post market clinical surveillance, experience of the industry by s. menzl - abbott medical optics...
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Stefan Menzl, PhD
Director, International Regulatory Affairs,
Abbott Medical Optics
Post Market
Clinical Surveillance
View from Industry
2nd Qserve Conference
18-19 November, 2013
Stefan Menzl 2013 2
• What is Post Market …
– Surveillance?
– Clinical Follow-Up / Surveillance?
• Requirements for Post Market (Clinical) Surveillance
– Current Medical Device Directive
– New Medical Device Regulation
– MEDDEV 2.12-2
– QM-System (ISO13485)
Content of the Presentation 1/2
Stefan Menzl 2013 3
• Elements of Post Market (Clinical) Surveillance
– PM(C)F Plan
– Vigilance (incl. Trending)
– Literature Review
– Registries
– Studies
• Challenges for Industry to meet Requirements
– Non harmonized requirements worldwide
– The ‚human factor‘
– Language
– …
Content of the Presentation 2/2
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Post Market (Clinical) Surveillance / Follow-Up
PMCF definition
Emphasis on the proactive nature of the program
Post-market follow-up, ... is a continuous process …and shall be part of the manufacturer's post-
market surveillance plan
To this end, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which is authorized to bear the CE marking, within its intended purpose ... with the aim of confirming the safety and performance throughout the expected lifetime of the device, the continued acceptability of identified risks and to detect emerging risks on the basis of factual evidence
PMCF plan mandatory unless duly justified
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Required update of risk assessment
and
clinical assessment in defined frequency
Consider PMS data
(incl. Events and Literature)
Requirement to have PMS-Plan for every
Product-family
ACTION
MDD, new Annex X, 1.1c
Requirement to actively update clinical assessment with data from
‘Post Market Surveillance’
MDD Requirements for Post Market (Clinical) Follow Up
Stefan Menzl 2013 6
MDD Post Market (Clinical) Surveillance / Follow-Up
MDD (93/42/EEC) requires PMS and PMCF
Additional requirement to comply with ‚state of the art‘
Literature-screening as part of PMS, clinical assessment and PMCF
Clinical assessment required for all classes of devices (2007/47/EEC)
ER (6a)
• Safety & Effectiveness
• Beneficial risk/benefit ratio
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New Medical Device Regulation Proposal Post Market Clinical Follow-Up
″ ... PMCF shall be performed pursuant to a
documented method laid down in a PMCF plan ...
″ specify general methods and procedures, such as
gathering of clinical experience gained, feedback from
users, screening of scientific literature and of other
sources of clinical data ...
″ The notified body shall periodically, at least once
every 12 months, carry out appropriate audits and
assessments to make sure that the manufacturer
applies the approved quality management system
and the post-market surveillance plan.”
Stefan Menzl 2013 8
MEDDEV 2.12-2
Definitions
PMCF study: a study carried out following the CE marking of a
device and intended to answer specific questions relating to
clinical safety or performance (residual risk) of a device when
used in accordance with its approved labeling
PMCF plan: the documented, proactive, organized methods
used to collect clinical data from actual use in humans on a
specific CE marked device (or device group) with the aim of
confirming long term clinical performance and safety, the
acceptability of identified risks, and to detect emerging risks on
the basis of factual evidence
MEDDEV 2.12-2 Post Market (Clinical) Surveillance / Follow-Up
Stefan Menzl 2013 9
QMS ISO13485 Post Market (Clinical) Surveillance / Follow-Up
Requirements of Quality-management System (Annex II.3)
• Known risks (e.g. from literature or event reporting)
need to be addressed in Risk-Management-Process and
have to be considered in clinical assesssment
• Remaining risks need to be addressed in labeling
• Medical benefit needs to outweigh remaining risk
(risk-benefit ratio)
Stefan Menzl 2013 10
Elements of Post Market (Clinical) Surveillance / Follow-Up Post Market Surveillance Plan
Featured prominently
in the proposal of MD
regulations released
on Sept 26
Importance of
Post Market Clinical Follow Up
Importance to apply the
concept throughout the life-cycle
of the device
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• PMCF should be conducted for any device that has used clinical
data from equivalence devices alone as the basis for the clinical
evaluation.
