The healthcare industry is continually evolving with groundbreaking research, medical progressions, and changing business models to improve the quality of care and advance the rate of innovation.
Companies are developing new technologies in an effort to support providers and enable them to work more quickly and effectively, and, as a result, those who work in this rapidly changing industry must be able to promptly identify where they can have the most impact to stay ahead. Medical device manufacturers, regulatory agencies and providers need to recognize the methodologies that will prove most successful not only for their own business needs but also for their patients.
A major component to improving the quality and safety of the healthcare industry is the ability to exchange information more effectively. To better manage this exchange, the FDA has established a seven-year phased implementation of a UDI system in hopes of effectively identifying medical devices through their distribution and use.
The FDA’s standard procedure for approving manufacturers to market a medical device is “reasonable assurance of safety and effectiveness” (RASE). In general, researchers must conduct clinical studies to demonstrate RASE for both high-risk and innovative lower-risk devices. A key dilemma for device regulation is how to ensure timely access while also providing evidence to guide safe and appropriate use.
When a device is approved for the U.S. market, there is a level of uncertainty about benefit and risk that is usually addressed through post-market evaluation. The idea behind NEST (National Evaluation System for Medial Devices) is to have a system where the FDA can access meaningful and reliable answers to questions after a device is marketed by using data already collected for clinical care purposes. If we have confidence in such a system (for example, leveraging UDI from registries), then we would be able to more readily assess benefits and risk in the real-world use of a device and more willing to shift the balance of bringing the devices in the market more quickly.
A national evaluation system that engages all stakeholders including provider and patient information could enable the FDA to focus efforts on the development and interpretation of more informative data essential for policy making and clinical decisions for individuals and populations. In addition, providers can better prescribe devices that are shown to be more effective to certain subsets of the population or even unique individuals.
The next compliance deadline occurred on September 24, 2016 and required labels and packages of class II medical devices to bear unique markings. This milestone will have the largest impact on the healthcare ecosystem because most medical devices fall into this category (approximately 800 unique devices.) Expected advantages for manufacturers include increased sales, improved inventory control and medical billing accuracy, as well as more time for the identification and resolution of product issues.
A variety of regulations are required of the industry, and differentiating what requirements will actually prove beneficial can be challenging. The goal of optimized, meaningful data collection and analysis is for patients to receive a notification when a medical device issue needs to be addressed. That way, healthcare providers can easily take appropriate and focused corrective and preventive actions.
After the FDA successfully implements UDI, the label on most devices will include a UDI in human- and machine-readable form that will improve patient safety, modernize device post-market surveillance and facilitate medical device innovation.
Because one of UDI’s goals is to unify the industry and enable key stakeholders in the healthcare industry to “speak the same language,” UDI will help to align with initiatives like precision medicine to lead to better care and more comprehensive information for various constituents across the healthcare ecosystem.
For medical device manufacturers, being able to uniquely identify devices would allow for a more streamlined approach when it comes to device recalls. This year alone, 25 devices have been recalled according to the FDA. As the extent of a recall can range in terms of severity, manufacturers can deploy highly targeted strategies in rolling out a recall when products bear a proper UDI.
For example, a certain set of devices can malfunction while the rest of product line remains fully functional. In that case, if manufacturers can quickly identify the set of affected devices, they can easily recall that group without spreading widespread concern. The goal of UDI is to target specific populations on an as-needed basis by improving the quality and safety of devices for the patients who are using them.
For regulatory agencies like the FDA, access to data-linked devices would enable more effective collaboration with medical device manufacturers for more streamlined device recalls. For innovation to take place, not only must the various players in the healthcare industry all work from the same knowledge base, they all need to communicate similarly for that knowledge to remain effective. By implementing UDI, product quality would increase, a key mission of the FDA, and devices would be harmonized through a singular identification system that would unite important information globally.
By implementing a more agile approach when it comes to recalls, healthcare providers can provide real-time feedback on device inaccuracies through Medical Device Reporting (eMDR), which will assist in reducing medical errors. UDIs will work in conjunction with EHRs and other device registries to house a wealth of information that will help providers assess a device’s benefit or risk to a patient.
The shift toward value-based care models has providers more focused on the quality of care they provide rather than quantity. Having the ability to more effectively track devices will give providers peace of mind that they are arming their patients with the most up to date and effective device available.
Although patients might not initially recognize the impact of UDI, they will directly benefit the most from the implementation. Patients will reap the benefits by becoming more informed; through timely notifications patients will be made aware of product replacements (if needed) to avoid potential life-threatening complications. Through proper device identification, doctors will be able to better connect with patients and can address issues ranging from failing devices to inaccurate billing.
The industry is working to ensure a successful next phase of the UDI implementation process. The initiative will provide the industry with access to better information, collaboration and safe and effective medical devices that will ultimately enable better patient health and will help the industry align with movements like precision medicine. With the goal of a completed UDI implementation set for September 24, 2020, medical device manufacturers the FDA, providers and patients will begin to witness the advantages over the next several years.
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