AAMI has sought clarity on what considerations U.S Food and Drug Administration (FDA) review staff would like the association and similar organizations to take into account during the standards development and revision processes.
The association made the request in written comments to draft guidance the agency issued in May on the appropriate use of voluntary consensus standards in premarket submissions. The draft guidance builds upon a document released in 2007, adding information on how applicants have used standards inappropriately in their premarket submissions.
In its comments, which generally welcomed the FDA’s revision, AAMI said that it would be helpful “to know more about ‘how’ standards are used incorrectly or inappropriately, so that AAMI can produce tools (e.g., checklists or guides) that make it easier for industry to know what they are doing incorrectly.”
Additionally, AAMI said having a list of what reviewers are looking for in standards would be beneficial, particularly since representatives from the FDA are not always present at standards committee meetings. “AAMI believes it would strengthen standards and improve the medical device industry’s understanding of what’s important in terms of substantive content of standards,” the association said.
AAMI also asked that the agency reorganize the document’s structure to make it more usable as a quick reference guide. It proposed an outline that includes a section on use of standards that is subdivided into “methods of use” and “general process.”
In addition, AAMI suggested that the document include examples or case studies “to better articulate excellent practices” and highlight potential incorrect uses of standards when submitting a premarket application.
AAMI also recommended that the agency reformat the Standards Data Report Form, also known as FDA Form 3654. The example form provided in a link from the draft guidance is “poorly developed” and should be updated so device manufacturers can add pages and lines.
Report Offers Tips for Smoother Device Approvals
Are you a medical device manufacturer trying to interpret standards and understand regulatory expectations to get your product to market as quickly as possible? AAMI is offering a free resource for you.
The S3 Challenge Forum – for solutions, synthesis, and standards – took place March 11-12, 2014, in Herndon, Va., and brought together a range of stakeholders to hear experts from the U.S. Food and Drug Administration (FDA) and industry offer their tips and advice. The sessions used a different format from the S3 Challenge’s predecessor, the International Standards Conference, encouraging participants to discuss the topics among each other to gain a greater understanding of how standards and regulations have an impact on getting products to market.
“The forum was excellent. This type of interaction will result in a better understanding by both industry and the FDA of the challenges each faces, which, in turn, will help drive positive change in the regulatory approval process,” said Michael Ball, director of biological services at Covidien Surgical Solutions Group, in the report.
The 23-page report summarizes the insights that came to light during the event by examining three top industry challenges: biocompatibility, sterility, and risk management. Each section defines the issue and lists relevant standards, then provides a summation of experts’ presentations. The final section of the report provides an overview of the last session, which focused on managing risk associated with catheters and endoscopes.
In addition, the report includes a section of questions for companies to consider when evaluating ways to improve their risk management processes. Developed by industry consultant Stan Mastrangelo, the questions cover an array of topics, including system- and component-level hazards and standards used to evaluate risks. “We intended that this guide would serve as a summary of insights from the event and prove valuable for the medical device industry,” said Carol Herman, AAMI’s senior vice president of standards policy and programs.
To read the free report, visit
AAMI has started work on developing two new professional certifications, one for quality systems experts in the medical device industry and the other for healthcare technology management (HTM) professionals. Both will be rolled out early next year.
AAMI already has certification programs for biomedical equipment technicians, radiology equipment specialists, and laboratory equipment specialists.
This summer, a group of subject matter experts from leading institutions across the country were invited to AAMI’s headquarters in Arlington, Va., to develop the blueprint for the new certifications, which will prove crucial in demonstrating knowledge of and dedication to the field.
“Often – too often, I might add – certification may be seen as another hurdle in professional development, and I’m amazed that people take for granted the value that certification recognizes,” said Jan paul Miller, who recently joined AAMI as director of certification programs. “Certification benefits not only the certificant, but also the employer and, most importantly, the public.”
Divided into two groups based on their expertise, the attendees developed separate lists that identified the tasks quality systems professionals or HTM managers should perform as part of their job duties. The groups then created a draft certification exam for each set of professionals.
Miller noted that the certifications are being fast-tracked using a format that compresses the development from 18 to six months.
“I’m very excited to see the manager certification program moving forward,” said Carol Wyatt, manager of the Biomedical Engineering Department at Baylor Scott & White Health Care in McKinney, Texas. “This is another way to show healthcare leadership that HTM managers bring an increased level of competency to the field.”
For more information on certification and its benefits, visit www.aami.org/certification.
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