OCD FY2003: Program Support
- CDRH’s Strategic Plan was introduced in FY 00. The Plan consists of four major strategic goals:
- Total Product Life Cycle Model (TPLC)
- Public Health Impact (PHI)
- Magnet for Excellence (ME), and
- Knowledge Management. (KM)
These four strategic goals are fundamentally linked to the Center’s mission of promoting and protecting the public health through safe and effective medical devices and safe radiological products.
The Strategic Plan Accomplishments webpage describes CDRH’s strategic goals. Objectives, implementation actions and a summary of accomplishments are available in the website. A brief summary is included in this section.
Total Product Life Cycle Model (TPLC)
The TPLC model promotes working in an integrated manner through the total life cycle of the products CDRH regulates. TLPC encourages education and partnership between staff and stakeholders and promotes working towards harmonizing CDRH and international regulation.
FY 03 TPLC accomplishments include:
- Creation of the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD). 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 IVDs,
- Establishment of six cross-Center product area review groups to work on MDUFMA implementation.
- Establishment of Center-wide initiatives that focus on the development guidance and standards.
- Launching the ODE/DRAD/EB Pilot Project. This pilot project will help CDRH determine when and how epidemiologists could best provide input and recommendations to premarket reviewers regarding potential postmarket investigations and to initiate, and later evaluate, product-specific postmarket plans based on premarket data.
- Participation at meetings attended by CDRH stakeholders and planning of the first annual MDUFMA Stakeholder Meeting, conducted on December 12, 2003.
- Realignment of OSEL research priorities and program review processes to ensure input from all CDRH Offices.
- Participation and work with GMDN and GHTF on harmonization initiatives.
- Using the Continuous Process Improvement (CPI) methodology to study and enhance CDRH processes. Process Improvement Teams (PITs), which evaluate and make recommendations regarding and CDRH specific process, worked on a number of projects Center covering, among other topics, PMA filing, inspections, science prioritization and use of external expertise Information on CPI can be found at http://www.fda.gov/cdrh/strategic/cpi.html.
Public Health Impact (PHI)
The public health impact goal embodies CDRH’s commitment to find ways in which to measure and improve the impact of the products it regulates on the public health. The Center is constantly:
- Working towards improving the time to market of new expedited safe and effective devices;
- Assessing and improving risk management processes; and
- Identifying and resolving public health hazards.
Public Health Impact FY 03 accomplishments include:
- Continue working on Mammography Quality Standards Act -related programs. (For additional information, see the Mammography Quality and Radiation Programs section of this report.)
- Recruiting additional MedSun reporting facilities from the east coast and mid-west region of the United States, for a total of 180 facilities.
- Targeting of the MedSun system to obtain specific medical product information.
- Beginning a MedSun pilot project to more directly target the sending of reports from laboratories (pathology and in vitro diagnostic tests) in the reporting hospitals.
- Working with third-parties towards inspection accreditation. In FY 03 CDRH received twenty three third-party inspection accreditation applications. By the end of FY 03 seventeen applications were under full review, five were under initial review and one application was denied.
Magnet for Excellence (ME)
Magnet for excellence means attracting and retaining a diverse workforce that will help the Center accomplish its public health mission. By working towards becoming a magnet for excellence the Center will be able to:
- Become an employer of first choice,
- Provide employees with opportunities to succeed, and
- Link performance to CDRH’s public health mission.
FY 03 magnet for excellence accomplishments include:
- Actively supporting the master reviewer career path.
- Launching the Georgetown/Virginia Tech training program to support staff capabilities.
- Using the newly established Medical Device Fellowship Program to bring in outside experts and provide professional development opportunities for staff.
- Using Gallup Survey to assess and improve the quality of workplace.
- Implementing “shared-hires” to share resources and allow staff to better use their expertise across the Center.
Knowledge Management (KM)
Knowledge Management supports the TPLC model in the information age. KM means:
- Working towards becoming an independent source of information on devices and radiological health;
- Finding ways to leverage to create, share, and use knowledge; and,
- Working towards becoming an e-Center.
