What I Learned While Presenting in Front of the FDA About UDI Management

UDI managementI was invited to speak at a UDI-centric conference a few weeks ago in which FDA made presentations and attended mine. Jay Crowley, Indira Konduri- (US FDA’s GUDID Program Manager) and representatives from GS1, ICCBBA and other organizations also presented. I was presenting on behalf of the AIM North America Healthcare Committee on the topic of UDI management software technologies, UDI Direct Part Marking Technologies, and Barcode validation and verification technologies. Since I was to answer audience questions that would tie into the things that were said in presentations that preceded mine, I was sure to pay close attention to the other presentations.

Key Take Aways:

  • The FDA only has a staff of 10 on their UDI support desk yet they have thousands of companies to support.
  • Indira said “If you send an email to FDA support desk and do not get a response within two months, please do not open another support request about the same topic.”
  • The FDA has not granted any exceptions in response to any request for exclusion from Direct Part Marking requirements.
  • A surprising number of people within the audience were not aware that since the FDA may reject a GUDID submission and require the medical device labeler to make changes it is prudent to make sure that UDI submissions are accepted by the FDA before labeling product.
  • The complexity of UDI management will become exponentially harder for many companies in the near future as regulatory bodies outside of the United States introduce requirements for their own versions of UDI. Read the example below:

China is planning to develop their own MDN (Medical Device Nomenclature) system. This will require companies that label medical devices that ship to China and rest of world to manage GMDN codes in addition to the MDN that is specific to China.

  • The most significant thing that I learned during this conference is that the majority of Medical Device Labelers are still managing regulatory data for UDI using spreadsheets.

At most, spreadsheets should be considered to be a stop-gap tool for collecting information for the achievement of initial UDI compliance. As the FDA said during the conference, post-GUDID submission data management will be a major ongoing challenge. Although it is possible to use multiple tabs, link spreadsheets, add drop-downs to improve data accuracy and consistency, add macros, add pivot tables, and VB scripts, spreadsheets are flat files. They are not relational databases. Spreadsheets are not designed for collaborative work. Therefore, copying and routing portions of spreadsheet for approvals, doing the same for trial uploads, managing spreadsheets for records that were not accepted by the GUDID, routing these for correction and re-approval by different departments, sending these out for upload again, receiving notification of acceptance for submitted records back in a spreadsheet format, is creating silos of related yet disconnected information in the form of multiple spreadsheets. Updating information from multiple spreadsheets into a master record is a manual process. Moreover, there is no audit trail as mandated by 21 CFR.

Although it is possible to use spreadsheets for regulatory data management—though it can be complex, largely manual and therefore risky—complexity will grow exponentially as other regulatory bodies come on-line with their own requirements. Subsets of the FDA listing of UDI attributes will likely be required along with some additions and some modifications. However, managing changes to records that are already in the FDA GUDID, is a more immediate challenge. As you know, medical device labelers are required to update information in the FDA GUDID by indicating when products are no longer being put into the supply chain. They also are required to upload and manage information in the GUDID for new products. Labelers are also required to update GMDN code information within the FDA GUDID as the GMDN code information changes. As the FDA reminded the conference attendees, labelers are also required to update changes to many other UDI attributes. As it is today, according to the GUDID_Data_Elements_Ref-Table_May1_2015.xls which may be found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/UCM396592.xls, the list of attributes which require maintenance or can trigger a need to create a new record with a new DI after the grace period is quite extensive. The information below is a condensed subset of the aforementioned spreadsheet that is tailored to illustrate the quantity of edit rules and or the need to create a new record with a new DI after the grace period (i.e. DI Triggers) for various GUDID attribute fields. This list includes:

UDI management

UDI management

UDI management

UDI management

UDI management

A properly designed application running on a relational database delivers the ability to allow for the finding, filtering, mass updating and approval of regulatory information as well as pre-submission checking and final submission while maintaining useful audit history as required by 21 CFR. More importantly, it makes the on-going management of submitted records practicable. All of this can be done with information that was imported from spreadsheets or is derived from other systems. The main point is that people in various departments can work on the on-going management of UDI using browser based software in a collaborative way instead of sending, receiving and managing spreadsheets. Subsets of the list of UDI attributes for the US FDA GUDID can easily be combined with the new information that will be required by other regulatory bodies thereby making data reuse workable. The use of the right technology makes the efficient ongoing management of UDI requirements possible and practical.


Taiwan’s Version of Unique Device Identification

unique device identificationMedical Device Manufacturers the world over are striving to stay abreast of developments as regulatory bodies other than the US FDA release details concerning their approach to Unique Device Identification for medical devices. Taiwan is progressing in the area of UDI, having produced a guidance document late last year.

Within this guidance information it is clear that Taiwan’s Unique Device Identification:

  • References both the US FDA UDI Rule and the IMDRF UDI Guidance
  • Will use a Taiwanese version of the FDA GUDID which will be called the UDID
  • Provides guidance on combination products
  • Targets Medical Devices that are manufactured in Taiwan and ones that are imported
  • Allows various forms of AIDC and recommends the use of human readable characters
  • References the use of GS1, HIBCC and ICCBBA
  • Recommends direct marking for medical devices which are to be reprocessed
  • Provides guidance that applies to software as a medical device (SaMD)

Although the tone has been set and many details are available, there is still much information that is yet to be put forth. Specifics about UDI attributes to uploaded and maintained as well as standards for the transfer of attribute information will go a long way towards helping the medical device manufacturing community assess the magnitude of the regulatory challenges that lie ahead.

