recall simulation - cbi | powering thought leadership ... · ivt december 2016 recall simulation...

© 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.


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


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


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.

Recall Strategy:KEY CONSIDERATIONS

© 2016 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.XCBI 2016-06-15

Why create a Recall Strategy?


Affected Product Logistics (including classification, type, &

timeline)

Regulatory Agency & Consignee

Notifications

Effectiveness Checks and Closure


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


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)


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


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


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


Regulatory Authority

Requirements and Expectations


• 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


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


• 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


Effective Consignee Notification


Purpose of Notification

What product is subject to the

action

What the recipient needs to do


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


Example FSN


Execution of Field Action and

Effectiveness Checks


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


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.)


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


Expect the Unexpected


• 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


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

recall simulation - cbi | powering thought leadership ... · ivt december 2016 recall simulation...

Documents