FY 03 examples of KM accomplishments include:
- Modification of device review tracking systems to include MDUFMA performance goals
- Organization and participation on workshops on relevant scientific and public health issues like the Novel Drug Delivery Systems (July 8, 2003) and Severe Acute Respiratory Syndrome (SARS, July 14, 2003)
- Implementation of Center scorecards to better manage, measure and track performance
- Work on Turbo-510(k) review templates
- Launching of the e-Room
- Support of electronic system such as IMAGE 2000
On October 26, 2002, the President signed the Medical Device User Fee and Modernization Act (MDUFMA). MDUFMA presents a wide range of new challenges and opportunities. By FY 07, CDRH will be required to do quality reviews assessing product safety and efficacy far faster than ever before, especially for expedited products. These and other changes since 2000 required updating the Center’s goals for the coming years.
In FY 03 CDRH adopted a number Phase II Strategic Initiatives that CDRH believes will to help face the new challenges in FY 04 and FY 05. These strategic initiatives are:
Management Systems for Measured Performance
Through this initiative CDRH will engage the use of scorecards to measure, manage and track performance. Scorecards clarify expectations and can be used to set targets for change for CDRH organizations and staff.
The project management initiative guides and facilitates CDRH’s efforts to achieve the integration of project managers and project management concepts into CDRH regulatory processes. Project management will help achieve MDUFMA goals, improve overall review and timeline goals; and, enhance CDRH ability to follow through on key milestones in complex work processes.
The consumer information initiative leads CDRH’s efforts to develop systematic, cost-effective ways to provide consumers plain language and up-to-date information about CDRH-regulated products.
Coordinated e-Center efforts will bring CDRH numerous opportunities for improved services to stakeholders. As a business practice being an e-Center is cost savings, reduces waste, could improve cycle times and could be used to leverage existing technologies for business benefit. Projects under this initiative include:
- Development of an electronic template, known as Turbo 510(k) that will clarify what is needed to complete OIVD 510(k) reviews; and,
- Use e-consults to improve a achieve consistency regarding how CDRH staff request and provide consults and, to allow recording the results of the consults in a manner accessible to others working on that products.
The scientific expertise initiative deals with enhancing the scientific capabilities of the Center to support and sustain a flexible workforce. CDRH’s commitments within this initiative include the implementation of training opportunities for current staff (like the Virginia Georgetown/Virginia Tech training program) and increasing partnerships and exchange programs with outside scientific organizations through programs like the Medical Device Fellowship Program.
The organizational focus initiative targets the focus and business practices of CDRH Offices. As part of the initiative CDRH Offices will evaluate their mission, functions, management systems and processes, and will develop strategies for implementing TPLC, MDUFMA, and Executive Branch initiatives.
Medical Countermeasures Shortages
CDRH’s plan for identifying and addressing potential medical countermeasures shortages of medical and radiological health products outlines the procedures that will be taken in 3 categories: identification of products needed; location of sources and capacity; and development of a system to communicate with all stakeholders involved in securing products.
In consultation with internal and external medical professionals, and with emergency response professionals, CDRH identified devices most likely to be needed in the event of a terrorist attack. These devices range from protective clothing, to diagnostic products to life support equipment. Amongst these products, 17 devices were identified as most likely to be in short supply in an emergency. To determine the availability of these products, CDRH established a manufacturer database for potential shortage devices that includes: 24 hour emergency contact information, current and potential production capacities, inventory availability and locations, and market share. In addition to the manufacturers of these products, CDRH identified 24-hour emergency contacts for the three major U.S. medical supply firms, and established contact information with emergency counterparts in the various medical device industry associations. CDRH continues to work with industry associations to identify ways in which CDRH and industry can collaborate in the event of an emergency shortage. CDRH initiated contact with representatives from the National Pharmaceutical Stockpile program to determine whether CDRH can provide assistance and to ensure that CDRH’s current efforts enhance overall emergency preparedness without unnecessarily duplicating efforts. CDRH has met with emergency response representatives from CDC and HHS to better develop a communication process when requests for devices are forwarded from any component.
Response Plans for Radiological Emergencies
CDRH completed the revision of the emergency response plans for radiological or nuclear emergencies which involve FDA-regulated products or require the use of medical products as countermeasures for radiological emergencies. CDRH specialists in health physics, medical physics, physics, medicine, and engineering respond to emergencies through two organized structures: the Radiation Emergency Response Team (RERT) and the Radiation Emergency Response Cadre (Cadre). The RERT is the primary response team for radiological emergencies and is composed of four trained radiation safety experts let by CDR Michael Noska, US PHS. The radiological emergency response plan, which is incorporated into the Center’s emergency plans, has been distributed to all Center staff and was shared with other components in FDA who have responsibilities in the radiological health area such as CFSAN and CDER. This plan was successfully implemented during the May TOPOFF II exercise with positive reviews from the FDA EOC and other Centers.
