RECALL DECISION MAKING AND ASSESSMENT … | VARIAN ONCOLOGY SYSTEMS VARIAN ONCOLOGY SYSTEMS RECALL...

1 | VARIAN ONCOLOGY SYSTEMS

VARIAN ONCOLOGY SYSTEMS

RECALL DECISION MAKING AND ASSESSMENT FACTORS

Doris Apel, Manager Regulatory Affairs Varian Medical System

Confidential


Agenda HWHAP Health Hazard Evaluation Decision to Recall Market Withdrawal vs Recall

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HWHAP – What is the Issue? Nonconformance in Field

• Complaint from User • Confirmed Malfunction • Warranty Issue • Complaint Trend

Confirmed Manufacturing Nonconformance • Performance Testing • Failure Analysis

Previously Unidentified Hazard


Issue to Action Process Map Product

Improvement Requests

Complaint Trending

Investigation

Complaint

Service FSE

Help DeskCustomer

Correction Strategy RESAF

Design & Development

Process

Service Execution

MDR

Preliminary Assessment

Risk Hazard Assessment

Day 60 Day 90Day 30Day 0

Adverse Event Reporting

Reportable Corrections Reporting (+10 Days of

Recommendation)Recall Status

Reporting

Correction Recommendation

NLT Day 50

Customer Communication

Stop Orders

Discrepancy Reports

CAPAs

Complaint Process Corrections Process

Regulatory Process

Data

NLT – No Later Than


Health Hazard Evaluation: What, When, Why


Health Hazard Evaluation 21 CFR 7.41 An evaluation of the health hazard

presented by a product being recalled or considered for recall

Purpose: 1) Determine the risk to health posed by product based on the

Severity of Harm and Probability of Harm associated with the identified Hazard.

2) Evaluate product Hazards that potentially could injure patients/users/others

3) Assess Clinical Impact of hazard – Medical Professional 4) Provide rationale for decision to take action OR not


Health Hazard Evaluation

HHE factors 21 CFR 7.41 (1) Have disease or injuries occurred from product use? (2) Could any existing conditions contribute to a clinical situation that could expose humans or animals to a health hazard. (3) Assessment of hazard to various segments of the population, (children, surgical patients, pets, livestock) who are expected to be exposed to the product being considered, (4) Assessment of the seriousness of the health hazard to which the populations at risk would be exposed. (5) Assessment of the likelihood of occurrence of the hazard. (6) Assessment of the consequences (immediate or long-range) of occurrence of the hazard.


Health Hazard Evaluation When does the Issue Need an HHE? 1) If death occurred due to product 2) If serious injury due to previously unknown hazard 3) If complaint rate/trend exceeds threshold Other Considerations: 1) New information regarding known hazard 2) Product setting 3) Detected prior to use


TYPICAL HHE CONTENT 1. Product identity 2. Complaints and/or Adverse Events 3. Injuries and/or deaths 4. Quantity of product affected & Quantity of product distributed 5. Are other products potentially be affected 6. Root Cause & if known or newly identified 7.Rate of Occurrence (estimated or empirical?) 8.Are risks immediate, long-term or both?

9. Are there any design/inherent clinical factors, etc. that can mitigate risks? If yes, how effectively? 10. What is population at greatest risk? 11. Are there any health risks beyond the Users of the product? 12. What is the medical assessment of the harm? 13. What is the likelihood of harm occurrence assessment? Assess 12 & 13 for Population at greatest risk AND overall population


Making the Decision: Does the Firm Take Action


Factors 1) Firm aware of an issue 2) Investigation is complete

1) Root Cause known 2) Failure mode(s) understood

3) Risk Assessment / HHE complete 1) Hazard(s) and Harm(s) identified 2) Severity of Harm(s) assessed 3) Probability of Harm(s) assessed


Who Makes the Decision

Varian Industry Study – 10 Medical Device Companies Interviewed: • Guidant Medical • Boston Scientific • ADAC Medical • Philips Healthcare • St Jude’s Medical • 5 other medical device

manufacturers

Who Makes the Decision to Recall? • President/CEO, VP RA/QA &

VP Medical Affairs equal vote • President and/or CEO makes

decision with input from MD • Recall Executive Committee:

• Every member has a vote • Each member has a voice,

decision by President/CEO, VP RA/QA & VP Medical Affairs


Assessment Factors What Do You Know? • Technical Assessment

• Identification of hazard • Likelihood of failure • Detectability of issue • Mitigations • Root Cause of failure • Rate of Occurrence

What is Risk to Health? • Identify of Hazard(s) • Assess Severity of Harm • Assess Probability of Harm SEVERITY OF RISK DICTATES TIMELINES

• Understand clinical relevance

of product issue • Are risks immediate, long-

term, or both • Medical Assessment of Harm

Note: Lack of reported injuries do not provide basis for Probability of Harm


Considerations and Materials Reviewed

• Mitigations • Customer impact • Company reputation • Business impact • Marketing history o Risk Evaluation o Proposed Strategy o Proposed Communication

o Notification to Users o Press Release o Script [Help Desk]

o Talking Points


Decision to Act [or Not] Some firms have defined Acceptable Risk in

chart form to use for Guidance in Decision


Decision to Act [or Not] Some firms use a combination of assessments 1) Safety Risk 2) Compliance Risk 3) User Impact 4) Health Hazard Evaluation The scores are added to generate a Total Risk Score. Firm will have defined thresholds for actions.


