Feasibility of Proactive Medical Device Surveillance - Semantic Scholar

BRIEF REPORT

Feasibility of Proactive Medical Device Surveillance The VA Clinical Assessment Reporting and Tracking (CART) Program Thomas T. Tsai, MD, MSc,* Tamara L. Box, BS,* Hans Gethoffer, Dr Ing,* Gregory Noonan, BS,* Paul D. Varosy, MD,* Thomas M. Maddox, MD, MSc,* Stephan D. Fihn, MD, MPH,wz Thomas P. Gross, MD, MPH,y Robert L. Jesse, MD, PhD,8z and John S. Rumsfeld, MD, PhD*8

Background: Timely identification and reporting of medical device problems is critical to postmarket device surveillance programs to maximize patient safety. Cardiac catheterization laboratories are high-device utilization areas well suited for device surveillance. Objective: To demonstrate the feasibility of the national VA Clinical Assessment, Reporting, and Tracking (CART) system, embedded in the electronic health record of all 76 VA cardiac catheterization laboratories, to document unexpected problems with medical devices at the point of care. Methods: We evaluated 260,258 consecutive cardiac catheterization and/or percutaneous coronary intervention procedures on 175,098 Veterans between August 2006 and February 2012. Unexpected device problems (UDPs) encountered for any equipment used during a procedure were entered by clinicians at the point of care as part of regular care documentation. All UDPs were reviewed in collaboration with the FDA to ascertain the likelihood of a device defect (eg, in manufacture or design) and/or contributing to a procedural complication (level I, unlikely; level II, possibly; level III, likely). Results: Of the 260,258 procedure reports, 974 (0.37%) UDP’s were reported by 71 (92.2%) of the 76 VA hospitals. After triage, 739 (75.9%) were deemed level I, 196 (20.1%) level II, and 39 (4.0%) level III. Of the 39 level III reports, 12 (30.7%) are in the submission phase as a FDA MedWatch report. The number of

From the *VA Eastern Colorado Health Care System, Department of Medicine, CART Coordinating Center, University of Colorado Denver, Denver, CO; wOffice of Analytics and Business Intelligence, VA Health Services R&D; zVA Puget Sound Health Care System, Seattle, WA; yCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD; 8VA Central Office, Washington, DC; and zRichmond VA Medical Center, Richmond, VA. The authors declare no conflict of interest. Disclaimer: The opinions expressed represent those of the authors and do not represent the official views or policy of the Department of Veterans Affairs or the United States government. This work was conducted entirely for operations; findings reported were not derived, in whole or in part, from activities constituting research. Reprints: Thomas T. Tsai, MD, MSc, VA Eastern Colorado Health Care System, Department of Medicine, CART Coordinating Center, University of Colorado Denver, Cardiology Section 111B, 1055 Clermont Street, Denver, CO 80220. E-mail: [email protected]. Copyright r 2013 by Lippincott Williams & Wilkins ISSN: 0025-7079/13/5103-0S57

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monthly UDP reports increased significantly from 2006 to 2012 (P < 0.001). Conclusions: Leveraging a clinical application embedded in the electronic health record and in collaboration with FDA, a proactive national cardiac device surveillance program has been successfully implemented in the VA. Key Words: patient safety, device safety, cardiovascular (Med Care 2013;51: S57–S61)

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he Institute of Medicine (IOM) has prioritized patient safety as a key domain of health care quality.1 One of the major safety concerns in the United States is medical device surveillance. Postmarketing surveillance, the practice of monitoring the safety of a device after it has been released on the market, continues to be a means of identifying potential device problems. This is very important because many medical devices are utilized more broadly in clinical practice than originally specified in the premarket evaluation or clinical trials.2–5 However, real-world surveillance programs are generally based on passive systems and are hampered by a reliance on voluntary reporting of device problems, a lack of device usage rates (denominator data), inadequate information for assessing comparative safety among devices, and insufficiently developed statistical methods to conduct active surveillance to identify device-related “safety signals” of harm. These shortcomings leads to an underrecognition of potential device safety issues and lags in their timely evaluation.6–10 The IOM convened a national stakeholders meeting in October 2010 to make recommendations on improving the device approval process and postmarket surveillance. Key recommendations included: (1) leveraging large, diseasespecific clinical registries for monitoring device safety; (2) creating postmarket surveillance infrastructures to support extensible and iterative device data collection; and (3) utilizing existing electronic health records (EHRs) to facilitate “meaningful” device surveillance at the point of care, minimizing barriers to providers and delays in evaluation.6 Accordingly, we leveraged an existing clinical application and quality oversight program, the VA Clinical Assessment, Reporting, and Tracking (CART) Program to conduct medical device surveillance on cardiac devices used in the VA cardiac catheterization laboratories. The CART program uses clinical software embedded in the EHR of all www.lww-medicalcare.com |

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76 cardiac catheterization labs in the VA to enable clinicians to document cardiac procedures and unexpected device problems (UDPs) as part of routine care. In addition, the CART program has established an active collaboration with the FDA to report on potential cardiac device safety issues and is an example of a national, proactive point-of-care cardiac device surveillance system. In this manuscript, we will describe the national VA CART device surveillance program and present the first results of this project.

