“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

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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)

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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

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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

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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

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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

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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.

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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

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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

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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….

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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

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It’s all

about the

data!!!

Read my

lips…

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