CDRH has been a member of the Environmental Clearance Committee for the Joseph Curseen, Jr., Thomas Morris, Jr. (formerly the Brentwood) Processing and Distributing Center. OSEL’s Division of Life Sciences (DLS) has just finished reviewing the Remedial Action Plan for the Trenton, NJ Postal Facility. In addition, DLS is on the Interagency Expert Panel on Efficacy Test Methods and Surrogates for Anthrax Spores (head is from EPA).
CDRH serves as chair for the consensus standard of the American National Standards Institute N43.17, radiation safety for personnel security screening systems using X-rays. CDRH has continued work on updating this standard. In addition CDRH staff serves as consultants to the Department of Homeland Security with regard to screening systems, ionizing radiation monitoring instrumentation and instrument calibration.
CDRH updated both CDRH and FDA levels of the Emergency Counterterrorism Preparedness and Response Plan for radiation during FY 03.
Continuity of Operations Plan (COOP)
CDRH completed COOP plans for all buildings housing essential Center functions. As one of the first Centers to complete COOP plans, CDRH’s initial drafts were referenced and used by the agency’s consultants as models for others in FDA. CDRH provided training or staff on the plans and successfully exercised them during an observed practice event. The “hot wash” feedback from the consultant group and the Center’s internal “after action review” showed that minimal changes were needed to the draft plans that were developed according to the templates provided by the agency. OHIP led the development of a COOP Plan for one of its buildings. The Plan is complete.
Public Health Response
Examples of actions taken that demonstrate CDRH commitment to this goal include:
- OraQuick® Rapid HIV-1 Antibody Test: In November 2002, the FDA/CBER Approved OraQuick® Rapid HIV-1 Antibody Test manufactured by OraSure Technologies, Inc., of Bethlehem, Pa. The test is the first rapid HIV point-of-care (i.e., testing and results are available in one visit) test approved by the FDA. It also is the first test for HIV that OIVD has waived under the Clinical Laboratory Improvement Amendments (CLIA). Following the CLIA waiver by OIVD the HHS Secretary Tommy G. Thompson announced that HHS has extended the availability of the OraQuick Rapid HIV-1 Antibody Test from 38,000 laboratories to more than 100,000 sites, including physician offices and HIV counseling centers. The Secretary added “Ensuring the widespread availability of a rapid HIV test to outreach services in communities where people are at high risk of HIV is vital to the public health, without today’s action (CLIA Waiver), this test would be limited to use in laboratory settings where many high-risk people do not go for testing.” Widespread availability of the rapid HIV test is likely to increase overall HIV testing and decrease the number of people—an estimated 225,000 Americans—who are unaware they are infected with the HIV virus. Early testing enables infected individuals to obtain medical care earlier in the course of their infection, potentially saving lives and limiting the spread of this deadly virus.
- Severe Acute Respiratory Syndrome (SARS): An IDE for a SARS Coronavirus, submitted by HHS, Centers for Disease Control and Prevention (CDC), was approved. This allowed CDC to make available to about 100 public health laboratories nationwide, a new experimental laboratory test for patients suspected of being infected with the SARS virus. The experimental diagnostic test was rapidly developed by CDC in an urgent effort to address this pressing public health need. FDA worked closely with CDC to develop appropriate information for patients and health professionals in order to make the test available on an investigational basis. Because information about the test’s performance is still being collected, patients will be asked for written consent before the test is used.
Communicating with Consumers, Health Care Professionals and the Industry
CDRH has been developing new, and updating existing webpages dealing with MDUFMA, new product approvals, recalls, patient safety news, advisory committees/panel meetings, CLIA, in vitro devices, and device safety alerts. During FY 03 CDRH worked with many partners throughout HHS to publicize Department public health outcomes on key public health issues. For example, it worked with many partners to provide diagnostic information for the Diabetes website. CDRH worked to publicize information on hospital bedrails, and on oxygen regulators. For example:
- Diabetes website - Since OHIP posted the Diabetes website in the Spring of 2002, it has continued to learn about designing and developing usable websites. In the spring of 2003, OHIP decided to perform a heuristic evaluation and a usability evaluation of the Diabetes website. The results of the two evaluations provided valuable feedback about the structure and content of the website. OHIP learned how to improve writing style to make it more appropriate to Web communication, how to increase search engine visibility, and how to structure the website to optimize user satisfaction. In addition, OHIP learned new techniques for conducting usability evaluations throughout the website development.
