Date of Manufacture and Expiration (Sterile Medical Device) question

fialor

Involved In Discussions
#1
My company is currently in discussion on how to represent dates of manufacture for a sterile device. I would appreciate some feedback from those who have a grasp of the details of this.

The dates format being discussed is the following examples:
* manufacturing date - 09/2016
* expiry date - 09/2017

The issue is, this is being read two ways in our usability study:
1* 13 months and
2* 12 months

Option 1 is read as the first day of the month of manufacture and the last day of the month of expiry hence 13 months.

Option 2 is read as first day of the month of manufacture and the last day of the month before the month of expiry.

Is there a guide to using months instead of the actual day of the month and year that I could be pointed to help with this dilemma?
Thanks!
 
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shimonv

Trusted Information Resource
#2
Re: Dates of Manufacture and Expiration (Sterile Medical Device) question

Hi,
Two suggestions:
1. Perhaps you can do without the manufacturing date. The important thing with a sterile device is its expiration date.
2. You should add a section for symbols in your instructions for use where you can show the symbol and text that says: "the device should not be used after the end of the year, month or day shown" as per EN ISO 980 - Symbols for use in the labelling of medical devices.

Hope it helps.

-Shimon
 
S

Schmadam

#3
If you are selling this medical device in the US and your device falls under the FDA's new UDI (Unique Device Identifier) system, the date of expiration has to be displayed in the following format... YYYY-MM-DD.
 
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