hello
a problem should our unit be double wrapping single items for out of theatre(we are one unit csd and theatre) units eg accident and emergency medical wards surgical wards podiatry out of hospital units doctors etc
if someone can verify for me
regards
elizabeth

Dear Elizabeth

EN 868-1 ("Packaging materials and systems for medical devices which are to be sterilized - general requirements") does not prescribe a certain packaging method, nor does it contain requirements for single or double layer packages. It contains a single requirement for sterility maintenance: "The packaging materials and/or systems assembled in the form in which they will be presented to the sterilizers, when assembled, stored, transported and used in accordance with the manufacturer's instructions, shall maintain the sterility of the contents from the time at which they are rendered sterile to the expiry date specified or to the point of use."
In fact there is little or no evidence that double peel pouches are required for in-hospital packaging. Consider that manufactures of sterile items, like gloves, syringes, and catheters, tubing gauzes e.g. only use one package and their products are shipped across the country and sometimes continents. A good quality peel pouch or paper sheet will keep the contents sterile until is opened or damaged. The only reason I know of why two peel pouches might be necessary is when several small items (pins, screws e.g.) have to be packed. In this case, the inner pouch is necessary for keeping the loose items together for presenting on the sterile field. Sterility maintenance of the device depends not only on the packaging material.
See the answer to question Q00048 by Pete Bobb and on the Educational page "Sterilization Basics: Packaging" from Jan Huys.
Conclusion: the use of double layer packages is not mandatory while the use of single layer packages is not excluded. As the above EN 868-1 does not specify any packaging procedures it is left to the hospitals to develop and validate a specific packaging concept.
Kind regards and good luck for your prevac!!

Kind regards
Josy Holdener