Optimize Your Field Safety Corrective Actions Systems

Transcription

1 Optimize Your Field Safety Corrective Actions Systems Patrick Caines, Ph.D. Baxter Healthcare 9 December

2 Agenda International regulatory requirements and expectations for FSCA and recalls Developing a successful recall strategy to ensure compliance with Global regulatory and FDA protocols Investigation strategy and risk assessments Health Hazard Evaluations Decision to FSCA / Recall Communication and collaboration strategy to aid in timely decision making and so all stakeholders have appropriate information. Market Withdrawal vs. Recall Distinguishing between design changes and new iterations of a device from a FSCA Strategies & Best Practices for effectively coordinating FSCAs globally Case Studies 2

3 Overview - Field Safety Corrective Action (FSCA) The Medical Device Directives require the Manufacturer to report to the National Competent Authority any technical or medical reason leading to a systematic recall of devices of the same type by the Manufacturer. Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the instructions for use which might lead to or might have led to the death of a patient or USER or to a serious deterioration in his state of health. When medical devices are suspected of being potentially harmful to users, due to nonconformity to quality, safety and performance requirements, they may be subjected to a Field Safety Corrective Action (FSCA). FSCA is synonymous with a systematic recall (FDA) or withdrawal of the device from the market FSCA needs to be reported on the Report Form: Field Safety Corrective Action: Annex 4 & Template Annex 5 (MEDDEV rev6 December 2009) (MEDDEV rev8 Jan 2013)) Provided to the Ministries of Health in all affected countries and to the national competent authority responsible for the manufacture. Along with relevant documentation: e.g. related parts of risk analysis, background, description, justification, advice to distributor and user, and affected devices (serial, lot, batch number ranges). 3

4 Definitions 4.6 FIELD SAFETY CORRECTIVE ACTION (FSCA) An action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market. Such actions should be notified via a Field Safety Notice. the return of a medical device to the supplier; device modification; device exchange; device destruction; retrofit by purchaser of manufacturer s modification or design change; advice given by manufacturer regarding the use of the device (e.g. where the device is no longer on the market or has been withdrawn but could still possibly be in use e.g. implants or change in analytical sensitivity or specificity for diagnostic devices) 4

5 Definitions FIELD SAFETY NOTICE (FSN) (Europe MEDDEV ): A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action. ADVISORY NOTICE (ISO 13485): Notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information and/or to advise what action should be taken in the use of a medical device, the modification of a medical device, the return to the organization that supplied the medical device, or the destruction of a medical device for the purpose of corrective or preventive action. 5

6 Post market Surveillance Components Post market Surveillance and Action System Surveillance (Information Input) Investigation & Analysis Action Communication Complaints Servicing Literature Reviews Customer Feedback Surveys Focus Groups Post market clinical studies; OUS events if same / similar product is marketed or manufactured in US Integrated data systems Failure Investigations Returned products Internal testing Medical review Risk Management MDR filing decisions Vigilance (MDV) analysis Field Alert Reports (FAR) BPDR CAPA Process Design Labeling Training Correction / removal All stakeholders Management Internal businesses & plants R&D; Risk Mgt. US / OUS Regulatory Agencies Hospitals, Physicians, Patients Suppliers Distributors Goal of PMS system is to take appropriate action to protect public safety and improve product performance 6

7 Vigilance System Manufacturer s Incident Report Customer Feedback & Vigilance Manufacturer s Trend Report Complaint Handling Medical Device Reporting (FDA ) Field Safety Corrective Action Recalls (FDA) 7

8 Action System & Outputs Product Inquiry Report Complaints & Complaint Trending PM Studies & Registries Product Testing Inspections Suppliers Escalation Medical Health Hazard Evaluation Quality Escalates Issue Investigation Root Cause Risk Management Regulatory Recommends Field Action / Recall Field Action Execution CAPA No Field Action CAPA Field Action Committee Senior Mgmt. Decision Makers 8

