The Association for the Advancement of Medical Instrumentation (AAMI) is reporting on the Food and Drug Administration (FDA)'s proposed series of steps to strengthen and modernize its postmarket surveillance of medical devices. The “smart, tailored modifications” will, according to the agency, both bolster patient safety and help to expedite clearance of new devices or new uses for existing devices through the faster generation of more comprehensive data.
The proposed changes are outlined in a 25-page report released by the FDA, "Strengthening Our National System for Medical Device Postmarket Surveillance." Several aspects of the report have already been made public by the agency, such as the proposed use of unique device identifiers (UDI). But the report provides the agency’s most comprehensive overview of its postmarket surveillance system and what it feels needs to be done to move it forward.
“FDA’s vision for medical device postmarket surveillance is the creation of a national system that conducts active surveillance in near real-time using routinely collected electronic health information containing unique device identifiers, quickly identifies poorly performing devices, accurately characterizes the real-world clinical benefits and risks of market devices, and facilitates the development of new devices and new uses of existing devices through evidence generation, synthesis, and appraisal,” the report says.
The agency proposes four specific steps:
1. Establish a UDI system and promote its incorporation into electronic health information.
2. Promote the development of national and international device registries for selected products.
3. Modernize adverse event report and analysis.
4. Develop and use new methods for evidence generation, synthesis and appraisal.
If enacted, the changes would impact healthcare technology professionals working in hospitals and other healthcare facilities, as well as manufacturers.
AdvaMed, a trade association representing medical device manufacturers, offered a cautious response to the report, noting that it was not guidance, but a general strategy with many specifics still up in the air.
“We’ve been waiting for it a long time,” says Jeffrey Secunda, vice president of technology and regulatory affairs at AdvaMed. “We’re familiar with most elements, and it’s good to see the detail is growing.” Secunda said there’s little disagreement that the current postmarket surveillance system is insufficient in some ways, but added the industry wouldn’t want to see a new set of postmarket requirements.
“The hope is that the development of a robust postmarket surveillance system will enhance the development of new medical devices through a better pre- and postmarket balance, and it will allow devices that perhaps are problematic to be detected very quickly and modified, changed, or withdrawn to protect the public health,” Secunda said in a phone interview with AAMI.
As for the FDA’s prediction that a modernized postmarket surveillance system would generate data that would streamline the premarket approval of new devices or new uses, Secunda expressed concern about the value of any data collected through a “passive” reporting system. “There’s no way to know the quality of the information,” he says.
For HTM professionals, efforts to modernize adverse event reporting and analysis could have the most impact. The FDA says it’s exploring the use of automated systems for medical device reporting (MDR), and wants to encourage the filing of more such reports electronically. Additionally, the agency is looking at the development and implementation of a mobile application for adverse event reporting.
The FDA report is a tacit acknowledgement that the current system is lacking and limited, allowing for potential underreporting of device problems or reporting that lacks critical or accurate information and timeliness. For example, in a section of the report that contrasts how postmarket surveillance currently works versus the proposed “future state,” the FDA says that healthcare systems, working with it, could determine “in weeks rather than years” whether a single model of a manufacturer’s product was associated with increased reoperation rates. In other words, is that particular model problematic and should it be recalled?
Another section of the report flatly states that one of the current tools used by the FDA to keep track of adverse events, the Manufacturers and User Facility Devices Experience (MAUDE) database, is not up to the job. “The base technology behind MAUDE is antiquated and is unable to handle the volume and complexity of devices report,” the report says.
Secunda agreed: “I don’t think there’s anyone out there who thinks MAUDE is just dandy.”
The FDA describes the report as a “first step,” stressing that it is seeking public comment on the proposals and adding that modernizing postmarket surveillance of medical devices would be a “long-term effort” requiring the input and participation of hospitals, the medical device industry, healthcare providers, and others. “We recognize that our postmarket vision cannot be implemented or achieved by FDA alone,” the agency says.
This FDA report comes 14 months after a report by the Institute of Medicine called on the agency to draft a strategy to better collect, analyze and act on medical device postmarket performance information.
To read the full FDA report and to provide feedback to the agency, CLICK HERE.