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© 2016 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.IVT December 2016
Recall SimulationPractical Strategies for Complaint Recall Execution
Pearley Bhambri
Sr. Director Global QS & Post Market Survillence
Hill-Rom, Inc.
Jennifer Judge
Post Market Compliance Specialist
Welch Allyn / Hill-Rom, Inc.
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© 2016 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.IVT December 2016
Primary Care Office
Emergency Room
Operating Room
Intensive Care Unit
Med-Surg Patient Room
Long-Term Care & Respiratory
Hill-Rom, Inc.Integrated and Innovative Clinical Solutions Across Care Settings
Physical exam, thermometry, blood pressure tools, and women’s health
Lights, booms, surgical tables, blades/ scalpels
Beds, surfaces, lifts, vital signs monitors, BP cuffs, and respiratory therapies
Stretchers, booms, lights, patient vital signs monitoring
Beds, surfaces, lifts, remote patient monitoring, respiratory therapiesPatient/Staff Communication Technologies
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© 2016 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.IVT December 2016
Disclaimer
• Content of this presentation is the viewpoint of the presenters only, and
does not necessarily represent the companies or organisations the
presenters are associated with.
• The examples provided do not necessarily reflect any actual circumstances
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© 2016 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.IVT December 2016
What is a Recall?
Any action taken by the manufacturer, importer, or distributor of the device to
recall or correct the device, or to notify its owners and users of its defectiveness
or potential defectiveness, after becoming aware that the device (a) may be
hazardous to health; (b) may fail to conform to any claim made by the
manufacturer or importer relating to its effectiveness, benefits, performance
characteristics or safety; or (c) may not meet the requirements of the applicable
Regulations.
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Why create a Recall Strategy?
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Affected Product Logistics (including classification, type, &
timeline)
Regulatory Agency & Consignee
Notifications
Effectiveness Checks and Closure
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ClassificationWhy is action in the field being considered?
RECALL
Fails to conform to
claims
Requirement of regulation
not met
Hazardous to health Non-Routine
Servicing
Customer Satisfaction
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TypeWhat action is being considered?
• SW upgrade
• Labeling change
Correction (in the field)
• Product destruction
• Replacement
• Repair
Removal
• Inform customers / users of the issue
• Provide instructions
Notification (i.e., Field Safety Notice)
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© 2016 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.IVT December 2016
Scope of Action
1. Consignee list
2. Level of consignee notification
• First level consignee (product sold to) or end user consignee (consumer of the
product)
• Regulatory requirements / authority may dictate level of consignee notification
• European Competent Authorities typically require execution to the end consignee level
• Consider Distributor contracts and relationships
• Will also impact who and how will action be implemented
3. Countries affected
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Notification Considerations
Regulatory Agency
• Reporting requirements & timelines vary
• Mfg’er, importer and distributor requirements
• Consistency –NCAR program
• Lead Authority for EU
• Notified Body
Consignee
• Format
• Reason & instructions
• Response Form
• Contact info
• Delivery method (e.g., UPS/Fedex),
• Distributors
• Instructions to forward to end user
Internal
• Cross functional stakeholders
• Sales
• FAQs for Customer Care
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© 2016 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.IVT December 2016
Effectiveness Check & Closure
• How do you measure?
– Proof of Delivery, Cert of destruction, confirmation of software upgrade or
product return
– Timelines
• When can you internally close?
– Percent of effectiveness checks
– Request for closure from authority
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© 2016 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.IVT December 2016
Regulatory Authority
Requirements and Expectations
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© 2016 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.IVT December 2016
• Notification to authority within the prescribed timelines (FDA Part 806, HC Section 64, Field Safety Corrective Action Report (FSCA), etc.)