The CART Program is the established national VA reporting system and data repository for cardiac catheterization laboratory procedures in the Veterans Health Administration. Using a clinical application embedded in the VA EHR, the CART program collects data for all diagnostic cardiac catheterizations and percutaneous coronary interventions performed in all 76 VA catheterization laboratories. At the point of care, clinicians use the CART application to enter clinical and procedural data using a combination of discrete and narrative data entry fields. The application simultaneously generates a report within the VA EHR and transfers all data elements to a structured query language (SQL) server. These data are then used to support quality improvement, workload tracking, and research on a local and national level.

UDP Evaluation In 2006, the VA CART program initiated medical device surveillance by embedding specific data elements within the clinical application to document UDPs at the point of care. This field is defined as “any unexpected problem with medical equipment used during the procedure that does not perform up to the standards expected by the operator.” This definition was intentionally broad to capture any potential problems with a medical device from the operator’s perspective. To facilitate data capture, the UDP fields were embedded within the user interface screens. When a procedure report is finalized that includes a UDP, the CART Coordinating Center is automatically notified for review. UDPs are reviewed by the surveillance team (consisting of an electrophysiologist, interventional cardiologist, and program coordinator) and categorized into 3 priority levels, designed to triage UDPs into probable device safety issues related to design or manufacturing versus the use of a medical device in unusual clinical or anatomic situations. The priority levels include: level 1 UDPs: unlikely to be related to device defects (eg, in manufacture or design) and more likely related to unusual interactions between the patient, device, and operator. Level 2 UDPs: possibly related to device defects or may be a novel problem of unclear significance that did not lead to patient harm. Level 3 UDPs: problems more likely device-related or may be a novel problem that was associated with a procedural complication (Table 1). Level specifications are assigned within 3 working days of automated e-mail receipt and additional specific information is gathered on level 2 or 3 UDPs through e-mail

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TABLE 1. Level Specification and Assignment for Unexpected Device Problems Level Criteria I II

METHODS/PROJECT DESCRIPTION The VA CART Program

III

Example

Procedural problems not specific Inability to deliver a stent into a to a medical device highly calcified and tortuous coronary segment Procedural problems possibly Longitudinal compression related to device defect (eg, (accordion) of a stent detected manufacture or design) or on cineangiography after stent novel problem of unclear deployment significance and without patient harm Device design or manufacturing Failure of vascular closure device defect that may have caused or resulting in a retroperitoneal contributed to patient harm or hematoma, blood transfusion, injury or novel problem or an extended hospital stay associated with procedural complication

communications directly with the operator. Specific information on the device (ie, model and lot number, type, etc.) and potential factors contributing to the unexpected problem or adverse event, such as patient or operator factors, are requested. Monthly reports are created and discussed with the FDA.

FDA Collaboration Recognizing that the CART program could serve as a mechanism to identify problems with cardiovascular devices, the VA and the FDA entered into a memorandum of understanding in 2008 to share information on device surveillance. Monthly conference calls with the FDA focus on: (1) all CART reported UDPs; (2) specific requests to the sites from the FDA regarding previously reported UDPs felt to warrant further investigation; (3) device problems originating from other FDA sources; and (4) cardiovascular product releases and recalls potentially relevant to VA catheterization laboratories. After UDPs are reviewed, those associated with an adverse event or that represent a product quality problem or product use error are considered for formal reporting via the FDA’s MedWatch reporting program (http://www.fda.gov/ Safety/MedWatch/default.htm).11 MedWatch reports are designed for health care professionals to facilitate voluntary reporting of adverse events noted spontaneously in the course of clinical care. Mutually agreed upon level 3 UDPs are submitted as MedWatch reports by the CART program on behalf of the provider.

Analysis Data from the national CART program were analyzed over the study period. The total numbers of UDPs reported were stratified into level I, II, and III reports. UDPs were further classified by product category (eg, stents, catheters, balloons) and strata-specific proportions were calculated. Changes in the monthly percentage of UDPs reported over time were analyzed using the Cochran-Armitage w2 test for trend. SAS v.9.1 was used for all analyses. r

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RESULTS Data for 260,258 consecutive diagnostic and interventional cardiac catheterization procedures from August 1, 2006 to February 29, 2012 were evaluated. These data were entered on 175,098 Veterans at the point of care by 3916 providers at 76 VA hospitals. There were 974 (0.37%) UDPs reported by 71 of the 76 hospitals (93.4%). Almost all (98.2%) UDPs were submitted within 24 hours of the procedure. The majority of the UDPs were considered level 1 (n = 739; 75.9%) and level 2 (n = 196; 20.1%) with fewer level 3 (n = 39; 4.0%) designations (Fig. 1). Seven (9.9%) sites reported Z28 UDPs during the study period (Fig. 2). Overall, the most common devices associated with UDPs were stents, balloons, catheters/sheaths/wires, closure devices, and imaging/hemodynamic systems (Fig. 3). Among level 3 UDPs, stents and fluoroscopy equipment were the most common devices associated with problems leading to the filing of MedWatch reports. Trends in UDP reporting shows an increase in the number of UDPs reported by month with a low of 0.06% in August 2006 to a high of 1.07% in March 2011 (P < 0.001 for trend). Through monthly conference calls with the FDA, 12 UDPs were formally submitted as MedWatch reports, including failures of the x-ray systems (4); catheter manifold, tubing, and connector problems (3); vascular closure device failures (2); a stent (1); a balloon (1); and hemodynamic system problem (1).

