CDRH is taking steps to increase its ability to identify, analyze, and act on postmarket information to improve the safety and effectiveness of medical devices and radiation-emitting products. In FY 2005 the Center overtook a comprehensive inventory of its postmarket safety programs, made changes to the condition of approval program and in collaboration with the industry and professional association worked to improve adverse event detection and management.
Medical Device Postmarket Transformation Initiative
In FY 2005 CDRH overtook a comprehensive inventory of its postmarket safety programs, including recalls, MDR and MedSun. In each of these areas, the Center looked at its successes and challenges in implementing an effective program. The postmarket safety program inventory considered how the Center identifies postmarket problems, assesses the information obtained, and responds to that information through both stakeholder communication and enforcement action. The Center's plan to strengthen its postmarket program focuses on: developing a "culture of collaboration" for postmarket safety within the Center; developing world-class data sources and systems to quickly and accurately collect, analyze, and disseminate information about potential risks; enhancing risk communication efforts; and improving coordination with the FDA field staff. A senior-level team, comprised of CDRH management and outside consultants experienced in medical device safety and product regulation will help guide the Center in this effort.
Improving Coordination of Post-Approval Studies
The post-approval studies program involves the review, design and tracking of clinical studies that are required of manufacturers as a condition of approval of a PMA. In January 2005 CDRH transferred the coordination of the Post-Approval Studies program to the Office of Device Evaluation to the Office of Surveillance and Biometrics. CDRH worked with sponsors design post-approval studies that answer important postmarket questions and are realistic and founded on good science, developed a guidance document for use by sponsors that specifies reporting requirements, and implemented a tracking system to ensure that studies are timely and accurate and provide useful results that are implemented into revised product labeling.
Developing a Medical Device Electronic Adverse Event Reporting System
CDRH is developing an electronic adverse event reporting system that will facilitate processing the reports and reduce operating costs. In FY 2005 CDRH received, processed, analyzed and responded to about 180,000 medical device adverse events reported through CDRH’s Medical Device Reporting (MDR) system. This system uncovered many public health issues and problems ranging from orthodontic headgear, hemodialysis systems and hospital beds, to cochlear implants, deep brain stimulators, and diagnostic tests for heart attacks and pregnancy.
Using Targeted Surveillance: The MedSun Network
MedSun is CDRH’s response to a section of the Food and Drug Administration Modernization Act (FDAMA), which required FDA to move from a mandatory program to surveillance reporting by a subset of clinical facilities. The program’s principal objective is to increase both the quantity and quality of user facility reporting by recruiting a cadre of well-trained and motivated facilities, and to establish a collaborative effort to better understand medical device use in the clinical environment. By mid-2005 MedSun expanded to approximately 350 health care institutions (mostly hospitals) nationwide.
In addition to enhancing the detection of emerging device problems, the MedSun network acts as a two-way communication channel between the CDRH and the clinical community and serves as a setting for applied clinical research on device issues. To succeed, the effort must train participants in the recognition and reporting of adverse events, assure reporting confidentiality, minimize the burdens of participation, and provide timely feedback on safety information.
FY 2005 efforts within the network, included:
- MedSun’s Annual Conference
- a survey on “single-use device” reprocessing
- development of educational materials
- implementation of the Device Safety Exchange Program (highlighting best safety practices and safety solutions)
- monthly newsletters (highlighting device reports, CDRH actions, and other notable safety initiatives by other agencies)
- clinical engineering audio-conferences
- launching a pilot program for CBER.
MedSun’s FY 05 Annual Conference attendees participated in a workshop on infusion pump safety, and received training on problem recognition with laboratory devices and with pediatric devices. A survey evaluation of the current status of “single-use device” reprocessing in the MedSun clinical community was completed. Of the 53 sites participating in this survey, none were aware of any increase in tracked infections in their facility or any deaths or serious injuries associated with the use of reprocessed devices. CDRH developed and made available to MedSun sites educational materials addressing problem recognition and reporting for laboratory devices and devices used on the pediatric population. The Center implemented the Device Safety Exchange (DS-X) Program for online sharing of questions and device quality improvement ideas by MedSun reporting sites. The DS-X web site allows participants to submit questions and ideas directly to MedSun staff who review, edit and post them for view by all MedSun sites. Topics addressed this year included, policies and risks associated with cell phones in the hospital environment and cybersecurity.
