Safe Space group testing digital forms to address recall notification issues

WASHINGTON – Medical device manufacturers can struggle with product recalls for various reasons, one of which is ensuring that stakeholders are aware of the recall and are doing their part in the process. A project started by the Medical Device Innovation Consortium (MDIC) has found that one solution could be as simple as using PDF software, like Adobe Acrobat, to better communicate recalls between manufacturers, providers and distributors.

The project, known as Safe Space, began as an MDIC project in 2018 and stemmed from of the Medical Device Information and Analysis Sharing (MDIAS) platform. The project allows industry stakeholders to anonymously and without fear of reprisal, discuss sensitive issues and share information that they otherwise would be hesitant to share.

Experts presented on the project and its findings on improving the recall process at MDIC’s 2023 Case for Quality Summit. During the meeting Daniel Walter, a policy analyst at the US Food and Drug Administration (FDA), discussed work he and others in the Safe Space group are doing.

“Could we get the disparate stakeholders in a place to share a problem that was a pain point for all of them without the fear that anybody was going to unintentionally reveal confidential information, or that there was going to be some violation of trade or that people were going to unwillingly be asked to be put in uncomfortable situations for them,” Walter told Focus.

Safe Space began with about half a dozen members and was eventually taken over by the MITRE Corporation in 2019 to manage as a trusted third-party who moderates conversations. After two years of building its governance structure and expanding to more than a dozen members, the group is starting to tackle those pain points and presented initial data from a study it conducted on how to improve the recall process.

Iris Sherman, a lead researcher at MITRE, presented on her involvement in Safe Space and noted that when healthcare providers joined the group, industry members developed a better understanding of the processes at hospitals that must be navigated to successfully complete the recall process.

Sherman said that industry members initially thought the problem with the recall process was a supply chain or risk management problem, but they realized that often stakeholders don’t know who the point of contact is at other organizations that they need to notify of the recall, and recall communication may get lost. They realized that digitizing the process could help to insert a failsafe to identify the point of contact and ensure the message gets through.

While nothing in the regulations prevents manufacturers from using digital means to notify healthcare providers of a recall, companies often send such notifications through the mail, which can cause delays if the notices don’t get to the people that should be receiving them.

"We don't really need to change the regulations,” said Sherman. “We just need to put together a process that works because the regulations allow for digital communications. But the process in-between has not been established and determined."

Sherman said that when addressing recalls, the group started by asking how they can design a simple web form that can escalate a recall in one day. While they considered a new software platform for recalls, stakeholders said they already have too many platforms to deal with daily and were adamant about not creating another one, she said. Instead, they found that existing tools, such as Adobe Acrobat, could meet their needs for confirming that a message has been received with the necessary details.

"Honestly, I didn't even realize you could modify it to every single level of every single input that you want to in the form using a regular Adobe account," said Sherman. “You can even repopulate the date and the person's email the minute it comes in. The person receiving it just has to acknowledge they got it. Everything else is already in there and they have to say they are the point of contact.”

With that in mind, Safe Space conducted an initial test where manufacturers were asked to send a standard Adobe Acrobat form via email to a known point of contact. They were also asked to do the same thing but by sending the form via standard mail. What the participants learned is, using the Adobe form was far more effective than using standard mail and the average response time for emails was three hours.

However, in the next stage of the tests, the manufacturers emailed health care providers more broadly and realized they didn’t have the right points of contact, so the study is currently stalled according to Sherman.

"We know we have a problem and we're going to solve it," she added. The group plans to go back to the drawing board to figure out how track down the right points of contact so they get the forms.

Once the initial study is completed, which is expected to take another six-to-eight weeks, the group plans to have a larger test in the real world with more volunteers to test out the form.

During the meeting, some participants raised concerns that Adobe Acrobat may have software limitations that may preclude it from being deployed for this purpose on a larger scale. Walter and Sherman said that Adobe Acrobat isn’t necessarily the solution and that other software that can generate a digital form similar to the one they have been testing could be used.

Walter said the reason FDA is participating in Safe Space is to give it a “tacit blessing” that the agency hears their problems and wants to help them find solutions. He noted that there are other areas that may benefit from having safe spaces for industry such as supply chain, human factors and digital health.

“We’re still early in the process but [Safe Space] is absolutely an exciting opportunity to approach a regulatory process without fear, to actually share and collaborate in a space that is not traditionally shared or collaborated,” said Walter.

Safe Space group testing digital forms to address recall notification issues

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