DISCUSSION This project demonstrates the feasibility and initial results of a national, proactive device surveillance system. Leveraging the VA CART program, this system (1) utilized an existing point of care clinical application, integrated into the VA EHR at all 76 VA cardiac catheterization laboratories; (2) leveraged a quality management infrastructure to facilitate the UDP program; and (3) partnered with the

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FDA to capitalize on existing data systems to allow more robust and efficient bidirectional surveillance. The CART program demonstrated the successful reporting of 974 UDPs from 71 sites from 2006 to 2012. Trends over the past 6 years also suggest a greater adoption of UDP documentation through CART from a substantial number of sites. The partnership between VA and FDA has enhanced the efficiencies of device surveillance by capitalizing on diverse data sources and data networks to evaluate potential safety signals. For example, the FDA received reports of intra-aortic balloon catheters that became stuck in the sheath causing delays in therapy, bleeding, or arterial injury. Similar problems were also reported through the CART program and an official recall was initiated by the FDA in October 2010 (http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/default. htm). Concurrent surveillance programs can amplify possible signals, help alleviate the problems of underreporting, and potentially allow swifter action when device complications are detected. To date, postmarketing surveillance of medical devices in the United States has largely remained a passive and voluntary activity. Underreporting of adverse events and product problems has long been recognized as a limitation of passive reporting systems.4,12–15 One suggested reason behind this underreporting is the burdensome nature of reporting for clinicians. Of the device-related adverse events and product problems reported, voluntary reporting from practicing clinicians and the public accounts for only 3% of reports that the FDA receives, whereas mandatory reporting through the Medical Device Reporting system by manufacturers, importers, and user facilities account for the rest.8,16 In CART, barriers to voluntary clinician reporting are mitigated in 2 major ways. First, clinicians use CART for their procedure reports, including discrete data entry. Because the UDP field resides within the CART application, the opportunity to report UDPs as part of regular care is less

FIGURE 1. Unexpected device problems surveillance flowchart. r


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FIGURE 2. Number of UDPs reported by VA site. UDP indicates unexpected device problem.

likely to be perceived as onerous. This is supported by the >98% submission rate of UDPs within 24 hours of procedure date. Second, CART provides support in submitting the MedWatch reports on behalf of the provider by populating the available data from the UDP into the report. This more efficient process allows the provider to read, review, and approve the CART prepared report without reentering the data into a form. Programs such as CART offer the opportunity for more targeted surveillance and enriched reporting by clinicians. The IOM report for enhanced device surveillance also emphasized the creation of infrastructure and extensibility to

support device data collection. The CART program utilizes the universal EHR and is identical in all 76 catherization laboratories. This common platform allows iterative changes to the application and is currently being expanded to include electrophysiology and peripheral vascular procedures. Furthermore, potential integration of unique device identifiers, when available, directly into the CART application is on the horizon and will enhance the specificity of device surveillance greatly.17 In addition to the point of care device surveillance by the CART system, patient data in CART are also linked to longitudinal outcomes. This allows the potential for analyses

FIGURE 3. UDP device category stratified by level of concern designation. UDP indicates unexpected device problem.

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of longer-term events, comparative safety evaluation of different devices, and lends itself well to automated computerized device surveillance tools to distinguish lowfrequency medical device safety risks not highlighted in premarket approval studies.13,18 Nonetheless, there are limitations to the CART device surveillance program. Areas targeted for improvement include the development of online training modules to standardize clinician training in the use of the application. Also, the UDP field is being augmented with specific data structure to capture additional device information at the point of care. Finally, efficiencies in completing the voluntary MedWatch report are being explored with the FDA to better facilitate the reporting process. With the current national focus on “meaningful use” of EHRs, the national VA CART program is an important example of the surveillance of cardiac devices through an existing clinical application at the point of care embedded into the EHR of all VA cardiac catheterization laboratories. This system demonstrates feasibility of a more proactive device surveillance program. Next steps include leveraging the clinical outcomes data using automated comparative safety algorithms and extending the CART program to cover detailed reporting of electrophysiology and peripheral interventions. Together, these current and future initiatives will contribute to a new era in patient safety. REFERENCES 1. Institute of Medicine. In: Kohn LT, Corrigan JM, Donaldson MS, eds. To Err is Human: Building A Safer Health System. Washington, DC: National Academies Press; 1999. 2. Garber AM. Modernizing device regulation. N Engl J Med. 2010;362: 1161–1163. 3. Gross TP, Kessler LG. Medical device vigilance at FDA. Stud Health Technol Inform. 1996;28:17–24.

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