The BfArM has gained knowledge about possible microbial contaminations of carrier trays made of moulded fibre materials, which were enclosed in so-called operation kits. During a review of sterilized surgical kits, a manufacturer identified such non-sterile carrier trays using a standard method for determining the total bacterial count. There is a risk of recontamination of the surgical devices and a possible infection of patients, if a non-sterile surgical kit is used in the surgical area.

Carrier trays made of moulded fibre material are disposable medical devices made of cellulose, recycled paper, cardboard, or similar moulded fibre materials and used for short-term use as kidney dishes or instrument trays, e.g. for holding instruments, body excrements or smaller wastes in the medical field.

The microbiological findings suggest that medical devices made of moulded fibre materials should not be used as part of a sterile treatment unit in the operating theatre when sterilised using conventional sterilisation procedures for surgical kits.

From the BfArM's point of view, the prerequisite for sterile applications is that the manufacturer describes a validated sterilisation procedure in the instructions for use for its carrier trays in sterile treatment units and that this is followed by the users. If this is not the case, the BfArM recommends using carrier trays made of moulded fibre material only for non-sterile applications.

In addition, we would like to point out that imprints such as "sterilizable" on the moulded fibre trays are no guarantee that the products will actually be sterile after sterilization that has not been performed according to a validated sterilization instruction.

In case of questions please contact:

Federal Institute for Drugs and Medical Devices
Medical Devices Division
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Telephone: +49 (0)228 99 307-3202 (Non-active medical devices)
Facsimile: +49 (0)228 99 307-5300
E-Mail: md-vigilance@bfarm.de