View
7
Download
0
Category
Preview:
Citation preview
“Our preliminary analysis found that firms
initiated about 700 recalls per year. However,
we found that firms were unable to correct or
remove all recalled devices even though subject
to the highest risk or Class 1 recalls…”
GAO Healthcare director Marcia Crosse
1
The Worldwide Melding of
Regulatory, Commercial, & Patient
Safety Information Needs
2
Jay Crowley
VP, UDI Solutions and Services
USDM Life Sciences
3
UDI and Device Recalls
GAO showed that device firms do not remove all unsafe
medical devices from the market because:
• The firm cannot locate all customers or devices, or
• Customers cannot locate the devices subject to recall.
In a review of class I recalls, in 53% of the cases – firms
were unable to correct or remove all of the faulty devices
from the market.
4
US Drug Registration and Listing
For each drug (at a NDC number level): • Name and DUNS of the establishment (not corporate HQ) • Contact information of responsible person for that establishment • All applicable business operations that establishment performs • Foreign establishments – name & DUNS of US agent and importers
• Full 10-digit NDC • Proprietary and non-proprietary name • Dosage form and route of administration; • The name (+UNII) and amount/strength of each active ingredient • Each inactive ingredient (name and UNII) • Copy of the most up-to-date labeling • A photo (JPG) of the outer packaging and principal display panel • Name and DUNS for each establishment involved in manufacturing
5
Why UDI…?
Manufacturer
Reuse
Clinical Use
Rentals
Sold
Physician
Preference
Off-master
purchase
Hoarding
Postmarket
Surveillance
FDA’s Sentinel System
Population Databases
Reorder
Reimbursement
EHR
Registries
Comparative Effectiveness
AE Reporting
Sales Rep
Recall
Distributor
Hospital
Unit
GPOs Clinical
Substitution
Direct Device X
Lot Y
Exp Date Z
6
IMDRF UDI Guidance Documents
Goal of “Globally Harmonized” approach largely realized – however: • Devices regulated differently in different countries • Requirements are not just from “regulators” • Multiple uses and users of “regulatory” data – manufacturers, health-
care providers, researchers, patients, purchasers, insurers, regulators • Different and varied (and growing) data needs • Different use cases (counterfeit, traceability, cost-control, patient safety,
reimbursement)
7
Commercial
Regulatory Patient Safety
Commercial (Market Requirements)
• US IDNs (Kaiser, others)
• US GPOs
• US ONC/EHRs, CMS
• Canadian GPOs
• Abu Dhabi, Cleveland Clinic
• Qatar, Hamad Medical
• Netherland (implants)
• Hospitals
Country Requirements
(Ministry of Health Others)
• UK NHS
• Taiwan
• Japan MHLW
Postmarket Requirements
• MDIC/`NEST
• RWD/RWE
• Case for Quality
• Registries, Sentinel
• EU MDR/IVDR
Regulatory Requirements
• Turkey
• India
• Saudi Arabia
• China
• Singapore
• Health Canada
• Columbia
Traceability Requirements
• EU class III implants
• Turkey
• Saudi Arabia
• Brazil
• Columbia
Medical Device Sector The Evolving Global Landscape
UDI and
Product
Data
8
GUDID/Eudamed/Others
Basic UDI-DI
Classification
GDSN
Price
Commercial
Is it (device, accessory)
Parent-child relationships (kits)
Labeling, pictures, IFUs,
implant card
WHO Economic Operators and
Other Stakeholders
HOW Regulatory and
Commercial
WHAT Global Product
Attributes
Manufactures
Contract/PL
Imports
Distributes
Registers
Authorizes
Maintains/services/repairs
Is manufacturer/labeler
Is Notified Body
Is responsible (AR)
Is country of origin
Is reg. contact
Is prescribing
Is trained/using
Regulated
On to market
Into country
Performing (PMS)
Paid (reimbursed)
Distributed (SC)
Recalled
Traceability
Safety and Performance
The Visibility and Control Imperative
9
Growing Requirements and Challenges
Ever-increasing data complexity throughout internal
systems and processes and external submissions.
Regulatory Requirements
Commercial Requirements
Post Market Requirements
Country Requirements
Traceability
• US FDA 2013
• EU-MDR 2020
• EU – IVDR 2021
• Turkey: 2018 and
beyond
• India: 2022
• Saudi Arabia:
2018/2019?
• China: Spring 2018?
• Singapore?
• Health Canada?
