Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Companies conduct packaging and shelf life testing for medical devices for the following reasons:

1. Show that the device is functional after aging (performance). This is doing device verification at T=2
2. The packaging and sterile barrier are intact after aging i.e. the device remains sterile in the primary pouch. This will include load test, dye test, seal test, burst test, etc. Once we do this, we can claim compliance to ISO 11607-1 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems). 

Often companies build one set of devices and accelerate age them, then do functional (#1) and packaging & shelf life testing (#2).  And companies build another set of devices and real time age them and do functional (#1) and packaging & shelf life testing (#2). 

1. ISO 11607-1 is only for packaging and shelf life (as per the scope), it does not state anything about functional performance (#1). Can anyone assist to provide a standard or any FDA guidance which requires companies to do performance testing after aging? I know companies do it as a best practise but which standard or regulations require us to do it?
2. We do accelerate aging (AA) and then do functional and packaging/shelf life testing and use that for our submissions to FDA. We also  real time age devices (RT) and repeat packaging/shelf life testing. My question is do we need to repeat functional testing after RT since we have already done functional testing upon AA? If yes, what is the rationale? If the answer to the above question was yes, does this mean we are doing functional testing (device verification) thrice; once at T=0 (no aging), then at AA at T=2 (for the submission) and then again after RT at T=2 (post submission)? If the answer to the question is yes, it seems overkill if there is no  requirement.
3. In order to claim a particular shelf life (1, 2 or 3 years) on your label, do we need both functional testing and packaging/shelf life testing OR we only need packaging/shelf life testing?

Kindly provide your experience and input. Thank you RAPS!

Dear Anon,

I am not aware of any guidance that requires functional testing after aging, or even for functional testing after shipping (the standards usually only call for package damage).  Although I do not work with all devices, and mostly with drug delivery and Combination Products, it has become standard practice for FDA to require that the device function (or now, meet "Essential Performance Requirements - EPRS) after shipping and at the end of expiration.

I believe that this is just an extrapolation of FDA's interpretation of the requirements of Design Verification and their current unstoppable march to require "worst-case" conditions as part of this Verification.

The latest draft of the ISO 11608-1 series, to be published this month, includes the confirmation of function after shipping and "functional stability" (testing at expiration) as part of Design Verification.

The requirement to retest at real time, even after accelerated aging is due to the application of the ASTM F1980 standard regarding packaging, which requires confirmation of AA with real time results.  However, once confirmed that they are predictive, real-time aging should not be required for testing modifications.

SO, I think you are stuck with testing function three times.  Once at T0, once after AA for submission (T2) and once at RT for confirmation after approval.

------------------------------
Lee Leichter RAC
President
P/L Biomedical
Fort Denaud FL
United States
------------------------------

Original Message:
Sent: 10-Mar-2022 22:16
From: Anonymous Member
Subject: Packaging and Shelf life Testing

This message was posted by a user wishing to remain anonymous

Companies conduct packaging and shelf life testing for medical devices for the following reasons:

1. Show that the device is functional after aging (performance). This is doing device verification at T=2
2. The packaging and sterile barrier are intact after aging i.e. the device remains sterile in the primary pouch. This will include load test, dye test, seal test, burst test, etc. Once we do this, we can claim compliance to ISO 11607-1 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems). 

Often companies build one set of devices and accelerate age them, then do functional (#1) and packaging & shelf life testing (#2).  And companies build another set of devices and real time age them and do functional (#1) and packaging & shelf life testing (#2).

1. ISO 11607-1 is only for packaging and shelf life (as per the scope), it does not state anything about functional performance (#1). Can anyone assist to provide a standard or any FDA guidance which requires companies to do performance testing after aging? I know companies do it as a best practise but which standard or regulations require us to do it?
2. We do accelerate aging (AA) and then do functional and packaging/shelf life testing and use that for our submissions to FDA. We also  real time age devices (RT) and repeat packaging/shelf life testing. My question is do we need to repeat functional testing after RT since we have already done functional testing upon AA? If yes, what is the rationale? If the answer to the above question was yes, does this mean we are doing functional testing (device verification) thrice; once at T=0 (no aging), then at AA at T=2 (for the submission) and then again after RT at T=2 (post submission)? If the answer to the question is yes, it seems overkill if there is no  requirement.
3. In order to claim a particular shelf life (1, 2 or 3 years) on your label, do we need both functional testing and packaging/shelf life testing OR we only need packaging/shelf life testing?

