Successful instrument reprocessing does not end when the cleaning and disinfection machine or autoclave completes its cycle. Only once the results have been checked, assessed and documented, and the instruments have been released, may the medical devices be stored, made available or used on patients again.
Documentation is far more than a mere formal obligation. It demonstrates whether all specified steps have been carried out correctly, whether the validated process has been adhered to, and who has taken responsibility for the final approval.
The key principle is:
Instrument reprocessing is only complete once documented authorisation for use has been granted.
Why is documentation so important?
For many reprocessing steps, the result cannot be fully assessed by a final check alone. For example, it is not possible to verify non-destructively before use whether a complex hollow instrument has been sufficiently cleaned internally or whether a packaged instrument has been reliably sterilised.
Quality is therefore ensured primarily through a controlled process. The documentation proves that:
the prescribed procedures were followed,
the process parameters were within the specified limits,
the necessary routine checks were successful,
deviations were identified and dealt with appropriately,
the medical devices were inspected and released.
The Medical Devices Operator Regulation requires suitable, validated reprocessing procedures for medical devices intended for use in a low-microbial-load or sterile environment, the success of which is verifiably guaranteed. Validation and performance assessment must be carried out on behalf of the operator by suitably qualified professionals.
Documentation thus ensures transparency, traceability and legal certainty. Above all, however, it supports patient safety and helps the practice team to identify errors at an early stage.
What does the documentation of instrument reprocessing involve?
Documentation should not begin only at the stage of sterilisation. It must cover the entire reprocessing process and be tailored to the procedures of the respective facility.
This includes, in particular:
Risk assessment and classification of medical devices,
Manufacturers’ reprocessing instructions,
Standard operating procedures for all process steps,
Responsibilities and authorisation to release items,
Evidence of qualifications and training,
Validation and performance evaluation reports,
Maintenance, inspection and repair records,
Routine checks and batch records,
documented approval decisions,
non-conformities and resulting corrective actions.
The joint requirements of KRINKO and BfArM regard reprocessing as a coherent process chain: from proper preparation and transport, through cleaning, disinfection, drying and functional checks, to packaging, sterilisation, labelling, release and storage.
Standard operating procedures form the basis
Reliable documentation requires clear work instructions. These describe how a process is carried out, monitored and released.
A standard operating procedure should specify, amongst other things:
which medical devices or product groups it applies to,
which equipment, programmes and process chemicals are to be used,
how the instruments are to be prepared and loaded,
which routine checks are required,
what acceptance criteria apply,
who is authorised to monitor and approve the process,
how the release is documented,
how to proceed in the event of deviations.
Work instructions must be accessible, comprehensible and unambiguous for staff. As soon as instruments, packaging, equipment, programmes or other process-related conditions change, a review must be carried out to determine whether the instructions need to be amended.
Documentation of cleaning and disinfection
During automated cleaning and disinfection, the cleaning and disinfection machine usually records key process data. Depending on the machine and the validated procedure, this may include:
date and time,
equipment number,
programme name,
batch number,
relevant temperatures and exposure times,
dosage or availability of process chemicals,
Process sequence and error messages,
Identification of the person operating or releasing the instruments.
However, the mere completion of a programme is not sufficient for release. After removal, the instruments must be checked for cleanliness, dryness and integrity. For instruments with areas that are difficult to inspect, supplementary testing procedures may be required.
The results must comply with the specifications of the validated procedure. For cleaning and disinfection equipment, DIN EN ISO 15883 sets out, amongst other things, requirements for validation, process monitoring, routine testing, documentation and re-qualification.
What should be done if visible residues are found?
If soiling, discolouration or other residues are detected, the instrument in question must not be released for further reprocessing steps. It must be cleaned again and then thoroughly inspected once more.
Simply wiping the instrument on the clean side is generally not an appropriate corrective measure, as this may deviate from the validated process and contaminate the clean working area.
Inspection, maintenance and functional testing
Following cleaning and disinfection, each medical device must be inspected. This involves checking whether it:
visibly clean and dry,
is free from corrosion or damage,
is complete and correctly assembled,
performs its intended function,
has been maintained in accordance with the manufacturer’s instructions,
can continue to be safely reprocessed and used.
