Experts Question FDA's Final Recall Guidance: Where Are the Patients?

This article is the second in a series on medical device safety. Subsequent reports will explore landmark Supreme Court rulings and other product safety issues.

Over the past few years, medical device recalls and product safety issues have gradually drawn public attention. Especially after high-risk events exposed systemic inefficiencies and jeopardized patient safety, patient groups have questioned the recall process and criticized the FDA and industry for inadequate responses.

For example, problems with surgical staplers have led to thousands of injuries, hundreds of deaths, and brought to lighta hidden FDA database of medical device adverse events. Meanwhile, Philips'ongoing recallof millions of sleep apnea machines and ventilators shows that patients may never receive recall notices or learn about the health risks of continuing to use faulty devices.

Last month, the FDAreleasedfinal guidance on voluntary recalls, requiring companies to be "recall ready" and offering recommendations on establishing internal processes and initiating recalls. The guidance covers many FDA-regulated products, not just medical devices, but has already drawn criticism from medical device safety experts who believe the FDA has not done enough to improve recall handling.

Device experts point out that the guidance omits key issues in the recall process or does not support them strongly enough, while there is widespread confusion about what specific steps the FDA will take next to address medical device recall and safety management.

Joan Melendez, CEO of Xcelrate UDI, said some aspects of the guidance are commendable, such as recommending that recall notices be sent electronically, but overall it feels like "five steps forward, three steps back."

"I'm disappointed," Melendez said. "Where is the patient?"

Before the guidance was issued, the FDA held two public meetings on device recalls and safety communications, where experts, patients, and industry representatives discussed how to improve a system that sometimes relies on outdated processes and leaves patients in the dark when devices fail.

Several reform proposals were repeatedly raised at the meetings, including at an FDA meeting last October: manufacturers using electronic communication rather than mail when notifying hospitals of recalls; using Unique Device Identifiers (UDIs) in recalls to link specific devices to specific patients; and improving patient notification so people don't miss potentially life-saving information.

An FDA spokesperson said in an email statement that the agency considered the October meeting recommendations when developing the guidance, calling the changes "largely editorial" and stating they "provide useful examples of applicable requirements for certain products but do not establish legally enforceable responsibilities."

Although the latest guidance does address electronic communication, other issues remain unresolved.

Terrie Reed, partner director at medical supply chain data software company Symmetric Health Solutions, said her first reaction after reading the guidance was "not worth reading," and she hopes this is not the final outcome of the FDA's recent meetings.

"If it is, then they completely ignored what people communicated," Reed said. "I hope change is coming."

Electronic communication

One highlight of the guidance is that the FDA encourages manufacturers to use electronic communication when sending recall notices to customers, a key element that device recall experts have been pushing for.

Guillermo Ramas, CEO and founder of NotiSphere, a supplier service company that helps handle recalls, praised the FDA for explicitly mentioning electronic communication, saying it will prompt manufacturers to change their processes.

"Many manufacturers seem unaware that they can use electronic communication. So this will raise awareness and prompt manufacturers to really reflect: 'Do we need to continue with the same old methods we've used for 40 years?'" Ramas said. "I think this is very positive."

Recall notices between manufacturers and hospitals are typically sent by mail. This not only slows down the process but can also result in notices being sent to personnel or departments not responsible for removing recalled products from hospital inventory.

Notices can take weeks or months to reach the relevant people at hospitals, leaving recalled products sitting on inventory shelves and sometimes even being implanted in patients.

Faster communication helps hospitals identify recalled or problematic devices more quickly, reducing the risk of recalled devices or supplies being used.

Madris Kinard, CEO of Device Events, a company that compiles and interprets FDA medical device reports and recalls, also agreed that including electronic communication is necessary, but added that the FDA is still not thorough enough in addressing the issue.

"I feel the guidance is not written strongly enough," Kinard said. "Because the recall process is seriously flawed, moving to fully electronic notification is critical and long overdue, but the guidance doesn't mandate it, or even encourage it strongly enough."

Although the changes in the guidance are recommendations rather than mandates, Ramas said manufacturers should take them seriously.

"I think this is a step in the right direction," he said. "I hope they don't stop here, and I hope more measures follow."

Missed opportunities

One of the most common complaints about the recall process is that patients are always notified too late about recalls or safety updates, or never at all.

A recent example is Philips' recall of more than 5 million sleep apnea machines and ventilators. Nine months after the recall began, and nearly a year after Philips first publicly acknowledged the problem, the FDA found that some customers were still unaware, andorderedthe company to notify all customers, including patients and healthcare providers.

The FDA called Philips' earlier efforts "inadequate," leaving customers not only unaware of the recall but also of the health risks of continuing to use the devices.

Although the FDA took the unusual step of intervening in a voluntary recall after issuing the guidance, the final guidance does not address in detail the issue of directly notifying patients. The guidance only states that manufacturers should initiate recalls by "promptly notifying each affected direct account and, when appropriate, issuing a press release or other public notice."

Melendez of Xcelrate UDI claims that when it comes to patient communication, the FDA "missed the point," and says the agency needs to mandate communication policies because sometimes patients with implanted devices may have no idea the device has been recalled.

