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Author Brian Edwards, Pegah Pormeh, Julie Avery |
| Abstract The WHO has both a human factors strategy and more recently published a global pharmacovigilance strategy although the latter does not refer to devices which continue to be regulated in a parallel system.However, many medicines depend for their effective use on devices (including kits), and some products are integrated drug-devices. Unlike other safety critical sectors, there are no international guiding principles for all stakeholders which might unify the optimal use of both medicines and devices. Based on discussion with pharmaceutical manufacturers, we have drafted the world’s first set of guiding principles for human performance and safety of medicines and devices. We position these principles as a practical bridge between pharmacovigilance and existing human factors and usability frameworks for medical device design (such as IEC 62366-1), making them relevant and usable for designers, regulators, and industry across both medicines and devices. |