9 FDA Designation RECALL (US FDA): The correction or removal of a device commercially distributed for human use in the US where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. Reasonable probability means that it is more likely than not that an event will occur. Per US FDA, CORRECTION means the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product/device without its physical removal from its point of use to some other location. Per US 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. Note: Recall does not include a market withdrawal or a stock recovery. Recall does not include routine servicing or an enhancement. Recall does not include routine servicing or an enhancement. FDA Code of Federal Regulations(CFR s) 21 CFR Part 7 Recall Enforcement Policy 21 CFR Part 806 Medical Device Reports of Corrections & Removals 21 CFR Part 810 Medical Device Recall Authority (also FD&C Act, Sec. 518(e)) 9

10 FDA Definitions Correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal to some other location. Removal as used in the definition of recall at 21 CFR 7.3(g), means the physical removal of a device to some other location for repair, modification, adjustment, relabeling, destruction or inspection. Stock recovery means a firm's removal or correction of a product that has not been marketed or that has not left the direct control of the firm, i.e., the product is located on premises owned by, or under the control of, the firm and no portion of the lot, model, code, or other relevant unit has been released for sale or use. A stock recovery is not a recall. Market withdrawal means a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the Food and Drug Administration or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc. A market withdrawal is not a recall. 10

11 FDA Designations Recalls are classified into a numerical designation (I, II, or III) by the FDA to indicate the relative degree of health hazard presented by the product being recalled. Class I - a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Class II - a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Class III - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 11

12 Violative Product Product that fails to meet Performance Claims and/or Product s Labeling Claims (misbranding) and/or Product s Intended Use and/or Product s specifications: Design specifications, Release specifications, Performance specifications, and/or Reliability claims or design expectations e.g. parts with normal wear and tear e.g. parts in Periodic Maintenance (PM) not lasting for entire validated PM cycle or performance that breaches historical performance (parts that systematically fail prematurely ) Product that is manufactured outside of GMPs Adulterated product e.g. Operators not properly trained; inspection equipment out of calibration; test methods not validated; 12

13 Global Competent Authorities and ISO Registrars UK - MHRA, Ireland HPRA, US FDA, Canada Health Canada Portugal INFARMED, Japan MHLW, France ANSM, Australia TGA, Brazil ANVISA, Spain AEMPS, Germany - BfArM/PEI, Singapore HSA, Colombia - INVIMA TUV BSI GMED Examples: Therapeutic Goods Administration (A/NZ) - Recall - means the permanent removal of therapeutic goods from supply or use for reasons relating to deficiencies in the quality, safety or efficacy of the goods. Health Canada Section 64: A recall is defined as: any action taken by the manufacturer, importer or distributor of the device that has been sold, 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: may be hazardous to health; may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety; or may not meet the requirements set in the Act or the Regulations. 13

14 FSCA / Recall Process Discussion: What are some first steps? 14

15 Field Safety Corrective Action Process Flow Issue Identified Issue Investigation Generate Issue Description and Affected Product Table Immediate FA Decision Generate Technical Analysis Perform Health Hazard Analysis Generate Decision Is a Field Action Required? Y E S Generate FA Plan and Communication Correct Issue Perform Effectiveness Checks Issue confirmed YES N O Close FA Close Assessment File Issue Escalation to FA Process? NO Document the rationale for no escalation in the quality record Baxter Confidential

16 FSCA / Recall Process Identify Safety or Quality Signal for further investigation and/or escalation. Develop Recall Strategy (Removal; Correction; Customer Impact; Business Impact) Evaluate Health and/or Quality (System) risks Scope of the issue (affected product); Locations, etc Classify Escalate to Management When and where should FDA or Regulator be advised of actions to be taken? How do we execute the recall strategy? In-house or 3rd party assistance? Secure potentially affected product within Operations (production halt, quarantine, product hold) Secure potentially affected product within supply chain (warehouse, in-transit) How to get device back (location; distributors or 3rd parties? Type of defect certain defects may prohibit shipping device back e.g. lithium batteries. Costs; Reduce recall fatigue Coordinate with in-house our outside legal team at each step Communication strategy so all stakeholders have appropriate information. 16

17 Recall Strategy Recall strategy means a planned course of action to be taken in conducting a specific recall, which addresses the depth of recall, need for public warnings, and extent of effectiveness checks for the recall. Each recall will have its own unique strategy. Tools to help develop strategy: Risk Assessment: AAMI on Benefit Risk Benefit/Risk: FDA s draft Guidance FDA s HHE form FDA s Guidance: Product Recalls ucm htm ls/ What else should be part of the Recall strategy? 17

