# The MDEpiNet Medical Counter Measures Study ## expand\_more ## The MDEpiNet Medical Counter Measures Study [1U01FD004493-01 ](https://reporter.nih.gov/search/aR6FjDUzB0a9JEoQ5cdZLQ/project-details/8464322) 09/2012 - 09/2018 ![innovation to patients scheme](/sites/g/files/omnuum9296/files/2025-03/aboutus%20%281%29.png) MDEpiNet is a Public-Private Partnership that brings together leadership, expertise, and resources from health care professionals, industry, patient groups, payers, academia, and government to build and operate a national medical device evaluation system. As a voluntary organization, the success of MDEpiNet depends on the time and effort of its members. Visit the [Who We Are](http://mdepinet.org/who-we-are/) and [Centers](http://mdepinet.org/mdepinet-centers-2/) pages on the MDEpiNet website to learn more. MDEpiNet is working to build this national system by improving and integrating real-world data infrastructure, developing appropriate methodologies, and conducting studies. Three [Centers](http://mdepinet.org/mdepinet-centers-2/) support MDEpiNet operations under a cooperative agreement with the [Center for Devices and Radiological Health](http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/) (CDRH). The [Projects](http://mdepinet.org/projects/) of MDEpiNet have been funded by a variety of partners (listed with the project descriptions). The vision for this national system was set out in a report of a Planning Board made up of major stakeholders in the medical device ecosystem for improving development, regulation, and use of innovative medical devices and to improve patient-centered outcomes. > Read the Planning Board Report: > [Strengthening Patient Care: Building an Effective National Medical Device Surveillance System](http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM435112.pdf) > © The Brookings Institution, 2015 MDEpiNet is working to: 1. create and manage data use agreements with partners and/or external organizations utilizing existing data infrastructure for evidence development activities, 2. support the development and execution of priority pilot programs and, 3. conduct assessments of evidence development activities to identify, adopt, and promote best practices in data capture, analytical methods, and technology changes. The MDEpiNet Public Private Partnership uses core centers with expertise in each area. **The Methodology Center** is responsible for: - Developing and applying novel statistical and epidemiological methods to monitor the safety and effectiveness of medical devices. - Advancing statistical and epidemiological methods to improve understanding of medical device vulnerabilities to chemical, biological, radiological, and nuclear events. - Developing a comprehensive set of methodological approaches for continuous evaluation of pre-market and post-market device data. The Methodology Center is located in the [Department of Health Care Policy at Harvard Medical School](http://www.hcp.med.harvard.edu/) and is charged with advancing statistical and epidemiological methods to improve the understanding of the safety and effectiveness of FDA-regulated medical devices. ## Publications Download 9 citations download- [BibTeX](/bibcite/export?pager_style=no_pager&number_of_items=12&sort_field=bibcite_year--desc&&content_filter%5B0%5D=516171&content_filter%5B1%5D=515996&content_filter%5B2%5D=516006&content_filter%5B3%5D=515971&content_filter%5B4%5D=516036&content_filter%5B5%5D=515956&content_filter%5B6%5D=516026&content_filter%5B7%5D=515946&content_filter%5B8%5D=515966&&format=bibtex) - [EndNote X3 XML](/bibcite/export?pager_style=no_pager&number_of_items=12&sort_field=bibcite_year--desc&&content_filter%5B0%5D=516171&content_filter%5B1%5D=515996&content_filter%5B2%5D=516006&content_filter%5B3%5D=515971&content_filter%5B4%5D=516036&content_filter%5B5%5D=515956&content_filter%5B6%5D=516026&content_filter%5B7%5D=515946&content_filter%5B8%5D=515966&&format=endnote8) - [EndNote 