12th May 2004


A surgeon today in the hospital I work in refused to use a can of Steritalc because he said it was out-of-date. It had been sterilised on 6/2001 by gamma-irradiation. The nurse who contacted me said she thought that gamma-irradiation had an 'eternal' shelf life unless the package was damaged or compromised in some way.

Since then, (as well as ringing several companies), I have been told many different things relating to gamma sterilisation. Here are a few of them:

1. Sterilised by gamma gives an indefinite shelf life - 'event related sterility'.
2. Sterilised by gamma lasts for 5 years.
3. Sterilised by gamma lasts for 10 years.

I am none the wiser, and really want to do the right thing and want the 'right' answer!

Can any one out there help me please so I will have the right response if the situation arises again?

Regards
Lynne Cleary
CNC/Manager CSSD
Tasmania
Australia

Dear Lynne,

The peremption date of a product doesn't depend on the sterilization method (see other questions on this topic under the category Sterile Storage) but in the first place on the eventual degradation of the medical device, the packaging, storage conditions e.g..
The answer on question Q00117 explains why it is obligatory in Europe to put a peremption date on a product.

The maximum peremption date in the EEC is 5 years and has to do with the product liabilty of the manufacturer and the administrative provisions of the Medical Device Dirctive 92/42/EC.
The M.D.D. says in article 11, 11: "Decisions taken by the notified bodies in accordance with Annexes II and III shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both parties, for further periods of five years."
Annex III: EC Type-Examination says in 7.3: "The manufacturer or his authorized representative must keep with the technical documentation copies of EC type-examination certifcates and their additions for a period ending at least five years after the last device has been manufactured."
This five year period is also forseen in annexes II, IV and V.

I hope this helps you.
Best regards,
Wim Renders