CDRH also launched a pilot program for CBER. The program will enable CBER to acquire information from MedSun sites on issues involving human cells and tissues. Engineering audio conferences on this development were provided to all MedSun sites.
Detection of Adverse Medical Device Events With Electronic Discharge Records
CDRH began several collaborations with the Agency for Healthcare Research and Quality, which administers several data sets of interest, including the Healthcare Utilization Project Nationwide Inpatient Sample (NIS) of hospital discharge claims and the State Inpatient Databases (SID) of hospital discharge claims. An interagency group used the NIS and SID to study short term health problems among those who had three types of hip prosthesis surgery: total hip replacement, partial hip replacement, and revision of an existing hip prosthesis. Although similar studies have been done with smaller patient groups, this is the first to use a national dataset to make national estimates of the short term outcomes of hip prosthesis surgery. A different team used the NIS data to estimate national numbers of discharges for specific diagnoses of device-related problems. This latter study is the first systematic description of the national burden of adverse medical device events using hospital discharge records. A third project, still in progress, is examining and comparing the data available in NIS and in the CDRH adverse event reports for automatic implantable cardioverter defibrillators.
Active Device Surveillance
CDRH continued the contract with the University of Utah for Phase 2 of a pilot on active surveillance of medical device problems in hospitals. The new direct observation portion of the project is meant to establish a “gold standard” estimate of the number of device-related adverse events occurring in a hospital setting. The methodology is to note problems with device use as comprehensively as possible by directly observing patient care and actively soliciting information on adverse device events from as many sources as feasible. This project builds on the pilot of active surveillance of medical device problems in hospitals.
CDRH is contracting with Lincoln Technologies in using their web-based safety data mining environment called WebVDME to mine device adverse event data. This software has been used at CDER to study age/gender effects, to predict the safety profiles of proposed combination drugs, and to separate contributions of individual drugs to safety problems in poly-therapy situations. This tool may be a way to optimize evaluation resources and enhance CDRH’s ability to identify device-related safety concerns. The use of enhanced data mining techniques may improve upon CDRH’s current ability to identify adverse event patterns in post-market safety databases.
Human Factors and Labeling
Human factors (HF) is the study of how people use technology. It involves the interaction of human abilities, expectations, and limitations, with work environments, and system design. The term “human factors engineering” (HFE) refers to the application of human factors principles to the design of devices and systems. It is often interchanged with the terms "human engineering," "usability engineering," or "ergonomics." The goal of HFE is to design devices that users accept willingly and operate safely in realistic conditions. In medical applications, HFE helps improve human performance and reduce the risks associated with use error.
CDRH’s human factors and labeling efforts help minimize use-related hazards, assure that intended users are able to use medical devices safely and effectively, and facilitate reviews of new device submissions. During FY 2005 the Center’s human factors and labeling activities included -- performing 84 labeling and 10 human factors reviews, working to apply eLabeling principles to 4 prototypes, and evaluating CDRH’s process for incorporating human factors principles into premarket review.
This fiscal year, CDRH worked with foreign governments to facilitate international harmonization, specifically under the United States/European Community Mutual Recognition Agreement on transatlantic trade and the Global Harmonization Task Force (GHTF).1
The Medical Device Annex of the MRA covers the exchange of quality systems evaluation reports for all medical devices and premarket evaluation reports for selected low to medium risk devices. The Sixth Annual Report of the Medical Devices Annex to the U.S./EC Mutual Recognition Agreement (MRA), a joint report by the FDA, the National Institute of Standards and Technology (NIST) and the Commission for the European Communities (CEC) was issued December 2004. The report addressed the implementation of the Medical Devices Annex and contained accomplishments from December 1, 2003 to December 1, 2004.
In September 2005 FDA hosted a GHTF Joint Study Group Meeting. A Joint Study Group Meeting was held to facilitate cross-consultation and joint consideration of issues by the study groups and provide a forum to update the members on the activities of all of the study groups.
1 GHTF is an international voluntary group of representatives from national medical device regulatory authorities and the regulated industry. The United States is one of the five founding members of GHTF. Members are from the following three geographical areas: Asia, Europe, and North America. The purpose of the GHTF is to encourage convergence in regulatory practices related to ensuring the safety, effectiveness, performance and quality of medical devices; and promoting technological innovation and facilitating international trade. The primary way in which this is accomplished is via the publication and dissemination of harmonized guidance documents on basic regulatory practices. Study groups are responsible for the drafting of the harmonized guidance documents.