7 XML](/bibcite/export?pager_style=no_pager&number_of_items=12&sort_field=bibcite_year--desc&&content_filter%5B0%5D=516171&content_filter%5B1%5D=515996&content_filter%5B2%5D=516006&content_filter%5B3%5D=515971&content_filter%5B4%5D=516036&content_filter%5B5%5D=515956&content_filter%5B6%5D=516026&content_filter%5B7%5D=515946&content_filter%5B8%5D=515966&&format=endnote7) - [Endnote tagged](/bibcite/export?pager_style=no_pager&number_of_items=12&sort_field=bibcite_year--desc&&content_filter%5B0%5D=516171&content_filter%5B1%5D=515996&content_filter%5B2%5D=516006&content_filter%5B3%5D=515971&content_filter%5B4%5D=516036&content_filter%5B5%5D=515956&content_filter%5B6%5D=516026&content_filter%5B7%5D=515946&content_filter%5B8%5D=515966&&format=tagged) - [Marc](/bibcite/export?pager_style=no_pager&number_of_items=12&sort_field=bibcite_year--desc&&content_filter%5B0%5D=516171&content_filter%5B1%5D=515996&content_filter%5B2%5D=516006&content_filter%5B3%5D=515971&content_filter%5B4%5D=516036&content_filter%5B5%5D=515956&content_filter%5B6%5D=516026&content_filter%5B7%5D=515946&content_filter%5B8%5D=515966&&format=marc) - [PubMedId](/bibcite/export?pager_style=no_pager&number_of_items=12&sort_field=bibcite_year--desc&&content_filter%5B0%5D=516171&content_filter%5B1%5D=515996&content_filter%5B2%5D=516006&content_filter%5B3%5D=515971&content_filter%5B4%5D=516036&content_filter%5B5%5D=515956&content_filter%5B6%5D=516026&content_filter%5B7%5D=515946&content_filter%5B8%5D=515966&&format=pubmed_id) - [RIS](/bibcite/export?pager_style=no_pager&number_of_items=12&sort_field=bibcite_year--desc&&content_filter%5B0%5D=516171&content_filter%5B1%5D=515996&content_filter%5B2%5D=516006&content_filter%5B3%5D=515971&content_filter%5B4%5D=516036&content_filter%5B5%5D=515956&content_filter%5B6%5D=516026&content_filter%5B7%5D=515946&content_filter%5B8%5D=515966&&format=ris) ### 2015 Amit Kumar, Michael Matheny, Kalon Ho, Robert Yeh, Thomas Piemonte, Howard Waldman, Pinak Shah, Richard Cope, Sharon-Lise Normand, Sharon Donnelly, Susan Robbins, and Frederic Resnic. 2015. “[The Data Extraction and Longitudinal Trend Analysis Network Study of Distributed Automated Postmarket Cardiovascular Device Safety Surveillance](/publications/data-extraction-and-longitudinal-trend-analysis-network-study-distributed)”. Circ Cardiovasc Qual Outcomes, 8, 1, Pp. 38-46. doi:10.1161/CIRCOUTCOMES.114.001123 Amit Kumar, Michael Matheny, Kalon Ho, Robert Yeh, Thomas Piemonte, Howard Waldman, Pinak Shah, Richard Cope, Sharon-Lise Normand, Sharon Donnelly, Susan Robbins, and Frederic Resnic. 2015. “[The Data Extraction and Longitudinal Trend Analysis Network Study of Distributed Automated Postmarket Cardiovascular Device Safety Surveillance](/publications/data-extraction-and-longitudinal-trend-analysis-network-study-distributed)”. Circ Cardiovasc Qual Outcomes, 8, 1, Pp. 38-46. doi:10.1161/CIRCOUTCOMES.114.001123 - add\_circle do\_not\_disturb\_on Abstract BACKGROUND: Current approaches for postmarket medical device safety surveillance are limited in their ability to produce timely and accurate assessments of adverse event rates.METHODS AND RESULTS: The Data Extraction and Longitudinal Trend Analysis (DELTA... ### 2016 Manuel Gomes, Laura Hatfield, and Sharon-Lise Normand. 2016. “[Handling Incomplete Correlated Continuous and Binary Outcomes in Meta-Analysis of Individual Participant Data](/publications/handling-incomplete-correlated-continuous-and-binary-outcomes-meta-analysis)”. Stat Med, 35, 21, Pp. 3676-89. doi:10.1002/sim.6969 Manuel Gomes, Laura Hatfield, and Sharon-Lise Normand. 