Submitted by @joanpatricemelendez on
Expansion of UDI to include all Class II and Class III devices
I fully support the commenter's statement regarding the importance of extending unique device identifier (UDI) requirements to life-supporting or life-sustaining devices, and I'd like to further clarify that this should encompass all Class II and Class III medical devices. It's a crucial point to consider, especially given that a significant majority of recalls involving reported deaths or serious events often remain unaddressed when UDI information isn't included in the patient's record.
The integration of UDIs into patient records can vastly improve the traceability and accountability of these devices, facilitating quicker and more effective responses in the event of recalls or adverse events. This is not just a matter of regulatory compliance but also of patient safety and quality care.
Furthermore, the adoption of UDI is gaining momentum internationally within the healthcare ecosystem. By including UDI for all medical devices, particularly Class II and Class III, which generally encompass more complex and higher-risk devices, we not only align with global best practices but also lead in establishing robust safety protocols. This move would represent a significant step towards ensuring patient safety and enhancing the overall quality of healthcare delivery.
In essence, expanding the UDI requirement is not just beneficial; it's essential in our ongoing efforts to improve healthcare outcomes, enhance device tracking, and ensure patient safety in an increasingly interconnected and data-driven global healthcare environment.
Submitted by swforrest on
Expand UDI to Life-Supporting/Life-Sustaining Devices
Currently in version 3 of the USCDI (and since version 1), unique device identifiers are only required for a patient's implantable medical devices. However, devices categorized as "life supporting or life sustaining" are likely to be more critical to patient health than many implantable devices. These devices are not elective and many times there are no other medical interventions available to the patient. According to 21 CFR 860.3, a life-supporting or life-sustaining device means a device that is essential to, or that yields information that is essential to, the restoration or continuation of a bodily function important to the continuation of human life. Examples include ventilators, dialysis machines, cardiopulmonary bypass machines, and defibrillators. These devices are identified by product code and they make up a smaller group (only about 4% of product codes -- 1/3 the number of implantable product codes). About 9% of implantable devices are also already considered life supporting/life sustaining. The essential nature of these devices to patient health makes them a high priority to collect device identification information. Device information on 160 additional medical device product codes (associated with close to 20,000 additional device submissions) could be collected and made available for analysis as well as many other uses. With the increasing use of real-world data (which may originate in health information systems – specifically electronic health records, and associated health records and transactions) as real-world world evidence for regulatory decision making, it is imperative that the data collected about devices is standardized across the healthcare ecosystem so that it may be used for interoperability. If these life supporting/life sustaining devices can be reliably identified from the point of use, insertion or implantation – we may be able to rely on some of the additional features of those devices e.g., use of standardized device settings and metrics in the future. We therefore recommend that unique device identifiers be required for life supporting/life sustaining devices in addition to the existing requirement for implantable devices. This may also advance the adoption of UDI across the healthcare ecosystem and improve the ability of various stakeholders to incorporate it into their primary and secondary business processes. For example, device identification information is important to effectively assess patient safety events (e.g., active surveillance, adverse events and/or recalls).