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Abstract

Over the last decade, the human factors (HF) community has actively worked to improve use safety and effectiveness into design. Yet, an area that has been neglected is reprocessing of reusable devices. Intuitive Surgical, manufacturer of da Vinci robotics surgical systems, recently redesigned reprocessing instructions for use (IFU) incorporating an HF process and iterative design.

It may appear that reprocessing is simply another design effort where the standard human factors process is applied. However, it is essential to consider the intersection of hospitals’ needs and limitations, the actual requirements for effective cleaning, disinfection, and sterilization, regulatory requirements, and the manufacturer’s maturity in developing instructions.

The redesign effort involved a process based on user-centered design with interdisciplinary team inputs. The focus was on improving comprehension and performance through the use of simple illustrated steps, concise text, improved headings, workflow aids, and intuitive navigation. In addition, a workflow-based use error risk analysis identified critical tasks, and was used to guide the redesign. Eight (8) reprocessing IFUs were revised simultaneously for two (2) robotics platforms, adding to the challenge. The IFUs addressed reprocessing for robotic surgical endoscopes, instruments, and accessories. The reprocessing of robotic devices is complex, requiring multiple steps that are at times inconsistent between devices.

An iterative process was used for drafting versions of the IFUs, conducting usability testing, making improvements to the IFUs, and then in retesting. A final validation test was conducted and provided evidence for the use safety and effectiveness of the IFUs. Throughout the redesign process, challenges were encountered, which required solutions through cross-functional alignment. As IFUs are part of the user experience, the process and design elements described may help guide the development of usable IFUs, and are shared in a broader context to help further improve experiences for user and patients.

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References

AAMI TIR12:2010. Designing, testing, and labeling reusable medical devices for reprocessing in health care settings: A guide for medical device manufacturers.

AAMI/FDA Summit (2011). Reprocessing: Priority Issues from the Medical Device Reprocessing Summit.

ANSI/AAMI ST81:2004/(R) 2010. Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices.

Backinger

Kingsley

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U.S. Food and Drug Administration (CDRH) (2015). Guidance for Industry and FDA Staff. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.

U.S. Food and Drug Administration (CDRH) (2016). Guidance for Industry and FDA Staff. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.

The Clean and Dirty of Redesigning Reprocessing Instructions for Use

Abstract

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