The FDA's Postmarket Transformation Team is well into restructuring the way it handles postmarket medical devices. Don St. Pierre, acting associate director for postmarket transformation, talks about the changes his team is making at CDRH
The safety of medical devices is a major concern for the FDA, manufacturers and consumers. One faulty drug or device can place lives at risk and ruin the public's trust. Recent events involving pharmaceuticals, medical devices, and combination products have heightened public awareness of product safety. The FDA's Center for Devices and Radiological Health ( CDRH ) responded to the public's concern by creating a new management system to improve the postmarket situation.
In January, 2006 the Center charged the senior leadership team (the Postmarket Transformation Leadership Team-PTLT) with mounting a new postmarket surveillance effort. The new group was formed by CDRH Director, Dan Schultz. The PTLT's charge was to: "evaluate the recommendations in the CDRH document, "Ensuring the Safety of Marketed Medical Devices Executive Synopsis and Recommendations,' (January '06), collect additional data as necessary, supplement the recommendations, if needed, and propose a prioritized implementation plan for a transformed postmarket process."
The PTLT came out with a report in November 2006 entitled "Report of the Postmarket Transformation Leadership Team: Strengthening FDA's Postmarket Program for Medical Devices." They made several recommendations in the document concerning:
• inadequacies in CDRH's internal communication network,
• shortcomings with the current system for receipt, processing and analysis of reports from the Medical Device Reporting system (MDR) system,
• underutilization of data and expertise outside of the Center to better evaluate postmarket issues,
• the inadequacy of the Center's current computer systems to efficiently track, search, and analyze data,
• confusion in the industry as to how and when to report adverse events,
• the lack of a comprehensive risk communication system for external stakeholders,
• the need for increased coordination between CDRH and ORA, especially given the shrinking resources available for field activities,
• an inadequately coordinated system for using postmarket data to inform premarket decisions and assist in enforcement and compliance actions.
To implement the recommendations in this report and move CDRH's postmarket transformation forward, Dr. Schultz named Don St.Pierre, formerly a deputy director in CDRH's Office of In Vitro Diagnostics, as the acting associate director for postmarket transformation. Also working on the transformation team are Susan Meadows and Diane Mitchell, M.D.
This sounds like more than a tune up for CDRH. "The major effort will be in changing the way the Center conducts business and developing organizational capabilities that will strengthen the postmarket safety of medical devices," St.Pierre says.
"In the past, we've spent a lot of time and energy on our pre-market program," he adds. "It was necessary but, in the process, post-market took a back seat. Following the Vioxx issue in the Center for Drug Evaluation and Research, there were a couple of device safety issues that also became apparent. All of these problems made it clear that we weren't focusing enough attention on our post-market program." St.Pierre adds that postmarket issues are "difficult to get your arms around."
"Postmarket issues can come from anywhere," he says. "Reports can come from a field office, MDRs, or from employees going to meetings and hearing about problems. There really hasn't been a good system for gathering these issues."
St.Pierre set out to create a better postmarket issue mousetrap. He quickly learned why gathering reports on postmarket issues is so challenging.
?Changes that affect one office can spill over into another office,? he says. ?And many of these problems have to do with the way we gather and analyze data, from office to office. Sometimes each office has only one piece of the puzzle and often that piece isn't shared. If we could improve our inter-office information coordination, our ability to speed our response to reported problems could have a big impact on public health.?
St.Pierre's team is helping to lead the transformation process. His team's transformation efforts focus on improving patient safety through ensuring effective postmarket oversight by:
• Collaborating across organizational lines
• Increasing pre/postmarket communications
• Creating procedures to improve postmarket safety decision-making
• Creating new tracking systems
• Increasing transparency
"The CDRH operates using functional units," St.Pierre says. "We need for them to work together, across units, in a collective networking effort. We created a CDRH matrix to increase collaboration within the Center. Within this matrix, we are establishing cross-functional product category teams with members participating from each office within CDRH."
IT infrastructure upgrades are being implemented as well. "These upgrades will improve our data collection capabilities", he says. The upgrades include:
• Investigating a unique identifier system for medical devices
• Implementing a mandatory eMDR (electronic medical device report) system
• Revising the Center's MAUDE (Manufacturer and User Facility Device Experience) Database
• Increasing the use of the Medical Product Safety Device Network ( MEDSUN )
"We're close to achieving electronic MDR reporting", St.Pierre says. "We are preparing a proposed rule to require electronic reporting next January 2008. This is on our priority list. The fact that we have an electronic MDR system in place for people to test and comment on, before we put out the proposed rule, is a step in the right direction."
There are plans to expand the MEDSUN network, initiated by the Center in 2000. "MEDSUN is a nice system", St. Pierre comments. "We want to sharpen our focus in areas of interest within this system. We've developed targeted areas within the network, such as KidNet for pediatric issues, HeartNet for cardiac issues, LabNet for diagnostic tests, and TissueNet. For 2008, we're also working on HomeNet, for home use devices, AudioNet, and EyeNet. If an issue comes up, we can target identified entities to see if they are aware of the issue and if it is indeed a problem."
St.Pierre says that the Center is working on a public MedSun website. "If all goes well, it should go public this fall," he says.
St.Pierre acknowledges that there is a lot of work to be done. ?I'm working to get this house in order," he says. "In 2009, CDRH will move from its multiple locations to one building, which will allow us to improve upon the system we're building. It will certainly improve communications."
"Sometimes I feel like we've barely scratched the surface of postmarket improvement," he muses. "But I see changes and sense movement in the right direction. As long as we are charged with safeguarding the public health, we'll continue making improvements to accomplish our goals."
Read more about FDA Compliance and Process Automation:
|Download Free Resources|