Implement Results-Oriented Management
During FY 03, CDRH worked with the Commissioner’s staff and CDER on the long-term goal of reducing the overall amount of time it will take the FDA to approve original PMAs and expedited PMAs in the next 5 years. This “approval cohort” was announced by the Commissioner in a press release, and is a part of the FDA’s Program Assessment Rating Tool (PART) goals developed with OMB. CDRH met with stakeholders to explain this goal and how it will be calculated.
In addition, during FY 03 CDRH modified performance tracking systems so it can track performance on MDUFMA’s long-term cycle and decision goals outlined in the MDUFMA commitment letter.
During FY 03, CDRH continued to work with Dr. Richard Chang, an expert in organizational scorecards. Dr. Chang facilitated efforts to develop CDRH organizational scorecards and improve performance metrics:
- Organizational Scorecards - CDRH 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, CDRH will establish baseline data for the performance measures and report initial performance results from these Performance Scorecards.
- Continuous Process Improvement (CPI) - CPI 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. Processes that were subject to formal Continuous Process Improvement efforts in FY 03 were PMA Filing, PMA Close-Out, Turbo 510(k), Inspections, Subject Matter Expert, External Experts, Science Priorities, After Action Review, BIMO/ODE PMA Review, and Risk-based Inspection.
- CDRH employees were formally certified as Performance Improvement Coaches for performance scorecards and Continuous Process Improvement.
Implement Strategic Human Capital Management
CDRH fully participated in the FDA‘s evaluation, implementation and migration to a shared services organization for administrative operations, known as the Office of Shared Services (OSS). CDRH’s Executive Officer served on the OSS Steering Committee; meeting routinely to set policy and direction and ensure stand-up of OSS on October 1. CDRH completed the de-layering process. CDRH’s organizational layers do not exceed four.
During FY 03 CDRH implemented a strategic evaluation of workforce needs and succession planning. This was achieved by prioritizing CDRH’s recruitment and retention needs for mission critical positions across the Center by the Center’s six product review groups.
Improve Information Technology Management
CDRH’s goal is to improve the use of information technologies resources, specifically:
- Computer Tracking Systems - Significant work was done to the document tracking systems for the 510k, PMA, and Modular PMA databases.
- New hold statuses were created and the data entry programs were modified to check MDUFMA payment status and to apply holds automatically.
- MDUFMA payment data was linked to the 510k and PMA data entry programs and new programs were written to notify CDRH staff of payments received.
- A new flag was added to the 510k and PMA tracking systems for the Summary Technical Documentation (STED) Initiative. The STED Initiative is a pilot program to assess the feasibility of using an internationally harmonized format in the review of certain submissions for device safety and performance.
- Video Conferencing - CDRH has the ability to conduct Room and Desktop Video Conferences with outside parties that have H.320 compliant systems, a standard for video conferencing over Integrated Services Digital Network (ISDN) lines and other narrowband transmission media. In FY 03, ODE held 8 video conferences involving industry and other Federal agencies.
- Image2000 - The CDRH system for storing copies of past device application submissions was upgraded to provide additional capabilities for CDRH reviewers. Reviewer input played a major role in the redesign of the document repository and the upgraded system has been well-received. The system now stores documents in PDF format and allows for full-text searching, for copying or saving documents and for printing all or part of the submission.
- E-Room - Implemented e-Room as a collaborative tool in the review of medical device submissions.
• CDRH also:
Hired contract personnel to assist in improved development of IT systems
Hired a contractor to perform as a mentor to the IT staff in implementation of improved IT systems development
Sent staff members to Project Management certification courses in order to apply newer standard techniques to IT systems development
- Remote access – CDRH Implemented secure remote access throughout the Center.
- E-journals – CDRH added a significant number of e-Journals to the library services provided to the Center.