Postmarket surveillance of medical devices: currentcapabilities and future opportunities

Kathleen Blake

Received: 1 July 2012 /Accepted: 7 January 2013 /Published online: 12 March 2013# Springer Science+Business Media New York 2013

Abstract Recalls of cardiac implantable electrical devices(CIEDs) currently impact hundreds of thousands of patientsworldwide. Premarket evaluation of CIEDs cannot beexpected to eliminate all performance defects. Robust post-market surveillance systems are needed to promote patientsafety and reduce harm. Challenges impacting existing sur-veillance mechanisms include underreporting of defects,low rates of return of explanted CIEDs, lack of integrationof surveillance into normal workflow, underutilization ofexisting resources including registries, a lack of capacityof aging resources, multiple proprietary platforms that lackinteroperability, and the unmet need for common data var-iables as well as newer methods to generate, synthesize,analyze, and interpret evidence in order to respond rapidlyto safety signals. Long-term solutions include establishing aunique device identification system; promoting expandeduse of registries for surveillance and post-approval studies;developing additional methods to combine evidence fromdiverse data sources; creating tools and implementing strat-egies for universal automatic, triggered electronic eventreporting; and refining methods to rapidly identify andinterpret safety signals. Protection from litigation and crea-tion of financial and other incentives by legislators, regula-tors, payers, accreditation organizations, and licensingboards can be expanded to increase participation in devicesurveillance by clinicians and health care facilities. Researchto evaluate the comparative effectiveness of surveillancestrategies is needed. Interim solutions to improve CIEDsurveillance while new initiatives are launched and thesystem strengthened are also presented.

Keywords Surveillance . Medical devices . Cardiacimplantable electrical devices

The public expects that medical devices will perform asintended to improve or protect health and will not causeharm. Unfortunately, this expectation has not always beenmet. In recent years, heart rhythm patients and doctors, theFood and Drug Administration (FDA), and manufacturers ofcardiac implanted electrical devices (CIEDs) have had toaddress performance failures of implantable cardioverterdefibrillator (ICD) and pacemaker pulse generators andleads [1]. CIEDs are typically listed as class III devices,those that “support or sustain human life, are of substantialimportance in preventing impairment of human health, orwhich present a potential, unreasonable risk of illness orinjury” [2, 3]. When a serious class III device performancefailure is identified, the FDA and manufacturer issue a classI advisory or “recall.” Unlike the automotive industry, whichhas the option of addressing defects with repair or replace-ment, CIEDs are generally not removed or replaced inresponse to a class I advisory. More often, monitoring fre-quency is increased, detection algorithms are added to de-vice software, and action is taken only when a safety signalconsistent with either impending or early failure is detected[4]. Recalls remind patients and clinicians of the importanceof having robust and reliable systems for premarket evalu-ation and postmarket surveillance of medical devices.

1 Premarket evaluation of medical devices

FDA approval of a new drug or device in the USA requiresevidence that it is safe and effective [5]. Evaluation of drugsfor use in humans has four phases. Phase I studies examinethe basic safety and effects of a new agent in humans. PhaseII studies in healthy individuals establish drug dose and

K. Blake (*)Center for Medical Technology Policy,Suite 631, 401. E. Pratt Street,Baltimore, MD 21202, USAe-mail: kblake@swcp.com

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identify additional safety problems. Phase III studies in thetarget population include at least one randomized clinicaltrial. Phase IV studies are initiated if collection of additionalsafety information during the late-phase premarket and post-market periods is deemed necessary [6]. Device evaluationis based on a total product life cycle (TPLC) approach thatincludes consultation with industry during the conceptual,prototype, and preclinical phases; studies of biocompatibil-ity and materials, environmental, and hazard analysis; andsimulation, reliability, and human factors testing. Iterativedevice modification in response to the results of preclinicaltesting is an integral feature of the TPLC approach. Once aninvestigational device exemption is issued, clinical studiesare performed in the target population, a premarket approval(PMA) or clearance decision is made, and postmarket stud-ies are ordered if deemed necessary [7].

