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Private Efforts Modernized the FDA's Oversight of CNS Shunts 

Summary: In the 20 years following the FDA Federal Food and Cosmetic Act of 1976, there were but a few small changes in guidelines to keep pace with the changing demands for CNS shunt technologies. PMA application requirements had become so stringent, that it deterred most new technological innovations in this 50,000 unit per year U.S. market. Conversely, FDA oversight failures allowed long known safety issues with anti-siphon shunts to slip under the radar for more than 15 years. MDR reporting slid to a mere 5%. The field had become dysfunctional with mixed outcomes with the existing shunt devices, and disincentives for companies to develop new technologies. Hundreds of millions of dollars were wasted in medical expenses, and the treatment of hydrocephalus with CNS shunts fell 20 years behind by 1995. As an affected patient user, Stephen Dolle petitioned the FDA that led to a special 1999 STAMP conference, then designed the 1st ever home monitoring system for patients with CNS shunts, the DiaCeph Test. The following Brief is taken from our Regulatory Affairs & Law page.

Brief: This case study demonstrates our expertise in FDA Regulatory Affairs matters. It was undertaken by Mr. Stephen Dolle, the founder of Dolle Communications, between 1995 and 1999 as a series of private initiatives to modernize FDA regulatory affairs of CNS shunt devices. A 1992 brain injury required Mr. Dolle to have a CNS shunt, that raised very troubling quality assurance issues. Over a several year period, he began acquiring and reviewing published articles on CNS shunts, speaking to staff at the FDA, acquiring Freedom of Information records, and talking to professionals in the field. By 1995, the consensus of many physicians was that CNS shunt treatment had fallen "20 years behind" in technological advancement, when compared with the progress in treatment of similar disorders.

FDA regulatory affairs practices are mandated and modified by acts of Congress, or by Petition. Shunt manufacturers and practicing neurosurgeons were unaware of their respective post market surveillance responsibilities, and each of the parties, including FDA staff, "assumed" the other parties were carrying out the required quality assurance practices. It took the FDA two years after Mr. Dolle authored an 1996 Petition for them to issue a "Ruling" and act on his very compelling findings.

Mr. Dolle had also observed a diagnostic technology void, and in 1997, designed the first ever home CNS shunt monitoring system he termed the DiaCeph Test. It had been stipulated in the FDA's Sept. 1998 ruling on his Petition, that they would hold an all new STAMP Conference on CNS shunts to address the issues he raised. Mr. Dolle went on to write a visionary Paper on FDA Modernization for this 1999 STAMP Conference, and parts of this have been adopted by industry today.

Mr. Dolle's Petition and efforts from 1995 to 1999, including the 1999 STAMP Conference, provided more modernization in quality assurance of CNS shunts than did the previous twenty years, without involvement by Congress and minimal costs to the FDA. The recent influx of newer shunt technologies, and pediatric neurosurgeons now performing shunt procedures on adults, has also provided a boost to CNS shunt technology. The FDA still continues to be out of touch with the needs of shunt users, and the marketplace. Their policies have stifled competition and imposed unfounded obstacles to the availability of new devices, leading to higher medical costs and a lower quality of care. Our hydrocephalus and shunt selection model sections chronicle the evolution of CNS shunts to modern time.

The above Case Study will be completed at a later date.