18 FDA Enforcement Report Once a recall is classified, it is published in the Enforcement Report. 21 CFR 7.50 The Food and Drug Administration will promptly make available to the public in the weekly FDA Enforcement Report a descriptive listing of each new recall according to its classification, whether it was Food and Drug Administration-requested or firm- initiated, and the specific action being taken by the recalling firm. rts/default.htm 18

19 Investigation Strategy Develop a clear and actionable problem statement. What is the problem and when did it begin and end? What objective evidence supports your decisions? Review Manufacturing data and Design history file Can additional lots or products be affected other than the lots or product analyzed and found to be subject to recall? How many different sizes may be affected? Utilize the appropriate and approved investigation tools necessary to drive the team to root cause. What data do you have that supports your decision? Has a root cause determination been made? What efforts have been made to assess the hazard and the scope of the recall? CAPA action plan and effectiveness checks. Work within and across functions, sites, and regions as necessary to assure connectivity of investigations between functional areas and sites. Effectively remove obstacles as required. Collaborate with functional leaders to prioritize team member workload to aid in timely decisions and completion of investigation. Solution selection & validation What else should be part of the Investigation Strategy? 19

20 Identifying and Scoping Affected Product What are some best practices for identifying the proper scope of the recall? What efforts can be taken to ensure the initial scope of the recall is correct and may not require expansion of the recall? What other records may provide insight into the affected products? What are some additional data sources to consider reviewing? Is a manufacturing record review sufficient? Key items to capture in your documentation are: Key milestones in the decision making process. Who decided and what was decided? Data that supports your determination and decision. Did you consider all sources of available data? Was your root cause investigation comprehensive? How was the decision communicated within your organization? Does it need a top management level review or concurrence? Does it need a legal review? What will you provide a regulatory agency or agencies that ask for your root cause determination, risk assessment and health hazard evaluation? 20

21 HHE Considerations Best practice Initial HHE to guide recall decision and classification. Update and final HHE as more information is obtained. HHEs should include: Product identity, Quantity of product affected and distributed. Other products potentially affected? # Complaints and/or Adverse Events, # Injuries and/or deaths reported, How identifiable is the product failure? Always, sometimes, never? What is the likelihood of occurrence? And likelihood of it occurring undetected? Root Cause; Is issue a known or newly identified hazard Is rate of occurrence different from that identified in Risk Management File? Consider safety impact in 2 populations general population and population most at risk (e.g. elderly, pediatric, co-morbidities) assess for both Population at greatest risk and overall population Are risks immediate, long-term or both? Are there any design/inherent clinical factors, etc. that can mitigate risks. If yes, how effectively? Are there any health risks beyond the patient e.g. Users of the product? 21

22 Recall Process What are the next steps? 1. Target Consignee Identification 2. Notification Management 3. Response Management 4. Retrieval / Correction Product Processing Remedy Management Resolution Management 5. Implement initial Action / Notify / Sequester and/or Disposition Product 6. Determine Root Cause and Implement all Corrective actions (with effectivity) 7. Updates to Regulatory Authorities 8. Verification of Effectiveness of the Recall 9. Close/Terminate Recall 22

23 Corrections vs. Enhancements (FDA Guidance) A device enhancement is a change to improve the performance or quality of a device that is not a change to remedy a violation of the FD&C Act. Device enhancements include, but are not limited to, changes designed to better meet the needs of the user, changes to make the device easier to manufacture, changes to improve the device s safety or performance, and changes to the appearance of the device that do not affect its use. Questions to consider: Differentiating Violative Devices from Non-Violative Devices Are the changes intended to resolve a failure to meet specifications or failure of the device to perform as intended? Yes = Recall, No = Enhancement Is the labeling for the device to which you are considering making changes false or misleading, does it fail to have adequate directions for use, or does it include indications for use that are not cleared? Yes = Recall, No = Enhancement Is product out of compliance with the FD&C Act or FDA regulations? Yes = Recall, No = Enhancement 23