The vast majority of medical devices in use today in theUSA have not undergone the PMA process. Instead, medicaldevices deemed equivalent to a previously approved predicatedevice are cleared, not approved, for marketing and commer-cial distribution using the 510(k) process, named after thesection of authorizing legislation passed by Congress in 1976[8]. A 510(k) clearance requires a manufacturer to notify theFDA 90 days in advance that it intends to market a newproduct it deems substantially equivalent to an already ap-proved predicate device. Agency action at this phase is limitedto confirmation that the device is indeed equivalent to itspredicate. In 2011, in response to a number of high-profiledevice safety issues, the FDA asked the Institute of Medicine(IOM) to review the 510(k) process and address two questions:“Does the current 510(k) clearance process optimally protectpatients and promote innovation in support of public health?And if not, what legislative, regulatory, or administrativechanges are recommended to optimally achieve the goals ofthe 510(k) clearance?” [9]. The committee found that, becausethe 510(k) process was only intended to confirm equivalenceof a device to its predicate, it could not bemodified and used toalso evaluate device safety and effectiveness. The committeealso reported that the available evidence was insufficient todetermine if the 510(k) process had contributed to or hinderedinnovation. The IOM committee recommended that the FDAissue a call for PMA applications for, and otherwise reclassify,class III devices that had previously received a 510(k) clear-ance. Although in practice most CIEDs have been subjected tothe PMA process, adoption of the IOM committee recommen-dation would result in all CIEDs receiving the more intensescrutiny associated with that PMA review pathway.

2 CIED postmarket approval experience

At the time of market release, it is impossible to know how aCIED will perform over the long term in the real world.

Biocompatibility, environmental, simulation, and reliabilitytesting may not always replicate the patient experience. Pre-approval device studies may enroll only a few hundredindividuals who comprise a relatively homogeneous studypopulation. Rare adverse events may not be observed until adevice is used in thousands of patients. PMA studies rarelyspan the TPLC of a new or comparator device. After ap-proval, devices may be implanted in patients who differsignificantly from the participants in premarket studies. Asa result, meaningful evaluation of real-world device perfor-mance depends on a high-performing postmarket surveil-lance system.

In 2005, in response to recall notices from three CIEDmanufacturers in the preceding year, the Heart RhythmSociety (HRS) and the FDA convened a multi-stakeholderNational Policy Conference on Pacemaker and ImplantableCardioverter Defibrillator Performance [10]. In October2006, a task force issued recommendations that included acall for greater transparency in device surveillance, analysis,and reporting; enhanced systems to increase the rate ofreturn of devices to manufacturers; improvements in recallcommunications to physicians and patients; and more coop-eration among industry, the FDA, and the physician com-munity [11]. Recommendations to improve CIED leadsurveillance followed in 2009 [12]. Many of the task forces’recommendations, such as regular product performancereporting by industry, have been adopted.

More recently, clinicians have become aware of perfor-mance defects associated with the St. Jude Medical Riatatransvenous defibrillation lead. A 2009 report by Epsteinand colleagues, based on their analysis of data from fourregistries with median follow-up of 22 months, had con-cluded that the percentage of Riata leads with conductorfractures (0.09 %) and insulation damage (0.13 %) was verylow [13]. However, the lead was removed from the marketin November 2010 because of reports that conductor cableswere wearing through the insulation that covered them [14].A class I advisory was issued 1 year later [15]. The manu-facturer estimates that 227,000 Riata leads have been dis-tributed worldwide. In a 2012 New England Journal ofMedicine perspective soon after the Riata advisory, Hauserexpressed concern that, “our current passive postmarketsurveillance system [still] fails to detect significant devicedefects before large patient populations have been exposed”[16]. In addition to advocating for postmarket studies ofRiata leads (ordered by FDA in August 2012), Hauser urgedregulators to quickly adopt strategies such as expandingtheir use of clinical registries and remote device monitoringto improve surveillance. Writing at the same time as Hauser,Resnic and Normand highlighted some of the challengesassociated with monitoring medical devices that are madeusing multiple components and frequently modified com-plex designs [17]. Complexity is more than a device

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hardware issue. In a 2006 review of ICD troubleshooting,Swerdlow and Friedman estimated that ICDs have approx-imately 500 programming options and expressed concernthat the time pressure of clinical practice and low reimburse-ment for device troubleshooting might increase the risk oflethal and nonlethal operator programming errors [18].

