Cambridge University Hospitals - NHS
Professional training, consultancy and specialist services for decontamination testing and validation

AVM Services: Importance of Documentation (process and record-keeping) in Sterilisation

Thu, 10/06/2021

Of the many highly important aspects to consider in the decontamination and sterilization process is the need for a fully-documented process, not only in terms of what processes and procedures are in place, but how these are adhered to, measured and tracked, and also from a training and education perspective.

Without these, one cannot verify that processes are successfully being completed, and there is no way of reviewing where processes could be improved to ensure the highest standards.

In terms of devices and instruments used in the decontamination and sterilization process, it is essential that manufacturer’s Instructions for Use (IFU) are reviewed, communicated and implemented. 

These IFUs will help staff set up processes and apparatus correctly, and also understand performance expectations against which the processes should be measured. Installation and operation qualifications should be implemented and signed off by a qualified team prior to healthcare professional beginning performance qualification testing, covering product and device families that will be processed using the apparatus.  

This process will also help the healthcare team that will be using the apparatus understand and identify any special requirements or instructions for special cycles, medical device compatibility and also what verification processes should be implemented to ensure that specific product and device testing was conducted.

In terms of documenting the process of decontamination and sterilization, a full document chain needs to be established in accordance with the requirements of Medical Devices — Quality Management Systems — Requirements for regulatory purposes BS EN ISO 13485: 2016.

Within this documentation process, staff should make use of checklists to avoid missing any of the vital steps, including:

  • Identify and develop a written work instruction (WI) outlining the department’s periodic device testing process. 
  • Identify, obtain/collect and store all original equipment manufacturer IFU for every device processed in the Sterile Service Department (SSD). 
  • Establish and complete a reusable medical device profile for all devices processed in the SSD department. 
  • Identify and place all reusable medical devices processed in the SSD department into product families. 
  • Identify three master products to be tested from each product family. 
  • Maintain documentation for future reference (to support surveillance and/ or credentialing audits, as well as risk analysis from future moisture events). 
  • Establish a periodic review and audit of the department’s processes to ensure they meet established specifications and requirements.

Decontamination Services experts need to use the above to establish a robust quality assurance process including periodic device testing, document efficacy, standard setting for consistency of results, and other QA procedures particular to the specific decontamination and sterilisation implements being processed.

For guidance and advice on setting up the correct documentation and quality assurance processes contact one of the specialists at AVM Services on 01223 254499 or email info@avm-addenbrookes.org.uk

AVM Services: Importance of Documentation (process and record-keeping) in Sterilisation