hi

i have a few questions about the expiry date of the sterile items and packaging materials and i want your help

1. what is the shelf life of the packaging materials? (duration)
2. what is the expiration date of the sterile item wrapped with paper bags or transparant rels?
3. we have a sterile items (acoated vicryl polyglactine 910 braided absorbable suture and black silk braided non absorbable suture (single use) with an expiry date 6/2003 so question is can we use it with this expired date?

and if your answer was yes or no please give me any documents that would help me to use it as an evidence.
thank you

l.aljadi
CSSD

Dear L Aljadi,

Questions Q00093, Q00110, Q00117, Q00176, Q00196 and the EFHSS Education pages give answers to your questions.
Items which come from the manufacturer with an expiration date, such as your sutures, frequently have an expiration date because the materials degrade with time. I would advise against using these items past their expiration date unless the manufacturer gives you an OK to use the item.

Regards,
Pete Bobb

Dear,

In Belgium we use the following very general rule for determination of the peremption date. Medical devices packed in:

• 2 layers of packaging material: up to 2 months,
• 1 paper bag: up to 2 months,
• 1 laminated pouch: up to 6 months,
• 2 laminated pouches: up to 12 months.

Best regards,
Wim Renders

Dear L. Aljadi

Respond to point 1 of your question:
In general the protective standards required for packaging material by the Medical Devices Directive is limited for a total of five years. It means, once sterilized, the pack is capable of maintaining sterility for a period of up to five years less the time from manufacture of the packaging material to the time of sterilization i.e. if the pack is sterilized two years from the date of manufacture the item is capable of remaining sterile for at last three years.
This time is based on the historical evidence of packaging manufactured to British National Standards, which have been used for sterilized single item for over ten years.
However information on how long packaging material may be used depends on kind/quality/ storage condition of the packaging material and can therefore only be given by the manufacturer.
Wipak e.g. recommends that STERIKING heat-sealing pouches should be used within 5, self-sealing pouches within 2 years. Non-wovens e.g. Dextex - sheets within 5 years.
It is the users responsibility to ensure that packaging materials are stored in accordance with the manufacturer's recommendations. As a rule: Temperature between 18°C - 24°C, dry environment condition and avoiding storing near sources of heat or direct sunlight.

Kind regards
Josy Holdener

i have items like tabial nail from s&n it is stiraile with gamma radiaion there is expired date in thes items can i use as steril items

Dear Sharif

Only Smith-Nephew can give you an answer on which you can rely 100%.

Best regards
Josy Holdener