Concerns about CIED complexity are not confined toICDs. A 2012 analysis of data from 2.9 million pacemakerimplants from 1993 to 2009 showed a rise in dual-chamberimplants from 62 to 82 % of all pacemakers, with a propor-tionate decline in single-chamber procedures. The totalnumber of implants increased 55.6 % over the same timeperiod. Recipients were older and sicker [19]. As moredevices of greater complexity are implanted in sickerpatients, the CIED surveillance burden is greater. Alongwith estimates by FDA officials that only 0.5 % of medicaldevice failures are reported, these data suggest that morepatients than ever would benefit from improvements inCIED surveillance and earlier (preclinical) detection of de-vice failure [20].

3 Current postmarket CIED surveillance mechanismsin the USA

The most widely used mechanisms for postmarket surveil-lance of CIEDs are presented in Table 1.

3.1 Transtelephonic, in-office, and remote monitoring

Transtelephonic monitoring and in-office interrogation ofCIEDs have been used for more than two decades to trackdevice function. Unfortunately, not all CIED recipients areroutinely monitored. Patients must “opt into” monitoring,make and keep appointments, and master the use of equip-ment. In-office device evaluation is performed less frequent-ly than phone monitoring and requires appointments,transportation, and expenditure of other resources. The yieldin terms of actionable data per session from transtelephonicand in-office ICD interrogation has been reported to be aslow as 6.6 % [21]. Because of the intermittent nature ofconventional monitoring, signals that herald impending de-vice failure may be missed between sessions.

Remote monitoring technology is a newer approach thatcan be used for automatic CIED surveillance. In-hometransmitters download device information, sending it to aserver that receives and forwards information to clinicians.Although CIED recipients must still opt into remote moni-toring, and products from one manufacturer require appli-cation of a wand over the device to retrieve data, automaticor semiautomatic data collection may improve monitoringfrequency and safety signal detection. A recent review ofthis technology concluded that remote monitoring does

result in earlier detection of performance defects comparedto conventional monitoring strategies [22]. Nevertheless,barriers to remote monitoring remain. Older CIEDs thatare still in service may not have remote monitoring capabil-ity. Not all currently marketed devices include this function.Therefore, device clinics must continue to provide access tomultiple monitoring options and be familiar with each man-ufacturer’s proprietary platform. As with conventional mon-itoring, even if a device has remote monitoring capability,not all patients are offered this service. Others opt out ofmonitoring or do not use equipment even after it has beenplaced in their home [23]. Medical practices need softwarewhich integrates monitoring software with electronic healthrecord systems, makes it a part of normal workflow, andalerts clinicians and patients when problems are firstdetected in order to realize more fully the potential of recentadvances in monitoring technology.

3.2 Postmortem evaluation of CIEDs

The 2006 HRS Task Force members encouraged postmor-tem interrogation, removal, and return of CIEDs to themanufacturer, especially in cases of sudden or unexpecteddeath [11]. The group also recommended that patients beasked to consent to postmortem evaluation of a CIED. In asurvey conducted by Kirkpatrick and colleagues, only 4 %of 71 funeral directors reported having ever returned anexplanted device to a manufacturer [24]. In the same study,82 % of 150 CIED recipients said they would be willing tohave their device interrogated after death, and 79 % indicat-ed that they would consent to having it returned to themanufacturer. Although the study population was small,these findings suggest a high level of acceptance of post-mortem CIED evaluation, and that an opportunity exists toincrease the number of devices returned for analysis.

3.3 Reporting by manufacturers of CIED performancedefects

Device manufacturers must inform the FDA when theybecome aware of a performance defect in one of theirproducts. Specifically, they are required to, “protect thepublic health and well-being from products that present arisk of injury or gross deception or are otherwise defective”[25]. One challenge they encounter is that specific thresh-olds for reporting do not exist. Companies are required toproduce annual medical device performance reports. Theaccuracy of those reports depends upon voluntary comple-tion by clinicians of questionnaires that ask for informationabout patient status and device function. Medical practicesmay be unable or unwilling to disrupt workflow or add tooverhead to complete this task. Patients may changeaddresses, physicians, or insurance and become lost to

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follow-up. Patient and device survival data are unlikely tobe missing at random, and analyses of censored data prob-ably underestimate device defects. When reasons other thana design flaw may also explain device malfunction or anevent is so infrequent that most clinicians would not recog-nize it or if a high-risk patient dies suddenly, defects mayescape detection. In addition, if a clinician is able to addressa performance issue by reprogramming a device or aban-doning a lead, manufacturers and regulators may not be

notified. Patients may not know that they may report a deviceproblem to the manufacturer and the FDA and may feel theydo not have the medical knowledge needed to make a report.