24 Recall information Provided to Regulator Field Action Identifier Manufacturer's Information: Address, Facility ID, Contact Information Product Regulatory License, Product/Device Regulatory Identifier, Approval, Clearance ID, 510(k)/IDE/PMA number etc. Product (s) Catalog, Lot and/or Version # Identifiers Number of affected devices manufactured, Date of manufacture, Imported, Distributed and/or on Stop Shipment; Issue Summary; Awareness Date of Issue, Containment actions (Stop Shipments, letters, etc.) and final actions) and Copies of the Customer Communication Global Consignee lists; #consignees responding, effectivity plan, Complaints (MDR / Adverse Event / Vigilance Reports) Health Hazard Evaluation Technical Assessment (TA) - Product Background Information: Technical, Chronology, Actions Taken and to be Taken Current Root Cause and CAPA Summary; Plan to assess CAPA effectivity and whether CAPA is/was deemed effective. Additional for Drug Recalls: NDA/ANDA/NADA Number NDC Number Indicate if prescription or OTC Strength Route of Administration 24

25 Documentation Regulators may request the following documentation: Your draft recall letter All labeling for products under recall. Your health hazard evaluation Draft Press Release ASAP (If applicable, typically Class I recall) Distribution List, domestic and foreign accounts. MDR Reports or summary of reports, if MDR s were submitted. Copy of 806 submission Corrections and Removal Report. Any investigation conducted, including sample results. Number and types of complaints. CAPA Records, such as device correction; verification/validation of device correction; root cause determination; CAPA to address root cause; verification or validation of CAPA. Labeling or user manual or device instructions Any corrective action planned and the timeframe to complete. 25

26 Coordinating Internal Team Medical Regulatory Quality Logistics Manufacturing Legal Public or Media Relations Marketing Sales Who should be involved in the discussions and what roles? Who should participate? Who should take the lead? What should be the decision making process for developing the recall strategy? Who is knowledgeable and can best describe and discuss the issue? 26

27 Include external stakeholders Regulatory Agencies Patients Users Providers Payers Investors Any other External stakeholders? Consignees! 27

28 Recall Effectiveness Checks May be formally required depending on Class of recall Evaluate success of recall by verifying plan worked accordingly. Company is responsible for determining whether the recall is effective. Recall effectiveness checks verify that: All consignees have been notified and have taken appropriate action. Recalled product is effectively dispositioned or destroyed Determine whether all actions were completed to the satisfaction of regulatory authorities. Determine whether recall was implemented as quickly as possible to limit adverse public health event. Steps include the following: Consignees received notification Consignees have taken appropriate action If response is less than 100% then recall strategy needs to be reassessed. Certain circumstances should factor in such as amount of product returned vs. expected amount, potential for injury and shelf-life of product. Verification should be documented 28

29 Elements of a Successful Recall Recall Team Defined Process Centralized Reporting Field Optimization Clear Lines of Internal & External Communication There may be communications with the patients, users, regulatory authorities and possibly media, providers, payers, and investors Recall committee member designations Recall responsibility assignments Key personnel and external contact information Recall procedures Communication templates 29

30 Best Practices Have well defined, written processes and well-defined procedures with roles and responsibilities. (Identify who will take the lead on the HHE, who is responsible for determining the scope of the recall.) Have well defined Effectiveness checks. Procedures should provide flexibility to allow for companies to make a rapid decision to recall product. For global multi-site firms, ensure central oversight of the recall process. May allow for local execution but centralized function responsible for wing-wing process. No action should be taken prior to the implementation of the actual authorized recall/fsca action. Employees can unknowingly cause/implement recalls by taking action without the authority, oversight or enough knowledge to do so. One organization should control this process to prevent inadvertent action taken by field personnel. FDA would consider this the start date of the recall (lack of control). Understand that the process may begin and continue under emergent circumstances and immediate action determinations must be a priority for the team. 30

31 Best Practices Establish specific timeframes for beginning the assessment, recommendations for action or no action, when a final decision should be made, the initiation of the action, and the notification of the regulatory authorities. Have a well defined, and well exercised process for determining where products were shipped and remain in available for recall and possible testing. All changes to product must be assessed for whether the change is an enhancement or recall. Communicate with Regulator early in the process. e.g. Recall classification firms makes a Class III recall decision; no report; but FDA disagrees during an inspection. Monitor Field Safety Corrective Actions published on web sites of Competent Authorities in the EU/EEA (typically MHRA in the UK). Actively monitor FDA s actions and recall classifications (Web Site: Enforcement Report) a company can maintain awareness regarding FDA s current thinking and adjust as needed. Conduct mock recalls at least annually to determine if current plan will evaluate appropriate information should a real recall need to be implemented. 31