Kindly provide your experience and input. Thank you RAPS!

I generally adhere to FDA's timeless guidance document "SHELF LIFE OF MEDICAL DEVICES" from April 1991 which generally expects functional testing of the subject device unless a defensible risk-based exemption can be forged.

My experience with FDA has been that a) accelerated aging seems to always as a general rule need to be backed up by real time studies; and b) the real time study needs to test the same endpoints that were assessed in the accelerated study.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 10-Mar-2022 22:16
From: Anonymous Member
Subject: Packaging and Shelf life Testing

This message was posted by a user wishing to remain anonymous

Companies conduct packaging and shelf life testing for medical devices for the following reasons:

1. Show that the device is functional after aging (performance). This is doing device verification at T=2
2. The packaging and sterile barrier are intact after aging i.e. the device remains sterile in the primary pouch. This will include load test, dye test, seal test, burst test, etc. Once we do this, we can claim compliance to ISO 11607-1 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems). 

Often companies build one set of devices and accelerate age them, then do functional (#1) and packaging & shelf life testing (#2).  And companies build another set of devices and real time age them and do functional (#1) and packaging & shelf life testing (#2).

1. ISO 11607-1 is only for packaging and shelf life (as per the scope), it does not state anything about functional performance (#1). Can anyone assist to provide a standard or any FDA guidance which requires companies to do performance testing after aging? I know companies do it as a best practise but which standard or regulations require us to do it?
2. We do accelerate aging (AA) and then do functional and packaging/shelf life testing and use that for our submissions to FDA. We also  real time age devices (RT) and repeat packaging/shelf life testing. My question is do we need to repeat functional testing after RT since we have already done functional testing upon AA? If yes, what is the rationale? If the answer to the above question was yes, does this mean we are doing functional testing (device verification) thrice; once at T=0 (no aging), then at AA at T=2 (for the submission) and then again after RT at T=2 (post submission)? If the answer to the question is yes, it seems overkill if there is no  requirement.
3. In order to claim a particular shelf life (1, 2 or 3 years) on your label, do we need both functional testing and packaging/shelf life testing OR we only need packaging/shelf life testing?

Kindly provide your experience and input. Thank you RAPS!

This is in addition to the sterile packaging aspects of the applicable version of ISO 11607-1 as amended or its derivative.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 12-Mar-2022 14:56
From: Kevin Randall
Subject: Packaging and Shelf life Testing

I generally adhere to FDA's timeless guidance document "SHELF LIFE OF MEDICAL DEVICES" from April 1991 which generally expects functional testing of the subject device unless a defensible risk-based exemption can be forged.

My experience with FDA has been that a) accelerated aging seems to always as a general rule need to be backed up by real time studies; and b) the real time study needs to test the same endpoints that were assessed in the accelerated study.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 10-Mar-2022 22:16
From: Anonymous Member
Subject: Packaging and Shelf life Testing

This message was posted by a user wishing to remain anonymous

Companies conduct packaging and shelf life testing for medical devices for the following reasons:

1. Show that the device is functional after aging (performance). This is doing device verification at T=2
2. The packaging and sterile barrier are intact after aging i.e. the device remains sterile in the primary pouch. This will include load test, dye test, seal test, burst test, etc. Once we do this, we can claim compliance to ISO 11607-1 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems). 

Often companies build one set of devices and accelerate age them, then do functional (#1) and packaging & shelf life testing (#2).  And companies build another set of devices and real time age them and do functional (#1) and packaging & shelf life testing (#2).