Despite these impediments to communication of deviceperformance issues to the makers of CIEDs, most medicaldevice recalls result from voluntary action taken by manufac-turers in response to field reports and/or analysis of returnedproduct. CIED pulse generators are relatively easy to removeand return for analysis. However, return of malfunctioning

Table 1 Current mechanisms for postmarket CIED surveillance

Strategy Issues Solutions

Routine clinician office visits Not “automatic” Use only for identified issuesVery infrequent

Requires scheduling

Consumes resources (time, money)

Low yield

Transtelephonic monitoring Not “automatic” Financial incentives and recognition programs forclinicians and facilities●Scheduling

●PQRS●Enrollment

●MOCInfrequent

●VBPRequires equipment mastery

●Accreditation by JCLow yield

Transition to remote monitoring technology

Remote monitoring Enrollment not “automatic” and maynot be offered to everyone

Facility/clinician incentives to enroll patients

Multiple proprietary platforms Develop interoperable software

Establish a common platform

Information overload Develop decision support tools

Develop reliable and valid alerts

Analysis of defective product Reprogramming resolves issue Universal identification system

Features are abandoned

Not a part of normal workflow Build into EHRs

Part of normal workflow

Facilities don’t allow return Incentives to return product (JC)

Potential for litigation Liability protections

Postmortem exam uncommon Incentives to obtain prior consent to postmortemCIED evaluation (PQRS)

Medical Device Reporting (MDR) Many explanations for a defect Track all devices electronically

Not part of normal workflow UPI

Threshold for action not precisely defined MDR templates in EHRs

Interoperable software

MDEpiNet

NCDR-ICD for f/u

Bring DELTA to scale

Modify BAA; include FDA

Add Pacemaker f/u module

Post-approval and 522 studies Costly Use registries, EHRs

Inefficient Expand MDEpiNetLow yield

PQRS physician quality reporting system, MOC maintenance of certification, VBP value-based purchasing, JC Joint Commission, EHRs electronichealth records, BAA business associate agreements

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leads is limited in part because lead extraction is riskier thangenerator removal, and because faulty leads may be aban-doned and capped, rather than removed and replaced.During extraction, leads can break, be partially retained, orotherwise damaged. Manufacturers and regulators must thendecide, using incomplete information, whether the reportedperformance defect is due to a design flaw or should beattributed to patient, operator, or other extrinsic factors.

4 The current FDA approach to medical devicesurveillance

Each year, several hundred thousand medical device reports(MDRs) of confirmed or suspected performance defects aresent to the FDA Center for Devices and Radiological Health(CDRH) [17]. The CDRH TPLC approach attempts to com-bine pre- and postmarket data on all of the devices it regu-lates [26]. In September 2012, the FDA released its plan for“Strengthening Our National System for Medical DevicePostmarket Surveillance” and hosted public meetings toengage stakeholders, review existing intra- and extramuralresources including registries, and discuss what methods areneeded to rapidly generate, synthesize, and appraise evi-dence [27–29]. At the present time, the FDA CDRH usesmultiple platforms and strategies for device surveillance, themost important of which are described here.

4.1 The manufacturer and user facility device experience(MAUDE) database

MAUDE was established over 20 years ago to receive andarchive MDRs from facilities, manufacturers, distributors,physicians, and patients [30]. MAUDE relies on voluntaryreporting by participants and suffers from the absence ofprespecified reporting thresholds, a plethora of reportingtemplates, and outdated software.

4.2 The medical product safety network (MedSun)

Established in 2002, MedSun is an FDA partnership withapproximately 280 health care facilities, mostly hospitals,trained by the agency to report instances of suspected abnormaldevice function [31]. FDA training is credited with the submis-sion, on average, of higher quality, more complete MDRs thanare submitted to MAUDE. MedSun generates approximately5,000 MDRs yearly. Most MedSun reports are about class IIdevices. Its contribution to CIED surveillance is limited.

