FY 2003 ODE/OIVD Annual Report - Part 4 - Major Program Initiatives
Continuous Process Improvement (CPI)
Guidance Documents and Standard
ODE/DRARD/Epi Pilot Project
Creation of the Office of In Vitro Diagnostic Device Evaluation and Safety
Creation of OIVD Webpage
OIVD Patient Safety Team
The ODE and OIVD management teams received formal training and actively participated in the Center’s initiative to develop office and division-level Performance Scorecards. These Performance Scorecards contain a series of performance measures that are linked to the offices’ performance goals and CDRH’s strategic plan. In FY 04, ODE and OIVD will establish baseline data for the performance measures and report initial performance results from these Performance Scorecards.
In addition five ODE employees and one OIVD employee were formally certified as Performance Improvement Coaches for Performance Scorecards and Continuous Process Improvement.
Continuous Process Improvement involves identifying a process that needs to be improved, analyzing the current process, researching potential improvements, and developing and implementing an improved process. The improved process ultimately will assist the Offices’ in meeting performance measures identified in the Offices’ Performance Scorecards. ODE and OIVD processes that were subject to formal Continuous Process Improvement efforts in FY03 were PMA Filing, PMA Close-Out, and Turbo 510(k).
During the fiscal year, Center management initiated an effort to speed the development of guidance documents in an effort to reduce regulatory burden, foster greater consistency in scientific evidence provided in premarket submissions and optimize our evaluation processes to achieve the MDUFMA performance goals. ODE's Deputy Director for Science and Regulatory Policy, in collaboration with the Office of Science and Technology, began efforts to involve scientists from throughout the Center in the guidance development process. Furthermore, specific efforts are underway to insure that FDA recognized consensus standards are fully integrated into appropriate guidance documents in an attempt to further streamline the FDA review and promote greater international harmonization.
As part of ODE’s effort to formalize Total Product Life Cycle precepts within the premarket review process, the Division of Reproductive, Abdominal, and Radiological Devices (DRARD) participated in a pilot cooperative project from February 2002 to February 2003 with the Epidemiology Branch (EB) of the Office of Surveillance and Biometrics. The purpose of the project was 1) to determine when and how the EB could best provide appropriate input/recommendations to DRARD regarding potential postmarket investigations and 2) to initiate, and later evaluate, product-specific Postmarket Plans. Over the course of the year each epidemiologist participated in the review of a PMA being evaluated by DRARD. Two of the PMAs that were approved during the year had post approval studies. In both cases the epidemiology reviewer played a large role in the study design. There were also a few “firsts” that took place during the pilot project. This was the first time that the EB was involved with an expedited PMA and the first time well-defined Postmarket Plans were developed prior to device approval. It was also the second time that the EB made a presentation to the panel as part of the FDA presentation of the PMA. Both groups believed that the involvement of the EB in the PMA review enhanced the review process. All participants believed that early involvement was the best approach. Both sides believed that there was not enough experience gained from just one year, but that the collaboration looked very promising. Therefore the decision was made to continue and refine the pilot project over the next year.
The Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) was established on November 17, 2002, and combines the functions of all the offices within Center for Devices and Radiological Health (CDRH) into one organizational unit for cradle-to-grave regulation of in vitro diagnostic devices (IVDs). It carries out this mission by combining the pre-market review responsibilities of Office of Device Evaluation (ODE), the enforcement responsibilities of Office of Compliance (OC), and the post-market surveillance responsibilities of Office of Surveillance and Biometrics (OSB). To support these regulatory responsibilities, OIVD maintains strong ties to Office of Science and Technology (OST) for technical assistance, Office of Health and Industry Programs (OHIP) for communication and outreach assistance, and Office of Systems and Management (OSM) for program management assistance.
OIVD consists of a multidisciplinary group of scientists and other professionals who are collectively dedicated to promoting and protecting public health through clear and consistent regulation of IVDs by applying good scientific principles throughout the Total Product Life Cycle of the device. OIVD has a dual charge to foster the rapid transfer of good new IVDs into the medical market while preventing marketing of unsafe or ineffective devices. The Office strives to ensure the work is transparent in order to allow all stakeholders to obtain the knowledge required to make informed decisions about the development, production, and use of IVDs. In addition, OIVD administers the Clinical Laboratory Improvement Amendments (CLIA) '88 complexity program for the Centers for Medicare and Medicaid Services (CMS) by categorizing commercially marketed in vitro diagnostic tests by level of complexity.
Consistent with CDRH’s center-wide “Knowledge Management” and “Transparency” initiatives, OIVD launched the OIVD webpage on February 2003. The URL for the OIVD webpage is: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/default.htm. The OIVD webpage is designed to serve as one-stop-shopping for all the OIVD customers, the FDA staff, the public, the public heath professionals, the academicians, and the regulated industry.
