A practical approach to designing operating instructions for medical products in late or post-design phases

Abstract

User instructions, and especially operating instructions, are an essential part of the FDA's “medical device labeling” requirements and are intended to help ensure that the device is used safely and effectively. Their design should go hand-in-hand with the design of the product that they are going to accompany. However, for one reason or another, they are usually treated as something that can be tacked on at the end of the device development process. At this stage, it is often realized that, had the device been designed differently, it would have been easier to instruct the potential users. However, it is generally too late and the instructions have to be formulated around the fixed design of the product. Also, in the clinical engineering environment of healthcare organizations, sometimes there is a requirement to produce tailored operating instructions for certain groups of users (especially patients and carers) in certain circumstances, e.g. when the manufacturer's instructions are inadequate or a device has been configured for a particular type of user group. This paper attempts to demonstrate a practical approach to producing effective operating instructions for a product that is already at the far end of its development process or even marketed.

Keywords:

• Device
• Instructions
• Usability
• Safety
• Effectiveness

Notes

*Assuming that these operating instructions would ultimately be laid out on a piece of paper, the phrase ‘instruction leaflet’ is used in this paper to mean either a separate sheet of paper or a part of a user manual that contains operating instructions.

*For the sake of simplicity and to explain the point in the section, the pictures of four key user steps are shown in figure 4. The authors strongly suggest that these steps should not be taken as a guide to using the product.

*The word ‘Click’ may have its own pros and cons—it may give a confidence to users that they have done it correctly, whereas, some users may not reach to the end of the slot because of the confusion caused by the increasing pushing force and may not hear a click.