4.3 Post-approval studies

CDRH at times requires additional studies as a condition ofdevice approval. Since 2008, the FDA has required post-

approval studies of all new or substantially modified ICDleads. These studies are designed to detect early signals ofpoor device performance by collecting data from at least1,000 patients for 5 years after implantation. These require-ments were not in effect when the Medtronic Fidelis and St.Jude Medical Riata ICD leads were approved [16].

4.4 Postmarket “522” studies

Section 522 of the Food, Drug and Cosmetic Act gives theFDA the authority to order a study of an approved device ifa safety issue has been identified [32]. Analysis of existingdata, observational studies, patient registries, and random-ized controlled trials has all been used to address FDAconcerns [33]. The FDA recently ordered a 3-year 522 studyof the St. Jude Medical Riata lead, “to determine howfrequently and how soon after implantation Riata insulationfails; how often and how soon both inner and outer layers ofinsulation fail and at what point migration or externalizationof the electrical conductors cause ICD lead malfunction orother problems; and risk factors that contribute to insulationfailure or externalization of the electrical conductors.” [34].The FDA has also ordered the company to conduct post-market studies of the QuickFlex LV CRT leads, QuickSiteLV CRT leads, Riata ST Optim, and Durata ICD leads.

5 Newer FDA medical device surveillance strategies

5.1 Unique device identification (UDI) initiative

Just as vehicle identification numbers have facilitated track-ing of product performance in the automotive industry, aunique device identification system is expected to improvetracking of medical devices. In July 2012, the FDA releasedfor public comment a proposed rule that would establish aUDI system [35]. Once operational, it is expected that UDIdata will be incorporated into electronic health records,claims databases, and other clinical information systems.Participants in the Medical Device Epidemiology Network(described below) are expected to use the UDI in databasesearches when responding to FDA queries about possibledevice performance failures.

5.2 The sentinel and the medical device epidemiologynetworks (MDEpiNet)

The FDA Amendments Act of 2007 instructed the agency toestablish a public private partnership and develop methodsto access disparate and widely distributed data sources tobetter evaluate the safety of drugs and devices [36]. Firstcreated, the FDA Sentinel Initiative is a distributed networkof databases that collectively contain health information

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about over 100 million individuals. Participating healthsystems, health plans, pharmacy benefit managers, and gov-ernment agencies including the Departments of Veteran’sAffairs and Defense and the Center for Medicare andMedicaid Services (CMS) retain exclusive access to theirdata. The Mini-Sentinel Pilot project tested the network’sability to respond to a drug safety query [37]. FDA submit-ted test queries through the coordinating center at theHarvard Clinical Research Institute (HCRI). Participantsqueried their databases and provided de-identified resultsto the HCRI. Summary statistics were forwarded to FDA,allowing the agency to decide if the evidence warrantedfurther investigation. Mini-Sentinel demonstrated the feasi-bility of this approach. The FDA Safety and Innovation Actof 2012 mandated expansion of Sentinel to medical devices[38]. The MDEpiNet has been expanded to fulfill this man-date and as a public–private partnership will develop meth-ods of analysis for use across diverse databases toinvestigate safety signals related to devices [39].

5.3 Longitudinal Patient Registries

The Agency for Healthcare Research on Quality User’sGuide to Registries defines an outcomes registry as “anorganized system that uses observational study methods tocollect uniform data (clinical and other) to evaluate specifiedoutcomes for a population defined by a particular disease,condition, or exposure, and that serves one or more prede-termined scientific, clinical, or policy purposes” [40].

The Society for Thoracic Surgery Database, TheInteragency Registry for Mechanically Assisted CirculatorySupport, and the National Cardiovascular Data Registry(NCDR) contain data on millions of patients who have under-gone cardiovascular procedures, including device implanta-tion [41–43]. The NCDR-ICD was established in 2005 inresponse to a National Coverage Decision by the CMS thatit would provide coverage for implantation of ICDs for pri-mary prevention of sudden cardiac death in high-riskMedicare beneficiaries so long as hospitals meet a Coveragewith Evidence Development requirement to submit data to anapproved registry or a clinical trial [44]. Data are submitted byparticipating facilities at the time of an implant but the registryis not designed to collect patient and device data betweenprocedures. Quarterly reporting of key indicators, bench-marked to national outcomes and facilities of similar sizeand case volume, is provided to each participating facilityand to CMS. Business associate agreements between theNCDR and each hospital govern data sharing and ensureprotection of patient-specific information. Data sharing be-tween hospitals and with other stakeholders is not permitted.The NCDR-ICD receives data related to approximately 90 %of all ICD implants in the USA. Its potential as a platform tostrengthen ICD surveillance is obvious. To date, only limited

