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Medical Devices Performance Goals

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Long Term Goal: Increase the number of safe and effective new products by increasing the predictability, efficiency and effectiveness of product development, including products for unmet medical and public health needs, emerging infectious diseases and counterterrorism.
Measure FY Target Result

1. Percentage of Expedited PMAs reviewed and decided upon within 300 days; Percentage of received Original Premarket Approval (PMA), Panel-track PMA Supplement, and Premarket Report Submissions reviewed and decided upon within 320 days./1 (15033) (Outcome)

Measure 1A: Percentage of Expedited PMAs reviewed and decided upon within 300 days.

2007 90% 9/09
2006 80% 9/08
2005 70% 9/07
2004 NA NA
2003 NA NA
2002  NA NA
Measure 1B: Percentage of received Original Premarket Approval (PMA), Panel-track PMA Supplement, and Premarket Report Submissions reviewed and decided upon within 320 days./1(Outcome) 2007 90% 9/08
2006 80% 9/07
2005 NA NA
2004 NA NA
2003 NA NA
2002  NA NA
2. Percentage of Premarket Approval Application of an estimated 80 (PMA) first actions reviewed and acted upon within 180 days. (15001) (Output) 2007 NA NA
2006 NA NA
2005 NA NA
2004 90% 93% of 39
2003 90% 97.7% of 43
2002 90% 97% of 33
3. Percentage of 180 day PMA supplements reviewed and decided upon within 180 days./1 (15031)(Outcome) 2007 90% 1/09
2006 80% 1/08
2005 80% 1/07
2004 NA NA
2003 NA NA
2002 NA NA
4. Percentage of an estimated 725 PMA supplement final actions reviewed and acted upon within 180 days. (15009) (Output) 2007 NA NA
2006 NA NA
2005 NA NA
2004 95% 96% of 111
2003 95% 95.5% of 157
2002 90% 95% of 498
5 .Percentage of 510 (k)s (Premarket Notifications) reviewed and decided upon within 90 days./1 (15032) (Outcome) 2007 80% 1/09
2006 75% 1/08
2005 75% 1/07
2004 NA NA
2003 NA NA
2002 NA NA
6. Percentage of an estimated 4,325 510(k) (Premarket Notification) final actions reviewed and acted upon within 90 days. (15002) (Output) 2007 NA NA
2006 NA NA
2005 NA NA
2004 95% 100% of 3,377
2003 95% 99% of 4328
2002 95% 100% of 4322
7. Conduct Medical Device Bioresearch Monitoring (BIMO) inspections with an emphasis on scientific misconduct, data integrity, innovative products, and vulnerable populations.(15025) (Output) 2007 295 1/08
2006 278 1/07
2005 295 335
2004 295 354
2003 295 364
2002  290 358

8. Reduce the average time for marketing approval for safe and effective new devices.

Measure:Reduction in FDA's total approval time for the fastest 50 percent of expedited PMAs approved, using the submission cohort for FYs 2005-2007. The baseline for this goal is the three year average of total FDA approval time for the fastest 50 percent approved for the applications filed during FYs 1999-2001.

*The reported results represent a three year average calculated using cohort data from the reported year and the two prior years.

2007 290 days 09/09
2006 NA 09/08
2005 NA 09/07
2004 NA 09/06
2003 NA 334 days*
2002 NA 338 days*
2001 NA 320 days*
Data Source: CDRH Premarket Tracking System and Receipt Cohorts and Field Data Systems.
Data Validation: To help ensure Agency consistency in tracking and reporting Premarket activities, CDRH utilizes the Premarket Tracking System, which contains various types of data taken directly from the Premarket submissions. FDA employs certain conventions for monitoring and reporting performance; among these are groupings of Premarket submissions into decision and receipt cohorts. Decision cohorts are groupings of submissions upon which a decision was made within a specified time frame, while receipt cohorts are groupings of submissions that were received within a specified time frame. The Premarket performance goals are based on receipt cohorts. Final data for receipt cohorts are usually not available at the end of the submission year. Because the review of an application received on the last day of the submission year, e.g., a PMA with 180 day time frame, may not be completed for at least 6 months or longer, final data for the submission or goal year may not be available for up to a year after the end of the goal year.
Cross Reference: These performance measures support HHS Strategic Goal 2.