Defective, heavily corroded or instruments that cannot be adequately cleaned must be discarded. Repairs may only be carried out in such a way that safe use and reprocessing remain guaranteed.
Depending on the organisational structure, successful verification may be recorded by means of a batch-specific confirmation, a digital approval or a documented reference to a sorting or packing list.
Documentation of the packaging process
Medical devices intended for sterile use require a suitable sterile barrier system. The packaging must allow the sterilising agent to penetrate and subsequently maintain sterility until the device is used.
In the case of mechanical sealing processes, the following aspects, amongst others, are relevant:
selection of suitable packaging,
correct filling,
sufficient spacing between the instrument and the seal,
set sealing temperature,
contact pressure and sealing time or throughput speed,
visual inspection of the seal,
specified routine tests,
documented results of the tests.
DIN EN ISO 11607-2 sets out requirements for the development and validation of forming, sealing and assembly processes for sterile barrier systems. It also applies to healthcare facilities where medical devices are packaged and subsequently sterilised.
A defective seal may compromise the sterilisation result and subsequent shelf life. Seals that are irregular, incomplete, creased or damaged must therefore not be released.
Documentation of sterilisation
For each sterilisation batch, it must be possible to trace the conditions under which it was carried out.
Depending on the equipment and the organisation’s documentation policy, complete batch documentation must include, in particular:
Date and time,
Identification of the steriliser,
sequential batch number,
sterilisation programme used,
allocation or description of the load,
key process parameters,
Results of the steriliser’s internal process monitoring,
results of any required routine or batch checks,
any faults or deviations that occurred,
Release decision,
Identification of the person authorising release.
The requirements for the development, validation and routine monitoring of moist heat sterilisation processes are described in DIN EN ISO 17665.
The message ‘Programme completed successfully’ is an important part of the evaluation. However, on its own, it does not constitute full release of the batch or the individual packages.
What does release mean?
Release is a deliberate and traceable decision. A qualified and expressly authorised person confirms that the reprocessing process has been carried out in accordance with the specified requirements and that the medical devices are suitable for storage or use.
The person granting release thus assumes a position of responsibility. They must be able to assess whether:
all necessary process steps have been completed,
the documented values fall within the acceptance limits,
the prescribed checks have been successfully carried out,
the load corresponds to the validated process,
the medical devices are clean, dry and in working order,
packaging and labelling are in order,
there are no unresolved non-conformities.
The persons authorised to grant release must be named in writing. The work instruction must specify both the format of the release documentation and the procedure to be followed in the event of non-conformities.
Three levels of release
In practice, release can be divided into three successive levels.
1. Operational readiness of the process
Before routine operation begins, a check is carried out to ensure that the equipment and processes can be used correctly. Depending on the manufacturer’s specifications and the validation report, this may include:
Visual inspection of the chamber, door and seals,
Inspection of equipment,
testing of water quality,
necessary functional tests,
vacuum or steam penetration tests,
Inspection of the sealing unit,
Checking that the RDG is operational.
It is not possible to specify in general terms which tests are required and at what intervals. The manufacturer’s specifications, the validation report, the risk assessment and the facility’s standard operating procedures are decisive.
2. Batch release
Following each automated process, the entire cycle is evaluated. This involves reviewing the process log, control displays, any error messages and, where applicable, the results from the testing systems used.
The batch may only be released if the process has been completed in full and correctly and all acceptance criteria have been met.
3. Release of individual medical devices
Even after a batch has been successfully released, it may be the case that individual instruments or packages are unsuitable for use.
Each sterile package must therefore be checked for at least the following points:
dryness,
integrity,
intact seal seams,
legible and complete labelling,
correct result of the processing indicator,
no visible contamination,
no damage to the medical device contained within.
Damaged or damp packaging must not be released, even if all the steriliser’s process parameters have been adhered to.
