AAMI CI86 Cochlear Implant Systems: Requirements for Safety, Functional Verification, Labeling and Reliability Reporting: Overview and Regulatory Implications from FDA’s Perspective Vasant Dasika, Ph.D. William Regnault, Ph.D. US FDA: Center for Devices and Radiological Health (CDRH)
21
Embed
AAMI CI86 Cochlear Implant Systems · 2018. 4. 3. · AAMI CI86 Cochlear Implant Systems: Requirements for Safety, Functional Verification, Labeling and Reliability Reporting: Overview
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
AAMI CI86 Cochlear Implant Systems: Requirements for Safety, Functional Verification,
Labeling and Reliability Reporting:
Overview and Regulatory Implications from FDA’s Perspective
Vasant Dasika, Ph.D.
William Regnault, Ph.D.
US FDA: Center for Devices and Radiological Health (CDRH)
2
No Disclosures
3
Summary
• ANSI/AAMI CI86 2017 (Ed. 1) was published in July 2017
• Requirements of AAMI CI86 include:– Nonclinical regulatory submission content– Engineering design and validation– Labeling
• Reliability Reporting • Device Specifications
• Device manufacturers may choose to voluntarily comply with AAMI CI86
• Expected End-Goal: Increasingly innovative, safe, effective, appropriately labeled and reliable devices. Increased regulatory certainty leading to a shorter time to market
4
BACKGROUND
5
Background: Standards
• Standard: Set of guidelines that a manufacturer can voluntarily comply to
• FDA actively participates in the development of standards for medical devices. FDA recognizes numerous published standards.
• Association for the Advancement of Medical Instrumentation (AAMI): A healthcare technology nonprofit and standards developing organization
5
6
Motivation for developing a US standard for CIs:Establish uniform guidelines for reliability reporting
• Manufacturer’s device-reliability reports have cited:– European consensus statement on internal device failures and explantation (no
authors listed, 2005)
– International classification of reliability for implanted cochlear implant receiver stimulators (Battmer et al., 2010)
– CI Soft Failures Consensus Development Conference Statement (Balkeny et al., 2005)
– ISO 5841-2:2000: Reporting clinical performance of cardiac pacemakers
• Limitations: Subjectivity was permitted in inclusion of data. E.g., not all explanted devices were reported (e.g., medical reasons) 6
7
Motivation for developing a US standard for CIs:Limitations with Earlier Standards
• BS EN 45502-2-3:2010 Active implantable medical devices. Particular requirements for cochlear and auditory brainstem implant systems
• ISO 14708-7:2013 Implants for surgery -- Active implantable medical devices -- Part 7: Particular requirements for cochlear implant systems
• Limitation: Earlier standards more restricted in coverage
A Manufacturer Shall Characterize a CI Device System in a Regulatory Submission
• General description of device, intended uses, and model designations• Inventory of system components• Interconnection between implantable and non-implantable parts• Wireless technology• System hardware• System software (including sound processing strategies)• Electrode specification and characteristics• Features of clinical fitting software• Electrical Stimulation
– Methodology/circuitry– Waveforms– Provisions for safe stimulation
11
A Device Shall MeetDesign & Verification Requirements
• Electrical– Stimulation– Battery
• Thermal• Mechanical
– Safety of electrode array insertion
• Manufacturing– Case Robustness and Integrity
• Biocompatibility• Sterility, packaging, and shipment• Safe use in various intended environments (e.g., MRI)
12
Requirements for Device Labeling
• Information on use, warnings, and hazards
• Specification sheets: a common set of information– Implant– Electrode– Sound-processing strategy– Sound processor– Remote-control
• Device reliability reports: uniformly generated– Use prescribed failure-analysis steps to categorize explants– Report cumulative explant rates; stratify by explant category & pt. age– Make publicly available on mfgr’s website, update 2x/year
– Manufacturers will provide documentation to clinics to assist troubleshooting, explantation & return of devices
13
AAMI CI86 Recognized by FDA in 2017
• Applicants may utilize an FDA recognized standard in a premarket submission to FDA.
• Conformity to a recognized standard can minimize the amount of data and documentation and increase certainty in what is needed in a pre-market submission.
• Other CI standards can consider harmonizing with AAMI CI86
• Begin work on Edition 2
19
Future Directions
• Document will be revised every 5 years from 2017
• Academic/outside analyses welcome (e.g., on reliability reporting, specification sheets)
• Committee participation encouraged to improve document & ensure appropriate requirements, e.g., – Device indications for use– Include human-performance measures
• speech, music, psychophysical performance, PRO measures
20
FDA Staff Acknowledgements
• Srinivas Nandkumar• Jim Kane• Jong Ho Won• Ting Zhang• Angie Khan• Sunny Park• Joyce Lin• Vasant Malshet• Oldooz HazratiYadkoori• Eric Mann• Leonid Livshitz• Audrey Zhou• Josh Guag
• Terry Woods• Sunder Rajan• Don Witters• Hamed Ghods• Pavel Takmakov• Ethan Cohen• Cristin Welle• Victor Krauthamer• Nancy Wersto• Shahram Vaezy• Leonardo Angelone• Howard Bassen• Jana Delfino• Donna Walsh