How must instrument reprocessing be documented?
How do I document instrument reprocessing correctly?
Legal basis, batch control and audit-proof release — this is how your documentation becomes complete and inspection-ready.
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Short answer
Every batch must be checked, released and documented in a traceable way. Handwritten records are permitted — but going paperless (e.g. with SteriTrace) saves time and makes your documentation audit-proof.
Documentation & batch release done right
Download the free template for handwritten batch release here.
How must instrument reprocessing be documented?
Legal basis of instrument reprocessing
The legal basis of instrument reprocessing is described in the guideline of the Robert Koch Institute (RKI). This RKI guideline was drawn up together with the Commission for Hospital Hygiene and Infection Prevention (KRINKO). Proper reprocessing is presumed under the Medical Devices Operator Ordinance (MPBetreibV, § 8 para. 2) if the recommendation „Requirements for hygiene in the reprocessing of medical devices“ is observed. In the RKI recommendation, the instrument reprocessing process is divided into the following 4 areas:- Instrument classification
- Reprocessing cycle
- Documentation
- Validation
- At least 5 years' retention obligation according to RKI
- 5 or 10 years according to StGB §78
- 30 years according to BGB §199
A reversed burden of proof applies to instrument reprocessing.
- A physician (the operator) must always be able to prove that the instrument reprocessing was successful.
- The documentation is necessary to safeguard against claims for damages resulting from negligent conduct.
Correct documentation of instrument reprocessing
The minimum requirements for the documentation of instrument reprocessing are described in device-specific standards.- EN 13060: The standard for small steam sterilizers (up to a chamber volume of 24 litres)
- EN 285: The standard for large steam sterilizers (from a chamber volume of 24 litres)
- EN ISO 15883: The standard for washer-disinfectors (cleaning and disinfection devices)
- EN 13060 stipulates that an automatic process evaluation system must be integrated into the autoclave. This means the autoclave continuously and automatically checks all relevant process parameters during the sterilization of instruments. It is therefore not necessary to manually check the process parameters such as the temperature reached and the holding time after sterilization. The autoclave must be able to do this itself.
- EN 13060 prescribes the presence of a fault detection system. For this reason, several high-precision temperature sensors, at least one pressure sensor and a precise real-time clock are built into autoclaves. Which faults must be detected is also described in the standard EN 13060.
- EN 13060 stipulates that the autoclave must be able to create process documentation itself. Most autoclaves are equipped with a printer or USB port in order to meet precisely this requirement of the standard. The documentation is therefore printed by the autoclave during the sterilization of instruments or saved to a stick.
Do the sterilization records have to be printed out to document instrument reprocessing?
The RKI recommendation is very clear here: No. It can be inferred from the RKI recommendation that the sterilization records do not necessarily have to be printed out. The records can also be saved on appropriate data media for archiving. The RKI (source: Robert Koch Institute „Requirements for hygiene in the reprocessing of medical devices“) states: „The measured values of the process parameters recorded during reprocessing … are to be documented. The records may also be kept on image or data media“.
The documentation options for Steri24 devices are:
| Device | Documentation options |
| Klasse B Pro autoclaves |
|
| Aqua-Plus washer-disinfector |
|
Data backups: The data on the USB stick should be backed up at regular intervals (for example weekly) to a PC or hard drive. According to a survey by Steri24, 94% of clinics and practices in the D-A-CH region use a USB stick to save the records from the autoclave. Printing out records is not mandatory. In general, the complete documentation of instrument reprocessing can be carried out entirely paperlessly.
How does correct batch control work for autoclaves in instrument reprocessing?
If hollow items such as handpieces are also sterilized in the autoclave, then a Helix test or PCD test (Process Challenge Device) is required. The aim of the test is to verify whether the sterilization of hollow items (e.g. handpieces) was successful. If no hollow items are sterilized in the autoclave and only simply packaged instruments are processed, a Class 5 indicator is sufficient.How do I use the Helix test? The Helix test consists of a Helix test device into which a test strip can be inserted. The test device simulates the geometry of a hollow item. Before each sterilization process a new test strip is inserted into the Helix test. The Helix test body is then placed into the autoclave together with the instruments and sterilized along with them. After sterilization, a colour change of the test strip indicates whether the sterilization was successful or not.
