Meeting regulatory standards and acquiring FDA approval is the last major hurdle to overcome before a new medical device can enter the market, serve its intended purpose, and benefit its intended users. Today, many of the regulations and guidelines that form the basis of FDA submission are intended to ensure that devices are designed with strong consideration towards human factors and usability, both of which are now recognized as indispensable tools for producing safe and effective medical products. What follows is a primer on the history of medical device regulation, the origins of human factors guidance, and the most prominent regulatory bodies developers must meet the standards of to satisfy FDA human factors requirements.
Medical Devices and Regulatory Oversight: A History
The history of regulatory oversight in medical devices begins in the 1960s when public interest first came to the topic. By the 1970s, Congress took notice, culminating in the 1976 passing of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. In 1982, the FDA divisions regulating medical devices and radiation-emitting products merged to form the Center for Devices and Radiological Health (CDRH).
1990 brought the most significant action to date; with the Safe Medical Devices Act's passing, the FDA was awarded expanded post-market activities that allowed for more thorough regulation. This included requiring user facilities to report adverse events, defining substantial equivalence related to marketing devices through the FDA 501(k) program, and allowing the FDA to enforce manufacturer-performed post-market surveillance on implanted devices. It also included modifying the procedures for the establishment, amendment, or revocation of device performance standards. Importantly, it also authorized the FDA to issue device recalls and impose civil penalties for manufacturers in violation.
The Origins of Human Factors and Usability Guidance
Though it may be surprising, the use of human factors engineering principles in the medical domain is a comparatively recent development. While some references to human factors in healthcare exist in research dating to the 1980s and early 1990s, it was not until 1995 that the topic was brought to significant attention with Professor James Reason's efforts.
The originator of what is commonly known as the "Swiss cheese model," Reason extensively researched and published numerous writings on error management related to human factors. Emphasizing the importance of individual and organizational factors in the design of safety-critical systems, Reason continuously pushed for a culture of analyzing risk events for their root cause, rather than blaming them on failures on the user's part. His work, the principles he and his colleagues defined, spurred the application of human factors to healthcare and formed the ideological basis for the regulations, standards, and guidelines sanctioned and followed today.
Some of the most prominent of these generated guidelines include the FDA human factors guidance; IEC usability regulations; and HE75:2009, created by the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI).
Other Regulatory Bodies
Along with the most commonly known governing body, the FDA has other notable regulatory and standards agencies to be mindful of when developing medical devices and seeking approval. AAMI is one such agency, a nonprofit organization founded in 1967 and the primary source of consensus standards, or those created by the persons affected and adopted by nationally recognized entities nationally and internationally. They contribute not only standards within the medical device industry but also practical information and guidance for healthcare technology professionals.
The ISO, or the International Organization for Standardization, is another prominent organization that is internationally based, non-governmental, and backed by a global network. They issue standards covering a wide range of market segments, of which healthcare is only one. Responsible for several standards relevant to human factors and usability and medical devices more generally, including quality management system standards like ISO 13485 and guidance on applying risk management standards as therein ISO 14971. Meanwhile, the International Electrotechnical Commission, or IEC, is a standardization organization that collaborates with the ISO to co-create and enforce relevant standards. Bringing together more than 170 countries worldwide and employing close to twenty thousand experts in various fields, the IEC operates internationally to ensure that medical products are safe and effective for use.
Ultimately, while developers may see these entities and their standards as a thorn in the side at times, they exist for the express purpose of safeguarding the health and safety of medical device users while aiding the device in performing to the best of its abilities. Armed with an intimate knowledge of their origins and backgrounds, developers will be better able to understand, navigate, and meet the requirements of FDA approval.
In the second part of The Overtures of Human Factors Guidance for U.S. Submission, we will discuss the most prominent regulations, standards, and prescriptions acknowledged by the FDA and other relevant agencies. Stick around for this crash course in human factors guidance.