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"Many times, disasters give rise to great things... but I don't even see a hint that the FDA might be improving its recall workflow and processes."

Terrie Reed

Partner Director, Symmetric Health Solutions

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Typically, device manufacturers' customers, such as suppliers and healthcare providers, are responsible for notifying patients. Melendez believes that the institutions and facilities where patients receive care or have devices implanted should be required to notify patients of any recall or safety update, regardless of how severe the health risk is.

Melendez said mandates are needed because sometimes providers don't notify until symptoms appear or patients return to the facility.

"Patients should know everything implanted in their bodies," Melendez said. "Patients should even know all the information before implantation."

Using UDIs in recalls is another repeatedly proposed recommendation that was not addressed in the FDA guidance.

A UDI is a numeric or alphanumeric code that distinguishes a single device. Experts say using UDIs helps link devices affected by a recall to specific patients.

Although UDIs are required on certain medical device labels, they arerarelyused in recalls. The FDA's final guidance does mention UDIs in labeling and product coding, but it does not directly state that UDIs should be used in recalls.

Medical supply chain consultant Nancy LeMaster said the guidance "falls far short" of what is needed. According to LeMaster, although some manufacturers want to use UDIs for recalls, company policies only allow them to do what the FDA mandates.

"It's better than nothing—we got a mention—but it's far from what I think is needed to truly improve the recall process and make patients and healthcare providers safer," LeMaster said.

According to the FDA, the guidance recommends that "firms use sufficient product coding to quickly identify positive batches and facilitate effective recall of all nonconforming batches."

However, experts argue that lot numbers are not precise because companies define "batches" differently, and notices may include thousands of lot numbers, whereas UDIs can be electronically recorded and directly linked to patients.

Beyond UDI use, Reed and LeMaster both said that the type and manner of data shared during recalls need to be structured and standardized to make the system more uniform rather than varying by company.

"Like many organizations, we submitted many comments asking the FDA to truly strengthen and modernize the recall process so manufacturers can submit structured data to a database that all stakeholders can access in a timely manner," LeMaster said. "Clearly, the responsibility is always on the manufacturer during a recall, but it feels like the FDA hasn't truly stepped up to take its own responsibility."

Reed, who worked at the FDA for 15 years and led the UDI program, also believes the FDA needs to address its role in the recall process and make changes, citing the Philips recall as an example.

In an email statement, Reed wrote that UDI tracking at the point of sale or when covered by payers such as private insurance or Medicare could easily link devices to patients; if UDIs are not recorded at the time of sale or reimbursement, a searchable database could help patients track devices after problems arise.

Reed believes the FDA could facilitate or even require such data collection and database creation. However, this was not part of the FDA's order to Philips; the focus remains on the company.

"Philips may spend millions, millions, and millions of dollars, and they may have already spent it—good for them—but this is a systemic issue that needs to be addressed simultaneously," Reed said. "Many times, disasters give rise to great things... but I don't even see a hint that the FDA might be improving its recall workflow and processes."

Strengthening enforcement

Once a recall is initiated or a product problem is identified, device companies and the FDA can coordinate the recall; however, the vast majority of recalls are voluntarily initiated by manufacturers. An FDA spokesperson told MedTech Dive in a background briefing last year that the number of FDA-mandated recalls could be counted on one hand, adding that voluntary recalls are easier and faster than forced removal of products.

Although the FDA claims this is a more effective way to conduct recalls, experts worry about the agency's lack of enforcement. The recent guidance is one example.

Kinard of Device Events said the agency should not focus on guidance but should consider developing enforceable regulatory changes so that action can be taken when there is not strict compliance.

"I've always been somewhat frustrated by the use of guidance rather than regulations... So my first reaction is, if they haven't followed guidance in the past, will they follow another guidance?" Kinard said.

Michael Heyl, a partner at the law firm Hogan Lovells, said the guidance is "clearly interpretive" and not "enforceable in and of itself," but the agency does have expectations of companies, and following and complying with the guidance's recommendations is best practice.

When asked about the difference between using guidance documents versus regulations, the FDA said in a statement that the agency "issues guidance documents to represent the agency's current thinking on a particular topic and to help manufacturers meet FDA review requirements under the agency's regulatory authority."

Several experts questioned whether the FDA has any other official changes in the works and whether the agency's two meetings will lead to more action.

Heyl said whether the FDA will take action on recalls "remains to be seen," adding that the guidance and the order to Philips may indicate the agency is more focused on ensuring recall communications get out.

In its statement, the FDA wrote that the agency "continues to explore how to improve the recall process," but did not disclose specific projects or potential changes underway. The agency shared alist of proposed guidance documents for fiscal year 2022 from the Center for Devices and Radiological Health; the recall guidance was not on that list.

Because the recall process involves multiple parties—device manufacturers, suppliers, providers, and regulators—meaningful change is not easy. However, some are optimistic that recall stakeholders are willing to update the system.

"No player today will look at you and say, 'This is not a problem for us,' or 'This is not something I need to focus on.' As always, when a problem requires many people to collaborate simultaneously, it's not an easy challenge because you need many suppliers and many providers to come together," Ramas of NotiSphere said. "But I think we are starting to see signs of that now."