• US IDNs (Kaiser,
others)
• US GPOs
• US ONC/EHRs, CMS
• Canadian GPOs
• Abu Dhabi, Cleveland
Clinic
• Qatar, Hamad
Medical
• Netherlands
(postponed to
2019/2020)
• Hospitals
• MDIC/NEST
• Case for Quality
• Registries, Sentinel
• (Ministry of Health
Others)
• UK NHS
• Taiwan: (Voluntary)
• Japan MHLW (already
in place)
• EU class III implants
• Turkey UTS
Growing regulatory requirements + internal data / systems / process complexities
10
General Safety and
Performance Rqmts AE Reports
Clinical
Evaluation
IFU/
Labeling/
Pictures
Regulatory
Contact
Own Brand/
Private
Label
Contract
Manufacturer
Parent-Child
Relationships
(e.g., kits) Implant Card
Patients and
HC Providers
Price
Recalled/
Discontinued
Country of
Origin
Commercial
Requirements
Complaint
Handling Registration
and Listing
Mark
et
Auth
ori
zation
Authorized Representative,
Importer, Distributor
Tra
ck a
nd T
race
Basic UDI-DI
Device
Attributes
(UDIDs)
Ris
k C
lass
GM
DN
Model Attributes
For each
country/region The Evolving Device Data Model
11
Global Regulatory Uses of UDI
EU MDR/IVDR • Traceability
• Enhance effectiveness of
PMS-related activities
• Improved incident reporting
• Targeted FCSAs (recalls)
• Better monitoring by CAs
• Help reduce medical errors
• Fight against falsified
devices
• Improve purchasing, waste
disposal and stock-
management
US UDI Rule • Reduce obstacles to
adequate identification
• Reduce medical errors
• Simplify Integration of device
use into data systems
• More rapid identification of
devices with AE reports
• More rapid development of
solutions to problems
• More rapid, efficient recalls
• Better focused and effective
safety communications
• And more…!!!
SFDA “Guidance” • Traceability of medical
devices, especially for FSCAs
• Control of devices at the
ports, especially for
counterfeits and recalls
• Identification of medical
devices at the point of use
• Identification in AE reports
• Reduction of medical errors
• Support safe and effective
use
• Documentation and
longitudinal capture of data
on medical devices.
12
UDI Implementation
Process
Top Management, Gap Analysis, Strategic Plan
ERP System
MDM, Data Integrity, Validated
Systems Manufacturing
Labels application, verification, DM
Service
(if appropriate)
Capturing UDI, Refurbishing,
Device Updates
Finance
Budgets, Appropriations, D&B, SAM.gov
QA & Document Control
SOP Revisions, Spec Changes, Internal audits
Regulatory
Regulatory Data, Review/ Verify Data, Submit to GUDID, Device
Changes
Product Development
DHF, Label, DM, Device Changes
Supply Chain
Inventory Suppliers (UDI Compliance)
Marketing & Sales
Brand Name, Descriptions
Suppliers
UDI Compliance DM Capabilities
Customers Distributors
ERP Systems, EHR, Billing
UDI Touches All Parts of Your Business
13
Clinical
Actual Use
Quality, Performance,
and Safety
The “New” Model
Proactively collecting and
evaluating (real world)
clinical data -- RWE
Actively and systematically gather
and analyze relevant data on the
quality, performance and safety
Post-market
Surveillance Report
PMSR/
PSUR Periodic Safety
Update Report
Premarket/Clinical
Evaluation Report • Indications/Intended Use
• Patient population
• Clinical evidence
• Clinical investigation
Post-market Clinical Follow-up Post-market Surveillance Plan
14
US UDI Implementation – Lessons Learned
1. Existing regulatory foundation need to be robust (device, label)
2. Data needs to be electronic, computable (not spreadsheets)
3. Need to adhere to MDM practices (owner, change rules)
4. Shared visibility and control (all users/owners engaged)
5. Same data needs to shared internally and externally
6. Reuse SAME data for all needs (regulatory, commercial, pt safety)
7. This is a global initiative – but there are regional differences/needs
8. Information needs to be internally consistent and aligned
9. CONTROL (and limit/understand) change
10.This is only the beginning….
15
Where is all of this going...?
1. MANY parent-child relationships (actors, kits, accessories)
2. (Global) Track and trace (serialization)
3. Larger influence of payors
4. Focus on patients (home care, telemedicine, other models)
5. (and therefore more focus on) COST effectiveness
6. Capture of all devices used
7. Blurring of lines between regulated products (drugs, devices, biologics)
8. Integration of (non-regulated) “data” (e.g., wearables, apps)
9. MUCH more product data …
10.Devices won’t be distributed, used or reimbursed if data doesn’t align
16
It’s all
about the
data!!!
Read my
lips…
17
Recommended