10 Tips for Developing and Implementing a Unique Device Identification (UDI) Program

Regulatory and Quality Solutions LLCRegulatory and Quality Solutions LLC

Regulatory & Quality Solutions LLC

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Overview Background

What? Why? When? How?

What to do, what to do?

Establish your Core Team Program Management 101 How to Get and Submit Data Establish Organizational Support Structure Understand Your Infrastructure Modify Your QMS Know Your Exceptions Implement Flexible Systems Inventory is Bad-Sort of Time

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What?UDI-Background

Background 2007 FDA Amendments Act of 2007 “You will develop a UDI system” 2012 July- Final proposal drafted 2012 July – FDA Safety and Innovation Act (FDASIA) provisions added

Final rule proposal by December 31, 2012Secretary closed 6 months after comment period doneTime frame added for implantable, life-saving, and life-sustaining devices

(no later then 2 years after regulations finalized) 2012 December- FDASIA comment period closed 2013 UDI Final Rule and draft GUDID Guidance

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Why?UDI-The Benefits

Objectives of the UDI Program Facilitate the rapid and accurate identification of a device Enable access to important information concerning the device Allow more accurate reporting, reviewing, and analyzing of adverse

event reports Provide a standard and clear way to document device use in

electronic health records, clinical information systems, claims data sources, and registries

Enable more effectively managed medical device recalls Establish a system to identify medical devices through distribution

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When?UDI- The Timeline

Compliance Date Requirement

Sept 24, 2014 Class III medical devices and devices licensed under the Public Health Service Act

Class III stand-alone software must provide its UDI

Sept 24, 2015

Implantable, Life-Supporting, and Life-Sustaining Devices

A Life-Supporting or Life-Sustaining Device that is required to be labeled with a UDI must a bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.

Stand-alone software that is a life-supporting or life-sustaining device must provide its UDI.

Sept 24, 2016

Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.

Labels and packages of Class II medical devices must bear a UDI.

Class II stand-alone software must provide its UDI.

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UDI System

Compliance Date Requirement

Sept 24, 2018

A Class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. Labels and Packages of Class I medical devices and devices that have not been classified into Class I, Class II, or Class III must bear a UDI. Class I stand-alone software must provide its UDI.

Sept 24, 2020

Class I devices, and devices that have not been classified into Class I, Class II, or Class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.

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How?UDI-What do I do?

UDI

1) Device Label and Device Package must display a UDI1) GS1, HIBCC, ICCBBA2) Device Identifier (DI)3) Production Identifier (PI)

2) Specific Information for Devices must be submitted to the FDAs Global Unique Device Identification Database

3) Manage and Maintain the UDI data

One other note: Dates on the Device must now follow specified format (YYYY-MM-DD)

Essentially three (3) Activities


1. Establish your Core Team

The Core Team must be dedicated and committed (to the program!) Composition

IT Data Management Quality Management Operations/Labeling/Engineering

UDI: IT=PDI (pretty darn important) FDA GUDID Data Management Operations/Labeling/Engineering

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2. Program Management 101

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Communicate, communicate, and when done, communicate. Make sure the URGENCY of this program is understood by all levels of your

organization. Sell

“We’ll get to it” attitude is not advisable…No, It is unacceptable! If you don’t sell then you are not going to get necessary help when and where it’s needed

(and you will need it from many functions within the organization). Your part:

Your Managment:

Your Part (optional):

“NO PRODUCT? That means…no money!”

“Have you NOT been listening to me?”

“You do not have product to sell after the respective deadlines if your UDI is not in

order- NO PRODUCT.”


3. Decide how to get the Data and how you are submitting to GUDID

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IT person and the Data Management person must work together.

Data Management lead understands the information required to properly deliver a UDI compliant label. GS1, HIBCC, ICCBBA Brute Force IT automated “data extraction”

Special Delivery- Getting the information to GUDID $ Manually - Web Portal $$ Little Less than Manual - You collect data, rent software, you own

submission $$$ Little Less than Turn Key - You collect data, third party handles

submission $$$$ Turn Key - 3rd Party does it all $? IF you Build it They will come - You do it all (IT Resources$?)


4. Establish Organizational Support Structure

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Core Team Mini-Me’s IT Data Management Quality Management System Labeling/Operations/Engineering

GUDID User Roles Regulatory Contact (only one) Coordinators (one or more) LDE User (one or more)

Core Team IT

Site 1 IT

Site 2 IT

Site 3 IT

Core Team QMS

Site 1 QMS

Site 2 QMS

Site 3 QMS

Can organize by business

or division ….


5. Understand your Infrastructure

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• If you are lucky and you are working with one company and a minimal number of products/product configurations, well good luck to you!

• However, if you have been part of, or absorbed, acquisitions, then you may have multiple Quality Management Systems to manage or you may have multiple data management, ERP systems, labeling systems to manage.

• Job #1 after organizing your core team and the supporting cast. Identify and understand the infrastructure that you are dealing with.

PI Data

DI Data

LPS

E-submit

FDAGUDID


6. Modify your QMS

Communicate this list to management… don’t forget it’s followed by training!


“I DON’T WANT TO PLAY” REQUESTING AN EXCEPTION or ALTERNATIVE Write up a request and:

Identify the device or devices that would be subject to the exception or alternative Identify the subject of the rule that is initiating the request If requesting an exception, explain why you believe the requirements are not

technologically feasible If requesting an alternative, describe the alternative and describe how it would

provide for more accurate, precise, or rapid device identification Provide the number of labelers and devices that would be impacted Send to appropriate department

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7. Know your Exceptions

Regulatory and Quality Solutions LLC

8. Implement Flexible Systems

Plan Ahead Other Quality and Regulatory agencies/bodies are going to be requiring their own version of UDI, so when you are developing your systems implement systems that are flexible. When these regulations come on board in two or three years, will your IT systems be capable of handling the additional information?

Also be prepared for the related procedural changes. Think of these additional changes as “UDI light”.

Maybe someday we really will

standardize


9. Inventory is Bad…sort of

Qualifier: This is information and not a strategy. If it is chosen by a company as a strategy then it is shortsighted and short-term.

• An interesting fact though is that product manufactured and labeled prior to the UDI deadline is grandfathered for three years. In other words, if you have inventory that was made prior to its required deadline, it is fine to sell that product up to the three-year anniversary date of the respective UDI requirement.

$ $$However =


10. Time

September 2420142015201620182020

How much time will you need to implement this program?

And,

When do you need to start?


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Thank you!

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10 Tips for Developing and Implementing a Unique Device Identification (UDI) Program

Healthcare

bear udi

udi program

udibackground background

udi final rule

medical device recalls

lifesustaining devices

document device use

medical devices