• The plan should ensure that residual risks identified for the
equivalent devices are addressed
Elements of Post Market (Clinical) Surveillance / Follow-Up Post Market Surveillance Plan
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Elements of Post Market (Clinical) Surveillance / Follow-Up Post Market Surveillance Plan
The data shall be reviewed at regular intervals
The plan shall define:
– Frequency of review to ensure continuous monitoring of benefit/risk ratio (including patient quality of life and public health impact)
– By whom
– Trending methodology: identification of trend and need for preventive/corrective action
Stefan Menzl 2013 13
Elements of Post Market (Clinical) Surveillance / Follow-Up Post Market Surveillance Plan- Content
The plan shall define the source of data and the means to
collect those data and shall be proportional to the risk of device/device family
The plan may include:
– Complaints Handling
– Return Product Analysis
– Vigilance Reports
– Literature Review
– Registry Review
– PMCF
– Regulatory Feedback
Stefan Menzl 2013 14
Elements of Post Market (Clinical) Surveillance / Follow-Up PMCF – Vigilance (New Medical Device Regulation)
″ ... European system for the notification and
evaluation of incidents and field safety corrective
actions ...
Advantage
Existing company system
Low additional cost
Challenges
Reactive
Issues late in the game
Stefan Menzl 2013 15
Elements of Post Market (Clinical) Surveillance / Follow-Up PMCF – Literature Review (New Medical Device Regulation)
Options
Review relevant sources at regular intervals, e.g. PubMed Conferences Journal alerting Services
Advantage
Relatively cheap Access to data world wide
Challenges
Reactive Data typically limited and heterogeneous
″ The process of reading, analyzing, evaluating, and summarizing scholarly materials about a specific topic.”
Stefan Menzl 2013 16
Elements of Post Market (Clinical) Surveillance / Follow-Up PMCF – Registries (New Medical Device Regulation)
Options – several
Paper/ EDC forms
Single/ multi center
...
Advantages
Value for money
Low site threshold
...
Challenges
No efficacy/ added value data
Stefan Menzl 2013 17
Elements of Post Market (Clinical) Surveillance / Follow-Up PMCF – Studies (New Medical Device Regulation)
Options
Small scale single arm
RCT
Advantages
Efficacy and/ or added value RCT is gold standard
Challenges
Not daily practice Huge investment Blinding
Stefan Menzl 2013 18
Elements of Post Market (Clinical) Surveillance / Follow-Up PMCF – Studies
When to do a PMCF study
• Presence of residual risk that may impact the benefit/risk ratio
• To examine long term performance and/or safety
• To examine the performance and/or safety of the device in a more
representative population of users and patients
• PMCF study is expected, a justification needs to be given when not
performed, e.g. medium/long term safety is already known from
previous use, other appropriate PMS activities provide sufficient data
to address the risks
Stefan Menzl 2013 19
Elements of a PMCF study
• PMCF plan:
– Research questions, objectives and related endpoints
– Scientifically sound design with appropriate rationale and statistical
analysis plan
• Implementation of the study according to plan
• Analysis of the data
• Appropriate conclusions
Elements of Post Market (Clinical) Surveillance / Follow-Up PMCF – Studies
Stefan Menzl 2013 20
Outcome
• Conclusions to be part of the clinical evidence report
• Depending on the conclusions, an update of the Essential
Requirements checklist and risk assessment may be appropriate
• Changes could result in corrective/preventive actions like
– Labeling changes
– Changes to manufacturing process
– Design changes
– Public health notifications
Elements of Post Market (Clinical) Surveillance / Follow-Up PMCF – Studies
Stefan Menzl 2013 21
Role of the Notified Body
• The Notified Body will review the PMCF procedures and plans as
part of design review (class III) or tech file review and
– Verify compliance of the plans to Annex X, meddev guidance and
standards
– Evaluate the need for a PMCF plan
– Assess the appropriateness of the PMCF plan
– Assess the justification given for not conducting a specific PMCF
plan
– Verify that data from PMCF plans is used to update the clinical
evaluation
Post Market Clincal Follow Up
Stefan Menzl 2013 22
Practically meeting post-market requirements The Challenge of non-harmonized Requirements
The challenge to meet international Vigilance requirements
• Country specific requirements
• Other challenges
Possible solutions to meet the challenge
• Harmonization
• Company internal processes and systems
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Practically meeting post-market requirements
Challenges besides Regulations – the “human factor”
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Practically meeting post-market requirements Other Challenges (than diverse regulation)
• The available information is different from country to country and from
customer to customer
• The language barrier
• Cultural approach to the reporting of complaints
• Availability of technical expertise in every country
• Different classification of products (drug / device) depending on country
regulation
• Responsibility for reporting are different from country to country
(subsidiary or distributor)
Stefan Menzl 2013 25
Ensuring safety data is consistently up-to-date
Elements in addition to complaint handling and vigilance
• Literature reviews
• Post market clinical follow up, Post market clinical studies
• Customer surveys
• Feedback from technical service
• …
Stefan Menzl 2013 26
Ensuring safety data is consistently up-to-date
Literature reviews
• Proactive measure for PMS
• Which journals
• Abstracts
• Presentations at conventions
• ‚yellow press‘ (e.g. BSE crisis)
• Define the process !!!
