Dan let me disagree on two things.
1) you say that "Regardless of its age, when the customer installs it, the device has its full functionality as a filter." I did not see any comment in Anon's thread that if the product exceeds the shel-life and installed for 6 months that it maintains its functionality. This requires functional safety/testing studies after real time aging. I am not sure that they have such data.
2) you said "What happens to the device that makes you think it is no longer sterile at the end of six months?". A lot of things can happen by then. There are a lot of parameters that can compromise the integrity of the packaging system, such as temperature, humidity, lighting, normal degradation of the packaging materials, human factors, etc. You believe that once a sterile device is sterilized and packaged properly, it will never grow microorganisms inside?
Anon, in general, this question is not an easy one. If your device will be used for a period of 6 months, you can check the functionality for 6 months after the device expires. You did not say anything about the shelf-life of the device, but imagine having a device on a shelf with no a/c (probably 10C during winter and 30C during summer) for 3 years. The plastic components do not live forever...
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Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
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Original Message:
Sent: 25-Nov-2020 16:26
From: Dan O'Leary
Subject: Expiration Date/Use by Date: Long Term Disposable Medical Device
The concept of setting an expiration date for a device is simple. (The implementation – not so much.) The device has some important characteristic that changes over time while the device is on the shelf. At some point, the characteristic goes out of specification, and so the device doesn't function as intended.
It sounds to me that your device doesn't have that issue. Regardless of its age, when the customer installs it, the device has its full functionality as a filter. Then, I infer the filter "gets used up" after six months. To go to a more extreme case, assume the customer stored the filter correctly and installed it on Jan. 1, 2022. The customer would expect to get six months of correct filtration. The customer would replace the filter on July 1, 2022.
You say the shelf life is based on packaging sterility. What happens to the device that makes you think it is no longer sterile at the end of six months? The "bugs" don't grow back. The sterile barrier doesn't have a small leak that lets new "bugs" in. What did you test to set the expiration date at six months? What is the mechanism by which a properly packaged and sterilized device loses sterility while sitting on the shelf?
Back to my example. On Jan. 1, 2022 the customer would throw away the unopened filter believing it is no longer sterile, rather than believing it will no longer filter.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 25-Nov-2020 14:49
From: Anonymous Member
Subject: Expiration Date/Use by Date: Long Term Disposable Medical Device
This message was posted by a user wishing to remain anonymous
All,
We currently sell Class II long term disposable medical devices (water filters), which last for ~6months in use. As it relates to the expiration date, I want to understand the limitations.
Question: Can a customer install the device prior to expiration, but use after expiration? Meaning, if the expiration date is 11/25/2020, can the customer install the device on 11/24/2020, and still get 6 months use out of the device?
As our expiration date primarily is based on the packaging sterility, and performance testing is not a concern as simulated use testing is conducted after expiration for up to 1 year, what are your thoughts? Does expiration mean expiration?