Vol. 4, No. 1, March 2006

In this issue, we explore the newly launched FDA initiative to more closely monitor the postmarket safety of medical devices.

This new focus by FDA could significantly change the way you monitor your devices and manage your postmarket surveillance programs.

We expect that the FDA will scrutinize data from a variety of traditional and non-traditional sources.

Understanding the sources and types of data FDA might consider is critical in allowing you anticipate, identify, and respond to any potential problems related to your device.

Read on to learn more and to identify some types of non-traditional data that could strenghten your own device postmarket surveillance.

Also in this issue, I am pleased to announce a number of additions to our clinical services group, as well as the election of Susan Rockwell, Manager, Clinical Trials and Clinical Development to the ACRP Board of Trustees.

As always, I welcome your feedback and comments.

Sincerely,

Bill Morton
President

What You Don't Know CAN Hurt You: FDA's New Approach to Postmarket Device Safety

Follow FDA’s Lead and Use Unconventional Data to Strengthen Your Postmarket Safety Program

By Judith Andrews, Ph.D., RAC, Director of QA & Compliance Services and Lisa King, Marketing Manager

Introduction
The safety of marketed medical devices is always a major concern for the FDA, manufacturers and consumers. Recent events involving pharmaceuticals, medical devices, and combination products have raised the level of interest regarding public safety to an even higher level, particularly for FDA’s Center for Devices and Radiological Health, which is in part responsible for safeguarding public health.

In January 2006, the FDA announced a new postmarket surveillance effort, “Ensuring the Safety of Marketed Medical Devices: CDRH’s Medical Device PostMarket Safety Program.” This initiative arose in part from FDA’s concern that currently available medical device adverse event data is inadequate to protect the public health. A close examination of this initiative can help you understand how FDA’s traditional postmarket surveillance activities may change in the future, and provide suggestions on some novel postmarket data sources you can access now to anticipate and respond to possible product risks or problems.

Is Current Postmarket Surveillance Data Adequate?
Traditionally, FDA has relied on mandatory reporting from manufacturers, voluntary reporting from individual users and healthcare institutions, warning letters, recalls, 483 reports, and in certain cases, postmarket condition of approval (CoA) studies to assess the postmarket safety of devices. FDA has expressed concern about whether these sources of data are adequate to identify unanticipated public health hazards.

FDA’s new initiative has two stated goals: to increase the agency’s ability to identify, analyze and act on postmarket information, and to increase communication of risk/benefit to all stakeholders. These goals will directly impact your postmarket surveillance program.

As a manufacturer, you may need to widen the range and types of information you monitor if you want to be fully aware of the postmarket performance of your device. It is no longer feasible to rely primarily on user complaints. By understanding where the FDA is looking, and what types of data it might scrutinize, you can develop a proactive plan to tap into many of the same data sources.

Alternative Postmarket Data Sources
Concerns about the quality of data available from manufacturers and the underreporting of adverse events through voluntary means has led the FDA to take steps to identify and develop more sources of information on the postmarket performance of medical devices.

These additional data sources include data collected from healthcare facilities through the Medical Device Surveillance Network (MedSun), data from international vigilance reports, and data gleaned from other more informal sources, such as public discussion groups and online listservs.

Medical Device Surveillance Network
The MedSun program was initiated in 2000 by CDRH. MedSun is a reporting network of over 350 healthcare facilities trained to recognize and report problems in real-time and benefit from rapid agency feedback. The program’s principal objective is to increase both the quality and quantity of user facility reporting. Adverse events reported by MedSun are forwarded to the manufacturer, but other data related to this program are more difficult to obtain. For more information on MedSun visit http://www.medsun.net/about2.asp

International Vigilance Reports
In Europe, the Global Harmonization Task Force (GHTF) proposed guidelines for sharing information between the Competent Authorities of various countries. This information may be shared with the manufacturer, but may not be easily available to the general public. The FDA is proposing to tap into this information and thereby obtain better information on postmarket performance of products outside the United States. Manufacturers are required to report foreign adverse events if the same or a similar product is sold in the US. For more information on the GHTF guidelines visit http://www.ghtf.org/sg2/sg2-proposed.html

Listservs and Online Discussion Groups
CDRH also uses listservs (e-mail based discussion forums) and online public and professional discussion groups as sources of data on postmarket product performance, potential hazards, and ethical issues. For example, there is a listserv site for patients using insulin pumps to share information, as well as sites geared more for the professional. The FDA has already identified a handful of listserv sites where laboratories share information. By monitoring this real-time data source, FDA has identified about a dozen “signals of interest” and has taken action to clarify several reported problems. In some cases, the listserv data was used to corroborate data from other more traditional sources. In other cases, it identified unique issues.

