Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Greetings,

I've been tossed a particular problem that is throwing me for a loop...

My company's contract manufacturer builds an adhesive pad that uses a hypoallergenic, atraumatic, silicone gel that adheres to intact patient skin. The shelf-life for the adhesive is 18 months and is the limiting factor in the expiration date of the product (note, device is class I exempt).

Because we have 257 boxes of these pads that are set to expire in August and we have a low product volume, my manager wants to extend the shelf-life of the product beyond 18 months using risk analysis and customer complaints to justify a longer shelf-life.  

In parallel, my manager has also asked that we conduct real-time age testing of the finished product to determine if we see trends in real-time in conjunction with complaint data. 

This issue has multiple red flags for me since we lack in-depth knowledge of the material composition, structure, failure-mode mechanisms, etc. We have no understanding of what type of degradation the adhesive manufacturer noticed after 18 months, if the biocompatibility of the product decreases, if the storage requirements, etc.

Any assistance in formulating a very strong, sound argument either for or against this issue would be helpful. 

Greetings anon,

Putting aside the comments you already made which are red flags for you, which I agree completely, I would never ... well maybe never is a strong word ... but certainly would not use risk analysis and customer complaints for a longer shelf-life justification.  The primary reason being you have no data to support the device packaging, material composition, degradation, and shelf-life information to go out to say 24 months.  Unless those customer complaints were related to them using the device outside of the shelf life, in real world application complaints could not support because the customers should not be using beyond the 18 month shelf-life.  Thus you have no empirical data, customer complaints in this case is not a correct data source.  Risk analysis is a hazard identification process - not a shelf life testing tool.  Shelf life, expiration, and life cycle are addressed (should be addressed) in risk analysis but again without the data, you would have to say this could be a significant hazard.

What you should be looking at is performing accelerated age testing to take the device beyond 18 months.  Which then you can start the real-time study now as suggested by your manager to correlate any real time market information, i.e. customer complaints.  If you can not perform accelerated age testing on the product, in my opinion, you really do not have another option until the real time data is obtained.

More importantly, your organisation should be looking at the root cause of the incident rather than how to band-aid something.  Why are there 257 boxes left on a 18 month shelf life?  Is the forecasting and build process not sufficient?  Maybe think about having a shelf life review process where each month material is reviewed?  This is probably not something you already know about or are doing, but justifying something just to save product inventory is not always the answer.  Scrapping 257 boxes of material with no strong justification is better then getting into some regulatory issues.  Or better yet go to your Sales and Marketing group offering a "short sale" discounted price on the product ! At least can recoup some of the cost of the product.

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

Original Message:
Sent: 24-Apr-2020 11:00
From: Anonymous Member
Subject: Extending Product Shelf-Life

This message was posted by a user wishing to remain anonymous

Greetings,

I've been tossed a particular problem that is throwing me for a loop...

My company's contract manufacturer builds an adhesive pad that uses a hypoallergenic, atraumatic, silicone gel that adheres to intact patient skin. The shelf-life for the adhesive is 18 months and is the limiting factor in the expiration date of the product (note, device is class I exempt).

Because we have 257 boxes of these pads that are set to expire in August and we have a low product volume, my manager wants to extend the shelf-life of the product beyond 18 months using risk analysis and customer complaints to justify a longer shelf-life.

In parallel, my manager has also asked that we conduct real-time age testing of the finished product to determine if we see trends in real-time in conjunction with complaint data.

This issue has multiple red flags for me since we lack in-depth knowledge of the material composition, structure, failure-mode mechanisms, etc. We have no understanding of what type of degradation the adhesive manufacturer noticed after 18 months, if the biocompatibility of the product decreases, if the storage requirements, etc.

Any assistance in formulating a very strong, sound argument either for or against this issue would be helpful.

Original Message------

Greetings anon,

Putting aside the comments you already made which are red flags for you, which I agree completely, I would never ... well maybe never is a strong word ... but certainly would not use risk analysis and customer complaints for a longer shelf-life justification.  The primary reason being you have no data to support the device packaging, material composition, degradation, and shelf-life information to go out to say 24 months.  Unless those customer complaints were related to them using the device outside of the shelf life, in real world application complaints could not support because the customers should not be using beyond the 18 month shelf-life.  Thus you have no empirical data, customer complaints in this case is not a correct data source.  Risk analysis is a hazard identification process - not a shelf life testing tool.  Shelf life, expiration, and life cycle are addressed (should be addressed) in risk analysis but again without the data, you would have to say this could be a significant hazard.

What you should be looking at is performing accelerated age testing to take the device beyond 18 months.  Which then you can start the real-time study now as suggested by your manager to correlate any real time market information, i.e. customer complaints.  If you can not perform accelerated age testing on the product, in my opinion, you really do not have another option until the real time data is obtained.

