Hi every one

Could any one tell me of any EU legislation that prevents sterile items to be stored in dark cupboards.

Please give any reference or suggest any litrature.

Thank you all in anticipation for your kind answers.

Naveed Ahmed

Dear Ahmed

There is no EU Legislation that prevents storing sterile items in dark cupboards.
Most national standards e.g. DIN 58953-8 recommend the storage of sterile devices in closed cupboards.
But in praxis open shelving in CSSDs is the most common method.
Open shelving is economical, easy to clean, with easy access to supplies, but strict environmental control is needed.
Closed shelving/cupboards limit dust accumulation, discourage handling and minimize inadvertent contact with sterile items.
But if I read your question right, your concern is the "darkness" in the closed cupboard. Darkness providing a good growing condition for some bacteria/fungi. But to grow and multiply microbes must also have energy source such as nutrients, moisture and a favourable pH. To reduce this sources shelving/ cupboards should be cleaned on regularly (weekly) scheduled basis.

Kind regards
Josy Holdener

Dear Ahmed,

There are no EU regulations regarding storage of sterile medical devices.

When storing sterile medical devices there are two important aspects to consider.

1. Deterioration of device and packaging
2. Sterility

Time, storage conditions and handling must be considered. Nearly all materials age during storage. Sunlight, changes in temperture, relative humidity and exposure to contamination can affect sterility. It is recommended to protect goods from sunlight, this can make the packaging material brittle and destroy the sterile barrier system. Commercially produced sterile items are contained within 3 layers of packaging and remain in darkness for a considerable time. All handling, whereby goods are moved or touched exposes them to contamination. This includes routine cleaning procedures, so cleaning of storage areas should not be over done, especially with regard to the use of liquids. Humidity is a critical growth conditon for many microbes, especially moulds.
Recommendations in Norway for storage of sterile medical devices in hospitals are:
Temperature: 18-25 oC
Relative humidity: 35-75%
> 100 CFU/m3

I can recommend the following study which shows the affect handling has on sterility of goods.
"A new standard for sterility testing for autoclaved surgical trays". A.F. Widmer, et al. Journal of Hospital Infection (1992) 21, 253-260
also "Effects of long-term Storage on Sterile Status of Devices in Surgical Packs. N. Arlene Klapes et al., Infection Control 1987 / Vol.8 No.7

Regards
Linda Ashurst