Utilization of UDI during the Product Recall. 18 September 2015 Terumo Cardiovascular Group Eileen Dorsey

Transcription

1 Utilization of UDI during the Product Recall 18 September 2015 Terumo Cardiovascular Group Eileen Dorsey 1

2 Speaker Biography Director, Corporate Post Market Surveillance, Terumo Cardiovascular Group 16 Years Class III, II, and I Medical Device Experience in Quality and Regulatory Bachelor s degree in Biology and Chemistry, University of Delaware CQA, ASQ Certified Quality Auditor CQE, ASQ Certified Quality Engineer CMQ/OE, ASQ Certified Manager of Quality and Organizational Excellence RAC (US), RAPS Regulatory Affairs Certification 2

3 Agenda Introduction UDI Regulation Review Recall Regulation Review High Level Case Study 3

4 UDI All devices, as defined by 21 USC 321(h), are subject to the requirements of the UDI Rule, unless an exception or alternative has been granted. Three accredited issuing agencies: GS1, HIBCC, ICCBBA 4

5 UDI = DI + PI Device Identifier (DI) a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device Production Identifier(s) (PI) a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device, unless excepted: the lot or batch number within which a device was manufactured; the serial number of a specific device; the expiration date of a specific device; the date a specific device was manufactured; for an HCT/P regulated as a device, the distinct identification code required by 21 CFR (c)6. 5

6 Fictitious Company Example FDA Guidance for Industry: Global Unique Device Identification Database (GUDID) Figure D1: GUDID Attributes Mapped to a Fictitious Medical Device Label NOTE: Representation of GMDN above is for illustration purposes ONLY. GMDN PT Name and Definition are NOT expected to appear on the label of a device. 6

7 UDI throughout the Quality System DMR Internal Audits DHR Quality System HHE/Recalls Complaints MDR 7

8 Code of Federal Regulations: UDI Definitions 21 CFR General Labeling Provisions 21 CFR Medical Device Reporting 21 CFR Medical Devices; Reports of Corrections and Removals 21 CFR Medical Device Recall Authority 8

9 UDI CFR Definition Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of of this chapter. A unique device identifier is composed of: (1) A device identifier a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and (2) A production identifier a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device: (i) The lot or batch within which a device was manufactured; (ii) The serial number of a specific device; (iii) The expiration date of a specific device; (iv) The date a specific device was manufactured; (v) For an HCT/P regulated as a device, the distinct identification code required by (c) of this chapter. Universal product code (UPC) means the product identifier used to identify an item sold at retail in the United States. Version or model means all devices that have specifications, performance, size, and composition, within limits set by the labeler. 9

10 Guidance Documents For UDI Global Unique Device Identification Database (GUDID), issued June 27, 2014 Unique Device Identification System: Small Entity Compliance Guide, issued August 13, 2014 Unique Device Identifier System: Frequently Asked Questions, Vol. 1, issued August 20, 2014 DRAFT- Unique Device Identification: Direct Marking of Devices, issued June 26, 2015 Global Unique Device Identification Database (GUDID): Date Submission Compliance Date of September 24, 2015, issued August 14,

11 Technical Documents The FDA is also making available, as separate technical documents, two components of the GUDID Guidance. These two files contain technical specifications only that do not describe the agency's interpretation of or policy on a regulatory issue, and the FDA will not publish them as part of the GUDID guidance in the future. The section formerly identified as "Appendix B", which summarizes the device attribute information that will populate the GUDID, renamed as "GUDID Data Elements Reference Table (May 7, 2014)" and The section formerly identified as "Appendix C", which summarizes the UDI formats accepted by the issuing agencies FDA that has accredited to date, renamed as "UDI Formats by FDA-Accredited Issuing Agency (May 7, 2014)." 11

12 21 CFR Reports of Corrections and Removals (a) Each device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer if the correction or removal was initiated: (1) To reduce a risk to health posed by the device; or (2) To remedy a violation of the act caused by the device which may present a risk to health unless the information has already been provided as set forth in paragraph (f) of this section or the corrective or removal action is exempt from the reporting requirements under 806.1(b). 12

13 UDI Requirements for Recall Reports 21 CFR (c)the manufacturer or importer shall include the following information in the report (5) The unique device identifier (UDI) that appears on the device label or on the device package, or the device identifier, universal product code (UPC), model, catalog, or code number of the device and the manufacturing lot or serial number of the device or other identification number. 13

14 Implantable, Life Saving, and Life sustaining devices ationandguidance/uniquedeviceidentification/ucm p df 14

15 Tips for Recalls Risk is assessed for recalls, but severity trumps the other factors. Class I recalls have resulted from one catastrophic outcome. FDA classifies the recall. Manufacturers should research competitors and confirm if there are similar recalls for similar situations. Need to be objective and cannot just not assume situation is different and therefore Class III. 15

16 Example 1 Device: Syringe, anti-stick Regulation Description: Piston syringe Product Code: MEG Regulation Number: Device Class: 2 UDI Compliance Date: 9/24/2016 *General Exceptions From the Requirement for the Label of a Device To Bear a Unique Device Identifier Exception for Individual Single-Use Devices, All of a Single Version or Model, That Are Distributed Together in a Single Device Package (a)(3) Refer to final UDI rule for all exceptions. 16

17 Example 2 Device: Dialyzer, capillary, hollow fiber Regulation: Description Hemodialysis system and accessories Product Code: FJI Regulation Number: Device Class: 2 UDI Compliance Date: 9/24/

18 Example 3 Device: Lancet, blood Regulation Description: Manual surgical instrument for general use Product Code: FMK Regulation Number: Device Class: 1 UDI Compliance Date: 9/24/2018 *The Unique Device Identifier of a Class I Device Is Not Required to Include a Production Identifier (c). Refer to final UDI rule for all exceptions. 18

19 Case Study Complaint: Customer complains sterility (package integrity) compromise HHE evaluation (UDI) 806 and communication to the customer (UDI) Manufacturer investigates complaint and confirms issue (UDI) Manufacture submits MDR (UDI) Customer tracks down product using UDI 19

20 Internally Audit UDI (DI+PI) Is it documented or defined in the DMR? Artwork revision procedure define how assigned? Does the DHR have a copy of the label with UDI? Documented in? Complaint record MDR HHE 806 Customer notification for recall GUDID work instruction, attribute data collection 20

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