funding for research and device surveillance has been avail-able. The FDA has announced plans to host workshops toexamine how it can leverage registry experience and expertise,establish common data elements, develop and share methods,promote interoperability among registries, set priorities, andpre-certify registries for use in post-approval studies [28, 30].Challenges to be addressed include the need for greater clini-cian engagement, registry sustainability, and creation of gov-ernance models that ensure transparency and inspire trust.

6 Modernization of adverse event reporting and analysis

The FDA plans to promote automated adverse event report-ing as a part of normal clinician workflow, expand itscapacity to receive data electronically, and develop mobilereporting applications [28]. The agency will replaceMAUDE, after more than 20 years in service, with theFDA Adverse Event Reporting System (FAERS). FAERSwill increase FDA’s capacity to receive and analyze adverseevent reports and to rapidly identify safety signals. The FDAplans to develop data storage standards, tools for data min-ing text, methods to combine data from diverse sources, anda master plan for data management. Early results from theData Extraction and Longitudinal Time Analysis (DELTA)system suggest that automatic safety signal detection forcardiovascular devices is possible [45].

The FDA’s initiatives ought to benefit from recent invest-ments in health information technology (HIT). In response toprovisions of the Health Information Technology forEconomic and Clinical Health and the Patient Protection andAffordable Care (PPACA) Acts, the Office of the NationalCoordinator for Health Information Technology (ONC-HIT)has created incentives for adoption and meaningful use of HIT[46–48]. The final rule for the second stage of meaningful useof HIT was issued in August 2012 [49]. Eligible providersseeking incentive payments for meaningful use of HIT havethe option of identifying and reporting specific cases to aspecialized registry (other than a cancer registry). Althoughmedical device surveillance is not specifically referred to inthe rule, clinicians monitoring CIEDs could use registry par-ticipation to fulfill one meaningful use requirement. The FDAand the ONC-HIT should coordinate their efforts and useevery opportunity to create incentives for HIT vendors toinclude UDIs, automatic device surveillance, and registriesin electronic health record platforms.

7 Evaluation of postmarket device surveillance systems

In addition to infrastructure and new methods for medicaldevice surveillance, critical assessment of each componentof a surveillance program is necessary in order to decide if

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continuing investment of resources is warranted. Other thanits intention to replace MAUDE, the FDA has not an-nounced any plans to phase out other existing programswhile it implements its plan to strengthen postmarket sur-veillance. Comparative effectiveness research focused ondifferent approaches is needed to ensure that funding deci-sions of regulators and payers and clinical decisions ofphysicians and patients are justified by scientific evidence.

Surveillance strategies should be evaluated using perfor-mance measures such as the time from the first confirmedinstance of a performance defect to regulatory action, thenumber of recipients affected, the number of correctiveactions taken, the severity of complications resulting fromdevice malfunctions and corrective actions, and the econom-ic and noneconomic costs associated with an advisory. Theprinciple underlying safe use of diagnostic radiation, aimingfor a level of exposure As Low As Reasonably Achievable,should be adapted for use in the medical device arena, tominimize patient exposure to performance defects, devicefailures, inappropriate shocks, and corrective procedures.Evaluation metrics should also account for the greater riskof extraction the longer a patient has a lead in place.Methods that shorten the time from first signal to actionbenefit not only those who have a lead removed andreplaced, but also those who have avoided receiving thatlead in the first place. Algorithms to improve preclinicaldetection of CIED malfunction, such as those developed atthe time of the Medtronic Fidelis lead advisory, shouldcontinue to be developed and tested [4].