NOTES:

/1 DECISION GOALS applied to MDUFDA will be based on baseline data collected in FY 2003 and FY 2004. Decision goals identify the number of days for FDA to perform a complete review and issue a decision letter.Decision letters include: approval, approvable, approvable pending GMP inspection, not approvable and denial.

PMA first actions include: approval, approvable, approvable pending GMP inspection, not approvable, denial or - major deficiency letter.

PMA Supplement final actions include: approval, approvable, approvable pending GMP inspection, not approvable, or denial.

510(k) first actions include: SE, NSE, or 'additional information' letter.

Long Term Goal: Improve problem detection and take timely and effective risk management actions with all FDA-regulated products.
Measure FY Target Result
9. Percentage of inspection and product testing coverage of the Radiological Health industry (estimated 2,000 electronic products). (15027) (Output) 2007 NA NA
2006 NA NA
2005 10% 10% of 2,000
2004 10% 10% of 2,400
2003 10% 14% of 2,000
2002  NA 5% of 2,000

 

10. Percentage of an estimated 9,100 domestic mammography facilities that meet inspection standards, with less than 3% with Level I (serious) problems. (15007) (Outcome) 2007 97% 1/08
2006 97% 1/07
2005 97% 97% of 9,100
2004 97% 97% of 9,100
2003 97% 97% of 9,200
2002 97% 97% of 9,008

11. Utilize risk management to target inspection coverage for Class II and Class III medical device manufacturers (domestic and foreign). (15005) (Output)

FY 05 Measure: Utilize Risk management to target inspection coverage for Class II and Class Ill domestic medical device manufacturers.

2007 1,300 1/08
2006 1,234 1/07
2005  1,104 1,265
2004  1,110  1,414
2003  1,080  1,428
2002  1,049  1,062
12. Utilize Risk management to target inspection coverage for Class II and Class Ill foreign medical device manufacturers at 7% of an estimated 2,500 firms. (15005.02) (Output) 2007 NA NA
2006 NA NA
2005  175 230
2004 225  295
2003 225 225
2002 225  209
Data Source: CDRH Radiological Health Data Systems and the Mammography Program Reporting and Information System (MPRIS)
Data Validation: The Mammography Program Reporting and Information System (MPRIS) is a set of applications used to support all aspects of the FDA implementation of the Mammography Quality Standards Act of 1992. This includes the collection, processing and maintenance of data on mammography facility accreditation and certification, FDA inspections and compliance actions. MPRIS is envisioned as a centralized repository of information that supports FDA's mission to improve the quality of mammography and improves the overall quality, reliability, integrity, and accessibility of facility certification, inspection, and compliance data by eliminating multiple versions of the data while expanding and automating data edits, validation, and security of a single integrated database.
Cross Reference: These performance measures support HHS Strategic Goal 2.
Long Term Goal: Improve problem detection and take timely and effective risk management actions with all FDA-regulated products.
Measure FY Target Result
13. Expand actively participating sites in MedSun Network. (15012) (Outcome) 2007 Expand actively participating sites in MedSun Network to 76% 1/08
2006 Expand actively participating sites in MedSun Network to 71% 1/07
2005 350 facilities 354 facilities
2004 240 facilities 299 facilities
2003 180 facilities 206 facilities
2002 80 facilities 80 facilities
14. Increase by 50% the patient population covered by active surveillance of medical product safety by 2008. Baseline data and performance targets under development. Expected completion- Sept 06
Data Source: CDRH Adverse Events Reports
Data Validation: FDA's adverse event reporting system's newest component is the Medical Device Surveillance Network, MedSun program. MedSun is an initiative designed both to educate all health professionals about the critical importance of being aware of, monitoring for, and reporting adverse events, medical errors and other problems to FDA and/or the manufacturer and; to ensure that new safety information is rapidly communicated to the medical community thereby improving patient care.
Cross Reference: This performance measure supports HHS Strategic Goal 5.

