Ensuring that reusable devices can be properly cleaned, disinfected and/or sterilized is imperative
to ensure patient safety and to minimize healthcare-acquired infections, corrective actions,
and recalls. Regulatory agencies and healthcare facilities are increasingly concerned about
the spread of diseases, including clinically relevant microorganisms, on reprocessed medical
devices. The COVID-19 pandemic has increased that concern even further. Therefore, having
proper cleaning, disinfection and/or sterilization instructions in place that have been validated
to ensure compliance with current regulatory standards is paramount. This is not an easy feat,
however, with many considerations to keep in mind when developing and validating these
In order to assist our customers with the development and validation of reprocessing instructions
in an ever changing regulatory landscape, Nelson Labs has a dedicated team of experts
actively serving on relevant ISO and AAMI committees capable of helping with every step of the
way. We offer full-range services starting from writing an appropriate Instructions For Use (IFU)
document, selecting worst-case devices that should be validated, and performing the actual
validations in ISO17025 and GLP accredited laboratories.
When performing intake conversations with our clients, it is clear that deciding which
regulatory aspects are applicable to a specific and individual medical device can be challenging.
In our series of advices, we have therefore attempted to summarize the regulatory guidance
that is offered and how it can be applied to a specific medical device. This list is by no means
exhaustive nor does it cover all aspects related to reprocessing validations. Instead, it covers a
selection of frequently asked questions. It is evident that our team of experts remains at your
disposal to answer any questions that remain.
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