AAMI Develops Benchmarking Tool for Device Makers

AAMI has developed a new benchmarking tool to help medical device designers and manufacturers determine how their quality management systems (QMS) compare with that of their peer companies, just as the U.S. Food and Drug Administration (FDA) increases its focus on quality.

The FDA maintains a strong focus on the importance of a QMS that enable manufacturers to develop and supply safe and effective medical devices. As stated in its 2013 Strategic Priorities, the FDA has developed a goal to “identify and prioritize systemic practices that advance device quality.” The agency noticed it was issuing more warning letters with design control or corrective and preventive action (CAPA) citations repeatedly noting the same issues, and it wanted companies to focus more on quality and not just regulatory compliance. By Dec. 31, 2013, the FDA plans to “increase the transparency and utility” of quality data while working with external parties on device quality.

In recognition of this emphasis, AAMI has created a new resource called Benchmarking Solutions—Quality Management System for Medical Devices, which is designed to help medical device quality system professionals compare their organizations’ QMS policies, processes, procedures, and performance metrics against those of other organizations in the field. The tool also can be used by a company to benchmark its different manufacturing facilities and operations. This is AAMI’s third online benchmarking tool; the other two are targeted at the healthcare technology management and sterile processing communities.

With AAMI’s new benchmarking program, companies subscribe annually to enter their data anonymously into an online survey platform. They can update and revise their data at any point during the year. “The quality management benchmarking solution is an easy and simple way to identify and learn best practices and a powerful tool in the quest for continual improvement and breakthroughs,” said Chris Driscoll, director of regulatory affairs at the New York Blood Center. “The comparison provided is helpful in identifying specific areas of opportunity for improvement,” added Shannon Hopkins, senior quality assurance manager at QIAGEN. “It’s also encouraging to find where your systems are aligned with current best practices.”

Initially, this new benchmarking tool will feature in-depth questions on two important QMS processes—CAPA and risk management—and will expand into other quality system processes in the future. The benchmarking questions for the two QMS processes were developed by a team of eight subject matter experts. A steering committee that oversaw the development of the benchmarking tool included representatives from the FDA, industry, AdvaMed, and Dynamic Benchmarking—AAMI’s software developer that produced all three of the benchmarking platforms. The work of the experts and the steering committee was facilitated by Ed Kimmelman, QMS technical consultant to AAMI and convenor of the ISO/TC210, WG1, the developer of ISO 13485:2003.

The CAPA section of the survey focuses on data related to management responsibilities; the organization that administers and controls the CAPA process; training and tools used; preventive actions; corrections, which fix known nonconformities; and corrective actions, which prevent their recurrence. Subscribers also are asked about timing targets related to key milestones in the handling and disposition of corrections, corrective actions, and preventive actions.

“It is clear from a review of FDA inspection findings that an organization’s CAPA process is the key to the maintenance and improvement of compliance with all regulatory QMS requirements,” said Kimmelman. “Knowing how other organizations of similar size and complexity are managing their CAPA processes can provide useful input.”

The risk management section will gather data related to the medical device organization’s risk management policies, planning, structure, and processes.

“The focus and administration of risk management is relatively new to the medical device arena,” Kimmelman noted. “Currently, there is still a lot of learning among the regulatory, certification, notified body communities, and the medical device organizations themselves. Benchmarking how risk management is handled and administered can be invaluable to all involved.”

After answering the questions on risk management and CAPA, a subscriber can compare its answers against other manufacturers based on organization size, complexity, market focus, and other criteria. Output results are displayed using simple, intuitive charts and graphs, which can be customized for internal presentations.

AAMI plans to expand the benchmarking tool each year with additional QMS process areas (e.g., design and development, process validation). A Benchmarking Advisory Task Force will review recommendations from subscribers and also make its own suggestions for improvement. Members of AAMI’s staff will review the task force’s recommendations.