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Stephen Dolle's request to David Feigal at FDA to include CNS shunts in new post marksurv.jul

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My written request to FDA's David Geigal Ph.D. in 2002 to include CNS shunts under the FDA's new Post Market Surveillance, which I felt was needed to mitigate the high failure rates with CNS shunts, and likely would have mitigated the widespread failures that occurred with programmable shunts between 1999 - 2013. I no longer have 949-642-4592 telephone number. Please reach me at contact[at]dollecommunications[dot]com

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Stephen Dolle's request to David Feigal at FDA to include CNS shunts in new post marksurv.jul

  1. 1. STEPHEN M. DOLLE FDA & Patient Advocate 3908 ½ River Avenue Newport Beach, CA 92663 July 11, 2002 David Feigal, Ph.D. Director Center for Devices and Radiological Health HFZ-1, 9200 Corporate Blvd. Rockville, MD 20850 Re: Request to Place CNS Shunts on List for New Postmarket Surveillance, Docket No. 00N-1367 Dear Dr. Feigal: It has come to my attention the Center for Devices and Radiological Health (CDRH) has undertaken new “Postmarket Surveillance” (PS), under Section 522 of the FDAMA, for medical devices posing frequent and dangerous product failures. I am requesting that “CNS shunts” be added to this PS list, or at the very least, you hold a special meeting with industry to establish new PS mechanisms of performance and outcomes assessment measurement. Central nervous system shunts are well known to pose an unusually high risk of product failure, often involving indeterminent and poorly understood outcomes. Currently, there is no standard or widely accepted means of ascertaining proper function and performance, and this burden is unfairly passed on to user physicians and patients. More detailed user information, documentation, and literature must be made available to user physicians, with specific user information made available to user patients for their safe and effective use. This request is based upon current problem device data known to the CDRH, the Multi-Center CNS Shunt Study results reported by Kestle, et. al. (1999), conclusions found by the 1999 STAMP Conference on CNS Shunts, data summarized in my Petition to FDA No. 96P-0444, and continued “shunting outcomes” concerns and adverse data. CNS shunts meet ALL of the criteria necessary under FDA risk assessment/ and baseline conditions for this new PS in that they: (1) Are intended to be implanted in the human body for more than 1 year; (2) Are life- sustaining or life-supporting and used outside a device user facility; and (3) Failure could be reasonably likely to have serious adverse health consequences.
  2. 2. David Feigal, Ph.D. July 11, 2002 Page Two CNS shunts may benefit from this new and additional PS, in that it may “identify actions that minimize risks, such as training, labeling, design modification, or patient selection criteria. In extreme cases, surveillance may show that the subject device be removed from the market.” According to the rule, the CDRH may require this new PS without consulting with shunt manufacturers. However, I would be agreeable if you held an industry meeting. This request comes a bit deja vu, in that after writing my shunt Petition No. 96P-0444 in 1996, and after having the CDRH hold the STAMP Conference on CNS Shunts in 1999, I would have thought such reforms in performance measurements and outcomes assessment would have been implemented. But this has not been the case. I am a patient user of a CNS shunt, and recently passed my 10-year mark requiring that I have a shunt to live. I was never given any user information on any of the CNS shunts implanted in me, nor do I believe my neurosurgeons sufficiently understood the shunts used in my care. I was also rendered “disabled” by hidden problems with my Delta shunt. Today, we have no true data on hydrocephalus and disability. I attribute such failures to “labeling, literature, study formats, and postmarket surveillance.” The poor performance status of CNS shunts, well known to the CDRH, forced me to design a shunt assessment model in 1997, named the DiaCeph Test, to provide test documentation for my corrective surgery in 1998. I regret to say today very little has changed in the way of outcomes and warnings information as was mandated by the CDRH in their ruling on the above Petition on these shunts. The CDRH and myself have been made to be a “fool” by such failures. My shunt outcomes assessment model sits on a shelf while patients face daily uncertainty and disability because the CDRH won’t pass much needed mandates and reforms, nor will any shunt manufacturer take the necessary initiatives. It is plausible that CNS shunts could become a Class III device. I respectfully request that the CDRH take the necessary immediate steps toward new PS, and implement any other new reforms that it deems are necessary. Truly, Stephen M. Dolle Hydrocephalus Patient & Advocate sd:

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