The correct documentation for instrument preparation

Legal Basis of Instrument Sterilization

The legal basis of instrument sterilization is described in the guidelines of the Robert Koch Institute (RKI). This RKI guideline was created together with the Commission for Hospital Hygiene and Infection Prevention (KRINKO). According to the Medical Devices Operator Regulation (§ 8 Abs. 2), proper preparation is assumed if the recommendation "Requirements for Hygiene in the Preparation of Medical Devices" is followed. The RKI recommendation divides the process of instrument sterilization into the following 4 areas:

1. Instrument Classification
2. Sterilization Cycle
3. Documentation
4. Validation

Further standards are binding for the process of instrument sterilization. The RKI, Civil Code (BGB), and the Criminal Code (StGB) regulate the retention periods of process protocols and release forms:

• At least 5 years retention according to RKI
• 5 or 10 years according to StGB §78
• 30 years according to BGB §199

In instrument sterilization, a reverse burden of proof applies.

1. A doctor (the operator) must always be able to prove that the instrument sterilization was successful.
2. Documentation is necessary to protect against claims for damages due to negligent actions.

In case of an evaluation, weaknesses in any part of the documentation of the instrument sterilization can negatively affect the overall result. It is therefore not enough to document only the last part of the instrument sterilization. In this article, we have summarized how instrument sterilization must be documented correctly. Contact us if you need WORD templates for printing.

Proper Documentation of Instrument Sterilization

The minimum requirements for the documentation of instrument sterilization 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 washer-disinfectors

All autoclaves from Steri24 fall under and meet the standard EN 13060, and our washer-disinfectors meet the standard EN 15883. What exactly is required in the standard EN 13060 regarding documentation and how is it fulfilled?

1. EN 13060 stipulates that an automatic process evaluation system must be integrated into the autoclave. This means that the autoclave continuously and automatically monitors all relevant process parameters during the sterilization of instruments. It is therefore not necessary to manually check the process parameters, such as the achieved temperature and holding time, after sterilization. The autoclave must be able to do this itself.
2. EN 13060 requires 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 types of errors that must be detected are also described in the standard EN 13060.
3. EN 13060 stipulates that the autoclave must be able to create a process documentation itself. Most autoclaves are equipped with a printer or USB port to meet this requirement of the standard. The documentation is thus printed by the autoclave during the sterilization of instruments or stored on a stick.

A detailed example of such an autoclave protocol can be found in the operating instructions of the autoclave.

Do sterilization protocols need to be printed out for documentation of instrument sterilization?
The RKI recommendation clearly states: No. The RKI recommendation states that sterilization protocols do not necessarily have to be printed out. The protocols can also be stored on appropriate data carriers. The RKI (Source: Robert-Koch-Institute "Requirements for Hygiene in the Preparation of Medical Devices") states: "The measured values of the process parameters recorded during the preparation process ... must be documented. The records can also be kept on image or data carriers."

The documentation options for Steri24 devices are:

Device	Documentation Options
Class B Pro Autoclaves	Export to USB stick Protocol printout on thermal paper
Aqua-Plus Washer-Disinfector	Export to USB stick Protocol printout on thermal paper Using external PC software

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

How does correct batch control work with autoclaves in instrument sterilization?

If hollow bodies, such as handpieces, are also sterilized in the autoclave, then a Helix test or PCD test (Process Challenge Device) is necessary. 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 packaged 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. A new test strip is inserted into the Helix test before each sterilization process. The Helix test body is then placed in the autoclave together with the instruments and sterilized. After sterilization, a color change of the test strip indicates whether the sterilization was successful or not.

The manufacturer recommendation for Class B Pro Autoclaves from our shop for routine operation also corresponds to the recommendations of the RKI. The recommendation is as follows:

 

Schedule	Description of the Test
Every day the autoclave is used	Visual inspection of the autoclave for damage Check the autoclave display for warning messages
Once a week before starting work	Start the "Vacuum Test" program
During each sterilization cycle	For "Critical B" instruments, Helix tests should be performed during each sterilization, and the test strips must be sterilized with them. For "Critical A" instruments, process indicators (Class 5) should be performed during each sterilization, and the test strips must be sterilized with them. For "Critical A-B" instruments, Helix tests should be performed during each sterilization. It is not necessary to keep the test indicators

 

Further Questions on the Documentation of Instrument Sterilization

If you have further questions about the correct documentation of instrument sterilization, do not hesitate to contact us. We are happy to answer your questions and look forward to your inquiry.