Medical device registries need much better coordination so they reflect the same set of device identifiers, shared minimum data elements and definitions and the ability to pool complementary data, according to an FDA-endorsed task force report.

The agency released a report from the Medical Device Registry Task Force Aug. 24 laying out a plan for establishing "coordinated registry networks" (CRNs) and recommending which devices to start with as part of FDA's broader effort to revamp the national postmarket surveillance system for devices. (See Also see "CDRH Details Path Forward For National Post-Market Surveillance System" - Medtech Insight, 29 April, 2013..)

The task force authors include clinicians, researchers, patient group representatives, industry representatives and government officials, who also collaborated with the public-private Medical Device Epidemiology Network. The report cautions against building a new comprehensive system of device registries to meet FDA surveillance goals due to lack of resources, stressing instead the need to leverage, link and build on existing registries. “Even if the funding necessary was allocated, the system would be outdated by the time it was ready for implementation,” they note.

But big improvements are necessary to established CRNs, which are partnered, complementary electronic health information systems that use the same device identifiers, core minimum data elements and definitions, and can share data across information systems. Currently, registries rely too much on “variable data elements, data definitions ... and [data] frequently from only limited subsets of patient exposures,” the report states.

To get the process started, the task force prioritizes which devices and procedures need coordinated registries most and also lays out 12 pilot projects, including projects to promote registry accreditation for cardiac, orthopedic and vascular devices; to support integration of procedural and claims data with other electronic data; and to create a new registry in a single device-based context, such as use of robots to remove cancers.

In addition to announcing availability of the report, FDA is requesting public comments on it by Oct. 24.

11 Device Procedures Prioritized

The registry task-force report builds on a plan released in February by a Planning Board for FDA's national medical device surveillance system initiative. (See Also see "Planning Board Proposes Postmarket Device Surveillance Timeline" - Medtech Insight, 24 February, 2015..) The goal of the registry coordination effort is “supporting better regulatory decisions” and to serve stakeholders across an expanding portfolio of device areas, the task force says in the report.

“Implanted devices and devices that enable major interventional procedures may entail a particular need for large [registries],” the report states. The task force pinpointed 11 priority devices/procedures for better registry coordination: (1) hip replacement; (2) knee replacement; (3) vascular procedures (including carotid, peripheral, AAA, and vascular access/catheters); (4) spine surgery/fusion; (5) cardiac valve replacement; (6) atrial fibrillation ablation; (7) ICD/cardiac resynchronization therapy; (8) coronary stents; (9) robotic/less invasive surgery; (10) ophthalmic procedures; and (11) surgical mesh.

To set priorities for specific device registries and CRNs most in need of development, the group relied on guiding principles such as whether “rapid uptake of the device is expected and adverse events are likely to be rare but very serious” and if “the device uses new technology whose long-term safety and effectiveness are not well understood.” The task force also recommends prioritizing device types that have substantial design variations, or for which performance might vary significantly across a population – for example, a device having different effects in men and women.

The group focused on implanted devices and those devices that enable the conduct of major interventional procedures.

Task-Force Recommended Device Procedures That Are Ripe For Better Registries

Device/Procedure

Estimated Number of Hospital Stays

Median Charge

Rationale For Better Data Collection

Hip Replacement

423,195

$49,647

Recalled metal-on-metal hips; limits of clinical trials in field; need to investigate hip head size, bearing, cementing.

Knee Replacement

634,354

$46,470

Performed twice as frequently as hip replacement in U.S. Systemic review showed no advantages for recently introduced technologies.

Vascular Procedures

197,760

$76,659

See next four rows of vascular procedure subcategories for rationales.

Vascular/Carotid Artery Stenosis (Carotid Stenting)

16,075

$50,131

A global carotid stent registry was set up in 1997, and there have been a large number of studies comparing stents and carotid endarterectomy. Stenting has been shown to be associated with a higher risk of stroke.

Vascular/Peripheral Artery Disease (Peripheral Vascular Stenting)

154,575

$75,152

Peripheral artery stenting has not been investigated as thoroughly as coronary stenting. Questions on if drug-eluting stent therapy reduces risks need to be resolved.

Vascular/Aortic Grafts/Stents (Endovascular AAA Repair)

31,715

$94,784

Endovascular abdominal aortic aneurysm repair has been shown effective in some populations, but six major devices on market have various characteristics and modes of failure.

Vascular/Inferior Vena Cava Filters* (*see “vascular procedures” above)

n/a

n/a

Has gained popularity in last 20 years, but questions regarding indication, safety management of IVCF remain unanswered.

Spinal Fusion

445,255

$78,257

Success depends on selection of right bone graft or device, but 200 bone graft extenders are on market. Also, major questions on related cages and spacers remain.

