Validation in podiatry: purpose, procedure and significance explained

Validation is a key component of the evidence chain, and you can use it to conclusively demonstrate that reprocessing procedures have functioned correctly in the event of a liability claim. Besides standardising manual processes, performing routine checks and maintaining medical devices, it forms an essential pillar of quality assurance. Only through validation can you ensure that the processes in cleaning and disinfection units (CDUs) and sterilisers run reliably.

The obligation to validate arises from Section 8 of the Medical Device Operator Ordinance (MPBetreibV), which states that the reprocessing of medical devices must be performed using ‘suitable validated procedures’. The specific incorporation of the requirements of the MPBetreibV is governed by the so-called KRINKO-BfArM recommendation, compliance with which, in accordance with Section 8(2) of the MPBetreibV, implies proper reprocessing.

According to the KRINKO-BfArM recommendation, validated procedures produce a defined result that is both reproducible and consistent. It can therefore be assumed that, in a validated process, machine-based reprocessing always achieves a well-maintained level of quality. For this reason, such procedures are preferable to manual reprocessing, which is subject to human-induced variations.

What is traditionally understood by process validation – that is, the independent testing of procedures by a technician – must be performed in accordance with Annex 1 of the KRINKO-BfArM recommendation for mechanical cleaning, disinfection and sterilisation. For all other process steps, standard operating procedures and, where applicable, other evidence of efficacy must be provided. Then, there is no obligation to validate sealing processes, as is often incorrectly claimed. However, Annex 4 stipulates that seal checks and seal strength tests must be performed. Nor is the validation of manual reprocessing steps justifiable either legally or technically. Consequently, there is no regulatory basis for a ‘validation’ of the entire reprocessing process – the combination of validation of the automated process steps and standard operating procedures for the entire reprocessing cycle fully meets the requirements of the KRINKO-BfArM recommendation.

Validation should not be confused with a service. Whilst a service involves checking the device’s components, such as valves and seals, and replacing wear parts, validation is a confirmation of the process’s success. A service, and so that the technology functions properly, is a prerequisite for successful validation.

Process validation for RDGs and sterilisers includes several steps, not all of which are performed simultaneously. The first part – the Installation Qualification (IQ) – takes place yet as soon as the equipment is installed. The supplier ensures that all conditions specified by the manufacturer are met. They then train the practice staff on how to use the equipment. An installation or set-up report is drawn up for both steps. In the case of equipment (e.g. second-hand) that you set up yourself, you can and should draw up this document yourself. It serves as informal confirmation that the equipment has been set up in accordance with the manufacturer’s specifications and that all staff have been trained in its operation. The installation initially only reserves the basic functionality of the device, but does not yet constitute proof of a reliable process.

During the subsequent initial operational qualification (OQ) and performance qualification (PQ) (usually referred to as initial validation), checks are carried out to ensure that the process complies with both regulatory requirements and the manufacturer’s specifications. This also verifies reproducibility, i.e. that the process consistently delivers equally good results. Furthermore, the process is tested under real-world conditions, i.e. with the specific load that is to be processed in practice. Consequently, validation can only be performed in practice and not, for example, at the manufacturer’s premises. This service takes approximately four to five hours and should be performed in the first few weeks following installation; periods of 6–8 weeks are usually accepted by the authorities.

In the following year, revalidation takes place, during which only the performance qualification is repeated. This involves checking whether there are any deviations in the process and/or the quality of results compared to the initial validation. Consequently, revalidations are significantly more affordable and take one to two hours less time. Validation is usually repeated annually, although for small sterilizers, the interval can be changed to two years after the first revalidation. In addition to validation, routine checks must be performed, as specified in the manufacturer’s operating instructions along with the requirements set out in the validation report. These routine checks are also referred to as long-term assurance and serve to ensure the quality of results in the period between validations.

Validation reports must be retained for the entire service life of the device and for at least a further five years after it is taken out of service – this retention period applies to all documentation relating to the reprocessing of medical devices. Digital storage is possible.

It is important that you read the results section of the validation report carefully. The laboratory may specify restrictions on the process and/or impose conditions that must be taken into account. If a subsequent inspection finds that the laboratory’s conditions have not been adhered to, it must be assumed, in the worst case, that the reprocessing procedure is not safe.

Validation services are offered by a wide range of laboratories and, in some cases, by manufacturers as well. However, it should be borne in mind that validation, much like a car’s MOT test, should be performed by an independent body. Then only can the process be assessed impartially and objectively. As ‘validation’ is not a protected term, you must ensure that the laboratory you choose is qualified. The easiest way to recognise this is thanks to accreditation by the German Accreditation Body (DAkkS). Accreditation provides official confirmation that the service meets regulatory requirements. This means that it is highly unlikely that a supervisory authority would refuse to accept the report.

It is worth obtaining quotes from several laboratories, as prices can vary significantly depending on the scope of the work and travel costs. When selecting from several accredited laboratories, you can confidently choose the most cost-effective quote. Examples of accredited laboratories operating throughout Germany include

• Hücker & Hücker GmbH
  
• Normec Hybeta GmbH
  
• Valitech GmbH & Co. KG
  
• WITHERM GmbH
  
• VALIPLUS
  

In summary, validation is an essential step in the quality management of medical device reprocessing. Validation ensures that processes run reliably and comply with regulatory requirements. Correct documentation and the selection of a qualified and independent provider are crucial to ensuring proper reprocessing and to providing legal protection in the event of a liability claim.

Sascha Ruß, M.Sc.

Hygiene Engineer

Sascha Ruß has been working as a hygiene engineer in a medium-sized testing laboratory for over seven years. In this role, he is responsible for validating the reprocessing procedures for medical devices. In addition, as technical manager, he ensures compliance with all relevant laws and technical standards. On his Hyg-Blog he shares learning on the subject of hygiene in the healthcare sector, with a focus on the aspects of practice related to medical device reprocessing.