• Responsibility & Frequency
Stefan Menzl 2013 27
Ensuring safety data is consistently up-to-date
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New Medical Device Regulation PMCF - Conclusion
PMS under new Medical Device Regulation
More stringent and controlled
Various Options
Literature Review Registries Randomised Controlled Studies …..
Stefan Menzl 2013 29
New Medical Device Regulation Post Market Surveillance – Potential Consequences
PMS plan itself
Product Improvements
Extend, maintain or reduce PMCF/registry
Product Labeling / IFUs
Extend, maintain or reduce Product Training / User Training
Update of Risk Management
FSCAs
AMO Products covered by the PMS/PMCF program
Vision. For Life. AMO’s strategy is to deliver advanced life-improving vision technologies for people of all ages
Three Integrated Businesses Provide Vision. For Life.
Corneal Proprietary formulations designed
to protect and lubricate ocular
surfaces
Refractive Advanced laser technologies
designed to deliver freedom from
eyeglasses
Cataract Leading products for intraocular
procedures that optimize visual
function
Eye Care Professionals
Abbott Medical Optics 3,700+ employees worldwide
3 Mfg/R&D sites
3 Mfg sites
4 Regional hubs
• Direct sales in 29 countries & presence in more than 60 countries
Puerto Rico Mexico
United States
Canada
Russia
China
Australia
Singapore
India
Spain
Africa
South
America
Ireland
Japan
Sweden
Netherlands
1 Global R&D site
Cataract -- IOL Platforms
• Tecnis® IOL
– Monofocal, aspheric IOL designed to correct spherical aberration to zero
• Tecnis® Toric IOL
– Toric IOL designed to correct preexisting corneal astigmatism
• Tecnis® Multifocal IOL
– Diffractive, aspheric IOL that provides near, intermediate and distance vision with exceptionally high spectacle independence
– Enjoys premium pricing and patient-shared billing in the U.S.; co-pay in several markets outside U.S.
• Synchrony® Accommodating IOL
– Addresses presbyopia in cataract patients
– Dual optic accommodating IOL designed to allow patients to see near, intermediate and distance vision
– Approved in Europe; pending FDA approval in U.S.
Cataract -- Phaco and Visco Platforms
• Healon® Viscoelastics
– Family of viscoleastics that provides a range of viscosity to satisfy different surgical needs
• WhiteStar Signature™ Phacoemulsification System
• Ultrasonic device that emulsifies and extracts a cataractous lens using less heat and turbulence and FusionTM Fluidics to optimize outcomes
• Ellips™ handpiece provides longitudinal combined with transversal motion
Refractive Technology Suite
• iFSTM Laser
– Femtosecond laser that focuses pulses of light below the surface of the cornea to create the flap before a LASIK procedure is performed
• WaveScan WaveFront System
– Diagnostic device that captures unique imperfections in each patient’s eyes and creates a personalized treatment plan
– iDesignTM system is next generation technology
• Star S4 IR Laser System
– Computer-driven excimer laser that corrects refractive errors by reshaping the cornea
– Performs Advanced CustomVue procedure, which corrects unique imperfections in each patient’s eyes and is capable of treating the industry’s broadest range of refractive conditions
Corneal Products
• RevitaLens Ocutec Multipurpose Disinfecting Solution
– Next-generation multipurpose disinfecting solution for silicone hydrogel and conventional soft contact lenses
• Complete Multipurpose Solution
– Convenient, single-bottle solution formulated to effectively clean and disinfect contact lenses
• Oxysept Ultracare System
– Hydrogen peroxide system that provides powerful disinfection efficacy for contact lenses
• Blink Tears
– Family of lubricating eye drops designed to provide relief to dry eye patients
Stefan Menzl 2013 37
Post Market Clinical Follow-UP
“Everything should be made as simple as possible, but not simpler”
Stefan Menzl 2013 38