Labelling and traceability
Labelling must enable the sterile goods to be unambiguously linked to the reprocessing process. The specific labelling scheme is determined by the facility’s procedures, risk assessment and quality management system.
Typical details include:
Name or contents of the packaging,
batch number,
reprocessing or sterilisation date,
specified storage period or expiry date,
Identification of the device used,
Identification of the person authorising release.
The labelling must not damage the sterile barrier system. In the case of transparent sterilisation packaging, markings or labels should be applied in such a way that neither the film is perforated nor the medical device itself is compromised.
Barcodes and machine-readable labels may also establish a link between the batch, the instrument, the treatment and the patient records, provided this is provided for in the organisation’s traceability concept.
When should a batch not be released?
Release must be refused if compliance with the specified procedure cannot be reliably assessed. This applies, for example, in the case of:
interrupted or malfunctioning programmes,
missing or incomplete process logs,
failed routine checks,
invalid process parameters,
an unsuitable programme,
a non-validated load,
abnormal test indicators,
damp packaging,
damaged seal seams,
incomplete labelling,
visible residues on instruments.
Affected medical devices must be clearly isolated and separated from approved products. The cause, necessary corrective actions and the next steps must then be documented.
Reprocessing may only take place once it has been established that the medical device is suitable for this purpose and the cause of the fault has been rectified.
Paper or digital?
Both paper-based and electronic documentation systems may be suitable. It is not the medium that is decisive, but the quality of the records.
Reliable digital documentation should ensure that:
users are clearly identified,
Approvals are attributed to a specific person,
the date and time are recorded correctly,
changes remain traceable,
original data is not overwritten without being noticed,
regular data backups are carried out,
records remain legible throughout the retention period,
and data can be exported and presented when required.
The KRINKO-BfArM recommendation permits storage on image or data carriers. At the same time, it must remain clear when subsequent changes have been made. The documents must be available and legible throughout the retention period.
A scanned signature or a shared user account for the whole team does not provide reliable personal attribution. Individual user accounts, personal PIN codes or qualified electronic approval procedures are preferable.
How long must the records be retained?
According to the KRINKO-BfArM recommendation, records relating to the reprocessing of medical devices must be retained for at least five years. Other legal provisions, contractual requirements or regulations concerning patient documentation may necessitate longer retention periods.
The organisation should therefore set out its retention periods in writing and apply them consistently to both paper and digital records.
Common errors in practice
In many facilities, the technology is up to the task, whilst weaknesses arise in organisation and documentation.
Typical errors include:
Approvals without personal attribution,
missing or out-of-date work instructions,
authorised persons not specified in writing,
incomplete loading details,
failure to review process logs,
shared user accounts,
documents that can be amended retrospectively without a change history,
Approval despite damp packaging,
undocumented deviations,
lack of data backups,
new instruments or packaging without process validation.
Good documentation must work in day-to-day practice. Overly complicated forms often result in information being entered incompletely or retrospectively. Digital systems should therefore guide staff through the approval process, rather than merely storing process data.
Checklist for safe release
Before releasing a processed batch, at least the following questions should be answered:
Was the intended and validated programme used?
Did the process run to completion without any relevant disruptions?
Do the process parameters comply with the specified limit values?
Were all the required routine checks successful?
Does the loading comply with the validated loading pattern?
Are the instruments clean, dry, undamaged and in working order?
Are the packaging and seal seams dry and intact?
Is the labelling complete and unambiguous?
Have any deviations been ruled out or dealt with appropriately?
Has approval been clearly assigned to an authorised person?
If any of these questions cannot be answered in the affirmative beyond doubt, approval should not be granted.
Conclusion: Authorisation is a professional decision
Documentation and authorisation are not administrative tasks that take place only after the actual instrument reprocessing. They are indispensable components of the process.
The technical process record shows what the device has measured. The visual and functional inspection shows the condition of the instruments and packaging. Only the professional assessment of all the information leads to documented release.
A safely reprocessed medical device is therefore not merely cleaned, disinfected or sterilised. It has been inspected, clearly labelled, documented in a traceable manner and released by an authorised person.