The manufacturer's recommendation for the Klasse B Pro autoclaves from our shop for routine operation also corresponds to the RKI recommendations. The recommendation is as follows:
| Schedule | Description of the check |
|---|---|
| Every day the steri is used | Visual inspection of the autoclave for damage Check of the autoclave display for warnings |
| Once a week before starting work | Start of the "Vacuum test" programme |
| With every sterilization cycle |
|
How does correct batch release work in instrument reprocessing?
The batch release phase begins after the sterilization cycle has been completed by the autoclave. A "release for the use of instruments" must be carried out by trained personnel. We train your staff with a training certificate - contact us. Probably the most frequently used method of batch release is by means of a checklist and documentation in a steri logbook. You do not have to spend any money on this. We are happy to send you a print template of the steri logbook. You can print out the documents and file them in a folder. Contact us via the contact form or chat and leave us your email address.The trained personnel must carry out the following steps:
-
Process evaluation: The Steri24 devices are equipped with an automatic EN 13060-compliant process evaluation. It is therefore sufficient to read the result of the sterilization record on the autoclave display. The process evaluation is carried out by the device itself without any additional work for the personnel.
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Documentation of the batch indicators: The batch indicators (positive / negative) must be documented.
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Visual inspection: A visual inspection must be carried out, for example for residual moisture or torn packaging. There is again a separate checklist for this, which we are happy to provide on request. Contact us.
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Release for reuse: The release for reuse is to be carried out by means of a signature.
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Labelling of packaged instruments: The packaged instruments are to be labelled by indicating the autoclave, the daily date, the use-by date, the batch no. and the person ID. There is a standardised label gun for this.
Figure 1: Template for documenting batch release
The packaging is labelled after autoclaving using a labelling tool. The label must contain at least the following information.
|
Personnel no. | Device no. | Batch no. |
The "Use by" date is usually 6 months after the date of sterilization.
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„Is my handwriting enough for the authorities?“
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Frequently Asked Questions
Documentation of instrument reprocessing – key questions answered clearly.
How must instrument reprocessing be documented?
Every batch must be checked, released and documented in a traceable way. Recorded are the process parameters of the sterilization cycle, the batch indicators, the visual inspection and the signed release. This can be done by hand (e.g. in the steri logbook) or paperlessly with SteriTrace.
Is handwritten documentation of reprocessing permitted?
Yes, handwritten documentation, for example via a batch release template and a steri logbook, is permitted. However, the digital, paperless option with SteriTrace is safer and makes your documentation audit-proof, because every batch is backed up multiple times.
What is the legal basis for documenting instrument reprocessing?
The central basis is the RKI recommendation „Requirements for hygiene in the reprocessing of medical devices“, drawn up together with the KRINKO. If it is observed, proper reprocessing is presumed under the Medical Devices Operator Ordinance (MPBetreibV, § 8 para. 2).
Into which areas does the RKI recommendation divide the reprocessing process?
The RKI recommendation divides the process into four areas: instrument classification, reprocessing cycle, documentation and validation. Weaknesses in one sub-step can negatively affect the overall result during an inspection.
What does the reversed burden of proof mean in instrument reprocessing?
A reversed burden of proof applies to instrument reprocessing: the operator (e.g. the physician) must be able to prove at any time that reprocessing was successful. The documentation therefore serves to safeguard against claims for damages resulting from negligent conduct.
How long must the sterilization and release records be retained?
The retention periods vary depending on the legal basis: at least 5 years according to RKI, up to 10 years according to StGB §78 and up to 30 years according to BGB. We recommend keeping the entire documentation for 30 years, ideally digitally.
Do the sterilization records have to be printed out?
No. According to the RKI recommendation, the records do not necessarily have to be printed out; they may also be kept on image or data media. The documentation can therefore be carried out entirely paperlessly.
Which standards govern the minimum requirements for documentation?
The device-specific standards define the minimum requirements: EN 13060 for small steam sterilizers up to 24 litres chamber volume, EN 285 for large steam sterilizers from 24 litres and EN 15883 for washer-disinfectors. All Steri24 autoclaves comply with EN 13060.
What does the standard EN 13060 require regarding documentation?
EN 13060 requires an automatic process evaluation system, a fault detection system and the ability of the autoclave to create process documentation itself. The autoclave checks all relevant parameters automatically and outputs the result.
Do I have to check the process parameters manually after sterilization?
No. Thanks to the automatic process evaluation system according to EN 13060, the autoclave continuously checks all relevant parameters such as temperature and holding time itself. It is sufficient to read the result of the sterilization record on the display.