Note: Reason for action may dictate if formal notification is required
• Will require: Affected product list Consignee List Reason and justification (likely the associated HHE/HRA) Draft of consignee notification High level strategy including effectiveness check
• Local language translations of FSN, if applicable
• Periodic Updates and request for closure• Specific form / format for closure request• May require completion in justification or globally
Requirements
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Europe Competent Authority Expectations
File and gain agreement on FSCA with lead authority
• Note: if the action originated within the jurisdiction of a CA other than your lead authority, then notification of the FSCA to the lead authority and the other affected CA shall be conducted in parallel
Additional Competent Authorities (CA)
• File the agreed FSCA with each of the affected authorities
• Report the number of affected units and the affected consignees in that country
Lead Competent Authority will issue National Competent Authority Report (NCAR)
• The FSCA will serve as an input to NCAR
Action for each country can commence when the CA for that country has been notified
Send status reports on a pre-defined basis
Submit a closing status report to each CA including:
• Rate of completion of the action for the Authority’s local jurisdiction and
• Relevant justification for any part of the action that is incomplete
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© 2016 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.IVT December 2016
• Be prepared once you announce your intention conduct a Field Action
• All required information will be expected in a timely manner
• CA’s and NB must be notified prior to your consignees
• Negotiate with the lead authority on the strategy of the action and field safety notice
before reporting to other CAs
• All other CA typically tend to agree with the lead authority
• Notify all remaining affected CAs once agreement from lead authority on the
FSCA
Note: lead authority will issue NCAR shortly after the agreement on the FSCA
• Notify your internal stakeholders at an appropriate time
Recommendations
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Effective Consignee Notification
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Purpose of Notification
What product is subject to the
action
What the recipient needs to do
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Clearly identify the product (affected batch, model, lot, serial number(s) etc.) and any other pertinent descriptive information to enable accurate and immediate identification of the product
Explain concisely the reason for the field action and the hazard involved, if any Provide specific instructions on what, if anything, should be done with respect to the
affected product or any other action the recipient needs to take Where appropriate, that further distribution or use of any remaining product should
cease immediately Instruction to distribute the notification to the applicable personal Contact information
Separate notification may be appropriate for Distributors • Notify its affected customers about the field action OR notify Manufacturer who
their affected customers are
Should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message.
Note: Follow authority guidelinesE.g., 10.5 ANNEX 5 - Template for a Field Safety Notice MEDDEV 2.12-1 rev 8
Notification Content
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Execution of Field Action and
Effectiveness Checks
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Execution of Field Action“develop effective closed loop systems that ensure the dissemination of the Field Safety
notices and the timely completion of the actions outlined.” MEDDEV 2.12-1 rev 8
• Cross-functional teams have clear understanding of expectations
• Consider Project Manager
Roles & Responsibilities
• Ensure timely attempts (e.g. 3 attempts with varying means)
• Track all attempts. E.g. Fedex/UPS/DHL report, email (read receipts), phone call follow up attempts – log contact and date of attempts.
Notifications
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© 2016 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.IVT December 2016
Field Action Effectiveness Checks
Level of effectiveness required should take into consideration the class of the recall,
regulatory agency guidance, and other risk assessments, as appropriate.
Plan your reconciliation report
Pre-define levels of effectiveness prior to commencing Action – agree this with
authorities. E.g. – Reasonable attempt.
Have all the contactable consignees been identified? If not, document why (e.g.
business closed, untraceable, etc.)
Document rationale for any unsuccessful action – e.g. product no longer in use,
product already consumed, etc.)
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© 2016 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.IVT December 2016
Recall Closure:
Considerations
• Can you demonstrate reasonable attempt to notify each affected consignee?
• Have you tracked dates sent, tracking numbers, status of delivery, rationale for non-delivery?
• Have you received response forms?
• Have consignees accounted for affected devices?
If not YES, have you been provided with a rationale as to why not
• Single use device that has been confirmed already consumed
• Re-usable device – confirmed no longer in service or cannot be located
Is reconciliation report complete with all of above for each consignee and/or each serial number (if serialised product)?
If you can reasonably demonstrate above, request closure from authority.
• Typically require completion at local jurisdiction
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© 2016 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.IVT December 2016
• Avoid contradicting what was previously communicated with authorities• Have you captured ALL affected product – define what is in-scope and what is not
(HRA/HHE should define this)• Have you captured ALL affected consignees – Accurate sales records
• Response Form: Ensure you capture all relevant data from your consignee (where applicable)• Certificate of Destruction• Quantities in stock• Software upgrade installed• Confirmation that Distributor has notified their end users• Confirmation that FSN has been circulated to relevant departments within organization
• Distributors:• What agreement is in place (Contractual agreements for Recall Activity)• Tracking communications received from indirect customers (i.e., distributor end-users
vs. your consignees)
Potential Pitfalls
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© 2016 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.IVT December 2016
Best Practices
• Always check the Vigilance Contact Points
– For example, European Commission website will generally have latest published
Contact points
– Contact points have and will change periodically
– Utilize generic contacts when possible
• Ensure your customer notification conforms with the authority guidance's
– For example, MEDDEV 2.12-1 Rev 8
• Internally, create a tracking tool for all your communications by each
authority
– Generally will have multiple communications per authority
• Expect some authorities to ask for a copy of your CAPA
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© 2016 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.XCBI 2016-06-15
Recalls Are a Part of Our Business