SMI Medical Device Recall Initiative

Team Breakout Meeting

Dallas, Texas

October 24, 2017

Slide 1

Today’s Objectives and Agenda

• Introductions

• Initiative Background

• The Regulations

• Phase One – Draft Recommendations

• Phase One – Education

• Phase Two – Best Practices

Slide 2

Initiative Team Composition To-Date

Slide 3

First Name Last Name Organization

Stewart Layhe Denver Health

Susan Sadler Denver Health

Dan Stephens St. Jude Medical

Karin Rollinger Sanford Health

Mike Erickson Sanford Health

Tom Lubotsky Advocate Health*

Dennis Black BD*

Jesse Shafer Mayo Clinic

Terri Nelson Mayo Clinic

Brian Maas Spectrum Health System

Jim Walker Jim Walker Associates

Guillermo Ramas Genesis Automation USA

John Cunningham Procured Health

Jeff Girardi HIDA

Ethan Abernathy Procured Health

Matthew Meyer Avera Health

Garth Gonseth Avera Health

Tom Harvieux Sanford Health

Elizabeth Hilla HIDA

Steve Huckabaa Avera

Jane Pleasants Duke

Mark Yale BD

Sissel Jacob Centura

Matt Mentel Mercy

SMI Recall Initiative

• Initiative Team Leaders

• Dennis Black, BD

• Tom Lubotsky, Advocate Health

• SMI Project Manager

• Jim Walker, Jim Walker & Associates

• SMI Initiative Executive

• Dennis Orthman, SMI

• SMI Staff Support

• Carolyn Huntington, SMI

Slide 4

Initiative Team Project Plan - Original

Slide 5

Initiative Phase Actions Time Frame

Preparation Phase Team kick-off, process stream mapping, identification of pain points and opportunities, FDA feedback

Feb. – May 2017

Recommendation Phase Develop recommendation for regulatory change, gather evidence and gain internal and external support

June - Nov. 2017

Submit Recommendation Present recommendations to regulators Dec. 2017 – March 2018

Possible Recall Phase II Initiative

Determine how to pursue non-regulatory opportunities and best practices

Nov. 2017 – May 2018

You are here

Initiative Overview

Team Accomplishments

✓ Engage healthcare providers, medical device suppliers, service companies and invited participants in a

collaborative process

✓ Create detailed process maps of the recall processes generally used by healthcare providers and suppliers

✓ Use the process maps to identify common “pain points” by industry segment

✓ Identify changes to regulatory requirements that address the pain points

✓ Collect Evidence to support recommendations

• Make recommendations to regulators for changes

• Develop an educational program (added)

• Utilize Best Practices development to address pain points not requiring regulatory change

• Consider Best Practice work to improve recall management within the Provider’s system

• Offer any output to the industry for download at no charge from www.smisupplychain.com

Slide 6

PhaseOne

PhaseTwo

Initiative Overview

Slide 7

Mapping WorkshopInitiative Overview

Slide 8

Initiative Overview

Slide 9

Initiative Overview

Slide 10

Initiative Overview

Slide 11

Initiative Overview

Slide 12

Initiative Overview

Major Themes from “Pain Points”

• Communications

• Returns and Credit Management

• Locations and Retrieval of Products

Slide 13

SMI is focused on regulatory change

SMI will focus on industry best practices

Initiative Overview

Communication Opportunities and Recommendations

Slide 14

Initiate Communication - Notice Phase I

Initiate Communication - Return Phase I

Develop a Universal LexiconPhase I

Assign a “Z” Number to each Recall Phase II

Initiative Overview

Successful Initiative CharacteristicsTo Date

• Significant IDN participation

• Team member commitment and talent

• Multiple conversations and feedback

from FDA

• Team consensus on most significant

pain points

• Process

• Pain Points

• Adding education to scope

Slide 15

Initiative Overview

Initiative Still Needs:

• to expand supplier participation

• to build a coalition

• to move faster

The Regulations

• The Food and Drug Administration (FDA) is the regulatory agency responsible for

medical device recalls

• Recall means a firm’s removal or correction of a marketed device that the FDA

considers to be in violation of the laws it administers

• Most recalls are performed voluntarily by the firm, not mandated by the FDA

• The FDA monitors the progress of the recall

• Failing to properly conduct a recall can result in patient harm, criminal and civil

penalties, seizure of products, and reputation damage

Slide 16

The Regulations

The Regulations

Summary

• A recall does not always involve physically removing a product from the market. Instead, there are two types of recalls: removals and corrections

