§ 7 Reprocessing instruments and sterilisation

In detail

Principles for instruments and materials

• Only CE-marked medical devices are used, for the purpose the manufacturer set Hygiene-V § 20(1).
• Single-use instruments are disposed of after one use; reusable ones are used, cleaned, disinfected and, depending on use, sterilised as the manufacturer specifies § 20(2), (4).
• Clean and unclean material are kept apart, in storage too; used material always counts as unclean. There are instructions for reprocessing that the staff concerned demonstrably know § 21.

The reprocessing procedure

• Reprocessing covers cleaning, disinfection and sterilisation with the related steps, and checking and restoring technical and functional safety. The reprocessed device must pose no risk, from infection or changed function for example § 23(1)–(2).
• For devices used low-germ or sterile there is a zone for clean and unclean. It can be separated by space or by time, within one room too § 23(3).
• A doctor or a member of staff is named responsible for reprocessing § 23(4).
• Cleaning and disinfection are manual or in washer-disinfectors § 23(6). Manual procedures follow documented standard operating procedures with tested agents suited to the device § 23(8).
• Sterilisation uses a steam steriliser to ÖN EN 285 or EN ISO 13060: at least 3 minutes at 134 °C or 15 minutes at 121 °C. The actual pressure and temperature are documented, printed or stored electronically. Instruments with cavities need a pre-vacuum process § 23(7).

Packing and storage

Sterile goods are packed with a heat sealer or in sterile containers, stored dry and dust-free, and labelled § 24.

Wound care and endoscopes

• For instruments used to change dressings and remove stitches, manual cleaning and disinfection with a tested product is enough; for wound care, the wound kit is also sterilised § 26.
• Endoscopes are pre-cleaned right after use following a work instruction. Endoscopes without a working channel are reprocessed by machine with records, or by hand with instructions and a daily signature; endoscopes with a working channel in a washer-disinfector, by hand only in an emergency; endoscopes for sterile areas are sterilised as well § 27. Every endoscope reprocessing is logged, following the template in Annex 1 § 29. Contaminated endoscopes and instruments go in separately marked containers § 30.

Records and doubtful cases

• The legally required record of reprocessing applies even when an external contractor reprocesses for you, wholly or partly § 5(2)(f).
• If in doubt whether something can be reprocessed, use single-use products. When buying a device, ask for a statement on how it is reprocessed § 28.
• External validation of reprocessing is needed only if an authority demands it with reason, unless § 68 of the Medical Devices Act says otherwise § 25.

The template forms of Annex 1 and the further annexes, on risk assessment and reprocessing for example, can be downloaded from the Medical Chamber, ÖQMED and www.arzthygiene.at § 31.