 



1. Complete Review and Decision on 90% of Expedited PMAs within 300 days; and Review and Decision on 90% of Original Premarket Approval (PMA), Panel-track PMA Supplement, and Premarket Report Submissions of received within 320 days/1. (15033)

  • Context of Goal: Complete decision constitutes the comprehensive review of the application package initially received by FDA and FDA's decision letter. A decision will result in one of the following designations for each application: substantially equivalent or not substantially equivalent.PMAs involve potentially high-risk devices with the most chance of significantly improving the treatment of patients. The steps taken in MDUFMA that will reduce approval times for PMA applications are expected to reduce approval times for all filed applications, while recognizing that some applications may not ultimately meet FDA's standards for safety and effectiveness and that performance measures based on all applications will take more time to observe.

    The FDA will achieve this goal by reducing unnecessary cycles, through encouraging and supporting higher-quality applications and more efficient resolution of outstanding issues. For example, MDUFMA encourages more pre-submission meetings, especially for expedited products. FDA will use these interactions with sponsors to clarify requirements and improve the quality of applications so that there are fewer cases where FDA needs to stop the review clock and go back to sponsors to ask for more information. FDA is also using a collaborative process by leveraging with outside experts.

    The MDUFMA legislation includes a required statutory minimum "trigger" amount of funds that must be appropriated each year for FDA's medical device and radiological health program; if this appropriation trigger is not met, FDA is not authorized to collect and spend user fees.In FY 2007, this trigger will be met at the Congressional Justification funding levels and performance will remain at the levels outlined in the MDUFMA legislation.

  • Performance:  The current baseline FDA marketing decision time for standard PMAs is 320 days. The approval of some key PMAs had been delayed, for example in the cardiac area, because CDRH did not have sufficient staff to handle simultaneous reviews that required the same review expertise.MDUFMA resources will be used both for new hires and to expand external expertise.


2. Complete Review and Action on 90% of Premarket Approval Application of an estimated 80 (PMA) first actions within 180 days. (15001)

  • Context of Goal: Complete review and action constitutes the comprehensive review of the application package initially received by FDA and FDA's response back to the device sponsor. PMAs involve potentially high-risk devices with the most chance of significantly improving the treatment of patients.It is essential that FDA complete the review process for these products quickly and thoroughly. FDA anticipates significant complexity of PMAs. For example, many new devices will incorporate computer technology as part of the diagnostic capability of the device itself and continuing improvements in image technology will require more sophisticated review skills.In addition, 40 percent of PMAs are breakthrough technologies and approximately 35 percent are from first-time submitters. These factors add time to the normal review process. For FY 2005, this goal was dropped and replaced with goal 15033.
  • Performance: This goal was completed successfully in FY 2004 with 93% of PMA first actions occurring in 180 days. The medical device program attained this goal in FY 2003 by completing review and action on 97.7% of PMA first actions within 180 days.


3. Complete Review and Decision on 90% of 180-day PMA supplements within 180 days. (15031) Note: Workload is anticipated to increase in FY 2007 due to advances in technology.

  • Context of Goal: Complete decision constitutes the comprehensive review of the application package initially received by FDA and FDA's decision letter. A decision will result in one of the following designations for each application: approval, approvable, approvable pending GMP inspection, not approvable, denial. PMAs involve potentially high-risk devices that have the highest likelihood of significantly improving the treatment of patients. Supplemental applications are generally submitted for changes in already approved products such as technology changes or the addition of a new indication.It is essential that FDA complete the review process for these products quickly and thoroughly. Real-time PMA Supplement review is a regulatory tool that gives sponsors the option of participating in "real-time" reviews of certain device changes. These reviews are conducted by teleconference or face-to-face, which gives manufacturers an opportunity to discuss all of FDA's review issues at one time. The MDUFMA legislation includes a required statutory minimum "trigger" amount of funds that must be appropriated each year for FDA's medical device and radiological health program; if this appropriation trigger is not met, FDA is not authorized to collect and spend user fees.In FY 2007, this trigger will be met at the Congressional Justification funding levels and performance will remain at the levels outlined in the MDUFMA legislation.
  • Performance: This goal will begin to report performance in FY 2005.