The webpage supports the OIVD’s “Transparency” initiative by allowing the monthly posting of the “Decision Summary Templates”. The Decision Summary Template is a standardized template where, at a glance, one can understand the basis for clearance of a particular in vitro diagnostic 510(k) submission. This program has been in place since August 1, 2003. To see these Decision Summaries for all 510(k) clearances since August 1, 2003, go to the following link from the OIVD home page:
Search All Cleared/Approved OIVD Products
The webpage supports the OIVD’s “Knowledge Management” initiative by allowing consumer access to the data base for Home Use Lab Tests [Over-the-Counter (OTC) tests] and collection kits that have been cleared or approved by the FDA. To see information related to OTC IVD products go to OIVD homepage and under Quick Links, click on Over-The-Counter Tests.
Another very useful “Knowledge Management” tool on the OIVD webpage is the Lab Safety Tips link that appears on the home page under Laboratory Information. This section gives information about maintaining a safe clinical laboratory environment. It offers lab safety tips related to patient care and management as it relates to using a variety of in vitro diagnostic tests. The Lab Tips provide the OIVD customers, the public, the public health professionals, and the laboratorians, with precautions and limitations when using a particular IVD. The Lab tips contain a discussion of quality control and quality assurance, details about reporting IVD problems, and resources for additional information.
Early in 2003 the Patient Safety Team (PST) was formed in OIVD as a part of a larger Total Product Life Cycle (TPLC) program. The team crosses all OIVD divisions and several offices including representatives from OSB, OST, OHIP and OSM. The team's mission is two-fold. First, to explore new avenues to obtain timely, useful and accurate postmarket information on the devices we regulate in order to feed this information back to the premarket review; and second, to facilitate the merger of pre- and postmarket activities to smooth the transition to the TPLC concept. The team now serves as the "umbrella" team to oversee several project teams summarized below.
IVD MedSun/LabSun Pilot Team - During the last year the LabSun Pilot team has been very active. The team designed two report forms: a short form for minor events in the laboratory where patients were not directly impacted and a longer report form for incidents of more significance. Working with CODA, the contractor for the MedSun Project, the team recruited and trained nine sites in the Maryland, Virginia and DC area for a currently ongoing four month pilot of laboratory reporting. We have already had several reports come in, one resulting in a compliance investigation.
IVD Listserv Team - The team has been participating in passive listening on several listservs and feeding issues back to the PST, the postmarket staff, and the respective divisions. There have been several incidences where discussion topics which were monitored resulted in compliance actions or in OIVD posting Lab Safety Tips on the OIVD website.
Patient Safety News Team - The Patient Safety News (PSN) team participates on the PSN editorial board that includes CDER, CBER and CFSAN in addition to CDRH. The board meets once a month to discuss upcoming stories and review literature and journal articles related to patient safety. This outreach activity delivers potentially life-saving information to health practitioners. PSN stories include: safety alerts and product recalls; ways to protect patient and prevent medical errors; products recently approved by FDA; and important FDA decisions and actions. Several OIVD products have been featured in the program.
Adverse Event Reporting Activity and Transition to OIVD Team - At each PST meeting, the team was updated on newly received adverse event reports that met criteria the PST specified – deaths, hospitalization, and voluntary reports. Two computer-based training sessions on review and analysis of adverse event reports were conducted by OSB analysts. Currently, nine OIVD staffs are being trained as analysts. On August 22, OIVD staff began to receive IVD adverse event reports directly and to manage their follow up. The OIVD analysts group meets regularly to discuss problems and issues. Each analyst reports adverse events regularly to the respective OIVD Division in order to integrate information from the reports into premarket reviews.
CMS Collaboration Team - OIVD met with CMS to discuss new opportunities for collaboration. Pending finalization of a memorandum of understanding, review scientists from OIVD will work with coverage analysts from CMS on general issues of joint interest, including projects related to pharmacogenomics and cervical cancer. OIVD and CMS will explore mechanisms by which they can increase sponsor awareness of how they can best meet the regulatory requirements of each agency for devices using new molecular technologies.
Outcomes Team - This team was formed to establish a process to measure both short and long term public health impact associated with the FDA clearance or approval of IVDs. This could include clinical outcomes associated with the IVD itself or those specifically associated with CDRH interventions such as labeling changes or the provision of critical information to the public. They selected four products or product types to follow by literature search, meta analysis and postmarket reporting. The overall goal is to evaluate OIVD's role in improving the quality of health care. In the process, they hope to establish contacts at CDC, NIH and CMS. CMS has expressed interest in participating with the group.
Training Team - There were several sessions of training given by OSB including an overview of OSB, a session on how MDRs are processed and the first two MAUDE database training sessions. Several members of the PST also participated in FDA/Industry roundtable meetings to discuss the postmarket reporting system.