Ratgeber-Banner: Sterilisation und Instrumentenaufbereitung

Sterilisation and instrument reprocessing: what practices need

4 min reading time

To reprocess instruments in a medical practice, you need products for four steps: cleaning, disinfection, packaging and sterilisation, complemented by indicators and documentation. Which steps an instrument must go through depends on its risk classification under the joint recommendation of KRINKO and BfArM and on the manufacturer's reprocessing instructions.

Risk classification: what needs which reprocessing?

The joint recommendation of the German Commission for Hospital Hygiene and Infection Prevention (KRINKO) and the Federal Institute for Drugs and Medical Devices (BfArM) on the reprocessing of medical devices assigns instruments to risk groups according to how they are used. This classification determines which reprocessing steps, and therefore which equipment, you need. The practice, as the operator, carries out the classification itself, usually with the support of its hygiene officer.

Risk group	Type of contact	Usual reprocessing steps
Non-critical	Contact with intact skin only	Cleaning and disinfection
Semi-critical	Contact with mucous membranes or pathologically altered skin	Cleaning and disinfection, plus sterilisation depending on classification
Critical	Penetration of skin or mucous membranes, contact with blood	Cleaning, disinfection and sterilisation

Semi-critical and critical products are further divided into subgroups depending on how demanding reprocessing is, for example with lumens, joints or surfaces that are hard to reach. The higher the group, the higher the requirements for processes, equipment and staff expertise.

Cleaning, disinfection and care

Reprocessing starts immediately after use. For manual reprocessing you need instrument disinfectants, an instrument tub with a sieve insert from the instrument trays and jars category, and cleaning brushes in suitable sizes. When purchasing, these points count:

Products listed in the VAH list for instrument disinfection
Concentrate with a dosing aid or ready-to-use solution, depending on your workflow
Service life of the prepared solution according to the manufacturer
Material compatibility with your instruments according to the manufacturer

Automated processes using a washer-disinfector are easy to standardise and validate, and the KRINKO-BfArM recommendation generally gives them preference. After cleaning, hinged instruments are lubricated. You will find suitable products under instrument care. Make sure the care product is suitable for the subsequent sterilisation process according to its manufacturer.

Packaging: the sterile barrier system

Instruments that are used sterile are packaged before sterilisation. Common options are paper-film pouches and reels, sterilisation wrap and sterilisation paper, and reusable sterilisation containers. You will find a selection in the sterilisation packaging and containers category. The requirements for packaging of terminally sterilised medical devices are described in the DIN EN ISO 11607 series of standards.

Suitability of the packaging for your sterilisation process according to the manufacturer
Self-sealing pouches or heat-seal pouches, with a matching heat sealer for the latter
Formats to fit single instruments, sets and trays
A printed process indicator showing that the pack has been through the process

Sterilisation: autoclave or dry heat?

In practices, steam sterilisation in an autoclave is the common method. Small steam sterilisers are divided into classes B, N and S under DIN EN 13060. Class B is intended for wrapped and unwrapped loads including hollow items, class N only for unwrapped solid products. Class S covers the loads that the manufacturer explicitly specifies.

Hot air sterilisers work with dry heat. Before buying, check whether the process is approved by the respective manufacturers for your instruments and packaging and whether it meets the requirements of your hygiene plan. The Sterilisation category provides a complete overview. For every device, plan installation, validation and regular maintenance from the start.

Indicators and documentation

The German Medical Devices Operator Ordinance requires reprocessing to use suitable, validated processes and its success to be traceable. For purchasing, this means:

Chemical indicators according to DIN EN ISO 11140-1, for example process indicators on packaging
Test devices to demonstrate steam penetration, such as the Bowie-Dick test or helix test, depending on the device
Biological indicators, if your hygiene plan requires them
Labels for batch number, sterilisation date and release
A documentation system on paper or via software, often connected directly to the device

Purchasing checklist

Risk classification of all instruments agreed with the hygiene officer
Instrument disinfectant from the VAH list, instrument tub and brushes
Care product that suits the sterilisation process
Sterilisation packaging in suitable sizes, a heat sealer if needed
Steriliser to match your loads, including validation and maintenance
Indicators, test devices, labels and documentation
Protective gloves for reprocessing from the Gloves and Masks category
Check whether single-use instruments reduce the workload for rarely used instruments

This article is intended as purchasing guidance and does not replace professional hygiene advice.

Related categories:

Frequently asked questions

Which steriliser class does my practice need?

That depends on your loads. For wrapped instruments and hollow items, DIN EN 13060 provides for a class B device; make the decision together with your hygiene adviser and based on the manufacturer's information.

Which sterilisation packaging is the right one?

Paper-film pouches and reels are common for single instruments, containers and wrap for trays and sets. What matters is that the packaging and the sterilisation process are compatible according to the manufacturer.

Who determines the risk classification of instruments?

The practice as the operator, usually supported by its hygiene officer or an external hygiene adviser. The basis is the KRINKO-BfArM recommendation and the manufacturer's reprocessing instructions.

How long can packaged sterile goods be stored?

The storage period depends on the packaging and storage conditions. Define it in your hygiene plan and follow the information provided by the packaging manufacturer.

Are single-use instruments worthwhile instead of reprocessing?

Single-use versions exist for many standard instruments. Whether they are worthwhile depends on frequency of use, storage space and your internal workflows.

Put together your instrument reprocessing equipment in the Sterilisation category. If you are looking for a specific device or accessory that is not listed, send us a product request.