8 Future challenges and opportunities to improvemedical device performance and surveillance

Highly reliable performance evaluation programs assume thatthere will be defects in the systems that they monitor andemploy multiple strategies to ensure early detection of perfor-mance defects and reduce the likelihood of harm. JamesReason has suggested that errors leading to patient harm resultfrom a series of defects in safety and monitoring systems, andhas argued against assignment of blame to any one step,person, company, or agency [49]. Instead, he recommends a“management program aimed at several targets: the person, theteam, the task, the workplace, and the institution” that isdefined by its “preoccupation with the possibility of failure”[49]. In such a program, participants share responsibility forpreventing harm. Reason’s conceptual model of harm preven-tion can be applied to device surveillance systems to effective-ly engage all participants, including patients and clinicians.

The unique device identification system will be devel-oped for new devices, but implementation may take 7 yearsand it will not be applied retroactively to devices alreadyimplanted in patients [35]. The merits of linking a UDI with

a unique patient identifier (UPI) are obvious. The USA isthe only developed nation without a UPI system [50].Opposition has been based upon concerns about patientprivacy and skepticism about the role of the government inthe lives of individuals. It is possible that provisions of thePPACA that prohibit denial of coverage based on preexist-ing medical conditions, place limits on rates charged tohigher risk individuals, and expand access to insurance tomillions of Americans will create a more favorable environ-ment in which to reconsider a UPI system. Until then, avoluntary nongovernmental approach could perhaps be con-sidered. Recipients of medical devices could be given theoption of a UPI that is linked to the UDI system. In themeantime, clinicians and health systems should considerusing currently available levers to increase patient partici-pation in remote CIED monitoring when possible, and con-ventional monitoring when it is not. Protocol-drivenenrollment in remote monitoring could become a require-ment of discharge from a facility after CIED implantation.Just as facilities and clinicians are striving to prevent post-discharge adverse events such as readmission for congestiveheart failure or device infection, similar strategies includingearly telephone and in-person follow-up could be used toincrease participation in CIED monitoring. Protocol-drivenreminders can also be used to improve participation ratesand initiate corrective action when remote or in-person devicesurveillance is overdue. Local initiatives at the practice orinstitutional level have the advantage of being under localcontrol and do not depend on regulatory or legislative actions.

Individuals and organizations act to earn incentives andlimit downside risks. The National Quality Forum (NQF)should call for performance measures that incentivize devicemonitoring and device registry participation. CMS couldthen include NQF-endorsed measures in its PhysicianQuality Reporting System, public reporting (Hospital- andPhysician Compare), and value-based purchasing programs.The Joint Commission (JC) could require device surveil-lance systems as a condition of hospital accreditation. TheJC could also create recognition programs for accreditedfacilities that routinely return explanted products to manu-facturers. Protections from litigation and limits on liabilityboth have the potential to increase rates of return of explantedproducts by facilities and clinicians. Participation in deviceregistries such as the NCDR could become a requirement foraccreditation or special recognition. The NCDR should lever-age its experience with ICDs and develop a module forpermanent pacemaker procedures. The FDA should contractwith the NCDR for CIED surveillance data and pre-certify theNCDR-ICD as a platform for postmarket studies [28]. TheAmerican Board of Medical Examiners could incorporatemedical device management into practice improvementrequirements for maintenance of certification in clinical car-diac electrophysiology [51].

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As the postmarket medical device surveillance system isstrengthened, and gaps are addressed, clinicians may wantto consider preferentially implanting CIEDs with longertrack records. Recently approved devices could be reservedfor patients who require the newer features. Both patientsand clinicians need better access to near real-time informa-tion about the device they are about to use and depend lesson annual performance reports. Patients, physicians, andother stakeholders should advocate for creation of incentivesso manufacturers continue to produce CIEDs with excellentlong-term track records. Health technology assessmentgroups and payers making coverage decisions could requireevidence that a new device improves clinical and patient-reported outcomes compared to existing options. All stake-holders need to balance the demand for innovation with theneed for reliable device performance.

9 Conclusion

A robust surveillance system depends upon rigorous evalu-ation and continuous improvement of the devices it mon-itors, the infrastructure it builds, and the methods it applies.Reliable systems require investments to develop state of theart infrastructure and methods. A commitment to invest inhigh-performing assets and a willingness to decommissionunderperforming infrastructure and tools are essential.Together, engagement of all stakeholders, a unique deviceidentification system, incentives to promote return ofexplanted devices, adoption of electronic health records,greater participation in registries, more remote monitoring,and integration of monitoring as a part of normal workflowhave the potential to dramatically improve medical devicesurveillance in the USA.

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