Other Data Sources
The FDA initiative identifies many other possible data sources for postmarket device data, including data from Centers for Medicare and Medicaid Services (CMS), the National Institutes of Health (NIH), and the Consumer Product Safety Commission (CPSC), as well as other professional societies and industry databases. Some of these sources are publicly available, others are not. Some are available for a fee. Some of the most interesting sources are summarized below.

Healthcare Cost and Utilization Project (HCUP) - Nationwide Inpatient Sample (NIS)
HCUP (pronounced "H-Cup") is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership and sponsored by the Agency for Healthcare Research and Quality (AHRQ).The NIS database is a unique and powerful database containing inpatient data from a national sample of over 1,000 hospitals. Researchers and policymakers use NIS to identify, track, and analyze national trends in health care utilization, access, charges, quality, and outcomes. Many of the HCUP databases are available for purchase. For more information on HCUP visit http://hcup.ahrq.gov/

The American College of Cardiology National Cardiovascular Data Registry (ACC-NCDR)
The focus of this registry is cardiac catheterization and percutaneous coronary intervention patient data. Currently there are over 700 institutions nationwide that submit cardiac catheterization data to the registry, to enable measurement of clinical management and outcomes of patients undergoing diagnostic cardiac catheterizations and percutaneous coronary interventions. This registry is just one example. Other professional society registries are also sources of information for the FDA. For more information on ACC-NCDR visit http://www.inacc.org/NCDR.htm

ECRI
ECRI (formerly the Emergency Care Research Institute) is a nonprofit health services organization that focuses on health care technology, health care risk and quality management. ECRI maintains databases that alert subscribers to reported incidents involving medical devices. ECRI consults regularly with MedSun staff at the agency and provides written device assessments, often including ECRI testing. For more information on ECRI visit http://www.ecri.org/

Conclusion
The FDA CDRH Postmarket Transformation Initiative is driven by risk. CDRH will rely upon a broad range of data sources, including voluntary and mandated reporting, inspections, and non-traditional data from public and private sources to identify, analyze, and act on issues they believe represent potential risks to public health.

Don’t be caught by surprise. Now is the time to review and possibly expand your own postmarket surveillance strategy to include additional data sources that will allow you to more accurately monitor the safety and effectiveness of your marketed medical devices, and respond proactively to any problems.

For more information on the FDA Postmarket Initiative visit http://www.fda.gov/cdrh/postmarket/mdpi.html

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MDCI Continues to Strengthen its Clinical Services Group

In response to growing demand for high quality device clinical trials, study management, monitoring, and data management, MDCI continues to build and strengthen its Clinical Services group. We are pleased to announce the following new members to our team.

Connie Lamore, RN, Clinical Research Associate
Connie brings over 10 years of experience as a clinical reasearcher at Rhode Island Hospital, Butler Hospital and Miriam Hospital. Connie is a certified clinical research coordinator through ACRP. She brings extensive cardiac device experience to our team.

Andrea Segal, Clinical Data Manager
Andrea most recently served as a Data Manager/CRA for the University of Arizona Cancer Center. She was also a Research Coordinator and Project Manager for the Joslin Diabetes Center in Boston.

Karen Cieplik, In-House Clinical Research Associate
Karen will support project managers who are involved in complex device studies involving large numbers of sites and/or monitors. She will take an active role in the development of study materials, study tracking, and data review. Karen was previously with the Office of Human Subject Protection at Dana Farber Cancer Center where she was responsible for over 900 protocal submissions a year.

Meghan Kelly, Intern
Meghan is a senior at Providence College studying Health Policy Management. She will gain valuable field experience and industry skills as she works closely with the clinical services group over the next few months.

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Susan Rockwell Elected to ACRP Board of Trustees

Susan M. Rockwell, Manager Clinical Trials and Development, was recently elected to serve a second term as a member of the Association of Clinical Research Professionals (ACRP) Board of Trustees, effective January 1, 2006.

ACRP is a worldwide association of clinical research professionals comprised of individuals dedicated to clinical research and development. Founded in 1976, the association currently has over 20,000 committed professionals. Its members represent the pharmaceutical, biotechnology, medical device and CRO industries.

As a board member, Susan will play a key role in helping ACRP achieve its goal of promoting professional standards and best practices in the field of clinical research. She will work to develop appropriate educational offerings, as well as support the exchange of knowledge, information, and resources throughout the organization.

As a researcher with over twenty years of experience in the medical device industry, Susan brings a valuable perspective to the ACRP. She is an active member of the ACRP Device Forum Steering Committee, as well as chair of the organization's Editorial Advisory Board. During 2006 Susan will co-present ACRP workshops focused on the unique clinical research challenges involved in medical device studies.

For more information on ACRP, visit www.acrpnet.org, or contact Susan directly at (508) 643-0434.

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