GU Advisory Panel Meeting

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2. Diagram. IntroductionPanel Update Regulation of Hemodialysis DevicesGuidance Documents for HemodialysisDefinition of Nocturnal Home HemodialysisMeeting Objectives . 3. . Linda Carr Consumer Safety TechnicianJeffrey Cooper, D.V.M. Veterinarian/Panel Exec. Sec.Linda Dart, M.S. BiochemistGema Gonzalez, M.S. Biomedical EngineerIrada Isayeva, Ph.D. Polym

Presentation Transcript

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GU Advisory Panel Meeting Nocturnal Home Hemodialysis Carolyn Y. Neuland, Ph.D. Boss, Gastroenterology and Renal Devices Branch Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health June 8, 2005

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Overview Introduction Panel Update Regulation of Hemodialysis Devices Guidance Documents for Hemodialysis Definition of Nocturnal Home Hemodialysis Meeting Objectives

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Linda Carr Consumer Safety Technician Jeffrey Cooper, D.V.M. Veterinarian/Panel Exec. Sec. Linda Dart, M.S. Organic chemist Gema Gonzalez, M.S. Biomedical Engineer Irada Isayeva, Ph.D. Polymer Chemist Kristina Lauritsen, Ph.D. Tumor Biologist Barbara McCool, M.S.R.N. Nurture Consultant Joshua Nipper, M.E. Biomedical Engineer Kathleen Olvey Biologist Claudia Ruiz-Zacharek, M.D. Nephrologist Rebecca Stephenson Chemical Engineer Kellie Straughn Clerk Typist Richard Williams Mechanical Engineer

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Panel Update

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P020006 - Enteryx Procedure Kit Boston Scientific Corporation Description/Indication – arrangement infused into the LES for the treatment of GERD in patients who are receptive to pharmacologic treatment Panel Meeting Date – January 17, 2003 GU Panel Recommendation – Approval with Conditions Modified doctor naming Modified patient naming Post advertise study with 36 months follow-up from the last infusion

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P020006 - Enteryx Procedure Kit Boston Scientific Corporation Current Status – PMA affirmed April 22, 2003 Post-endorsement Study 3 year post-implantation follow-up Medical Device Reporting (MDR)

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Nocturnal Home Hemodialysis

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Regulation of Hemodialysis Devices Class II Medical Devices Risk Based characterization Moderate level of hazard Requirement for General Controls and Special Controls to guarantee wellbeing and viability 510(k) - Premarket Notification There are as of now no gadgets cleared by FDA for Nocturnal Home Hemodialysis

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Regulation of Hemodialysis Devices Establishes significant comparability (SE) to a legitimately showcased predicate gadget As sheltered and as compelling as predicate gadget Performance information: Bench concentrates Clinical reviews (particularly for Home Systems)

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Dialysis Devices Most are directed as Class II gadgets Primary grouping controls utilized: §876.5820 – Hemodialysis frameworks and frill Conventional Dialyzers Reuse of Conventional Dialyzers Dialysis Delivery Systems and Tubing Sets Hemodialysates §876.5860 – High porousness hemodialysis frameworks High Flux Dialyzers Reuse of High Flux Dialyzers Dialysis Systems with Ultrafiltration Controller

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Dialysis Devices §876. 5600 - Sorbent recovered dialysate conveyance framework for hemodialysis §876. 5665 - Water sanitization framework for hemodialysis §876. 5540 - Blood get to gadget and adornments Class III for embedded catheters §876.5630 - Peritoneal dialysis framework and frill

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Guidance Documents for Hemodialysis Devices Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers – 1998 Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems – 1998 Guidance for Hemodialyzer Reuse Labeling – 1995 Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis – 1997

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Guidance Document "Direction archives are reports arranged for FDA staff, candidates/supports, and the general population that portray the organization's understanding of or strategy on an administrative issue" 21 CFR §10.115

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Definition of Nocturnal Home Hemodialysis Nocturnal Home Hemodialysis (NHD) is a kind of hemodialysis performed in the home by the patient, while the patient is sleeping ( commonly during the evening ), over a 6-10 hour time span, utilizing slower stream rates for blood and dialysate, and a treatment recurrence of 5 to 7 days for each week.