2016. “[Handling Incomplete Correlated Continuous and Binary Outcomes in Meta-Analysis of Individual Participant Data](/publications/handling-incomplete-correlated-continuous-and-binary-outcomes-meta-analysis)”. Stat Med, 35, 21, Pp. 3676-89. doi:10.1002/sim.6969 - add\_circle do\_not\_disturb\_on Abstract Meta-analysis of individual participant data (IPD) is increasingly utilised to improve the estimation of treatment effects, particularly among different participant subgroups. An important concern in IPD meta-analysis relates to partially or completely... Laura Hatfield, Daniel Kramer, Rita Volya, Matthew Reynolds, and Sharon-Lise Normand. 2016. “[Geographic and Temporal Variation in Cardiac Implanted Electric Devices to Treat Heart Failure](/publications/geographic-and-temporal-variation-cardiac-implanted-electric-devices-treat)”. J Am Heart Assoc, 5, 8. doi:10.1161/JAHA.116.003532 Laura Hatfield, Daniel Kramer, Rita Volya, Matthew Reynolds, and Sharon-Lise Normand. 2016. “[Geographic and Temporal Variation in Cardiac Implanted Electric Devices to Treat Heart Failure](/publications/geographic-and-temporal-variation-cardiac-implanted-electric-devices-treat)”. J Am Heart Assoc, 5, 8. doi:10.1161/JAHA.116.003532 - add\_circle do\_not\_disturb\_on Abstract BACKGROUND: Cardiac implantable electric devices are commonly used to treat heart failure. Little is known about temporal and geographic variation in use of cardiac resynchronization therapy (CRT) devices in usual care settings.METHODS AND RESULTS: We... Daniel Kramer, Matthew Reynolds, Sharon-Lise Normand, Craig Parzynski, John Spertus, Vincent Mor, and Susan Mitchell. 2016. “[Hospice Use Following Implantable Cardioverter-Defibrillator Implantation in Older Patients: Results From the National Cardiovascular Data Registry](/publications/hospice-use-following-implantable-cardioverter-defibrillator-implantation-older)”. Circulation, 133, 21, Pp. 2030-7. doi:10.1161/CIRCULATIONAHA.115.020677 Daniel Kramer, Matthew Reynolds, Sharon-Lise Normand, Craig Parzynski, John Spertus, Vincent Mor, and Susan Mitchell. 2016. “[Hospice Use Following Implantable Cardioverter-Defibrillator Implantation in Older Patients: Results From the National Cardiovascular Data Registry](/publications/hospice-use-following-implantable-cardioverter-defibrillator-implantation-older)”. Circulation, 133, 21, Pp. 2030-7. doi:10.1161/CIRCULATIONAHA.115.020677 - add\_circle do\_not\_disturb\_on Abstract BACKGROUND: Older recipients of implantable cardioverter-defibrillators (ICDs) are at increased risk for short-term mortality in comparison with younger patients. Although hospice use is common among decedents aged >65, its use among older ICD recipients... Neil Wimmer, Susan Robbins, Henry Ssemaganda, Erin Yang, Sharon-Lise Normand, Michael Matheny, Naomi Herz, Josh Rising, and Frederic Resnic. 2016. “[Assessing the Cost Burden of United States FDA-Mandated Post-Approval Studies for Medical Devices](/publications/assessing-cost-burden-united-states-fda-mandated-post-approval-studies-medical)”. J Health Care Finance, 2016, Spec Features Neil Wimmer, Susan Robbins, Henry Ssemaganda, Erin Yang, Sharon-Lise Normand, Michael Matheny, Naomi Herz, Josh Rising, and Frederic Resnic. 2016. “[Assessing the Cost Burden of United States FDA-Mandated Post-Approval Studies for Medical Devices](/publications/assessing-cost-burden-united-states-fda-mandated-post-approval-studies-medical)”. J Health Care Finance, 2016, Spec Features - add\_circle do\_not\_disturb\_on Abstract Approved medical devices frequently undergo FDA mandated post-approval studies (PAS). However, there is uncertainty as to the value of PAS in assessing the safety of medical devices and the cost of these studies to the healthcare system is unknown. Since... ### 2017 Laura Hatfield, Christine Baugh, Vanessa Azzone, and Sharon-Lise Normand. 2017. “[Regulator Loss Functions and Hierarchical Modeling for Safety Decision Making](/publications/regulator-loss-functions-and-hierarchical-modeling-safety-decision-making)”. Med Decis Making, Pp. 272989X16686767. doi:10.1177/0272989X16686767 Laura Hatfield, Christine Baugh, Vanessa Azzone, and Sharon-Lise Normand. 