More importantly, your organisation should be looking at the root cause of the incident rather than how to band-aid something.  Why are there 257 boxes left on a 18 month shelf life?  Is the forecasting and build process not sufficient?  Maybe think about having a shelf life review process where each month material is reviewed?  This is probably not something you already know about or are doing, but justifying something just to save product inventory is not always the answer.  Scrapping 257 boxes of material with no strong justification is better then getting into some regulatory issues.  Or better yet go to your Sales and Marketing group offering a "short sale" discounted price on the product ! At least can recoup some of the cost of the product.

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

Anam,

Sorry, I am not sure what you mean by a biowaiver for immediate released product.  This is not something I am familiar with in for medical devices, maybe for biologics or drug products this might be terms used.

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

Original Message:
Sent: 26-Apr-2020 04:51
From: Anam Mukhtar
Subject: Extending Product Shelf-Life

Hi Richard, 

Hope u fine. Actually i m new one in using this RAPS duscussion. I have a question if u can help me. Is there biowaiver for immediate release product over sustained release product. ?

Kindly reply me on mail. So that i can check.

Regards

Thank you.

Original Message------

Greetings anon,

Putting aside the comments you already made which are red flags for you, which I agree completely, I would never ... well maybe never is a strong word ... but certainly would not use risk analysis and customer complaints for a longer shelf-life justification.  The primary reason being you have no data to support the device packaging, material composition, degradation, and shelf-life information to go out to say 24 months.  Unless those customer complaints were related to them using the device outside of the shelf life, in real world application complaints could not support because the customers should not be using beyond the 18 month shelf-life.  Thus you have no empirical data, customer complaints in this case is not a correct data source.  Risk analysis is a hazard identification process - not a shelf life testing tool.  Shelf life, expiration, and life cycle are addressed (should be addressed) in risk analysis but again without the data, you would have to say this could be a significant hazard.

What you should be looking at is performing accelerated age testing to take the device beyond 18 months.  Which then you can start the real-time study now as suggested by your manager to correlate any real time market information, i.e. customer complaints.  If you can not perform accelerated age testing on the product, in my opinion, you really do not have another option until the real time data is obtained.

More importantly, your organisation should be looking at the root cause of the incident rather than how to band-aid something.  Why are there 257 boxes left on a 18 month shelf life?  Is the forecasting and build process not sufficient?  Maybe think about having a shelf life review process where each month material is reviewed?  This is probably not something you already know about or are doing, but justifying something just to save product inventory is not always the answer.  Scrapping 257 boxes of material with no strong justification is better then getting into some regulatory issues.  Or better yet go to your Sales and Marketing group offering a "short sale" discounted price on the product ! At least can recoup some of the cost of the product.

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

Original Message------

Anam,

Sorry, I am not sure what you mean by a biowaiver for immediate released product.  This is not something I am familiar with in for medical devices, maybe for biologics or drug products this might be terms used.

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

I think I understand your question! The answer is no! You will not get biowaiver for immediate release when you are comparing it to sustained release product. If my understanding of your question is incorrect, then let me know.

------------------------------
GRSAOnline
------------------------------

Original Message:
Sent: 03-May-2020 13:06
From: Anam Mukhtar
Subject: Extending Product Shelf-Life

Hi.

Oh ok. Actually this is related to drug product. 

Have you refer anyone for this answer. 

Actually i post on regulatory open forum.

Regards

Original Message------

Anam,

Sorry, I am not sure what you mean by a biowaiver for immediate released product.  This is not something I am familiar with in for medical devices, maybe for biologics or drug products this might be terms used.

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

Original Message------

I think I understand your question! The answer is no! You will not get biowaiver for immediate release when you are comparing it to sustained release product. If my understanding of your question is incorrect, then let me know.

------------------------------
GRSAOnline
------------------------------

This message was posted by a user wishing to remain anonymous

I don't understand the connection to complaints/ identifying risks with your device to increasing the shelf life. The two are not related...

In any event the "quick" fix is to conduct accelerated aging. I would also recommend reaching out to the vendor of the device as they may tell you it's pointless to extend shelf life testing or they may have already conducted it.
Original Message:
Sent: 24-Apr-2020 11:00
From: Anonymous Member
Subject: Extending Product Shelf-Life

This message was posted by a user wishing to remain anonymous

Greetings,

I've been tossed a particular problem that is throwing me for a loop...

My company's contract manufacturer builds an adhesive pad that uses a hypoallergenic, atraumatic, silicone gel that adheres to intact patient skin. The shelf-life for the adhesive is 18 months and is the limiting factor in the expiration date of the product (note, device is class I exempt).

Because we have 257 boxes of these pads that are set to expire in August and we have a low product volume, my manager wants to extend the shelf-life of the product beyond 18 months using risk analysis and customer complaints to justify a longer shelf-life.

In parallel, my manager has also asked that we conduct real-time age testing of the finished product to determine if we see trends in real-time in conjunction with complaint data.

This issue has multiple red flags for me since we lack in-depth knowledge of the material composition, structure, failure-mode mechanisms, etc. We have no understanding of what type of degradation the adhesive manufacturer noticed after 18 months, if the biocompatibility of the product decreases, if the storage requirements, etc.

