What needs to be considered?

Documentation and retention obligations in the AEMP:

The reprocessing of medical devices in a reprocessing unit for medical devices (AEMP) requires not only the highest standards of hygiene, but also extensive documentation and strict compliance with retention periods. This is based on various legal regulations and recommendations that are mandatory for AEMP operators.

1. what must be documented?

The documentation obligations in an AEMP result in particular from the KRINKO/BfArM recommendation "Hygiene requirements for the reprocessing of medical devices". This sets out the key steps and work instructions that must be documented in a quality management manual (QM manual). In addition, the recommendation requires complete batch documentation of the relevant reprocessing processes. Particularly noteworthy is the requirement that records of the reprocessing of medical devices must be kept for at least five years.

2. retention periods: How long do the documents have to be kept?

The retention period for documentation in the AEMP is at least five years. However, other statutory provisions, such as those relating to patient files, may stipulate different periods. Sections 194 et seq. of the German Civil Code (BGB) regulate the limitation periods, which can be between three and 30 years depending on the claim for damages. For example, the documentation of claims for damages based on injury to life or health must be kept for up to 30 years.

The ten-year retention period under Section 630f BGB, which applies to patient records, should also not be confused with the limitation period. This period only begins once the person concerned has become aware of the circumstances that justify their claim.

3. long-term storage: 30 years can be useful

In certain cases, it may make sense to keep documentation on the reprocessing of medical devices for up to 30 years beyond the minimum legal requirements. This is particularly advisable if potential claims for damages cannot be ruled out. Longer storage may be necessary in particular if hygiene deficiencies or treatment errors only become apparent years after the treatment.

4. further legal regulations and recommendations

In addition to the KRINKO/BfArM recommendation, there are numerous other regulations that must be taken into account in an AEMP. For example, workplace-related regulations apply to the handling of hazardous substances and biological agents as well as documentation obligations as part of quality assurance. A comprehensive overview of the various documentation and retention obligations can be found in the guidelines of the German Hospital Federation, which are regularly updated.

Conclusion

Compliance with documentation and retention obligations is of crucial importance for quality assurance in AEMP. Although the minimum retention period for the reprocessing of medical devices is five years, a longer retention period - up to 30 years - may be appropriate in many cases. The exact retention periods should be defined in the individual quality management system of the AEMP in order to minimize legal risks and safeguard against possible claims for damages.