• According to the FDA, “removal” means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection. This results in permanent removal of a product from where it is used or sold

• In such cases, Manufacturers will instruct customers to return the defective product, then they typically destroy it

• Manufacturers will provide a replacement product or a credit to the customer

• “Correction” means repair, modification, adjustment, relabeling, destruction or inspection (including patient monitoring) of a product without its physical removal to another location

Slide 17

The Regulations

Recall Procedure 21CRF7

FDA Regulatory Procedure Manual

• Recall Procedure 21CRF7

• Section 5: Recall Communication and Notification

Current Language:

Recall communications should be sent in the most expeditious manner and commensurate with the hazard of the product being recalled, and, where appropriate, sent with proof of receipt (e.g., by certified mail). All communication methods related to the firm’s recall should be documented accordingly.

Recall communication, particularly letters to direct accounts and subaccounts should include a postage-paid, self-addressed post card, envelope, or other arrangement to enable the consignee to report the amount of the product available and its disposition.

Recall communications should direct that the consignee submit a report regardless of whether or not any of the products are on hand. It should also stress prompt return of the postcard or other report. (See Exhibits 7-4, 7-5, 7-6, 7-7, FDA Recall Industry Guidance webpage for model letters, envelopes and recall return response forms.)

Slide 18

The Regulations

Classes of Recalls

• The FDA has defined three classes of recalls to distinguish the degree of health risk involved in each recall situation

• A Class I recall means there is a reasonable chance the product will cause serious health problems or death

• A Class II recall means the product may cause a temporary or reversible health problem, or there is a slight chance it will cause serious health problems or death

• A Class III recall means the product is not likely to cause any health problem or injury

• The classification the FDA assigns to each product recall helps determine the level of oversight the FDA applies to the manufacturer’s recall efforts. Regardless of the recall classification, customers must follow all recall instructions from the manufacturers

Slide 19

The Regulations

Communication Opportunities 1 & 2

Electronic Communication - Notice

• Send pdf of letter (w/ Z #)

• Electronic receipt replaces green card

• Establish a national registry of standardized recall notice emails: recall@mayo.edu

Slide 20

Electronic Communication –Return

• Electronic Business Reply

• Return of signed pdf of letter w/ Z #

• All communications in single stream

• Electronic receipt replaces green card

• Establish a national registry of standardized recall notice emails: recall@mayo.edu

Draft Recommendations

Days at risk

Slide 21

Total Days Days to Issued Entered Days between Completed

Recall # Mfg Name Recall Description at Risk Close Status Date Date issued and Received Date

4789 Cook Medical Urgent Medical Device Correction: Cook Medical 1 1 Closed 4/3/17 4/3/17 1 4/3/17

Cook Zenith Alpha Thoracic Endovascular Graft:

Instructions for Use

4792 Verathon Urgent Medical Device Recall: Verathon - 4 3 Closed 4/4/17 4/4/17 1 4/7/17

Glidescope GVL 2 STAT: Mis-labeling of one

lot number

4793 Philip Urgent Field Safety Notice: Philips - Philips 20 1 Closed 3/9/17 4/5/17 20 4/5/17

Allura Xper X-ray Systems: Potential System

damage due to leakage of coolant liquid from

the detector cooling system

4796 Advanced Urgent Product Recall: Advanced Sterilization - 11 8 Closed 4/4/17 4/6/17 3 4/18/17

Sterilization STERRAD 100s Cassettes: Due to a discrepancy

with the machine readable expiration barcode

Draft Recommendations

Manufacturer Recall Data

Slide 22

Notes

Recall Scope Distributor# shipments

to distributor

# Units -

cases or

(eaches)

Shipped to

Total #

Distributor

shipments

(eaches)

(A) Total #

ship to

customers

(B) #

customers

with multiple

lines

(C ) #

Mutiple

mailing to

(B)

customers

(D) Multiples

(C ) as % of

Total (A)

A 24 184 4791 4265 222 1120 26.26%

B 78 338 883 845 47 324 38.34%

C 4 18 2130 358 8 19 5.31%

D 19 166 5218 5111 102 4013 78.52% retail pharmacy

E 2 7 3932 3844 141 2651 68.96% retail pharmacy

D 50 257,200 6,139 6062 102 4504 74.3% retail pharmacy

F 49 1,030,200 22,822,021 587 53 215 36.6% Dist executed action

1 SKU / 1 Lot

BD Data Dist Data Analysed Data

3 SKU /7 Lots

Draft Recommendations

Electronic Communication – Notice and Return

Explanation/Background

Analysis of 70 recalls from 5 major IDNs indicates that a delay can exist from the time a manufacturer initiates a recall to the receipt of recall notice by appropriate healthcare personnel. In our analysis, 50% of recall notices were received by hospitals in our sample in 1 day, while 50% were received between 2-9 days using current delivery methods of U.S. mail or overnight express services.

