The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that the Food and Drug Administration (FDA) is encouraging medical device manufacturers to go beyond simply complying with regulatory requirements and instead independently implement predictive and proactive measures to improve quality.
In 2011, the agency launched its Case for Quality initiative after an in-depth review uncovered manufacturing quality risks and showed that companies that drive quality organization-wide reap “tremendous benefits,” such as fewer complaints and internal investigations and lower quality-related costs. Despite these findings, little has changed within the industry, according to the FDA.
“In the four years since the conclusion of the analysis, FDA has continued to observe that the percentage of inspections calling for official action by FDA has remained static, with the same issues recurring frequently year after year,” according to a FDAVoice blog post, written by Jeffrey Shuren, MD, JD, the director of the Center for Devices and Radiological Health; Howard Sklamber, JD, deputy commissioner for global regulatory operations and policy; and Melinda Plaisier, associate commissioner for regulatory affairs.
As part of the Case for Quality, the FDA piloted a new inspection approach focused on the quality of batteries used in implantable devices. According to the FDA’s implementation report, “The pilot established a collaborative framework for determining specific operations, design considerations, and controls that impact the quality and safety of implantable devices that contain batteries.”
Overall feedback from program participants showed that the piloted inspections provided a better exchange of information regarding quality between inspectors and manufacturers. However, most industry participants reported that the program did not change discussions with management or any internal practices. Moving forward, in addition to inspecting manufacturers on a regular basis, the FDA is thinking about other ways to support quality beyond traditional regulatory approaches.
“Across FDA, we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive—and increase—product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review and analysis of that data, which in turn can promote the practice and culture of quality within firms,” Shuren, Sklamber and Plaisier wrote.
To assist manufacturers in meeting regulatory requirements for quality management systems, the standard ANSI/AAMI/ISO 13485 has been revised and should be available during the first quarter of next year. The updated version of Medical devices—Quality management systems—Requirements for regulatory purposes incorporates risk as part of the quality management process and provides general updates to management practices already followed by industry.