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Efficient Clinical Management: Device Recalls and Advisories
Management of patients impacted by cardiovascular implantable electronic device (CIED) recalls and advisories can be daunting and stressful for doctors, clinicians, and patients. It is critical for device clinics to develop a standardized approach for the management of patients with impacted devices.1
Upon notification of the recall or advisory, clinicians should gain an understanding of the performance concern. Typically, letters from the manufacturer, Food and Drug Administration (FDA) communications, and HRSonline.org Safety Alerts will share recalled product model numbers, device indications, the reason for the recall, and specific steps for evaluating and mitigating the device issue. Often, only certain serial numbers of a device model may be affected. This necessitates researching each potentially impacted device on the vendor website to determine if it is impacted by the recall.
Over the last few years, CIED product performance issues have occurred more frequently. Clinical teams managing device clinic populations know all too well that the volume of patients impacted by FDA-classified recalls, safety alerts, and device advisories can affect a substantial segment of their patients. This is partly due to both the exponential growth of patients eligible for CIED implants and emerging CIED indications.2,3
Software Supporting Recall Identification
Perhaps one of the most challenging aspects of recalls and advisories is simply identifying all patients within a clinic that are affected. Clinics cannot solely rely on vendor-supplied patient lists, as these lists often do not capture patients that may have been “inherited” or “adopted” from other implanting centers.
The PaceMate™LIVE software stores every device and lead datapoint, providing full-scale identification, custom search capabilities, and retrospective analysis of patient datasets. These capabilities drive PaceMate™’s best-in-class recall identification, search engines, and custom query abilities, which provide users with the ability to automatically identify patients who are impacted or potentially impacted by CIED component recalls or safety advisories and monitor those patients longitudinally. The powerful data algorithms and queries allow clinicians to easily identify all patients affected by a recall or advisory, instead of relying on the vendor’s often incomplete records.
The PaceMate™LIVE software identifies multiple types of recall/advisory-impacted or potentially impacted patients.
- For devices and leads impacted by a recall or advisory, the software automatically identifies and flags the impacted patient upon the first report.
- For potentially impacted patients that require serial number verification, the software automatically links the user to the vendor’s lookup tool for manual identification.
- For all patients automatically or manually determined to be affected by recalls and advisories, a web link to specific details is provided on every remote and in-person report. These web links connect directly to FDA and vendor websites to provide the care team with the most recent and specific information and guidance from the vendor and FDA.
Management Beyond Identification
Multidisciplinary clinical teams often develop recall/advisory mitigation and management strategies for each device recall or advisory issue. These strategies include identification of impacted patients, risk stratification for the purposes of management, and patient notification and education. Specific management strategies are guided by the type of recall or failure mechanism and the patient’s status and comorbidities.4 Remote monitoring is a Class I indication for patients with a CIED or lead affected by a recall or advisory status.5 Continuous remote monitoring is considered necessary, and in some cases, intensified follow-up is warranted.
PaceMate™’s deep analytics capabilities allow clinics to further stratify risk for their affected populations. Often, it is necessary to identify patients who may be at higher risk in the setting of a device or lead recall. PaceMate™ enables users to identify higher-risk patients with pacemaker dependency, secondary prevention implantable cardioverter-defibrillator indications, prior ventricular tachycardia or ventricular fibrillation therapies, and patients who are not actively participating in remote monitoring.
Efficient Long-Term Management
PaceMate™’s robust analytics platform leverages access to all discrete device data and discrete electronic health record (EHR) data (delivered through Fast Healthcare Interoperability Resources application programming interfaces) to effectively identify patients at elevated risk. For clinics with large volumes of patients with devices on recall, this PaceMate™LIVE feature saves clinicians countless hours of manual chart reviews and ongoing maintenance.
PaceMate™’s proprietary recall engine and data analytics platform tracks device and lead performance over time and facilitates ongoing longitudinal device and lead surveillance at the patient, doctor, clinic, and health system levels.
CIED recall and advisory processes are dynamic and ongoing. They extend beyond the initial identification of affected patients and devices and early mitigation and management strategies. PaceMate™LIVE users quickly realize the benefits of a powerful recall search engine and data queries beyond the traditional manual identification of a CIED or lead advisory or recall.
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This article is published with support from PaceMate™.
References
1. Zhang S, Kriza C, Schaller S, Kolominsky-Rabas PL; National Leading-Edge Cluster Medical Technologies Medical Valley EMN. Recalls of cardiac implants in the last decade: what lessons can we learn? PLoS One. 2015;10(5):e0125987. doi:10.1371/journal.pone.0125987
2. Maisel WH, Sweeney MO, Stevenson WG, Ellison KE, Epstein LM. Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators. JAMA. 2001;286(7):793-799. doi:10.1001/jama.286.7.793
3. Anderson S, Newsholme AM, Veasey R, et al. Abstract 27. CIED advisories: impact and effect on pacing clinic and patient care. Heart. 2019;105:A24-A25. doi:10.1136/heartjnl-2019-BCS.26
4. El-Chami MF. Cardiac implantable device recalls: consequences, and management. HeartRhythm Case Rep. 2021;7(12):795-796. doi:10.1016/j.hrcr.2021.11.005
5. Slotwiner D, Varma N, Akar JG, et al. HRS expert consensus statement on remote interrogation and monitoring for cardiovascular implantable electronic devices. Heart Rhythm. 2015;12(7):e69-100. doi:10.1016/j.hrthm.2015.05.008