Any assistance in formulating a very strong, sound argument either for or against this issue would be helpful.

You did not mention how you originally determined shelf life in your original regulatory submission. If you are extending shelf life using anew method that might require a new submission. FDA is picky about using new bench testing methods for new claims.

------------------------------
Edward Panek
VP, QA/RA
Blue Spark Technologies
------------------------------

Original Message:
Sent: 24-Apr-2020 11:00
From: Anonymous Member
Subject: Extending Product Shelf-Life

This message was posted by a user wishing to remain anonymous

Greetings,

I've been tossed a particular problem that is throwing me for a loop...

My company's contract manufacturer builds an adhesive pad that uses a hypoallergenic, atraumatic, silicone gel that adheres to intact patient skin. The shelf-life for the adhesive is 18 months and is the limiting factor in the expiration date of the product (note, device is class I exempt).

Because we have 257 boxes of these pads that are set to expire in August and we have a low product volume, my manager wants to extend the shelf-life of the product beyond 18 months using risk analysis and customer complaints to justify a longer shelf-life.

In parallel, my manager has also asked that we conduct real-time age testing of the finished product to determine if we see trends in real-time in conjunction with complaint data.

This issue has multiple red flags for me since we lack in-depth knowledge of the material composition, structure, failure-mode mechanisms, etc. We have no understanding of what type of degradation the adhesive manufacturer noticed after 18 months, if the biocompatibility of the product decreases, if the storage requirements, etc.

Any assistance in formulating a very strong, sound argument either for or against this issue would be helpful.

Let me address this in a few different ways.

The first is financial. You have slow moving inventory that, after expiration, you cannot sell. Presumably, you will pull it from stock and scrap it. This will incur a cost. However, if you can figure out a way to extend the shelf life, then you can avoid the scrap problem. Extending the shelf life also incurs a cost. Start by comparing costs to make the decision. (The assumption is that you have a shelf life extension method.) Often management will consider that there is no marginal cost for an employee's time, since the employee is paid regardless of the project.

Also, in the financial analysis, you need to understand why you had excess inventory. You should look at the parameters in your MRP system to get a better match between product demand and production.

Risk analysis and complaints can help you make the decision, but they are not the deciding factor.

The adhesive pad adheres to intact patient skin. In your ISO 14971:2019 risk management file you should have identified a hazard related to lack of adhesion. There should also be analyses of sequences of events, hazardous situations, harms, risk estimate, and risk acceptability evaluation.

If you have not already, write another sequence of events that includes shipping an expired product.

You want to ensure that each residual risk generated from this hazard is acceptable. In the expired shelf life case, the risk control measure would stop shipment of the expired product, so you should also consider the risk acceptability before that risk control measures.

In the next step, review all complaints related to this hazard. This is a standard practice, so you should have the information already. Lack of complaints, unfortunately, is not evidence that the risk control measures are effective.

Unless you have solid information on the adhesive's degradation model, an accelerated shelf life study is not practical. You won't know what factors to change to accelerate the degradation. I also infer that your contract manufacturer purchases the adhesive; this makes it less likely you can get the degradation model.

I recommend you start a real time study. Presumably you have a specification for the adhesion and a method to measure it. Write a (small sample) sampling plan and pull the sample once a month (say) from inventory. If the sample passes, extend the shelf life by one month.

I infer the device label has an expiration date, so you will need to update it before each shipment. I recommend putting the product into quarantine, and updating the label prior to shipment. The items in stock would have the original labels. (You will probably use a sticker with the new expiration date, so you don't want them to pile up.)

I also recommend you look at the contract manufacturer's inventory control methods for the adhesive. Presumably, your product's expiration date comes from the expiration date of the adhesive. Your contract manufacturer should first-in first-out, FIFO, inventory control. In addition, the lots they send to you should all come adhesive lots with the same expiration date.

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

Original Message:
Sent: 24-Apr-2020 11:00
From: Anonymous Member
Subject: Extending Product Shelf-Life

This message was posted by a user wishing to remain anonymous

Greetings,

I've been tossed a particular problem that is throwing me for a loop...

My company's contract manufacturer builds an adhesive pad that uses a hypoallergenic, atraumatic, silicone gel that adheres to intact patient skin. The shelf-life for the adhesive is 18 months and is the limiting factor in the expiration date of the product (note, device is class I exempt).

Because we have 257 boxes of these pads that are set to expire in August and we have a low product volume, my manager wants to extend the shelf-life of the product beyond 18 months using risk analysis and customer complaints to justify a longer shelf-life.

In parallel, my manager has also asked that we conduct real-time age testing of the finished product to determine if we see trends in real-time in conjunction with complaint data.

This issue has multiple red flags for me since we lack in-depth knowledge of the material composition, structure, failure-mode mechanisms, etc. We have no understanding of what type of degradation the adhesive manufacturer noticed after 18 months, if the biocompatibility of the product decreases, if the storage requirements, etc.

Any assistance in formulating a very strong, sound argument either for or against this issue would be helpful.