Niccolo Machiavelli (1523)

Transcription

1 Nothing is more difficult to undertake, more perilous to conduct or more uncertain in its outcome, than to take the lead in introducing a new order of things. For the innovator has for enemies all those who have done well under the old and lukewarm defenders amongst those who may do well under the new. Niccolo Machiavelli (1523) 1

2 UDI Experiences and Challenges of Implementation of the U.S. FDA UDI Rule 22 October 2015 Presented by: Jay Crowley Vice President UDI Services and Solutions USDM Life Sciences

3 What is a medical device? A device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals. 3

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5 Accessories <.> of Parent Devices support the performance of a parent device by enabling or facilitating that device to perform according to its intended use. supplement the performance of a parent device if it adds a new function or a new way of using the parent device, without changing the intended use of the parent device. augment the performance of a parent device by enabling the device to perform its intended use more safely or effectively 5

6 What is NOT an Accessory? It is important to note that articles that do not meet the definition of an accessory will not be treated as accessories simply because they may be used in conjunction with a device. [FDA] Spare parts supplied for replacement of existing components of a device, the conformity of which has already been established, are not medical devices. If spare parts, however, change significantly the characteristics or performances of a device with regard to its already established conformity, such spare parts are to be considered as devices in their own right. [EC] 6

7 What Do You Produce? Do you have visibility into your entire product portfolio? Is it a medical device, drug, combination product? Is it an accessory or component (and therefore a device) or spare part or? How did it get to market and what is its procode? Who is the manufacturer (labeler)? OEM/3rd party? How do you manage devices with no independent premarket path? How do you identify/mange configurable devices?

8 How Do You Label/Package It? UDI default location is the label - where is the device s label (regulatory concept not a sticky piece of paper)? Do you need UDI on label/package below the orderable/shippable unit? How many levels of packaging do you have? Shipping container shipper Is date in standard format even exempt levels/devices?

9 Who is the Labeler?

10 Who is the Labeler? How does this affect your OEM/private label/contract manufacturing relationships? Who will have responsibility for which parts? What will this look like in the GUDID? Labeler is any person who causes a label to be: applied to a device with the intent that the device will be commercially distributed; or replaced or modified with the intent that the device will be commercially distributed.

11 Who is the Labeler? EU definition The manufacturer is any natural or legal person who is responsible for designing and manufacturing a product with a view to placing it on the Community market "under his own name" (or trademark). GHTF/IMDRF definition of manufacturer any natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s).

12 Do You Have Quality Barcodes? Deconstruct barcode correct and formatted data. All issuing agencies require barcode quality of grade C or better. You need barcode verifiers! This requires specialized barcode verifiers, not scanners And a process to perform this routinely, not just in label design The UDI rule amends the Quality System Regulation by requiring examination of the accuracy of the UDI as part of the scope of the labeling inspection, that the device history record include any UDI

13 How Do You Describe it (GUDID)? Have you captured, normalized and verified (and successfully submitted) the GUDID attributes? Optional vs conditionally required if it is on the label it needs to be in the GUDID (e.g., clinically relevant size) Brand name, description, Model/version (regulatory) vs catalogue number? Packaging hierarchy DUNS numbers Submission to GUDID Organizational challenges workflows, process validation, SOPs, people, education

14 How Do You Describe it - ACCESSGUDID

15 SUD Packaging Exception UDI can go on SUD next higher level of packaging when: The individual single-use devices (SUDs) are: 1.distributed together in a single device package, 2.intended to be stored in that package until used, and 3.which are not intended for individual distribution. Can not be used for implants (do you know if your device is an implant?) Need to document above. -- And Unit of Use (UofU/ virtual ) DI required in GUDID 15 15

16 Convenience kits? UDI on kit/cp assumes that: Manufacturer has traceability/visibility into all of the components All of the components are consumed (or discarded) when opened/used If not then need to reconsider use of kit exception (at least for some components) 16

17 Existing Inventory Exception Finished devices manufactured, packaged and labeled prior to compliance date Existing inventory regardless of where it is located Consignment is considered your inventory Continue to put into commercial distribution +3 years past compliance date to use w/out UDI Where is at all? BUT need process to identify and manage inventory 17 17

18 Non-Sterile Implant Extension On 19 November 2014 in response to AdvaMed s request, FDA extended the labeling requirements compliance date for most nonsterile implants from 2015 to 24 September However, GUDID submissions are still required in AdvaMed had requested or 2 additional years (2017). The unchanged GUDID date was a concession for the additional year for labeling requirements. Most of the devices that meet these criteria are supplied nonsterile by the manufacturer and are intended to be sterilized (or cleaned and sterilized) before use. 18

