The correct documentation for instrument preparation

How must instrument reprocessing be documented?

LEGAL BASIS OF INSTRUMENT REPROCESSING

The guidelines of the Robert Koch Institute (RKI) describe the legal basis for instrument reprocessing. This  RKI guideline was created together with the Commission for Hospital Hygiene and Infection Prevention (KRINKO). Proper reprocessing is assumed according to the Medical Devices Operator Ordinance (§ 8  Para.  2) if the recommendation "Hygiene requirements for the reprocessing of medical devices" is observed. In the RKI recommendation, the process of instrument preparation is divided into the following 4 areas:
  1. instrument classification
  2. treatment cycle
  3. documentation
  4. validation
Other standards are binding for the instrument reprocessing process. The RKI, the German Civil Code (BGB) and the Criminal Code (StGB) regulate the length of the retention requirements for process logs and release forms:
  • At least 5 years storage obligation according to RKI
  • 5 or 10 years according to StGB §78
  • 30 years according to BGB §199

In the case of instrument preparation, the burden of proof is reversed.
  1. A doctor (the operator) must always be able to prove that the instrument reprocessing was successful.
  2. The documentation is necessary to protect against claims for damages due to negligent action.
In the case of an evaluation, weaknesses in a sub-step of the documentation of the instrument preparation can have a negative impact on the overall result. So it is not enough to just document the last step of instrument preparation. In this article we have summarized for you how the instrument preparation must be correctly documented. Contact us if you need WORD templates to print out.

THE CORRECT DOCUMENTATION OF THE INSTRUMENT PREPARATION

The minimum documentation requirements for instrument reprocessing are described in device-specific standards.
  • EN 13060: The standard for small steam sterilizers (up to a chamber volume of 24 liters)
  • EN 285: The standard for large steam sterilizers (from a chamber volume of 24 liters)
  • EN 15883: The standard for thermal disinfectors
All Steri24 autoclaves meet and meet the EN 13060 standard and our thermal disinfectors meet the EN 15883 standard. What exactly does the EN 13060 standard require in terms of documentation and how is it met?
  1. EN 13060 stipulates that an automatic process assessment system must be integrated in the autoclave. This means that 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.
  2. EN 13060 prescribes the presence of an error detection system. For this reason, several high-precision temperature sensors, at least one pressure sensor and a precise real-time clock are installed in autoclaves. The EN 13060 standard also describes which errors must be detected.
  3. EN 13060 stipulates that the autoclave must be able to create process documentation itself. Most autoclaves are equipped with a printer or USB port to be able to meet exactly this requirement of the standard. The documentation is thus printed out by the autoclave during the sterilization of instruments or saved on a stick.
A detailed example of such an autoclave protocol can be found in the operating instructions for the autoclave.

Do the sterilization protocols to document the instrument preparation have to be printed out?
The RKI recommendation says very clearly: No. The RKI recommendation states that the sterilization protocols do not necessarily have to be printed out. The logs can also be saved on appropriate data carriers for backup purposes. The RKI (source: Robert Koch Institute "Hygiene requirements for the processing of medical products") writes: " The measured values ​​of the process parameters recorded during the processing ... must be documented. The records may also be kept on image or data carriers ”.

The documentation options for Steri24 devices are:
Device documentation options
Class B Pro Autoclave
  1. Export to USB stick
  2. Report printout on thermal paper
Aqua-Plus thermal disinfector
  1. Export to USB stick
  2. Report printout on thermal paper
  3. Using external PC software

Data backups: The data on the USB stick should be backed up to a PC or hard drive at regular intervals (e.g. weekly). According to a survey by Steri24, 94% of clinics and practices in the DA-CH area use a USB stick to save the autoclave logs. Printing logs is not mandatory. In general, the complete documentation of the instrument preparation can be done completely paperless.

HOW DOES THE CORRECT BATCH CONTROL WORK FOR AUTOCLAVES IN INSTRUMENT PROCESSING?

If hollow bodies 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 bodies (e.g. handpieces) was successful. If no hollow bodies and only simply wrapped instruments are sterilized in the autoclave, 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 body. Before each sterilization process, a new test strip is inserted into the Helix test. The Helix test body is then placed in the autoclave together with the instruments and sterilized at the same time. After sterilization, a discoloration of the test strip indicates whether the sterilization was successful or not.

The manufacturer's recommendation of the class B Pro autoclaves from our shop for routine operation also correspond to the recommendations of the RKI. The recommendation is as follows:

 
Time schedule Description of the exam
Every day the sterile is used Visual inspection of the autoclave for damage
Inspection of the autoclave display for warnings
Once a week before starting work Start of the "vacuum test" program
With every sterilization cycle
  • For "Critical B" instruments, helix testing should be performed with each sterilization and the test strips must also be sterilized.
  • For "Critical A" instruments, process indicators (class 5) should be performed with each sterilization and the test strips must also be sterilized.
  • For "Critical AB" instruments, helix testing should be performed at each sterilization.
It is not necessary to keep the test indicators
 
 

HOW DOES THE CORRECT BATCH RELEASE WORK WHEN PREPARING INSTRUMENTS?

The batch release phase begins after the autoclave has completed the sterilization cycle. "Approval 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 commonly used method of batch release is by means of a checklist and documentation in a steri book. You don't have to spend any money on it. We would be happy to send you a print template of the Steri book. You can print out the documents and file them in a folder. Contact us via contact form or chat and leave us your email address. The trained staff must carry out the following steps:

  1. Process evaluation: The Steri24 are equipped with an automatic EN13060-compliant process evaluation. It is therefore sufficient to read the result of the sterilization protocol on the autoclave display. The process evaluation is carried out by the device itself without additional work for the personnel.

  2. Documentation of batch indicators: The batch indicators (positive / negative) must be documented.

  3. Visual check: A visual check must be carried out, for example for residual moisture or torn packaging. There is a separate checklist for this, which we will be happy to send you if required. Contact us.

  4. Approval for renewed use: The release for renewed use must be carried out with a signature.

  5. Labeling of packaged instruments: The packaged instruments must be labeled by specifying the autoclave, the current date, the use-by date, the batch number. and the person ID are designated. There is a standardized adhesive label gun for this.



Figure 1: Template for the documentation of the batch release

Labeling of the packaging after autoclaving is carried out using labeling tongs. The label must have at least the following content.
 

Personnel No. | Device No. | Batch number
Date of sterilization
Date "Use by"


The "Use By" date is typically 6 months from the date of sterilization.

SteriTrace Documentation App
SteriTrace Documentation App
Batch release and tracking
Printout of labels for instrument traceability
Fast barcode verification using SmartScan
Batch tracing
Audit trail
Secure cloud storage
199,00 EUR
plus 20% tax excl. Shipping costs
SteriTrace Documentation Light
SteriTrace Documentation Light
Batch release and tracking
Printout of labels for instrument traceability
Fast barcode verification using SmartScan
Batch tracing
Audit trail
Secure cloud storage
399,00 EUR
plus 20% tax excl. Shipping costs
SteriTrace Documentation
SteriTrace Documentation
Batch release and tracking
Printout of labels for instrument traceability
Fast barcode verification using SmartScan
Batch tracing
Audit trail
Secure cloud storage
499,00 EUR
plus 20% tax excl. Shipping costs
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