AAMI Update: CDRH Reorganization Heralds New Focus on Medical Device Standards

The Center for Devices and Radiological Health (CDRH) recently announced a major organizational change. The Office of Strategic Partnership and Technology Innovation (OST) has been promoted to a CDRH Super Office, creating a new division dedicated to standards in the process.

“The Super Office designation allows the Center, specifically OST, to be well-positioned and capable of adapting to and addressing future public health needs and challenges while continuing to advance the voice of patients, innovation and safety, regulatory science, and service excellence with our customers,” CDRH Director Jeffrey Shuren stated.

As part of the reorganization, the Standards and Conformity Assessment Programs (S-CAP) has been promoted to division level and is now the Division of Standards and Conformity Assessment. Within DSCA there are two programs: Standards Management Program (SMP) and Conformity Assessment Program (CAP). DSCA’s new management team consists of DSCA Director Terry Woods, CAP Assistant Director Eric Franca and SMP Assistant Director Jianchao Zeng.

“The reorganization recognizes the importance of standards and conformity assessment to the Center’s mission and vision, assuring that patients and providers have timely and continued access to safe, effective and high-quality medical devices and safe radiation-emitting products,” Woods said. “We look forward to continuing to collaborate with SDOs and the entire medical device community in the development, recognition, appropriate use, and conformity assessment of voluntary consensus standards for medical devices, radiation-emitting products and emerging technologies.”

“The creation of the DSCA is a unique and welcome opportunity for both AAMI and the entire standards development community,” added Matt Williams, vice president of Standards, AAMI. “The chance to continue and explore new collaboration with CDRH will certainly further AAMI’s mission of standards development with an eye towards optimal patient outcomes.”

Additionally, OST’s elevation comes alongside the establishment of a new Office of Readiness and Response (ORR). ORR’s mission is relevant to both AAMI’s membership and standards development committees, as it includes the development and implementation of new consensus standards for medical devices.

OST was founded in 2019, with the intent to “create an agile infrastructure capable of adapting to future organizational, regulatory and scientific needs.” Per the CDRH release, its primary functions include an external focus on issues such as “medical device cybersecurity, digital health, standards, and patient science,” and coordinating the Center’s readiness for crisis events such as pandemic outbreak or supply chain shortages.

OST’s new status as a super office has major implications for CDRH’s organizational structure, with the imminent establishment of five new offices inside of OST. These include:

The Office of Supply Chain Resilience (OSCR) will lead the Medical Device Resilient Supply Chain and Shortages Program with an eye towards ensuring strong supply chains and addressing potential medical device shortages.

The Digital Health Center of Excellence (DHCoE) will focus on the digital health environment, and the office will “connect and build partnershipsto accelerate digital health advancement, share knowledgeto increase awareness and understanding.” Further, DHCoE will “innovate regulatory approachesto provide efficient and least burdensome oversight while meetingFDA standards for safe and effective products.”

The Office of Technology and Data Services (OTDS) will focus on executing CDRH’s Digital Transformation Initiative and ensuring the smooth use and handling of data by CDRH data both inside and outside the Center.

The Office of Readiness and Response (ORR) will focus on issues such as cybersecurity, standards, and overall readiness with an eye toward hedging against public health threats. ORR will also “drive the development, recognition, and appropriate use of voluntary consensus standards for medical devices.”

The Office of Equity and Innovative Development (OEID) will focus on health equity issues by “fostering device innovation that expands access to diverse patient populations, including underserved populations, and ensuring all patients have access to medical devices informed by solid patient science and engagement.”

The new Super Office will continue its existing partnerships with “various medical device stakeholders, including patient organizations, health care professional organizations, industry, and scientific and other organizations in the U.S. and abroad.” The office’s new structure is meant to boost the effectiveness of CDRH and ensure that CDRH can meet its strategic priorities and abide by its MDUFA V commitments.

How Data Sharing Can Promote Patient Safety
In late 2023 the U.S. Department of Health and Human Services (HHS) issued a proposed rule that would implement financial disincentives aimed at health systems and health IT vendors that block electronic data sharing.

To better understand the recently finalized rule and its implications, AAMI News recently interviewed infectious disease physician and medical informaticist Dr. David Classen. Classen is a professor of medicine at the University of Utah in Salt Lake City as well as CMIO at federally certified patient safety organization Pascal Metrics. One of his primary focus areas is leveraging health IT to enhance patient safety.

Classen pointed out that the new rule, called the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule, has been released by the Office of the National Coordinator (ONC), which as part of Health and Human Services, “oversee[s] the electronic health world that we live in.”

The rule directly targets information blocking, but also introduces new guidelines around artificial intelligence. But the penalties for health systems and vendors that obstruct electronic health information sharing could be steep, including Medicare impairments, a zero score for the Merit-based Incentive Payment System (MIPS), and ineligibility for the Medicare Shared Savings Program.

Why might health systems and IT vendors be hesitant to share data? Per Classen, “Health systems might not share it because they might be worried about data privacy and security if they share it outside their walls. They might be worried about competitive position if for example they’re one of just two health systems in a community.”

But Classen pointed out that the new rule builds on previous regulatory action. Further, even with concerns about data privacy, security, and competition among health systems and vendors, Classen indicated that the case for increased sharing of patient data is strong.

The new rule is meant to directly promote data sharing, something Classen believes is crucial for effective and safe patient care. “Let’s say I’m in my doctor’s office and my doctor’s about to prescribe a new medication for me that I had an allergic reaction to at another doctor’s office. I really want my doctor’s office to get that information, so they don’t give me the same medication … So that’s why information sharing is so important for the safe care of patients who often get care at different hospitals and different doctors’ offices.”

The conversation later turned to the value of health IT standards, particularly those developed by AAMI, in facilitating information sharing and ensuring patient safety. Classen highlighted AAMI’s efforts in creating safety software standards that apply to both vendors and users, and focus on areas like quality systems, risk management and usability.

“These standards are called life cycle standards and they’re a new thing. They’re developed so that we can give guidance to both vendors and users who are both customizing the software and help them create a sense of shared responsibility. And we believe that shared responsibility is what ultimately leads to the safest systems that we can possibly deliver.”

For more information, visit aami.org.