Manufacturers are also challenged to insure that all personnel and departments at every facility using the recalled item are notified. The manufacturer is also responsible for assuring confirmation of receipt of the notice. Manufacturers surveyed indicated less than 100% response rate, requiring them to send multiple notices to most customers.

The current process can create delays in the time it takes to notify the appropriate personnel. This manual process can also create delays in obtaining confirmation from hospital personnel who have been notified. Provider and supplier members of SMI overwhelmingly support using electronic communication (Email) to dramatically decrease provider notification time and response confirmation, thereby increasing patient safety.

Slide 23

Draft Recommendations

Best Practices Supporting Recommended Augmentation to 21CRF7 Section 5

Slide 24

Best Practice Rationale

Establish a centralized Email address for each Provider specific to recall notification and response

Real time alert notifications will reduce the days at risk, including days added by the notice being in transit via the postal service or overnight delivery

Provider will identify a point person or department to facilitate internal dissemination of information in a timely manner and eliminate need for duplicate notices to be sent by the Manufacturer

Provider is uniquely positioned to communicate recall details in the most timely manner to the internal end-users of the recalled product

Develop a National Provider Email Registry Assure accuracy to execute recalls most efficiently

Draft Recommendations

Draft – SMI’s Recommendation to FDA

Add the following language to Augment Recall Procedure 21CRF7 - Section 5 :

The Manufacturer initiating a recall may do so utilizing electronic communication to notify the consignee of the recall, and may also utilize electronic communication to expedite completion and return of the recall return response form.

Slide 25

Draft Recommendations

Communication Opportunity #3Develop a Universal Lexicon

Explanation/Background

The FDA utilizes the following terminology for recalls

• Medical Device Recall Removal• Medical Device Recall Correction

Providers have voiced concern about potential confusion created when Manufacturers or 3rd parties utilize different language when issuing recall notices.

From 70 recall notices collected, we observed the following notification language

1. Urgent Field Safety Notice2. Health Device Alert3. Event Overview4. Urgent Medical Device Removal5. Product Recall Notification6. Urgent Product Recall Field Correction7. Medical Device Recall Extension8. Urgent Product Advisory Notice9. Urgent Medical Device Recall

Slide 26

Draft Recommendations

Draft Recommendation Develop a Universal Lexicon

Draft – SMI’s Recommendation to FDA

That the FDA establish a joint public (FDA) and industry (SMI and others) initiative to establish clear, concise, standardized language and a standard notification template for communicating a medical device recall.

Rationale

Manufacturers, Distributors and 3rd Parties could be more consistent with formatting notices and ensuring all relevant information can easily and consistently be universally understood

This information may include: product numbers, UDI, distributor names, distributor product numbers, purchase order numbers, manufacturer’s product number for a recall involving a component of a larger product, and pictures of the product

Slide 27

Draft Recommendations

Draft RecommendationsNext Steps

1. Team Recommendations to FDA Must be Approved by the SMI Board of Directors

2. Who should we contact to “build the coalition of supporters for the recommendations?

Slide 28

Draft Recommendations

Welcome to thisThis Webinar is sponsored by the

SMI Initiative Team working on

“Medical Device Recall Initiative”

Visit www.smisupplychain.com for more information

SMI is a not-for-profit, independent consortium of supply chain executives from across healthcare industry segments working together

as a change agent to reshape relationships and reengineer processes for the overall improvement of the healthcare supply chain.

On-Demand Webinar

Education

SMI2U Webinar The Medical Device Recall Process

Webinar Outline

1. SMI and the SMI Initiative

2. The Regulations

3. The End-To-End Recall Process

4. Recommendations for Change

5. Q&A

Slide 30

Education

How do we properly explain the process map?

Discussion on

How do we identify the best practices?

Should we survey SMI members?

Slide 31

Phase Two Best Practices

SMI Recall Initiative

DISCUSSION

and

NEXT STEPS

Slide 32