National and International Postmarket Research and Surveillance Implementation: Achievements of the International Consortium of Orthopaedic Registries Initiative

Journal The Journal of Bone and Joint Surgery
Authors Sedrakyan, Art; Paxton, Elizabeth; Graves, Stephen; Love, Rebecca; Marinac-Dabic, Danica
Year Published 2014
Link to publication

Nearly every American will be exposed to a medical device during his or her life, and tens of millions of people will be treated with an implantable device. However, regulatory and public health systems in the United States and internationally have critical gaps. The U.S. Food and Drug Administration (FDA) has released a national medical device postmarket surveillance plan, in which the agency identifies as a main priority the goal of promoting the development of national and international medical device registries for selected products. Another top priority of the FDA is the creation of a unique device identification (UDI) system for medical devices in response to a 2007 federal law.

Comparative Effectiveness of Robotic-Assisted vs Thoracoscopic Lobectomy.

Journal Journal of Endourology
Authors
Subroto Paul, MD, FCCP; Jessica Jalbert, PhD, MD; Abby J. Isaacs, MS; Nasser K. Altorki, MD, FCCP; O. Wayne Isom, MD; Art Sedrakyan, MD, PhD
Year Published 2014
Link to Publication

BACKGROUND:  Robotic-assisted lobectomy is being offered increasingly to patients. However, little is known about its safety, complication profile, or effectiveness.

METHODS:  Patients undergoing lobectomy in in the United States from 2008 to 2011 were identified in the Nationwide Inpatient Sample. In-hospital mortality, complications, length of stay, and cost for patients undergoing robotic-assisted lobectomy were compared with those for patients undergoing thoracoscopic lobectomy.

RESULTS:  We identified 2,498 robotic-assisted and 37,595 thoracoscopic lobectomies performed from 2008 to 2011. The unadjusted rate for any complication was higher for those undergoing robotic-assisted lobectomy than for those undergoing thoracoscopic lobectomy (50.1% vs 45.2%, P < .05). Specific complications that were higher included cardiovascular complications (23.3% vs 20.0%, P < .05) and iatrogenic bleeding complications (5.0% vs 2.0%, P < .05). The higher risk of iatrogenic bleeding complications persisted in multivariable analyses (adjusted OR, 2.64; 95% CI, 1.58-4.43). Robotic-assisted lobectomy costs significantly more than thoracoscopic lobectomy ($22,582 vs $17,874, P < .05).

CONCLUSIONS:  In this early experience with robotic surgery, robotic-assisted lobectomy was associated with a higher rate of intraoperative injury and bleeding than was thoracoscopic lobectomy, at a significantly higher cost.

Long term survival with thoracoscopic versus open lobectomy: propensity matched comparative analysis using SEER-Medicare database

Journal BMJ
Authors
Subroto Paul,  Abby J Isaacs,  Tom Treasure, Nasser K Altorki, Art Sedrakyan
Year Published 2014
Link to Publication

Abstract

OBJECTIVE:

To compare long term survival after minimally invasive lobectomy and thoracotomy lobectomy.

DESIGN:

Propensity matched analysis.

SETTING:

Surveillance, Epidemiology and End Results (SEER)-Medicare database.

PARTICIPANTS:

All patients with lung cancer from 2007 to 2009 undergoing lobectomy.

MAIN OUTCOME MEASURE:

Influence of less invasive thoracoscopic surgery on overall survival, disease-free survival, and cancer specific survival.

RESULTS:

From 2007 to 2009, 6008 patients undergoing lobectomy were identified (n=4715 (78%) thoracotomy). The median age of the entire cohort was 74 (interquartile range 70-78) years. The median length of follow-up for entire group was 40 months. In a matched analysis of 1195 patients in each treatment category, no statistical differences in three year overall survival, disease-free survival, or cancer specific survival were found between the groups (overall survival: 70.6% v 68.1%, P=0.55; disease-free survival: 86.2% v 85.4%, P=0.46; cancer specific survival: 92% v 89.5%, P=0.05).

CONCLUSION:

This propensity matched analysis showed that patients undergoing thoracoscopic lobectomy had similar overall, cancer specific, and disease-free survival compared with patients undergoing thoracotomy lobectomy. Thoracoscopic techniques do not seem to compromise these measures of outcome after lobectomy.

Unique device identifiers for coronary stent postmarket surveillance and research: a report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier demonstration.

Journal The American Heart Journal
Authors Tcheng, James; Crowley, Jay; Tomes, Madris; Reed, Terrie; Dudas, Joseph; Thompson, Kweli; Garratt, Kirk; Drozda, Joseph Jr.;  on behalf of the MDEpiNet UDI Demonstration Expert Workgroup
Year Published 2014
Link to publication

Abstract
BACKGROUND: Although electronic product identification in the consumer sector is ubiquitous, unique identification of medical devices is just being implemented in 2014. To evaluate unique device identifiers (UDIs) in health care, the US Food and Drug Administration (FDA) funded the Medical Device Epidemiology Network initiative, including a demonstration of the implementation of coronary stent UDI data in the information systems of a multihospital system (Mercy Health). This report describes the first phase of the demonstration.

METHODS: An expert panel of interventional cardiologists nominated by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions was convened with representatives of industry, health system members of the Healthcare Transformation Group, the American College of Cardiology National Cardiovascular Data Registry, and FDA to articulate concepts needed to best use UDI-associated data. The expert panel identified 3: (1) use cases for UDI-associated data (eg, research), (2) a supplemental data set of clinically relevant attributes (eg, stent dimensions), and (3) governance and administrative principles for the authoritative management of these data.

RESULTS: Eighteen use cases were identified, encompassing clinical care, supply chain management, consumer information, research, regulatory, and surveillance domains. In addition to the attributes of the FDA Global Unique Device Identification Database, 9 additional coronary stent-specific attributes were required to address use case requirements. Recommendations regarding governance were elucidated as foundational principles for UDI-associated data management.

CONCLUSIONS: This process for identifying requisite extensions to support the effective use of UDI-associated data should be generalizable. Implementation of a UDI system for medical devices must anticipate both global and device-specific information.

Precarious innovation of anti-infective coated devices

Journal The Lancet
Authors Sedrakyan, Art
Year Published 2014
Link to Publication

Surgeons focus on technical performance, teamwork, and communication to achieve the highest degree of safety. They will use new measures or devices that can potentially improve the safety and outcome of surgery, and often rely on sparse data from manufacturers to argue their case for the use of a new device in a hospital where costs might be of increasing concern. Heated debates are expected since recent studies have shown that most new devices do not have clinical or long-term safety data.1–3 One can no longer assume that new devices and equipment are superior products that have been carefully studied and selected. An increasing number of surgeons are becoming aware that incremental device innovations are based on scarce or no data and should not be adopted rapidly just because they are new