an inside look fda’s perspective
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AAMI CI86 Cochlear Implant Systems: Requirements for Safety, Functional Verification,
Labeling and Reliability Reporting:
An Inside Look from FDA’s Perspective
William Regnault, Ph.D.Vasant Dasika, Ph.D.
US FDA: Center for Devices and Radiological Health (CDRH)
2
CDRH Vision ‐ Total Product Life Cycle
Vision:Ensuring the health of the public throughout the Total Product Life Cycle— it’s everybody’s business
3
Pre‐Market
Pre-Market
4
Pre‐Market Testing ‐ Implants• Power Consumption
– Thermal Safety Limits • Output Signal Characterization
– Amplitudes, Timing, and Charge Density Limits• Inductive Link Characterization• Mechanical and Environmental Testing
– Implant Impact Testing (Case, Coil, etc.)– Hermeticity– Electrode Lead Flex and Tensile Testing
• MRI Testing• EMC Testing• Immunity from Damage due to Medical Procedures
– X‐rays, Ultrasound, etc.
5
Pre‐Market Testing – Non‐Implantable PartsSound Processors, Head Pieces, and Accessories
• Battery Testing– Discharge Rates, Thermal Limits
• Environmental Testing– Atmospheric, Thermal, Storage, and Recreational
• Mechanical Testing – Drop tests, Cable Pull and Crush tests
6
Commercial Availability
Commercial Availability
7
Labeling and Specification Sheets
• Size, Weight, Battery Chemistries• Electrode Array Characteristics
– Length– Number of contacts – Curved/straight – Surgical Approach (RW, Cochleostomy)
• Sound‐Processing Strategies & Stimulation Parameters• Audio Inputs & Streaming Options• Accessories
– Head Pieces, Body‐Worn Assists, Color Options, Cable Lengths, Auxiliary Inputs, Remote Controls (Programming)
8
User Experience/Reliability Reporting
User Experience/Reliability Reporting
9
Explant Failure Patterns by Population & Pediatric SubPopulations(Data collapsed across explant year: 2000‐2007
Peds differ from adults thru ~8yrs post‐implant
Ped GP 0‐9 Yrs peaked at ~2 yrs& differs from Ped GP 9‐18 Yrsthru ~4 yrs post‐implant
Ped GP 9‐18 Yrs – broad maximum ‐ small # explants consistent over time – center @ ~4 yrs post‐implant
180-
359
540-
719
900-
1079
1260
-143
9
1620
-179
9
1980
-215
9
2340
-251
9
2700
-287
9
3060
-323
9
3420
-359
9
3780
-395
9
4140
-431
9
4500
-467
9
4860
-503
9
5220
-539
9
5580
-575
9
6300
-647
9
6660
-683
9
7740
-791
9
0
20
40
60
80
100
120
140
180-
359
540-
719
900-
1079
1260
-143
9
1620
-179
9
1980
-215
9
2340
-251
9
2700
-287
9
3060
-323
9
3420
-359
9
3780
-395
9
4140
-431
9
4500
-467
9
4860
-503
9
5220
-539
9
5760
-593
9
6300
-647
9
NMADULTS (n=687) NMPED (n=1352) 3 pts AAv smooth 3 pts AAv smooth
# Ex
plan
ts
Implt Life (180 Day Intervals)
0 5 10 15
Implant Life (Years)
NMPed- Age: 0-9 (n=939) NMPed- Age:9-18 (n=413) 3 pts AAv smooth 3 pts AAv smooth
Implt Life (180 Day Intervals)
0 5 10 15
0
20
40
60
80
100
120
140
Implant Life (Years)
10
Failure Analysis, Classification, Survival Analysis, & Reporting
Clinic performs Standard Tests and/
or Swaps Parts (Annex A)
Did complaint resolve?
Clinic/company perform in‐vivo tests (Sections 10.1, 10.2, 11.1.5, 11.1.6,
Annex A, 11.2.1 and Annex D)
L(11.4.2.2 L)
Stop – Problem Resolved
No
Yes
No(Dead in Head)
Is device to be explanted?
Is device removal necessary for
diagnostic, therapeutic medical procedures, or personal conditions unrelated to the
implantation or function of the device? (11.2.2.4a)
Yes
Yes
Is Patient Alive?(11.4.2.2 D)
D(11.4.2.2.D)
Complaint/Event
Did the Device or Implantation Contribute
to the Patient’s Death?
No
DFE
Is Explanted Device Returned to Mfg?
(Sections 10.2, 11.1.4, 11.1.5, and Annex B)
L(11.4.2.2 L)No
Is the patient willing to continue
Standard Follow‐up Care?(11.4.2.2 L)
Yes
Yes
No
In‐Service Devices
Yes
No
Did complaint resolve to patient’s
satisfaction?Yes
No
Is Explanted Device Returned to Mfg? (Section 10.2)
Yes
UME(11.4.2.2 UME)
Intake and Decontamination
(11.2.2.3)
No
Is Device Registered?
Yes
No
Yes
Non‐Destructive Tests
of Section 10.3 a – c(11.2.2.3)
1a
1b
1c
1d
1e
Is Failure Mode consistent with observed clinical complaint and not related to the electrical function of the device?
(Section 10.3)
All Remaining TestsSection 10.3 & Annex C
Fail
No
Yes
UME or EUE?(11.2.2.4 a or c)Pass
UME
1e’
EUE
No
Is device available?
Yes
No
1f
1g
1g
D(To Be
Determined)
1 of 5
Section 11.1.4
11
12
What is Expected from the Reliability Reports?
13
Summary• With the adoption of this Standard, clinicians and users will have
information to make better informed decisions about device selection through uniform and transparent public reporting of reliability information and device specifications.
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