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Advices for the application of NaCl basin liners

Ref.-No. 3686/14

Sterile covers/liners/inserts are intended to be used with NaCl bowls which may be electrically heated. Manufacturers claim that disinfection / sterilisation of the electrically heated NaCl bowls could thus be omitted.

BfArM received reports where following problems occurred:
- damage of the liners through sharp-edged OP devices or bone parts during use
- holes/breakages due to folding of the packed liners
- damage through melting due to local overheating of the NaCl bowl
- optical masking of the control elements of the NaCl bowl

The liners may show different design solutions, and not all liners may show the listed problems. Nevertheless, when the liners are damaged the sterility of the liner/basin content cannot be assured. So far, BfArM could not identify a therapy or usage where the use of these liners could not be omitted. Further, we could not identify a direct medical benefit for the patient, and we see primarily economical considerations in the usage of these liners.

Manufacturers of liners and/or bowls should provide evidence of compatibility of the covers/liners with NaCl bowls, and vice versa. Users should obtain information from the manufacturers to ensure compatibility.

In case of questions please contact:

Federal Institute for Drugs and Medical Devices
- Medical Devices Division -
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Facsimile: +49 (228) 207-5300
E-Mail: medizinprodukte@bfarm.de
phone: (0228) 207-4962 (Nichtaktive Medizinprodukte)

Date 2015.01.29