19 Purpose of Time Extension FDA is initiating this extension to allow time for the development and implementation of an alternative that would provide for more accurate and precise device identification than the requirements of 21 CFR 801 subpart B. [Labeling Requirements for Unique Device Identification which requires the label of every medical device to bear a UDI]

20 Reiterated Purpose of UDI Rule In keeping with the purpose and intent of the UDI rule, FDA reiterated that the goal is to establish a system for the adequate identification of medical devices through their distribution and use, via the entire supply chain to point of use with patients. FDA also stated that the direct mark requirement for implants in the proposed was not included in the final rule because it was presumed that implants would be accompanied by their unique device identifier (UDI) label or package with UDI label up to the point of implantation. 20

21 And the Conforming Amendments? Adds to each the requirement to use UDI: Part 803 Medical Device Reporting Part 806 Reports of Corrections And Removals Part 810 Medical Device Recall Authority Part 814 Premarket Approvals Part 820 Quality System Regulation Part 821 Medical Device Tracking Requirements Part 822 Postmarket Surveillance

22 Conforming Amendments Manufacturers must include the UDI on the device label or on the device package in individual adverse event report submissions The manufacturer or importer must include on reports of corrections and removals: the 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 Records of corrections and removals not required to be reported to FDA shall contain the UDI, or the device identifier, UPC, model, catalog, or code number of the device and the manufacturing lot or serial number of the device or other identification number The holder of an approved pre-market approval shall identify in its periodic report each device identifier currently in use for the device, and each device identifier for the device that has been discontinued since the previous periodic report.

23 Conforming Amendments Device history records must include any UDI or UPC, and any other device identification(s) and control number(s) used Manufacturers must include in their complaint files any UDI or UPC, and any other device identification(s) and control number(s) used Service reports that represent an event that must be reported to FDA must include any UDI or UPC and any other device identification(s) and control number(s) used A manufacturer of a tracked device must include the UDI, lot number, batch number, model number, or serial number of the device or other identifier necessary to provide for effective tracking of these devices Class II and III device manufacturers required to conduct postmarket surveillance must include both premarket application/submission number and device identifiers in the postmarket surveillance plan submission Labeling shall not be released for storage or use until a designated individual(s) has examined the labeling for accuracy including, where applicable, the correct UDI or UPC, expiration date, control number, storage instructions, handling instructions, and any additional processing instructions.

24 2015 EHR Certification Criteria (1 of 2) (a) (14) Implantable device list. Record Unique Device Identifiers associated with a patient s Implantable Devices. Parse the Unique Device Identifier: Device Identifier and Production Identifier(s) Obtain and associate with each Unique Device Identifier: The GMDN PT Name attribute associated with the Device Identifier in the Global Unique Device Identification Database OR The SNOMED CT Description mapped to the attribute referenced in in paragraph (a)(14)(iii)(a)(1) of this section. The following Global Unique Device Identification Database attributes: Brand Name ; Version or Model ; Company Name ; What MRI safety information does the labeling contain? ; and Device required to be labeled as containing natural rubber latex or dry natural rubber

25 2015 EHR Certification Criteria (2 of 2) Display to a user an implantable device list consisting of: The active Unique Device Identifiers recorded for a patient; and For each active UDI, the description of the implantable device. A method to access all Unique Device Identifiers recorded for a patient. For each Unique Device Identifier recorded for a patient, enable a user to access: The Unique Device Identifier; The description of the implantable device specified by this section; The identifiers associated with the Unique Device Identifier The attributes associated with the Unique Device Identifier Enable a user to change the status of a Unique Device Identifier recorded for a patient.

26 Meaningful Use Stage 3 - Expanded Common Clinical Data Set Common Clinical Data Set Definition- The Common Clinical Data Set would replace the Common MU Dataset including: Patient Name Date of Birth Ethnicity Smoking Status Medications Laboratory Test(s) Vital Signs Procedures Immunizations Assessment and Plan of Treatment Health Concerns Sex Race Preferred Language Problems Medication Allergies Laboratory Value(s) / Results (s) Care Plan Field(s) including goals and instructions Care Team Member(s) Unique Device Identifier(s) for a Patient s Implantable Device(s) Goals

27 And Finally Have you documented use of any exceptions? Have you updated relevant G/SOPs? Have you trained staff? Have you communicated to your downstream trading partners? Do you know where your existing inventory is? Is your solution extensible to other countries?

28 Summary UDI requires a solid foundation UDI is a program not a project Understand what finished medical devices (and accessories and components) you distribute Understand who is the labeler Understand the (additional) Direct Marking requirements Understand barcode verification Understand the GUDID data elements Understand the conforming amendments

29 Questions?