By Heather Colbert
On September 29th and 30th, 2015, the FDA hosted a public workshop on “Medical Device Patient Labeling.” The workshop was organized by the Center for Devices and Radiological Health (CDRH) with participation by FDA staffers from the Center for Drug Evaluation and Research (CDER). The purpose of the workshop was to discuss the clarity of the current patient labeling guidelines and gather input for upcoming updates to the existing 2001 “Guidance on Medical Device Patient Labeling.” Attendees included stakeholders representing medical device manufacturers and pharmaceuticals, along with human factors professionals, patient and caregiver advocates, and other industry experts.
Medical device patient labeling includes any medical device information that is intended for a lay audience. Examples of patient labeling include: medication guides, patient package inserts and instructions for use. Presentations from patients, caregivers, and home healthcare providers provided some important context on how medical devices may be used in the home and how patient labeling can best support patients and caregivers. Typically, device training occurs when a patient is discharged from a hospital or other healthcare facility. This can be a very difficult and high stress time to be learning how to use a complex device. There are many distractions and patients and caregivers can be overloaded by information. Access to easy-to-understand information is critical and improving traditional written instructions is only part of the solution. More novel approaches to communicating information such as visual “quick start guide” instructions, online information repositories and social media tools provide possibilities. However, some major caveats need to be considered, including low literacy levels and limited access to technology for many patients in the United States.
Presenters from CDRH, CDER, and Industry experts reviewed the current state of guidance and research on Patient Labeling. Among the sources for labeling guidance discussed was an updated version of ANSI/AAMI HE75 Human Factors Engineering – Design of Medical Devices standard is about to be released for public comment. This update includes recommendations on how best to incorporate instructional information and materials, including the use of quick start guides, videos, and “new media.”
Throughout the two-day event, several panel discussions were also held to discuss the “nitty-gritty” details of patient labeling. Topics discussed included:
- What are the key areas of patient labeling?
- How should the information be presented?
- How can section headings and placement of key areas be most useful in patient labeling?
- How can information about the description of the device be most useful?
- What information is important to include as additional information, appendices & references?
A key human factors point raised when discussing Instructions for Use (IFU) labeling in particular was to approach the design of instructions with the question “What does the end user need to accomplish with this device?,” rather than “What can I tell the end user about the device?.” Key areas identified included:
- What are the steps to set up the device safely?
- What are the “red flags” that something is wrong and what should I do or whom should I call in this situation?
Other suggestions included the use of a Frequently Asked Questions (FAQ) section that would mimic the dialog between a patient and Health Care Provider. Also it was suggested that headings be kept simple and usable, and the use of “generic nouns” be avoided. For example, “Do not use if…” is a much more meaningful section heading than “Precautions.”
The Role of Human Factors
Stakeholders agreed that Human Factors testing, including both whole device testing (which incorporates device labeling in realistic use scenarios) and separate label comprehension testing with representative end users is extremely beneficial in developing effective labeling that supports safe and effective device use. Human Factors tools, such as task analysis, are also considered important inputs to developing labeling.
Human Factors MD provides a broad range of Human Factors services related to device labeling, including labeling development, formative and summative human factors studies and label comprehension testing. Contact us at 800.639.7941 to discuss your specific medical device labeling needs.
ANSI/AAMI HE75:2009. Human Factors Engineering—Design of Medical devices.Arlington, VA: Association for the Advancement of Medical Instrumentation.
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health (2001, April 19). Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers.
Links for Additional Information
Comments on the workshop (regardless of attendance) and the current guidance document are invited at http://www.regulations.gov [Docket No. FDA-2000-D-0067].
Webcasts and presentations from the Medical Device Patient Labeling public workshop.