How does correct batch release work?
Batch release begins after the sterilization cycle has been completed and must be carried out by trained personnel. The steps are: process evaluation on the display, documentation of the batch indicators, visual inspection, release by signature and labelling of the packaged instruments.
What must batch release include?
Batch release according to RKI comprises the process evaluation, the documentation of the batch indicators (positive/negative), a visual inspection (e.g. for residual moisture or torn packaging) and the release for use by signature. It can be done by hand or digitally with SteriTrace.
Who is allowed to carry out batch release?
Release for use must be carried out by trained personnel. Steri24 trains your staff on request with a training certificate. Feel free to contact us via the contact form or chat.
What must appear on the labelling tag of the instruments?
The label must contain at least the personnel no., device no. and batch no., the date of sterilization and the „Use by“ date. The expiry date is usually 6 months after sterilization. Labelling is done, for example, with a labelling tool.
How long can autoclaved instruments be used?
The „Use by“ date is usually 6 months after the date of sterilization. It is noted on the label of the packaging together with the batch, device and personnel.
How does batch control work for autoclaves?
If hollow items such as handpieces are sterilized, a Helix or PCD test (Process Challenge Device) is required. If only simply packaged instruments without hollow items are sterilized, a Class 5 indicator is sufficient. The test is sterilized along with the load in every cycle.
How do I use the Helix test correctly?
A new test strip is inserted into the Helix test device, which simulates the geometry of a hollow item, before each cycle. The Helix test body is sterilized together with the instruments. A colour change of the strip then indicates whether the sterilization was successful.
When is a Class 5 indicator sufficient and when do I need a Helix test?
A Class 5 indicator is sufficient if only simply packaged instruments without hollow items are sterilized (critical A). As soon as hollow items such as handpieces are reprocessed (critical B or A-B), a Helix/PCD test is required with every sterilization.
Do the test indicators have to be kept after sterilization?
No, it is not necessary to keep the test indicators. However, the result of the batch indicators (positive/negative) is documented as part of the batch release.
How often must the vacuum test be carried out and documented?
The manufacturer's recommendation, in line with the RKI, provides for the vacuum test once a week before starting work. In addition, a daily visual inspection of the device and the display for warnings must be carried out.
Which daily checks are recommended to be documented for the autoclave?
On every day the autoclave is used, a visual inspection for damage and a check of the display for warnings should be carried out. Weekly, the vacuum test is added, and with every cycle the appropriate batch indicators.
How are the sterilization cycles documented and where are the records stored?
With the Premium autoclave, all cycles are stored automatically internally (up to 100,000 records) and can be transferred via SD card/USB stick as well as over WLAN/LAN. With the Pro devices, a USB stick is required, which is plugged into the interface box; storage runs fully automatically.
How do I back up the records on a USB stick?
The records can be backed up on a USB stick; the USB port is located on the right of the door or at the bottom right of the device. Use a stick that is as empty as possible with max. 16 GB and FAT formatting. The records are saved as txt files.
How often should I back up the data from the USB stick?
The data on the USB stick should be backed up at regular intervals, for example weekly, to a PC or a hard drive. This way the records are archived permanently and fail-safe.
What documentation options do the Steri24 devices offer?
The Klasse B Pro autoclaves offer export to USB stick and record printout on thermal paper. The AquaPlus washer-disinfector additionally offers documentation via external PC software. The Premium devices document digitally via SteriTrace with WLAN/LAN connectivity.
What is SteriTrace and what is it for?
SteriTrace is a digital tool for complete, traceable documentation and batch tracking in accordance with the KRINKO recommendation. It enables the electronic recording and management of sterilization data; printer paper is not required for this.
What does paperless documentation mean?
Paperless documentation means that all relevant sterilization data is recorded and stored digitally without the need for a paper printout. The data is held, for example, on the memory card, the USB stick or in the network and is secured audit-proof.
Is SteriTrace compatible with the autoclave I have already bought?
Yes, SteriTrace is compatible with existing autoclaves. For the automatic transfer of the sterilization records it must be set up by a technician. The exact costs depend on the model and the desired connectivity.
Can I carry out batch release directly on the autoclave?
Yes, with the Premium autoclave you can carry out and document batch release according to RKI directly on the touchscreen. This eliminates the media break between the device and paper documentation.