4. Complete Review and Action on 95% of an estimated 725 PMA supplement final actions within 180 days. (15009)

  • Context of Goal: Complete review and action constitutes the comprehensive review of the application package initially received by FDA and FDA's response back to the product sponsor. PMA supplements involve potentially high-risk devices that have the highest likelihood of significantly improving the treatment of patients. Supplemental applications are generally submitted for changes in products that already have been approved, such as technology changes or the addition of a new indication. It is essential that FDA complete the review process for these products quickly and thoroughly. Real-time PMA Supplement review is a regulatory tool that gives sponsors the option of participating in "real-time" reviews that are conducted by teleconference or face-to-face. This gives manufacturers a chance to discuss all of FDA's review issues at one time.In FY 2001, sponsors of over 25 percent of the 641 PMA supplements used the real-time review option, mostly by teleconference. For FY 2005, this goal was dropped and replaced with goal 15031.
  • Performance: In FY 2004, this goal was completed successfully with 96% of PMA supplemental final actions occurring in 180 days. The CDRH met the target for this goal, completing review and action on 97% for the applications received in FY 2003.


5. Complete Review and Decision on 80% of 510(k)s (Premarket Notifications) within 90 days. (15032)

  • Context of Goal: Complete decision constitutes the comprehensive review of the application package initially received by FDA and FDA's decision letter. A decision will result in one of the following designations for each application: substantially equivalent or not substantially equivalent. This goal for review and decision on 510(k)s within 90 days addresses the statutory requirement to review a 510(k) within 90 days. The MDUFMA legislation includes a required statutory minimum "trigger" amount of funds that must be appropriated each year for FDA's medical device and radiological health program; if this appropriation trigger is not met, FDA is not authorized to collect and spend user fees.In FY 2007, this trigger will be met at the Congressional Budget funding level and performance will remain at the levels outlined in the MDUFMA legislation.
  • Performance: This goal will begin reporting performance for the FY 2005 cohort.


6. Complete Review and Action on 95% of an estimated 4,325 510(k) (Premarket Notification) final actions within 90 days. (15002)

  • Context of Goal: Complete review and action constitutes the comprehensive review of the application package initially received by FDA and FDA's response back to the product sponsor. This is an FY 1999 goal, dropped in FY 2000, and picked back up for FY 2001, FY 2002, FY 2003 and FY 2004 as a more meaningful measure of performance in this area. This goal for final actions on 510(k)s within 90 days addresses the statutory requirement to review a 510(k) within 90 days.Pressures to improve review time will be increased in FY 2005 to meet MDUFMA goals. As directed by OMB, this goal was dropped for FY 2005 in order to streamline FDA's Performance Plan.
  • Performance: This was completed successfully in FY 2004 with 100% of 510 (k) completed within 90 days. This performance has resulted, in part, from FDA utilizing innovative ways to improve review efficiency.


7. Conduct Medical Device Bioresearch Monitoring (BIMO) inspections with an emphasis on scientific misconduct, data integrity, innovative products, and vulnerable populations. (15025)