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Nocturnal Home Hemodialysis Objectives of Meeting To talk about and give suggestions on the clinical and logical issues related with hemodialysis gadget configuration, naming, and preparing for Nocturnal Home Hemodialysis To examine and give proposals on clinical trial configuration to concentrate Nocturnal Home Hemodialysis To get logical criticism which can be utilized to help in gadget assessment choices and may prompt to the future improvement of a direction archive for Nocturnal Home Hemodialysis

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Nocturnal Home Hemodialysis Overview of Conventional Hemodialysis System Joshua Nipper – Biomedical Engineer Gastroenterology and Renal Devices Branch

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Overview of Conventional Hemodialysis Delivery Devices Joshua C. Nipper, M.E. Biomedical Engineer Gastroenterology and Renal Devices Branch Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health June 8, 2005

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Overview Conventional Hemodialysis (HD) Systems A "standard" gadget Monitored parameters Alarms Accessory Devices Water treatment frameworks Hemodialysis blood tubing Remote observing frameworks Blood get to gadgets

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Disclaimer Any cases in this introduction are not planned as an underwriting or feedback of a particular innovation, gadget or organization No gadgets are right now cleared for nighttime home hemodialysis

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Hemodialysis Delivery Systems Classified under two distinct areas of the Code of Federal Regulations (CFR): 21 CFR §876.5820 for a low penetrability framework 21 CFR §876.5860 for a high porousness framework (ultrafiltration controller) Suggestions for the substance of a 510(k) accommodation found in the FDA direction archive: "Direction for the Content of Premarket Notifications for Hemodialysis Delivery System"

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A "Standard" HD Delivery System Informational Display Saline PT = Pressure Transducer Anticoagulant PT Blood from Patient Dialysate/UF Out (green/yellow) Blood Leak Detector Conductivity Meter PT Mixing System Pre-blended or sorbent recovered Dialysate In Water, Acid Concentrate, Bicarbonate Concentrate In PT Venous cinch Drip Chamber Air Detector Blood come back to Patient

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Solute Transfer & Ultrafiltration C blood > C Dialysate P blood ≈ P Dialysate C blood > C Dialysate P blood > P Dialysate Blood Dialysate

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Monitored HD Parameters Blood and dialysate stream rates (pump speed) Pressure Arterial Venous Dialysate Waste/Dialysate Out Transmembrane Pressure (TMP) Patient liquid evacuated (UF) Temperature

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HD Alarms Typically come in two assortments: CAUTION WARNING

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Temperature Blood spill Flow rates Pressure Arterial Venous Transmembrane Pressure (TMP) Dialysate Waste/Dialysate Out Excessive UF Air embolism Conductivity/pH Water quality System alerts Vascular get to disengagement – venous weight? Standard HD Alarms

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Accessory Devices Water Treatment Systems HD Blood Tubing Remote Monitoring Systems Blood Access Devices

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Water Treatment Systems Classified under 21 CFR §876.5665 Guidance for The Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis Converts consumable water to decontaminated water meeting the necessities of the Association for the Advancement for Medical Instrumentation (AAMI) RD:62 standard Can be intended for various patients, or can be single patient

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Water Treatment Systems Water In Water Out Deionization Reverse Osmosis Pre-treatment Carbon Filters Worker/Polisher Ultrafilter Data Out

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Blood Tubing Serves as fundamental course for blood Contains a "blood pump" portion Can have different association focuses Patient get to (blood vessel & venous) Pressure transducers with transducer defenders Air finders Roller/peristaltic blood pump

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Blood Tubing Can be "tape" based, which constrains the quantity of client associations required Kinked tubing can bring about hemolysis, which can prompt to death

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Remote Monitoring Systems Can be utilized for information transmission Connect HD machine to Internet by means of modem or broadband association Can transmit ongoing cautions, or potentially finished treatment information FDA marks flow frameworks are contraindicated as the sole technique for observing a patient amid hemodialysis

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Blood Access Devices Long-term, handcuffed HD Catheters Single or twofold lumen Contain luer locks meeting ISO benchmarks for association with blood tubing Arterio-Venous (AV) Grafts Implanted prosthesis intended to sidestep segments of local vessels AV Fistulas Surgical methodology, not a gadget managed by FDA Fistula needles are restorative gadgets, and contain the same luer bolts as catheters

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Nocturnal Home Hemodialysis Michael Mendelson, D.D.S., M.S. Biomedical Engineer, Director Health Promotion Officer Human Factors Science and Engineering Branch

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Human Factors and Nocturnal Home Hemodialysis Michael Mendelson, D.D.S., M.S. Biomedical Engineer, Director Health Promotion Officer Human Factors Science and Engineering Branch Division of Device User Programs Office of Communication, Education, and Radiation Control Center for Devices and Radiological Health June 8, 2005

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Topics Introduction to human components (HF) Magnitude of medicinal mistake brought about antagonistic episodes HF techniques Nocturnal Home Hemodialysis (NHD) difficulties and perceptions Human Factors Branch suggestions for premarket entries

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General Definition of Human Factors Human Factors finds and applies data about human conduct , capacities, confinements , and different attributes to the outline of devices, machines, frameworks, assignments

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