How do I set up batch release by signature or password?
In the settings (menu at the top left, at the very bottom „Settings“) you choose whether the batches are released by signature or password. Several users with individual passwords can be created in the user management.
How do I correct a batch release granted by mistake?
A granted release can no longer be edited, but you can save a note. In the case of a release granted by mistake, delete the affected record in the record list via the minus icon.
Can labels with a barcode or QR code be printed and scanned?
Yes, the labels are printed automatically or on request and carry a barcode that is readable by any practice software or digital patient file. A barcode reader connected to the PC is used for scanning.
Are labels or barcodes mandatory for marking?
Labels or barcodes are not mandatory; handwritten marking is also permitted. For critical instruments, however, there is a batch tracking and labelling obligation. We are happy to clarify which option suits you in a consultation.
Where do I find templates and forms for documentation and batch release?
We provide free templates, e.g. the handwritten batch release form as well as a detailed knowledge document on steri24.de. Alternatively, digital documentation via the SteriTrace app is possible.
Do I get a free template for the steri logbook?
Yes. You do not have to spend any money on the checklist and the steri logbook – we are happy to send you a print template that you can print out and file in a folder. Contact us with your email address.
Which documents and certificates are included?
Relevant details are provided in the operating manual; a separate technical data sheet is not included as standard. Certificates such as the CE declaration of conformity or the EN 13060 test report can be downloaded in the shop in the certificates tab or obtained on request.
Does the documentation app also work without internet in the steri room?
Yes, the digital documentation also runs without a permanent internet connection. The data is recorded locally and can be synchronised later if needed or transferred to the practice software.
Can the washer-disinfector (RDG) be integrated into the same documentation?
Yes, like the autoclave, a washer-disinfector can export all records to the same network folder, so that the entire reprocessing documentation is available centrally. The connection is typically made via LAN.
Can the autoclave be connected to my practice software?
Yes, especially the Premium autoclaves can be connected to common practice and documentation software via LAN/WLAN or a serial interface. Our technician handles the setup; just let us know which program you use.
Do I also have to document the cleaning and disinfection step?
Yes. The RKI recommendation requires documentation of the entire reprocessing process, not just the sterilization step. Weaknesses in one sub-step can negatively affect the overall result during an assessment, so complete documentation across all stages is important.
Do I need an additional device or app for the batch labels?
For batch tracking via a label printer you need either the app on an Android smartphone or SteriTrace. The label printer connects wirelessly via Bluetooth.
How do I connect a record printer to the autoclave?
The printer is connected to the COM2 port of the interface box or the Premium autoclave using the supplied RS232 cable and the power cable. In SteriTrace you select the appropriate printer under Settings.
Do the Pro autoclaves have a built-in record printer?
Yes, the Pro devices have an integrated record printer; the thermal paper must be ordered separately. For a label printer or fully digital documentation, the Premium model with SteriTrace is suitable.
How do I set up several employees for release?
In the user management of the documentation solution, several users with individual passwords can be created. This way it is traceably documented with every release which person released the batch.
Why is it not enough to document only the sterilization step?
Because during an assessment, weaknesses in a single sub-step can negatively affect the overall result. It is therefore not sufficient to document only the last sub-step – the entire reprocessing cycle from cleaning to release must be traceably documented.
What is the difference between documentation and validation?
Documentation records every single reprocessing and release operation in routine use. Validation is the formal, recurring verification that the entire process meets the standards and sterilizes reliably. Both are part of the RKI requirements.
Can I keep the entire documentation completely paperless?
Yes. Since the RKI does not require the records to be printed out, the complete documentation of instrument reprocessing can be carried out entirely paperlessly – for example via USB storage, the network and digital batch release with SteriTrace.
How does the documentation solution differ from established expensive providers?
Unlike many established expensive providers, at Steri24 you receive a standards-compliant documentation and release solution at a fair price, including free templates and personal advice. The configurator or our service will clarify which option suits your practice.
I have an error in the record – how do I proceed?
Send us a photo of the sterilization or error record and fill out the service form at steri24.de/help. A technician will then check whether it is a genuine fault or an operating/sensor notice and will get back to you with a solution.
Which device suits my documentation needs?
This depends on the type of instruments, the volume and the desired degree of automation: Pro devices with USB and record printer or Premium devices with SteriTrace and network connectivity. The autoclave configurator helps you find the right model, or we will advise you personally.