The Design of a Medical Device – Challenge of the Decontamination Process

According to the Regulations and guidance, reusable medical devices should be cleaned, disinfected and/or sterilized in accordance with the manufacturer’s instructions. To facilitate effective cleaning, it is critical that all medical device surfaces are fully exposed to the cleaning solution during the cleaning cycle in a washer disinfector. For various reasons (e.g. safety, functionality etc), the manufacturer’s instructions did not require all medical devices to be fully disassembled prior to cleaning. The manufacturers anticipated that body fluids and other contaminants would not penetrate through the seal mechanism.
Despite reprocessing in accordance with manufacturer’s instructions, accumulation of debris was observed in hidden areas of devices. Surgical site infection was reported to link to the inadequately decontaminated orthopaedic and ophthalmic devices, which was associated to the death of a patient and further 19 patients affected in 2009.
An example of incident investigation is presented. It began with a concern raised by a Sterile Services Manager over a loan retractor, which finally led to the publication of 4 Field Safety Notices, global product recall, delayed surgery and product being redesigned.
Actions were taken at local and national level to prevent its recurrence. Initiatives in Scotland were instigated in 2010 through a quality assurance workshop to agree on methodology in assessing the challenging medical devices prior to their introduction to the service. The national reporting system for incidents and near-misses was established. Stakeholder commitments on pre-assessment, national reporting incidents and share learning were gained. When designing and evaluating innovative medical devices, it is important to consider and evaluate the ability to be decontaminated effectively, preferably using the existing process.