Is there an Industry Norm for Expiry of Sterilisation Validity?

mpfizer

Involved In Discussions
#1
For a sterile medical device is there an industry norm for expiry of sterilisation validity?

product says sterilisation date 09/2013 & sterilisation expiry 09/2016 what does it mean ? 30.09 2016 or any other date in September 2016 . The product has a three year sterilisation date .

how does the buyer know which date the the product was sterilised , if a product is sterilised say on 10.09.2013 can it mean expiry on 30.09.2016 ?? would that be a right understanding given the above .

why is only the month and year given and not the date is there any standard for this ?

Please help in clarifying

Thanks

michelle
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: sterilisation date expiry

For a sterile medical device is there an industry norm for expiry of sterilisation validity?

product says sterilisation date 09/2013 & sterilisation expiry 09/2016 what does it mean ? 30.09 2016 or any other date in September 2016 . The product has a three year sterilisation date .

how does the buyer know which date the the product was sterilised , if a product is sterilised say on 10.09.2013 can it mean expiry on 30.09.2016 ?? would that be a right understanding given the above .

why is only the month and year given and not the date is there any standard for this ?

Please help in clarifying

Thanks

michelle
Hi,

I don't think that there's a standard mandating the specification of the exact sterilization date (ie to the day), but I may be wrong.

Normally when expiry is indicated for a certain month it means by the end of the last day of that month. If a manufacturer states sterilization on a certain month and expiry by the same calendar month X years later, they should have validated the sterile barrier for (X*12)+1 month - worst case scenario. If they've only validated X years (X*12 months) they should have stated expiry by the previous month.

As the end user I would either sort it out with the manufacturer or assume expiry one month earlier than indicated. I think anyway most institutions have procedures to rotate stock and flag any sterile product that is <6 months from its expiry for urgent use (except for special cases where shelf life is inherently short).

Cheers,
Ronen.
 

rob73

looking for answers
#3
Michelle
MDD 93/42 13.3 "(e) where appropriate, an indication of the date by which the device
should be used, in safety, expressed as the year and month;"
Although ISO 15223 also states the day may also be added depending on the regional requirements.
 

Sam Lazzara

Trusted Information Resource
#5
Interestingly the US FDA UDI regulation requires any dates expressed on package labeling to be in YYYY-MM-DD format. That should eliminate possible confusion about end of month, start of month, etc.

US 21 CFR Part 801.18 Format of dates provided on a medical device label.
(a) In general. Whenever the label of a medical device includes a printed expiration date, date of manufacture, or any other date intended to be brought to the attention of the user of the device, the date must be presented in the following format: The year, using four digits; followed by the month, using two digits; followed by the day, using two digits; each separated by hyphens. For example, January 2, 2014, must be presented as 2014-01-02.

Sam Lazzara
2017-03-01
 

mpfizer

Involved In Discussions
#6
Re: sterilisation date expiry

Hi

If a manufacturer states sterilization on a certain month and expiry by the same calendar month X years later, they should have validated the sterile barrier for (X*12)+1 month - worst case scenario.
Thanks for the above reply , is there any standard or guidance for the above ?
If the manufacturer has validated sterile barrier (X*12)+2 can he claim the above ie say 03/16 to 03/19 three years because it is more than 36months ?

in short is there any law saying that if a manufacturer has validated procedure for say five years can he put a three year expiry ? if not why not ? or

is there any standard which says if the validity is for x months the manufacturer has to put expiry as x-1 ie for 36 months validation he should put 35 months expiry or any other equation

many thanks for your reply
 
Last edited by a moderator:

Ronen E

Problem Solver
Staff member
Moderator
#7
Re: sterilisation date expiry

Thanks for the above reply , is there any standard or guidance for the above ?
No, it's just common sense, for example sterilization on 3/2017 and expiry on 3/2020 means 37 months [(3*12)+1] at the worst case, because it could actually be sterilization on 1 march 2017 and expiry (or use) by 31 March 2020. Labelling indicating that the sterile barrier is effective for 37 months while it was only validated for 36 months is misleading / non-compliant.

If the manufacturer has validated sterile barrier (X*12)+2 can he claim the above ie say 03/16 to 03/19 three years because it is more than 36months ?

in short is there any law saying that if a manufacturer has validated procedure for say five years can he put a three year expiry ? if not why not ? or

is there any standard which says if the validity is for x months the manufacturer has to put expiry as x-1 ie for 36 months validation he should put 35 months expiry or any other equation
I'm not aware of any law or standard mandating indicating the max validated sterile barrier life on the labelling. As long as the validated life is longer than or equal to the stated/implied one, that's acceptable.
 
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