By AAMI
As the breadth and scope of combination products around the world continues to ramp up, are U.S. manufacturers equipped with the best design plans possible? A brand-new guidance document, released by the Association for the Advancement of Medical Instrumentation (AAMI), will assist manufacturers in aligning with the latest best practices for manufacturing combination products.
AAMI TIR48:2024; Quality Management Systems (QMS) Recommendations On Application Of The U.S. FDA’s CGMP Final Rule On Combination Products recommendations on application of the U.S. FDA’s CGMP final rule on combination products is designed to assist manufacturers with abiding by the Food and Drug Administration’s regulation on current good manufacturing practices (CGMPs) for combination products.
Combination products are defined as products that incorporate drugs or biologics with medical devices. However, the taxonomy and regulations surrounding these products may vary wildly from country-to-country, leading to confusion for manufacturers looking to stay compliant with U.S. requirements. AAMI TIR48 provides a comprehensive resource for manufacturers navigating FDA requirements for combination products and ensuring they can bring medical devices to market that will benefit patients. AAMI TIR48:
- Assesses FDA’s codified ‘Streamlined Approach’ for compliance with CGMPs and identifies manufacturer considerations.
- Provides a clause-by-clause assessment of the pertinent sections of 21 CFR and identifies compliance pathways.
- Addresses viable alternative and streamlined mechanisms for complying with CGMPs.
- Compiles management responsibilities for manufacturers of combination products, addressing aspects such as executive oversight, quality policy, risk based QMS, auditing and more.
- Applies design controls and risk management to combination products.
- Includes information on purchasing controls, corrective and preventive action (CAPA), and inspection readiness for manufacturing facilities.
AAMI TIR48 was produced by the AAMI Combination Products Committee, which is co-chaired by John Weiner, director of the Office of Global Operations at FDA, and Susan Neadle, an industry veteran and leading expert in the field of combination products. According to Neadle, “Sometimes you’re using the exact same words for the drug world as you use in the device world, but the interpretation is different. That creates all sorts of confusion not just for industry but also for health authorities. So, the inspection readiness piece of TIR48 will help you contend with that both internal to your organization and as you’re interfacing with health authorities.”
In short, AAMI TIR48 provides the most current industry guidance for combination products manufacturers as they deal with an increasingly complex regulatory environment. The standard is available for purchase in the AAMI store.
HTM Leaders Demonstrate Promising STEM Career Paths for Students
While healthcare technology management (HTM) departments around the U.S. and abroad struggle to fill open positions, AAMI’s members and HTM leaders are inspiring the next generation to consider the essential field as a rewarding career path. Most recently, Bryant Hawkins Sr., site manager for TRIMEDX and the Children’s Hospital of New Orleans, hosted a career fair for students, showcasing what they could accomplish as a HTM professional.
The event was co-hosted with STEM NOLA, a 501(c)(3) nonprofit dedicated to sharing valuable perspectives about STEM career opportunities with students across the U.S., and featured five workstations for students to gain hands-on experience with HTM tools and technologies.
With the help of several other HTM leaders from across the U.S., students learned about sign monitors, defibrillators, MRI unit coils, and learned valuable insight into where an HTM career could take them from a college instructor. Some students even had the opportunity to join Hawkins for a recording of his HTM on the Line podcast, sharing the next generation’s perspective on career prospective and their personal goals.
“Their attentiveness, insightful questions, and valuable suggestions on how the HTM industry could evolve were impressive,” Hawkins later noted. “To say I was blown away by their engagement and insight would be an understatement!”
“Interestingly, only two attendees were previously aware of the HTM industry,” he added, highlighting the importance of bringing more attention to the essential field. “By the end of the fair, every student had gained a comprehensive understanding of the field, signaling the event’s overwhelming success in spreading awareness.”
Maria Denson representing the HTM Women in Leadership Society; D’Juan James, director of clinical engineering at St. Elizabeth Healthcare; HTM instructor and professor Jeffrey Smoot, who is also the CEO of Interactive Healthcare Designs; and Allison Woolford, biomedical equipment specialist at Duke University Health System, supported the event.