Cardiac Valves (Aortic or Mitral Valve Surgery)

104,445

$156,611

Results from randomized trials and large studies show no difference in long-term mortality between mechanical valves, bioprosthetic valves used in both mitral and aortic positions, but confirm higher bleeding risks with mechanical valves. The safety of specific devices is unknown, particularly in various patient populations.

Atrial Fibrillation Ablation (Catheter Ablation/AFib)

62,250

$85,660

Whether catheter ablation should be recommended as a first-line therapy for selected patients has been debated, and there is currently no consensus.

Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT)

77,285

$138,009

Whether CRT-D (an ICD enabled with CRT) is superior to CRT alone has been unclear and warrants further study, and CRT is associated with safety failures.

Coronary Stenting

535,780

$62,668

Concerns that coronary stents have been overused and a lingering debate over the superiority of drug-eluting over bare-metal stents.

Robotic/less invasive surgery: Laparoscopic VATS (video-assisted thoracoscopic surgery)

141,995

$44,421

Robotic/minimally invasive surgical technology has been adopted rapidly, although only a few randomized controlled trials have been carried out; evidence on iatrogenic complications associated with less invasive technology requires investigation. The four most common procedures: Laparoscopic VATS (video-assisted thoracoscopic surgery), robotic prostatectomy, robotic hysterectomy and laparascopic hysterectomy.

Robotic Prostatectomy

45,140

$39,684

Robotic Hysterectomy

39,215

$37,230

Laparascopic Hysterectomy

30,790

$30,205

Ophthalmic Devices

n/a

n/a

There are ongoing clinical trials for ophthalmic devices, but real-world data are very limited. A registry could help ensure these devices are safe in a real-world setting.

Surgical Mesh

n/a

n/a

These include mesh for vaginal prolapse, abdominal wall repairs, or inguinal, femoral or umbilical hernia repairs. It will take years before FDA-ordered postmarket studies on vaginal mesh for pelvic organ prolapse yield data. The studies were prompted by findings of erosion of mesh and infection, urinary problems, bleeding, organ perforations as consistently-reported complications.

Source: "Recommendations for a National Medical Device Evaluation System," Medical Device Registry Task Force & Medical Device Epidemiology Network, Aug. 20, 2015. Hospital stay and cost statistics from the U.S. 2012 National Inpatient Sample.

Pilot Projects: Strengthen Old Registries, Build New Ones

The report also proposes 12 different pilot projects to be carried out by stakeholders including manufacturers, FDA, the Agency for Healthcare Research and Quality, CMS, commercial payers and professional societies.

For each pilot project, a goal or specific group of devices in need of better registries is identified, as are immediate research questions to be answered, necessary stakeholders, existing national resources to leveraged, efficiencies promoted, and applied national standards and definitions.

For example, one project calls for “identification of a commonly used priority device area where devices have proliferated and there is no national registry,” and it identifies osteoarthritis and bone fractures as the disease(s), and orthopedic devices as the device focus.

Immediate research questions in this area call for examining the comparative effectiveness of commonly used techniques at the device characteristic level; determining and revealing outlier devices, such as those that are best performers/worst performers; and evaluating surgeon-device interaction based on volumes, regions and specific classes of products.

The engaged stakeholders,including orthopedic device makers, FDA, AHRQ and CMS, would leverage state-funded registries and professional society-based registries as well as Medicare and commercial insurance claims to a create a national infrastructure for large scale investigations. They would also apply Global Medical Device Nomenclature standards for device attributes and ICD-9 codes for comorbidities and adverse outcomes events.

Benefits And Barriers To Building CRNs

The task force states that by building CRNs, manufacturers, agencies and patients should be able to enjoy “better, more efficient regulatory science-based decisions with device information dissemination customized to stakeholder groups.” Because better and more comprehensive registries would be able to capture and update so much more data than currently isolated registries, agencies could make improved and faster regulatory and reimbursement decisions, and best practice recommendations, according to the report.

Better registry data could also supply “true safety signals” that “could profoundly inform and even incentivize early feasibility and pivotal premarket evaluations of novel device designs,” says the task force.

While the task force writes that it could conceive of “business models that could assign segmented costs” of building CRNs to areas of work and deliverables, in the “current medical device landscape of fragmentation and distrust, no amount of funding could guarantee success of a national system” of registries, it states.

Additionally, owners of electronic health information systems “will need to perceive CRN participation as an inclusive, even incentivized source of new opportunities, not as a loss of independence or source of added cost or work on behalf of others,” the report adds.

Comments on the “Recommendations for a National Medical Device Evaluation System” report should be sent to docket no. FDA-2015-N-2048.

Task Force Advocates Making Registries Better Than Sum Of Their Parts

More from Regulation

More from Policy & Regulation