Decision Made: Is Action a Medical Device Recall


What is a Medical Device Recall? • Recalls are actions to “protect the public

health and well being from products that present a risk of injury or gross deception or are otherwise defective. 21 CFR 7.40

• A firm’s voluntary removal or correction of a

marketed product • intended to reduce a risk to health AND • address violation of Federal Food, Drug & Cosmetic

Act where FDA would initiate legal action 21 CFR 7.3(g)

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What is a Medical Device Recall? An alternative to FDA initiated legal action for removing or correcting violative or potentially unsafe product from the market

• Seizure • Import Detention/Alert • Injunction • FDA Requested Recall • FDA Mandated Recall • Foreign Country Notification

A violative product is either: • Misbranded – Labeling Issues • Adulterated – Product Issues

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Removal vs Correction

Removal: physical retrieval of device from where it is used, stored or sold for: o Adjustment o Destruction o Inspection o Modification o Relabeling o Repair that is not part of regular scheduled maintenance

Correction: On-site remediation of the device for: o Adjustment o Destruction o Inspection o Modification o Patient Monitoring o Relabeling o Repair

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Questions to Consider

• Is your product a MEDICAL device?

YES

• Is the device in commercial distribution?

YES

• Are you REMOVING the device from the field?

OR

• Are you MAKING a CHANGE to the device in the field?

Recall


Questions to Consider

RECALL

Is the device failing to perform as intended or failing to meet any specification?

Is the device labeling false, misleading, otherwise inaccurate or deficient?

Is the device otherwise out of compliance with FDA regulations?


Example: Decision Tree Questions Is the product a medical device?

Is the product exclusively within firm’s direct control? Does product meet Specification AND is the labeling (user documentation, intended use, etc.) adequate?

SECTION A A1. Is only a reiteration of labeling information required? A2. Is a removal of product in the field required? A3. Is a recall (replacement or technical fix) required?

SECTION B B1. Is there reasonable probability that use or exposure to product will cause serious adverse health consequences or death? (Severity=Catastrophic AND Probability ≥ Probable) OR (Severity=Critical AND Probability=Frequent) B2. Would use or exposure to product cause temporary or medically reversible adverse health consequences? B3. Is probability of serious adverse health consequences remote or unlikely?


Shortages or Use Limitations Marketplace shortages may dictate recall

strategy options: o Will the benefits of continued use outweigh the risk

of product failure? o Strategy Options: Detailed Instructions for Continued Use Monitoring protocols, if applicable

o On-going Evaluations by FDA o Final Assessment by FDA


When is Firm’s Action Not a Recall? Market Withdrawal - Firm’s removal or correction of a distributed product which does not violate or is a minor violation that would not be subject to legal action by the FDA. 21 CFR 7.3(j); 806.2(h)

• Does not violate: normal stock rotation practices, routine equipment adjustments and repairs, etc.

Stock Recovery - Firm’s removal or correction of a product that has not been marketed or that has not left the direct control of the firm. 21 CFR 7.3(k); 806.2(l)


Potential Consequences - Recall

Additional Regulatory Scrutiny • Increased inspections Additional Enforcement • Warning Letters • Seizure • Injunction/Consent Decree Litigation • Products liability and discovery • Firm conduct and written

product (e.g., notifications, agency reports. etc) viewed out of context

Publicity • Recalls are:

• Published in FDA’s weekly Enforcement Report and in various trade publications

• Posted FDA website • Discussed in global agency

communications • Subject of press and television

reports


Potential Consequences – No Recall •FDA Requested Recall •FDA Ordered/Mandatory Recall [518(e) under

the Act/21 CFR 810 Regulation] •Product Seizure •Injunction – Recall clause, consent agreement •Import Alert •Foreign Country Notification •Public Notification – Public outreach


Potential Consequences – No Recall Repair, Replace or Refund

FDA can order a firm to: • Repair the device so that it does not present the

unreasonable risk of substantial harm

• Replace the device with a like or equivalent device which is in conformity will all applicable requirements of the FDA’s laws

• Refund the purchase price (less depreciation from use)


Recommendations Final Thoughts


Recommendations

• Establish recall procedures and define timelines • Corporate • Each facility/business unit

• Establish a recall manager / recall team • Operational • Define single point of contact with the FDA • Recall team members and function

• Establish risk to health criteria for the product(s) • Product risk (design & production) • Health risk criteria associated with each type of marketed product

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Recommendations

• Identify decision makers and review forum • Define decision format • Establish decision criteria

• Mitigations • Customer impact • Company reputation • Business impact • Marketing history

• Designate documentation and archiving of Decision

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Final Point

• Global Company Global Considerations • What other regulations may be applicable? o Radiological Health Regulations 21 CFR 1000 o HIPPA Regulations 45 CFR 106, 162 & 164

o OUS regulations

o Health Canada o China Food and Drug Administration o Therapeutic Goods Administration [AU/NZ] o EU Medical Device Vigilance System MEDDEV 2.12/1

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Date post:	10-Apr-2018
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