2017. “[Regulator Loss Functions and Hierarchical Modeling for Safety Decision Making](/publications/regulator-loss-functions-and-hierarchical-modeling-safety-decision-making)”. Med Decis Making, Pp. 272989X16686767. doi:10.1177/0272989X16686767 - add\_circle do\_not\_disturb\_on Abstract BACKGROUND: Regulators must act to protect the public when evidence indicates safety problems with medical devices. This requires complex tradeoffs among risks and benefits, which conventional safety surveillance methods do not incorporate.OBJECTIVE: To... Frederic Resnic, Arjun Majithia, Danica Marinac-Dabic, Susan Robbins, Henry Ssemaganda, Kathleen Hewitt, Angelo Ponirakis, Nilsa Loyo-Berrios, Issam Moussa, Joseph Drozda, Sharon-Lise Normand, and Michael Matheny. 2017. “[Registry-Based Prospective, Active Surveillance of Medical-Device Safety](/publications/registry-based-prospective-active-surveillance-medical-device-safety)”. N Engl J Med, 376, 6, Pp. 526-35. doi:10.1056/NEJMoa1516333 Frederic Resnic, Arjun Majithia, Danica Marinac-Dabic, Susan Robbins, Henry Ssemaganda, Kathleen Hewitt, Angelo Ponirakis, Nilsa Loyo-Berrios, Issam Moussa, Joseph Drozda, Sharon-Lise Normand, and Michael Matheny. 2017. “[Registry-Based Prospective, Active Surveillance of Medical-Device Safety](/publications/registry-based-prospective-active-surveillance-medical-device-safety)”. N Engl J Med, 376, 6, Pp. 526-35. doi:10.1056/NEJMoa1516333 - add\_circle do\_not\_disturb\_on Abstract BACKGROUND: The process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an... Bilal Chughtai, Matthew Barber, Jialin Mao, James Forde, Sharon-Lise Normand, and Art Sedrakyan. 2017. “[Association Between the Amount of Vaginal Mesh Used With Mesh Erosions and Repeated Surgery After Repairing Pelvic Organ Prolapse and Stress Urinary Incontinence](/publications/association-between-amount-vaginal-mesh-used-mesh-erosions-and-repeated-surgery)”. JAMA Surg, 152, 3, Pp. 257-63. doi:10.1001/jamasurg.2016.4200 Bilal Chughtai, Matthew Barber, Jialin Mao, James Forde, Sharon-Lise Normand, and Art Sedrakyan. 2017. “[Association Between the Amount of Vaginal Mesh Used With Mesh Erosions and Repeated Surgery After Repairing Pelvic Organ Prolapse and Stress Urinary Incontinence](/publications/association-between-amount-vaginal-mesh-used-mesh-erosions-and-repeated-surgery)”. JAMA Surg, 152, 3, Pp. 257-63. doi:10.1001/jamasurg.2016.4200 - add\_circle do\_not\_disturb\_on Abstract Importance: Mesh, a synthetic graft, has been used in pelvic organ prolapse (POP) repair and stress urinary incontinence (SUI) to augment and strengthen weakened tissue. Polypropylene mesh has come under scrutiny by the US Food and Drug Administration... Daniel Kramer, Matthew Reynolds, Sharon-Lise Normand, Craig Parzynski, John Spertus, Vincent Mor, and Susan Mitchell. 2017. “[Nursing Home Use After Implantable Cardioverter-Defibrillator Implantation in Older Adults: Results from the National Cardiovascular Data Registry](/publications/nursing-home-use-after-implantable-cardioverter-defibrillator-implantation)”. J Am Geriatr Soc, 65, 2, Pp. 340-47. doi:10.1111/jgs.14520 Daniel Kramer, Matthew Reynolds, Sharon-Lise Normand, Craig Parzynski, John Spertus, Vincent Mor, and Susan Mitchell. 2017. “[Nursing Home Use After Implantable Cardioverter-Defibrillator Implantation in Older Adults: Results from the National Cardiovascular Data Registry](/publications/nursing-home-use-after-implantable-cardioverter-defibrillator-implantation)”. J Am Geriatr Soc, 65, 2, Pp. 340-47. doi:10.1111/jgs.14520 - add\_circle do\_not\_disturb\_on Abstract OBJECTIVES: To evaluate the incidence and characteristics of nursing home (NH) use after implantable cardioverter-defibrillator (ICD) implantation.DESIGN: Cohort study.SETTING: Medicare beneficiaries in the National Cardiovascular Data Registry-ICD...