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.

Rethinking analytical strategies for surveillance of medical devices: the case of hip arthroplasty

Journal Medical Care
Authors Normand SL; Marinac-Dabic D; Sedrakyan A; Kaczmarek R
Year Published 2010
Link to Publication – (PDF)

Background

Randomized trials that sometimes serve as the basis for device approval are small, short term, and generalizable to an increasingly smaller percentage of patients. Some of the most common and challenging devices are those used in hip replacement. Artificial hips are implanted in thousands to alleviate pain caused by noninflammatory joint disease and to restore patient mobility. During 2004 in the United States, although 68% of hospital stays for partial or total hip replacements were for those aged 65 years and older, younger patients will account for 52% by 2030.

Methods

Using hierarchical modeling, we propose a framework for combining information from premarket and postmarket settings. Our key assumption is that device performance characteristics and outcomes obtained from 1 cohort are related to device characteristics and outcomes of the same or similar devices observed in other cohorts. We illustrate methods by jointly modeling Harris Hip Scores (HHSs) and revision-success data from 1851 subjects who participated in 3 pivotal randomized or observational studies of artificial hips.

Results and Conclusions

Subjects participating in randomized studies had better 2-year HHS than those in observational studies (posterior mean increase in HHS = 4.1, posterior standard deviation = 0.6). Patients implanted with ceramic-on-polyethylene hip used in 1 study had higher 2-year HHS than those implanted with a different ceramic-on-polyethylene hip in another study (mean difference = 4.2, standard deviation = 0.6). Our approach is feasible and will advance regulatory science using a transparent and dynamic new paradigm for knowledge management throughout the total product life cycle.

Automated surveillance to detect post-procedure safety signals of approved cardiovascular devices

Journal JAMA (Journal of the American Medical Association)
Authors Resnic FS; Gross TP; Marinac-Dabic D; Loyo-Berríos N; Donnelly S; Normand SL; Matheny ME
Year Published 2010
Link to Publication – (PDF)

Context

Ensuring the safety of medical devices challenges current surveillance approaches, which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety.

Objective

To determine whether automated safety surveillance of clinical registries using a computerized tool can provide early warnings regarding the safety of new cardiovascular devices.

PATIENTS:

Prospective propensity-matched cohort analysis of 7 newly introduced cardiovascular devices, using clinical data captured in the Massachusetts implementation of the National Cardiovascular Data Repository CathPCI Registry for all adult patients undergoing percutaneous coronary intervention from April 2003 through September 2007 in Massachusetts.

MAIN OUTCOME MEASURE:

Presence of any safety alert, triggered if the cumulative observed risk for a given device exceeded the upper 95% confidence interval (CI) of comparator control device. Predefined sensitivity analyses assessed robustness of alerts when triggered.

RESULTS:

We evaluated 74,427 consecutive interventional coronary procedures. Three of 21 safety analyses triggered sustained alerts in 2 implantable devices. Patients receiving Taxus Express2 drug-eluting stents experienced a 1.28-fold increased risk of postprocedural myocardial infarction (2.87% vs 2.25%; absolute risk increase, 0.62% [95% CI, 0.25%-0.99%]) and a 1.21-fold increased risk of major adverse cardiac events (4.24% vs 3.50%; absolute increase, 0.74% [95% CI, 0.29%-1.19%]) compared with those receiving alternative drug-eluting stents. Patients receiving Angio-Seal STS vascular closure devices experienced a 1.51-fold increased risk of major vascular complications (1.09% vs 0.72%; absolute increased risk, 0.37% [95% CI, 0.03%-0.71%]) compared with those receiving alternative vascular closure devices. Sensitivity analyses confirmed increased risk following use of the Taxus Express2 stent but not the Angio-Seal STS device.

CONCLUSION:

Automated prospective surveillance of clinical registries is feasible and can identify low-frequency safety signals for new cardiovascular devices.