  • Context of Goal: In FY 2007, FDA plans to conduct 280 domestic and 15 foreign Bioresearch Monitoring (BIMO) inspections for a total of 295.Traditionally, FDA's approach to BIMO inspections focused on data audits of Premarket Approval (PMA) applications.While this permitted FDA to provide review divisions with a validation of the data submitted in marketing applications, these inspections were retrospective and had little impact on ongoing clinical trials.Beginning in FY 2004, FDA began assigning inspections earlier in the process, during the investigational device exemption (IDE) phase. This has a greater impact by identifying systemic problems and focusing on exploitable or vulnerable populations. The focus of these inspections is informed consent, IRB review and approval, data monitoring, and data collection rather than data verification. CDRH has approximately 1,000 active Investigational Device Exemptions (IDEs) of high-risk investigational devices (e.g., artificial hearts, drug eluting stents). FDA is interested in expanding its presence with the regulated industry through a risk-based inspection strategy.This strategy places more emphasis on (1) the detection of scientific misconduct, (2) data auditing and validation to support the device review process (greater importance on time constraints of MDUFMA and studies relying principally on foreign data), (3) innovative devices with high public health impact, and (4) vulnerable populations (elderly, minorities, pediatrics, etc.).
  • Performance: In FY 2005, FDA exceeded this goal of 295 by conducting 335 medical device related BIMO inspections.


8. Reduce the average time for marketing approval for safe and effective new devices.

  • Context of Goal: MDUFMA commits FDA to significant improvements in device review performance. This is important to the entire device industry, which is expanding in size and technical complexity. The industry is relying on FDA to take a leadership role in regulating a rapidly emerging frontier of medical device technology with timeliness, quality, scientific consistency, and international harmonization. Most of the device industry is small and rapidly changing. Many small and new start-up firms rely heavily on FDA for guidance and outreach, and the reviews from these firms take extra FDA time and energy.
  • About 25 percent of PMAs are for breakthrough technologies; and
  • Over 25 percent of PMAs are from first-time submitters.

    The area of expedited devices is particularly important because they are the most complex, raise new medical and scientific issues, and FDA often works with first time or small device sponsors. These devices are for uses that haven't been approved yet, and therefore expediting their safe and effective approval will have great clinical impact. Our expedited program is the area where we have the most improvements to make.

    Standard PMAs are also for the most complex (Class III) devices, and also have significant clinical impact.  For example, a drug-eluting cardiac stent could, if used properly, reduce repeat angioplasty of bypass surgery by 15-30 percent.

    The implementation of MDUFMA has allowed FDA to take steps to improve its device review program by analyzing the application review process and taking action to reduce multi-cycle reviews. MDUFMA requires more pre-submission meetings, especially for expedited products. CDRH will use these interactions with sponsors to clarify requirements and improve the quality of applications. FDA is also taking steps to improve the quality of reviews. CDRH is piloting an after the fact quality review system to review a sample of reviews to assess the quality of the review and the scientific consistency of the review process and the review decision. The results of this study should be available by the end of FY 2005. This information will be shared with reviewers to improve reviews.

  • Performance: The FDA approval time for the fastest 50 percent of Expedited PMAs approved for the FY 2001-2003 cohort is 275 days as compared to 360 days for the baseline FY 1999-2001 submission cohort. This is a reduction of 85 days versus the FY 2005-2007 target of a reduction of 30 days. CDRH initially calculated the baseline data for this goal, time to approval for the fastest fifty percent of expedited PMAs, for the time period of FYs 1999 - 2001.


9. Maintain inspection coverage and product testing coverage of the Radiological Health industry at 10% of an estimated 2,000 electronic products. (15027)

  • Context of Goal: FDA is seeing a resurgence of problems in both the medical and consumer radiological product area such as widespread new uses for fluoroscopy by relatively untrained practitioners, increasing the risk of overexposure and high emission rates from consumer products. FDA has monitored cases of unnecessary radiation emitted during fluoroscopy. Principal risks to patients from overexposure include long-term possibilities for cancer induction and a short-term potential for skin burns. FDA has promulgated new regulations that require more restrictive specifications for new fluoroscopy equipment. FDA estimates the new regulations can spare 723 lives per year from radiation-induced cancer, recognizing that long-term radiation-induced cancers take 30 years on average to emerge after exposure.FDA has also established a working collaborative with the American College of Cardiologists to educate these frequent fluoroscopy users. FDA also receives approximately 5,000 electronic product reports yearly. Since FDA can't review these on a one-by-one basis, FDA selects product areas that require immediate attention by testing specific automatic screening criteria for electronic reports.
  • Performance:  In FY 2005, FDA met this goal by inspecting 10% of 2,000 radiological health firms. Accomplishment varies by industry for non-medical electronic products, averaging 10% overall.FDA initiates activities to prioritize and leverage its radiation protection efforts with state governments, professional societies, and other federal agencies. This compliance status was estimated by CDRH's Office of Communication, Education and Radiation Programs by reviewing inspection reports from FDA and State inspectors and product testing reports submitted by industry.