1. ISO 11607-1 is only for packaging and shelf life (as per the scope), it does not state anything about functional performance (#1). Can anyone assist to provide a standard or any FDA guidance which requires companies to do performance testing after aging? I know companies do it as a best practise but which standard or regulations require us to do it?
2. We do accelerate aging (AA) and then do functional and packaging/shelf life testing and use that for our submissions to FDA. We also  real time age devices (RT) and repeat packaging/shelf life testing. My question is do we need to repeat functional testing after RT since we have already done functional testing upon AA? If yes, what is the rationale? If the answer to the above question was yes, does this mean we are doing functional testing (device verification) thrice; once at T=0 (no aging), then at AA at T=2 (for the submission) and then again after RT at T=2 (post submission)? If the answer to the question is yes, it seems overkill if there is no  requirement.
3. In order to claim a particular shelf life (1, 2 or 3 years) on your label, do we need both functional testing and packaging/shelf life testing OR we only need packaging/shelf life testing?

Kindly provide your experience and input. Thank you RAPS!

There are some interlocking questions, so I'll try to separate them.

In one case, you are asking about the stability of the device and in another you are asking about the stability of the sterile barrier.

If you claim a shelf-life for the device that means that something in the device changes over time such that the device no longer meets a specification. Determine the shelf-life through accelerated aging and real time aging. This applies to the device whether or not it is sterile.

If the device is supplied sterile, there is a question about how long and under what conditions the sterile barrier remains intact. This can apply to a device that that does deteriorate over time.

Is there a standard that requires functional testing after aging the device?
I don't know of a standard that defines how to perform a medical device aging test because of the great variety of medical devices. They are usually designed ad hoc using statistical methods. However, you cannot get any results unless you conduct a functional test.

For sterile barriers, the functional test is integrity such as load test, dye test, seal test, burst test, etc. These may also be part of a shipping and transportation study without an aging test.

When designing the functional aging and the packaging aging tests there are cost advantages to combining them since you can use fewer devise overall.

In conducting the device functional test, items subject to the acceleration factors are not suitable for the real time test. That is why you need to have two sets of devices.

In the device accelerated test, if the functional test is non-destructive then you could put the same items back on test for more time.

The sterile barrier tests, such as a burst test, is destructive. You cannot put the item back on test.

In the final question you ask if you need to do device testing three times. The answer is a qualified yes.

Test the device before starting the test (either real time or accelerated) so don't test a device that has already failed. For the devices in the accelerated test, you need to do a functional test to get the results. For the devices in the real time (which cannot be the devices in the accelerated test) you need to do a functional test to get the results.

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

Original Message:
Sent: 10-Mar-2022 22:16
From: Anonymous Member
Subject: Packaging and Shelf life Testing

This message was posted by a user wishing to remain anonymous

Companies conduct packaging and shelf life testing for medical devices for the following reasons:

1. Show that the device is functional after aging (performance). This is doing device verification at T=2
2. The packaging and sterile barrier are intact after aging i.e. the device remains sterile in the primary pouch. This will include load test, dye test, seal test, burst test, etc. Once we do this, we can claim compliance to ISO 11607-1 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems). 

Often companies build one set of devices and accelerate age them, then do functional (#1) and packaging & shelf life testing (#2).  And companies build another set of devices and real time age them and do functional (#1) and packaging & shelf life testing (#2).

1. ISO 11607-1 is only for packaging and shelf life (as per the scope), it does not state anything about functional performance (#1). Can anyone assist to provide a standard or any FDA guidance which requires companies to do performance testing after aging? I know companies do it as a best practise but which standard or regulations require us to do it?
2. We do accelerate aging (AA) and then do functional and packaging/shelf life testing and use that for our submissions to FDA. We also  real time age devices (RT) and repeat packaging/shelf life testing. My question is do we need to repeat functional testing after RT since we have already done functional testing upon AA? If yes, what is the rationale? If the answer to the above question was yes, does this mean we are doing functional testing (device verification) thrice; once at T=0 (no aging), then at AA at T=2 (for the submission) and then again after RT at T=2 (post submission)? If the answer to the question is yes, it seems overkill if there is no  requirement.
3. In order to claim a particular shelf life (1, 2 or 3 years) on your label, do we need both functional testing and packaging/shelf life testing OR we only need packaging/shelf life testing?

Kindly provide your experience and input. Thank you RAPS!