Key Takeaways

• The FDA’s Patient Engagement Advisory Committee, organized under the Center for Devices and Radiological Health (“CDRH”), held a public meeting on October 6, 2021, to discuss issues surrounding the communication of medical device recalls to patients. The Committee focused on patient perspectives in the recall process and how to revamp both the content and method of recall communications.

• The Committee will likely make recommendations to the CDRH on how to update patient recall communications, which may include the imposition of additional obligations on device manufacturers or additional involvement by the FDA in the recall process. Direct-to-consumer communications and increased use of Unique Device Identification in recall notices received significant attention throughout the meeting.

Introduction

What do medical devices have in common with cars? As the FDA, patient advocacy groups, and industry struggle with how best to communicate device recalls to patients, the vehicle recall process has been raised as a potential model. On October 6, 2021, the FDA’s Patient Engagement Advisory Committee (“PEAC”) held a virtual public meeting to discuss the medical device recall process. The meeting featured patient roundtables as well as discussions with patient advocates, doctors, former FDA employees, and industry representatives, focusing on the challenges of communicating recalls to patients, including both the content and method of communications, and possible solutions to improve the process.

Background on Medical Device Recalls.

Under federal regulations, medical device recalls include “corrections” and “removals.” A correction recall involves fixing, adjusting or relabeling the device onsite while a removal recall involves removing the device for inspection, repair, adjustment, or destruction offsite. 21 C.F.R. § 806.2(d), (j). Although the FDA can ask a device manufacturer to initiate a recall, medical device recalls are voluntary and almost always initiated by manufacturers after learning about an issue, often through post-market surveillance and adverse-event reporting. The manufacturer develops a recall strategy and communicates the recall to the public. 21 C.F.R. § 7.42(a)(1). Generally, manufacturers notify their immediate customers—the distributor, hospital, or doctor—who in turn notify the relevant patients. The manufacturer must, however, report to the FDA any correction or removal that was initiated “[t]o reduce a risk to health posed by the device” or “[t]o remedy a violation of the [FDCA] caused by the device which may present a risk to health.” 21 C.F.R. § 806.10(a).

The FDA’s role is to monitor the manufacturer’s recall communications and procedures, which includes classification of the recall and may include providing further communications to patients. After analyzing the health concerns, the FDA classifies each recall as follows:

• Category I, where a device has a reasonable chance of causing serious health problems;

• Category II, the most common type, where a device may cause temporary health problems or has a slight chance of causing more serious health problems; or

• Category III, where a device is unlikely to cause any health problems.

21 C.F.R. § 7.41(b). Although manufacturers are the primary source for recall communications, the FDA communicates many recalls by reposting company press releases on its website and through social media, Safety Communications, or Letters to Healthcare Providers. FDA is especially likely to communicate a recall itself if, among other things, the recall is particularly urgent. The FDA also lists all recalls in its Medical Device Recalls database and Enforcement Report and summarizes the most serious recalls in its Yearly List of Medical Device Recalls.

Content of Medical Device Recall Communications.

A focus of the meeting was ensuring that recall communications are clear and that patients know whether they are impacted by a recall and how. Patients expressed frustration with the use of industry jargon. For example, recalls often refer to a patient experiencing an “adverse event” rather than a “symptom” or similar term that would be easier for a layperson to understand. Even the use of the term “recall” can be confusing to patients in actions that merely involve corrections.

Another topic of discussion focused on providing notices that clearly communicate information that patients need, such as how they personally may be impacted by the recall and whether and how they need to take action. To address this, some Committee members suggested that recall notices include (1) options for corrective actions or alternative treatments, (2) information as to who would bear the costs of those actions, and (3) instructions for patients whose implanting physician is no longer practicing.

Methods of Medical Device Recall Communications.

Several different concerns were raised regarding existing methods of  patient communications. Participants noted the importance for both the FDA and industry to consider communication barriers experienced by demographics that likely use recalled products, including language barriers and spotty internet connections in rural communities.

One of the biggest challenges with recall communications is ensuring that affected patients know whether they have been implanted with the device in the first place, a responsibility that generally falls on the implanting physician. Another consideration is that doctors might choose not to inform patients about recalls because, for example, they would not recommend removing or fixing the implant. 

Meeting participants focused on two proposed methods of enhancing device recall communications: (1) implementation of direct-to-consumer recall notices from manufacturers or FDA, similar to those used in the vehicle context, rather than relying on physicians to communicate device recalls, and (2) use of a Unique Device Identification System.

Direct-to-Consumer Notices

Direct-to-consumer notices pose numerous difficulties in the medical device area. First, direct-to-consumer notices require the FDA or manufacturers to learn which specific patients used the recalled devices, information that they often lack due to privacy concerns not present in the vehicle arena. Getting that information may also raise logistical problems because doctors may not clearly record which specific device was used in each patient. Unlike state vehicle registration records, there is no public, comprehensive database of medical-device patients. Second, direct-to-consumer notices increase the costs of the recall process. Third, direct-to-consumer communication may not be as effective as communications directly from patients’ trusted doctors, who roundtable patients at the meeting indicated would be vital to their decision as to how to respond to a recall notice. Indeed, direct notices might even undermine patients’ relationships with their implanting doctors or cause undue concern. Moreover, even with direct-to-consumer notices, patients would need to consult a doctor for advice about whether to repair, remove, or replace the device.

One Committee member suggested that the FDA invest more heavily in physician associations’ registries of patients who have medical devices. Another member suggested that doctors should include implanted devices in medical records along with patients’ medication lists, ensuring that the information is not lost. And another member alternatively advocated that FDA use data-driven “personas”—representative patient examples—to create communications targeted to patient demographics. The FDA indicated that it had already begun to develop techniques to deal with certain types of communications barriers, including the use of personas.

Unique Device Identification System

Both the Committee and participants gave substantial attention to the FDA’s Unique Device Identification (“UDI”) System, which could be used to align device recalls with vehicle recalls while still operating within the current provider-focused model. The UDI System was introduced in 2013 and requires manufacturers to use device and product identifiers (or “UDI-DIs” and “UDI-PIs”) issued by FDA-accredited agencies to label their products and/or packaging, like vehicle identification numbers used by car manufacturers. See 21 C.F.R. §§ 801.20, 801.45. Provider-participants discussed the role UDIs play in their recall procedures, enabling them to identify which patients have been implanted with an affected device and whether any affected devices remain in their inventory. Participants recommended increased and more prominent use of UDIs by manufacturers and the FDA in recall notices and databases so that healthcare providers can identify affected patients and inventory more quickly. Even with industry participation, however, a major impediment to the use of UDIs is incentivizing electronic-medical-record vendors to include UDI fields in records.

Conclusions

Although the Committee appears intent on making recommendations to the FDA regarding patient recall communications, it is unclear what those recommendations will be. It seems likely that they will involve increased or changed responsibilities for manufacturers, which will be important to anticipate and track. Indeed, several Committee members probed one of the only industry representatives at the meeting about specific proactive steps it had taken to communicate device information directly to patients. Some participants suggested that the FDA should withhold initial device approval from manufacturers without an effective plan for communicating recalls to patients. Notwithstanding the different issues involved in medical device recalls, those in medical device industry will likely be called upon to evaluate the procedures they use to create and transmit recall communications.