The performance of your medical device is only as safe as the instructions and training the end users receive. At Starodub we have seen cases where inadequate instructions for use (IFU) have led to use errors that manufacturers hadn’t accounted for during device development.
When information crucial for safe use of a device is omitted or described in ambiguous terms in the IFU, the user may unwittingly perform actions that are contrary to what the manufacturer intended. Undesirable effects may result in harm to patients or users, necessitating time-consuming and resource-intensive corrective and preventive actions.
Adherence to the ISO 14971 standard on risk management during medical device development means applying a hierarchy of risk mitigation measures. Only when inherent safety by design cannot be achieved is incorporation of a protective measure an option. Only when a protective measure is not possible is mitigation by instruction considered acceptable.
Adequacy of the IFU is subject to verification and validation, encompassing risk management activities and rigorous usability testing. These steps form a crucial part of device development and should be factored in as early as possible and not as an afterthought in the tail end of the development process. This helps ensure that the IFU are optimally aligned with the product and that they adequately reduce the risk of use error. Because when it comes to use error, prevention is better, safer and ultimately less costly than cure.
Starodub supports risk management activities related to usability, in both pre-market and post-market settings. Contact us through our website at www.starodub.nl.