10. Ensure at least 97% of an estimated 9,100 domestic mammography facilities meet inspection standards, with less than 3% with Level I (serious) problems. (15007)

  • Context of Goal: This goal will ensure that mammography facilities remain in compliance with established quality standards and improve the quality of mammography in the United States. Under the Mammography Quality Standards Act (MQSA, which was reauthorized in 2004), annual MQSA inspections were performed by trained inspectors with FDA, with State agencies under contract to FDA, and with States that are certifying agencies. State inspectors do approximately 90 percent of inspections. Inspectors performed science-based inspections to determine the radiation dose, to assess phantom image quality, and to empirically evaluate the quality of the facility's film processing. MQSA requires FDA to collect fees from facilities to cover the cost of their annual facility inspections. FDA also employs an extensive outreach program to inform mammography facilities and the public about MQSA requirements. These include: an Internet website, collaboration with NIH to provide a list of MQSA-certified facilities, and a toll-free facility hot line.
  • Performance: FDA met this goal in FY 2005 by ensuring that 97 percent of an estimated 9,100 mammography facilities met inspection standards with less than 3 percent level 1 (serious) problems. Inspection data continue to show facilities' compliance with the national standards for the quality of mammography images. Improving the quality of images should lead to more accurate interpretation by physicians and, therefore, to improved early detection of breast cancer. FDA works cooperatively with the States to achieve this goal.


11. Utilize Risk management to target inspection coverage for Class II and Class III medical device manufacturers (domestic and foreign). (15005)

  • Context of Goal: Important features of the risk-based strategy for this goal will be reducing the occurrence of illness and death by focusing resources on manufacturing establishments and other industry components that have the greatest potential for highest risk. This will result in different inspection frequencies as establishment processes come under control and present lower risk, or as new risks are identified. We note that these goals were reported in previous years as inspection of a fixed percentage of the inventory of establishments. However, given the fluctuation in the inventory, the inspection resources available, and the risk-based prioritization approach that FDA is developing, we believe that it is more appropriate to state the goal in terms of the number of inspections of the highest-risk establishments. We have reformulated the goals accordingly, including prior years for comparability. This strategy will also allow FDA to better communicate to our stakeholders about device safety risks.

    This goal includes inspections done by FDA directly, or through state contracts or partnership agreements on Class II and III domestic and foreign medical device manufacturers. Class II and III medical devices pose the most significant risk because failures of these devices are likely to cause significant temporary or permanent injury, or death. The approximate annual inspection inventory for this goal is 8,100 domestic and foreign firms. The approximately 4,000 Class I lower-risk domestic firms are not inspected on a routine basis. These firms will be inspected on a "for cause" basis to follow up on problems identified in recalls or reported by the public.

  • Performance: FDA exceeded the FY 2005 domestic medical device performance goal of 1,104 by inspecting 1, 265 domestic high-risk Class II and Class III medical device manufacturers.

    FDA exceeded the FY 2005 foreign medical device performance goal of 175 by inspecting 230 manufacturers.


