FDA intends to allocate $34 mil. to its Medical Product Surveillance Network (MedSun) in FY 2006, with the goal of recruiting 350 facilities into the program.

"This will help to increase the number and quality of reports, which in turn will lead to earlier diagnosis of adverse events," ^FDL-1 HHS' annual plan states. "The enhancement of the adverse events data system and linkages with other healthcare systems is the first line of defense against medical errors."

In explaining the spending request, HHS cites a recent survey demonstrating that 78% of MedSun participants agreed that the surveillance network improved patient safety in their hospitals.

The document contends that expanding MedSun will facilitate FDA's strategic goals of improving the quality of healthcare services, reducing medical errors and enhancing patient and consumer safety.

In addition, MedSun is critical to achieving FDA's long-term goal to "increase by 50% the patient population covered by active surveillance of medical product safety by 2008," the document reports.

In FY 2006, the agency plans to "maintain a cohort of 350 sites, replacing sites that wish to leave the program or have not been active participants," according to the document. As of October 2004, 299 hospitals were enrolled in the program, surpassing the fiscal year goal of registering 240 facilities.

Currently, MedSun enrolls approximately 20 children's institutions, according to FDA. The agency expects that number to increase modestly in 2005.

The MedSun program would be financed by part of the $213.4 mil. program level request for the Center for Devices & Radiological Health for FY 2006.

Mandated by the FDA Modernization Act of 1997 and launched in 2002, MedSun is meant to replace the universal user reporting system, providing a representative profile of reports from major medical device product users (¹ Also see "MeDSuN Pilot Phase II Ready To Start In February; Reg Is 2-3 Years Away" - Medtech Insight, 21 January, 2002., p. 6).

In FY 2004, MedSun reports prompted FDA to issue a public health notification on absorbable hemostatic agents; the devices were linked to 110 adverse events, including paralysis and other neural damage (² Also see "Hemostatic Agent Public Health Notification Sparked By MedSun" - Medtech Insight, 12 April, 2004., p. 26).

During the past fiscal year, MedSun introduced several new programs: a workshop on electrosurgical units; a project to evaluate common problems with sutures; a collaboration with ECRI on auto suture devices; a study on pulmonary catheters; and a study on drug-eluting stents.

A pilot of the LabSun program for clinical laboratory reporting also debuted in FY 2004, yielding approximately 30 reports, two of which were actionable.

LabSun, overseen by CDRH's Office of In Vitro Diagnostic Device Evaluation & Safety, recruited nine sites in 2004. In the next few months, FDA will extend the program to all labs within the MedSun network.

A long-awaited interactive forum termed the Device Safety Exchange (DS-X) will also become available in 2005. Originally called the Medical Device Engineering Network, DS-X will allow users to post queries on events and guidance on usability issues (³ Also see "M-DEN Event Reporting Forum To Join FDA’s MedSun Pilot" - Medtech Insight, 2 February, 2004., p. 9). As the name change implies, however, the resource now will be accessible to a wider audience including physicians and nurses - not just biomedical engineers.

Meanwhile, FDA expects to have its "Accredited Persons" program fully operational in FY 2005. In 2004, the agency published updated draft guidance and sponsored training seminars for establishments seeking certification. Authorized by MDUFMA, the AP initiative will enable third parties to conduct inspections of eligible device manufacturers.

Another program highlighted by the ^FDL-2 budget documents is third-party 510(k) review, which saw increased use in FY 2004 (⁴ Also see "Third-Party 510(k) Reviews Increasingly Time-Consuming For CDRH – Kahan" - Medtech Insight, 18 October, 2004., p. 9). FDA received 255 submissions over the year - a 34% increase over FY 2003, and twice that of FY 2002.

The agency encourages industry to participate in the program, stressing that products undergoing third-party reviews earn marketing clearance approximately 30% faster than comparable 510(k)s reviewed exclusively by FDA.

Diabetes management is also listed among the agency's priorities. FDA says it plans to work with the diagnostics industry, health professionals and the diabetic community to ensure availability of safe, effective, user-friendly, less invasive diagnostics.

Currently, FDA is devising a workshop to focus on next-generation non-invasive glucose meters, with the goal of streamlining the submission process, determining appropriate study formats and identifying data thresholds.

FDA says it will continue to enact a risk-based approach toward premarket review that is consistent with the "least burdensome" principles outlined in the FDA Modernization Act of 1997.

As an example of the least burdensome approach, the agency singles out its 2004 approval of R2 Technology's ImageChecker , the first computer-aided d (CAD) system for detecting lung nodules on CT scans. FDA says it helped develop the methodology to assess the technology.

In addition, the agency points to its 2004 joint efforts with industry to reduce the regulatory burden for in vitro diagnostic hepatitis A virus assays.

The initiative culminated in a proposal to reclassify HAV serological assays from Class III to Class II.

FDA separately acknowledges a need to protect the nation's bloody supply, stressing the lack of an approved blood or tissue diagnostic test for Creutzfeldt-Jacob disease - the human form of bovine spongiform encephalopathy.

"A reliable blood-screening test for CJD is an extremely important goal and is currently the object of considerable activity," FDA emphasizes.

Rounding out its list of accomplishments, FDA notes that CDRH held 21 Federal Advisory Committee panel meetings in 2004. The panels reviewed and made recommendations to FDA on 20 PMAs, one 510(k), two reclassification petitions and three policy issues.

FDA also says it reduced premarket inspection delays, from 53% in 2003 to 15% in 2004, despite foreign inspection travel restrictions.

In the international arena, FDA is extending the submission period for its Summary Technical Document program until July 2006.

The pilot program enables device manufacturers to submit premarket applications in a format developed by the Global Harmonization Task Force.

Expanded MedSun Surveillance Network Highlighted By FDA; Funding Planned

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