device should we put on the label as expiry date the validity of the sterilization method or Should we take into account in addition the validity of the CT image used for the manufacturing of the implant ?

My question is to decline surgeon responsibility (accurate imaging) witch could may be impacte the shelf life the device .

Sorry , but I very confuse on how and from when should determine the shelf life.

Thank you in advance for your reply.

Rgds,

------------------------------
Nadine Adia
Quebec QC
Canada
------------------------------