The 2011 IPAC-RS conference, held in Rockville, MD March 29-31, featured speakers from a number of FDA offices discussing the agency’s efforts relevant to orally inhaled and nasal drug products (OINDPs). Among those speakers was Ronald Kaye, Human Factors Pre-Market Evaluation Team Leader from the Office of Device Evaluation in the Center for Devices and Radiological Health (CDRH), who announced that his office intends to begin reviews of OINDPs as soon as he has the staff to handle the added workload.
An FDA guidance titled Early Development Considerations for Innovative Combination Products specifies that, “For certain combination products that include a device constituent part, it may be necessary to evaluate the human factors of device use on the safety and effectiveness of the combination product.”
These studies, the guidance says, “would evaluate how users operate the system in realistic, stressful conditions. In many cases, these studies include an assessment of all components and accessories necessary to operate and properly maintain the device; e.g., controls, displays, software, logic of operation, labels, instructions, analysis of critical tasks, use error hazard and risk analysis.”
The guidance goes on to “recommend that human factors evaluations take place early in the combination product development process to identify design features that may need modification before conducting the key studies to establish the safety and effectiveness of the combination product.”
“The agency,” says Kaye “has woken up” and has become much more aware of the importance of human factors to the design of medical devices. The goal, according to the current guidance, Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management, “is to minimize use-related hazards, assure that intended users are able to use medical devices safely and effectively throughout the product life cycle, and to facilitate review of new device submissions and design control documentation.” An update of this guidance is circulating internally, he reports.
According to Kaye, the Human Factors (HF) Pre-Market Evaluation Team, which currently consists of three staff members, has devoted an increasing amount of its time to combination products but has so far focused mostly on pen- and auto-injector products. Although they are aware of OINDPs, which he refers to by the acronym “PADs” for “pharmaceutical aerosol devices,” to date they have looked at only one.
While he was unsure as to whether the “PAD” the team had reviewed was a metered dose inhaler (MDI) or a nebulizer, he did seem certain that they had not yet been consulted on a dry powder inhaler (DPI). The Human Factors Pre-Market Evaluation Team will undoubtedly become much more familiar with the various types of inhalers and other OINDPs soon because Kaye asserted in his presentation, “We do review [PADs] and expect to do more of these in the future.”
The FDA provides a list of documents relevant to the role of human factors engineering in the manufacture and distribution of medical devices here.
Kaye’s slide presentation is available on the IPAC-RS web site.
Day 1 summary of IPAC-RS conference
