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: [email protected]
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: [email protected]
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