32 Best Practices Competent Authorities have reciprocity agreements regarding recalls and they meet, share information, as well as monitor each other s web sites. For recalls, FDA inspects not only industry, but your customers as well to assure: The communication is effective (clear content and by sending to and receiving back replies from proper consignees), Confirming that customers both received the communication and are doing as instructed. Reconciling quantities of recalled product to measure effectiveness of the recall. Customers (and Sales Reps) are well aware of your firm s recalls; several publications provide recall data (e.g. Medical Devices, Pharmaceuticals) Customers not only receive but also forward to these Publishers any letter received from companies, FDA and other Competent Authorities can (and likely do) subscribe to these Publications. 32

33 References 21CFR Part 7, Subparts A and C - Recalls - General guidelines, 21 CFR Part Medical Device Corrections and Removals, PHS Act - 42 U.S.C Mandatory recall of biological products, FD&C Act, 518(e) - Mandatory Device Recalls FDA Medical Device Enhancement vs. Recall Guidance document /ucm pdf CDRH Learn: Introduction to Medical Device Recalls: Industry Responsibilities Recall Module 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals Recall Communication: Medical Device Model Press Release Video Recall Communication: Medical Device Model Recall Notification Letter Medical Device Recalls: Guidance for Industry Video 33

34 Questions & Discussion 34

35 Case Study 1 A firm received complaints that one model of its drug infusion pumps has a computation error in its software, so that patients are receiving less volume than needed and represented. There were two reports where the patient required medical intervention to address potentially life-threatening situations. The firm s testing of returned units did not confirm the issue, however, upon further analysis, the firm determined that Users were incorrectly programming the device causing it to under-deliver the expected volume. The firmed verified the devices were working as specified. What immediate and longer-term actions should the firm take if any? Should the firm initiate a recall? Should the firm inform FDA and global regulators? What other factors should the firm consider? 35

36 Case Study 2 A firm learns, and confirms, that one model of its infusion pumps has a computation error in its software, so that patients are receiving less volume than needed and represented, rendering the device violative. As the firm was about to release a new SW version for the pump, that would offer several new features that customers requested, including a new setting for pediatric patients, the firm decided to bundle the SW change for the volume error with this new SW release. The firm concluded that there was no recall as the SW upgrade was planned and it will be less disruptive for customers to receive the enhancements in one SW version. The firm sends representatives to install modified software to all devices as part of a SW upgrade. Would FDA and Regulators agree with the Firm s decision? What other factors should the firm consider? 36

37 Case Study 3 When conducting in-house final release testing of its disposable cardiac surgery catheters, a firm detects a deformity on the tip of some of the catheters that may pose a risk to patients if the catheter was used. The firm was able to confine the defect to lots manufactured within the last week. Six of the ten lots were either in the firm s manufacturing facility or warehouse awaiting distribution. However, 4 of the lots were recently shipped to 2 large customers on consignment i.e. they lots first go to the customer s warehouse and the customer would replenish its inventory as needed. Because the firm verified that none of the affected lots were used, and the lots on consignment were in the customer s warehouse, the firm initiated a stock recovery for these lots. Would FDA and Regulators agree with the Firm s decision? What other factors should the firm consider? 37

38 Case Study 4 A firm received a request from two Ministry s of Health (MOH) Japan and Australia to change the labeling on one of its devices to provide greater emphasis for certain risks associated with device use. The device is marketed globally including the US and Europe. The current labeling already mentions these risks and the device meets all of its approved and cleared labeling requirements and performance specifications. The new labeling did not introduce any changes to the device specifications. The firm s Medical Advisory committee advised the Regulatory department that the new labeling may cause some Physicians to be confused whether or not the device is still safe to use in pediatric settings. The firm, therefore, expanded its labeling change beyond what was requested by the MOHs and provided new claims about the device s safety and efficacy when used in pediatric settings. The firm deemed these labeling changes as enhancements as there were no changes to the device itself. Would FDA and Regulators agree with the Firm s decision? What other factors should the firm consider? 38