12. Utilize Risk management to target inspection coverage for Class II and Class III foreign medical device manufacturers. (15005.02)

  • Context of Goal: This goal has been incorporated with the domestic device inspection goal for FY 2006 and FY 2007. This goal includes joint inspections of high-risk device manufacturers with European Union Conformance Assessment Bodies, although implementation of the Mutual Recognition Agreement with the EU has not been as successful as anticipated. Most choose not to participate but cite a preference for an FDA inspection. In the long term, if the MRA is successfully implemented, it could reduce the number of foreign firms that FDA will need to inspect. FDA supports a web site dedicated to MRA activities, including the implementation plan, eligible device lists, MRA meeting minutes, and the list of nominated US and EU Conformity Assessment Bodies (CABs) that are participating in confidence building activities. The web site is: http://www.fda.gov/cdrh/mra/index.html.
  • Performance: FDA exceeded the FY 2005 foreign medical device performance goal of 175 by inspecting 230 manufacturers.


13. Expand actively participating sites in MedSun Network to 76%. (15012)

  • Context of Goal: FDAMA gives FDA the mandate to replace universal user facility reporting with the Medical Product Surveillance Network (MedSun) that is composed of a network of user facilities that constitute a representative profile of user reports. FDA estimates that there may be as many as 300,000 injuries and deaths each year associated with device use and misuse. FDA has developed a long-term goal to increase the percent of the population covered by active surveillance, which will allow for more rapid identification and analysis of adverse events. FDA's long-term goal is: "Increase by 50% the patient population covered by active surveillance of medical product safety by 2008".

    MedSun is a critical component towards achieving this long-term goal. FDA is using MedSun to reducing device-related medical errors; serve as an advanced warning system; and create a two-way communication channel between FDA and the user-facility community. MedSun is designed to train hospital personnel to accurately identify and report injuries and deaths associated with medical products. Data collection began in March 2002 and continues to date, along with recruitment of participating centers. In FY 2005, FDA expanded the network to 354, and replaced those facilities that choose to leave. This completed the planned expansion of the network to the total target number specified in the initiative. FDA is now turning its focus to increasing the number of active facilities (facilities that have been enrolled for longer than a year and submit at least one report per year).

    The goal for FY 2006 will be to increase the number of facilities that are actively participating in the MedSun Network from 66% to 71%. In FY 2007, the target would be to further increase the number of facilities that are actively participating in the MedSun Network to 76%. FDA plans to use the cohort of 350 facilities to pilot the effectiveness of various incentives, to pilot use of the MedSun facilities as a laboratory to obtain specific medical product information, and to pilot various types of feedback intended to encourage reporting by the facilities. FDA will continue to research and develop improved feedback mechanisms to the participating facilities about problems with medical devices. The agency will implement targeted surveillance of different parts of hospitals (e.g., ICU, Operating Room, etc.), and of particular devices; and will also continue to explore how to improve reporting from hospital laboratories (LabSun), develop educational materials to raise awareness about the need to report device problems within institutions and to FDA, and continue the successful audio conferences which discuss items of interest to biomedical engineers.

  • Performance: In FY 2005, FDA exceeded its MedSun recruitment goal by recruiting a total of 354 facilities.


14. Increase by 50% the patient population covered by active surveillance of medical product safety by 2008.

  • Context of Goal:  Historically, FDA has relied on spontaneous reporting systems to ascertain risks associated with regulated medical products, and more recently dietary supplements and foods. However, there is considerable evidence that the spontaneous reporting systems for adverse events and medical product problems do not allow for an adequate characterization of the true safety profile for these products. These systems largely depend on health care providers taking time away from the delivery of health care to complete reports, which means there are many adverse events that go unreported. In addition, many events that are reported may be coincidental, not causally related to the use of the product. However, these systems can provide valuable information, particularly on rare, serious adverse events that may be caused by the product.

    The Agency needs to maximize the efficiency and effectiveness of the spontaneous reporting systems, and at the same time increase active surveillance through prospective data collection through hospitals participating in MedSun, CDC surveillance systems and direct access to safety data through health care providers' information systems. Active surveillance will allow FDA to better ascertain risks associated with medical products and focus its resources on the highest impact problems.

  • Performance: Baseline data and performance targets under development. Expected completion - Sept 06.

 

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