 


Real Benefits of UDI in the Operating Room and Beyond

benefits of udiLet’s face it, there are still those amongst us who grumble at the mention of having to comply with the UDI regulations. To them, it’s simply a matter of having to comply to stay in business. There are those of us however, who are advocates of the regulation and appreciate the benefits of UDI. We believe in its overall benefit for patient health and safety, and also as a means of facilitating business and reducing cost and errors.

The AIM North America Healthcare Committee recently presented a webinar to investigate the functionality of a system which makes extensive use of the UDI as a means of identifying medical devices in the operating room and associating those devices with patients’ medical health records. Through the use of in-line scanning technology during production, each device is entered into the chain of custody process where it is controlled throughout the supply chain from production to patient implantation. Part of this control includes anti-counterfeiting through confirmation of the pedigree at multiple checkpoints. Combatting counterfeit product is one of the benefits of UDI as counterfeit medical devices have wreaked havoc in the lives of patients, caregivers and others in the medical device community. Although the challenge in UDI is that multiple agencies and multiple barcodes can be used, there are differentiators that can allow a scanning device to be pointed at any barcode and in turn determine the agency and barcode type.

NOTE: The presentation below does contain some product marketing from the company which created the software however, it is a good demonstration of what a central device database can provide to the entire medical device industry. Capabilities include the ability to:

  • Identify which items are used and generate an invoice, thereby eliminating manual data entry
  • Compare costs, revisions, waste, and recalls, by manufacturer device, hospital and/or surgeon through real-time analytics
  • Identify and measure outcomes by physician, hospital and/or implants
  • Cross-reference devices, allowing stakeholders to alert patients when a recall occurs.
  • Deliver access to member information by recalled device
  • Provide member access to master implant database
  • Identify prior implantations by member/surgeon/payer
  • Eliminate overbilling by ensuring accurate device utilization by case
  • Identify actual device implants as opposed to paying for wasted or defective implants
  • Know exactly where each implant has been placed, targeting devices that need to be replaced because of a recall
  • Identify the responsible party when a revision or replacement is required

With AIM focused on AIDC matters, about 30 minutes into the presentation, focus shifts to the AIDC implications and the use of bar codes and issuing agencies and complexities that go along with it. You can view the presentation at this location: https://youtu.be/VaPZPVYI_cg. This is not an endorsement of the company or product, just a means of whetting the appetite for all of the possibilities that UDI provides.


UDI Implementations In Full Swing With Innovatum

UDI Implementations

So far this summer is off to a sizzling start with Innovatum managing seven global labeling UDI implementation projects concurrently. Four of these projects had their go live take place in the month of June 2015 alone! In conjunction with successfully submitting significant amounts of product UDI attribute information to the FDA Production Global UDI Database (GUDID) via Innovatum’s ROBAR Master Data Manager (ROBAR MDM) and ROBAR Communication Manager (ROBAR COM) products, Innovatum’s customers are taking advantage of Innovatum’s intensive experience with UDI implementation management. An extension of this for two major Medical Device Manufacturers is that they are now relying upon Innovatum’s expertise as a validation services provider to manage their complete validation processes.

Innovatum customers are fully exploiting the efficiencies of using ROBAR MDM and ROBAR Labeling along with ROBAR COM to deliver a system that uses one database to coalesce regulatory device and device production data throughout the enterprise and use the very same data for multiple purposes. The ROBAR product family does this while tightly managing security permissions and data access to various business departments. It makes the same data available for product labeling, can convert the data into Health Level 7 Structured Product Label (HL7 SPL) for regulatory data upload to the GUDID, and can supply product attribute data via a Global Data Synchronization Network (GDSN) certified data pool, a combination of data pools and other trading partners including “GUDID like variants” that will be required by other regulatory bodies.

According to Innovatum’s President Ardi Batmanghelidj, “Word is getting out. We have the only complete UDI management offering in the industry which includes a Master Data Management database that is the single source of truth or can get to the single source of truth. New fields can be added as requirements advance without a need for programming changes or validation. All of this data is easily tied to our industry leading medical device labeling system and/or our integrated regulatory data submissions and communication system though a few simple configuration changes. This greatly improves efficiency and reduces complexity by eliminating any requirements for duplicate approvals on the same data since one set of data is approved and then used for several purposes.” Innovatum has also announced its plans to integrate eIFU management starting in 2016 which further exploits the efficient use of this data. One of the overarching goals of Innovatum’s product set design is to minimize the involvement of IT resources required for implementation and on-going management.

The ROBAR Labeling, ROBAR MDM and ROBAR COM products maintain full audibility and are fully validatable in Medical Device Manufacturers environments with 21 CFR Part 11, 820, 830 and others. ROBAR Labeling is available separately or it can be used in conjunction with ROBAR MDM and ROBAR COM.


2015 UDI Conference Highlights

2015 UDI ConferenceAlthough the 2015 UDI Conference had record participation, many Medical Device Manufacturers were not able to attend, consequently this summarization of highlights from the sessions should be of value.

FDA kicked the first session off with an overview of UDI, a review of compliance dates, a listing of benefits derived from UDI and an update on GUDID status. Biggest achievements since the conference last year: Brookings Institution to create a “roadmap” for provider systems, patients, payers, supply chain personnel, and many others, to adopt and utilize UDIs. Another major achievement noted during the 2015 UDI Conference was the announcement of AccessGUDID. Challenges either addressed or being addressed: Managing input to the UDI helpdesk through implementation of tracking software, software labeling guidance, Contact Lens labeling guidance and UPC for retail guidance. A challenge that FDA is calling upon the Medical Device Manufacturing industry to address is ensuring data quality, such as product codes matching pre-market information.

FDA went on to lay out plans for the future including: working with SMI (strategic market initiative), working with standards organizations, expanding capabilities within AccessGUDID such as moving from basic search capabilities to advanced search capabilities and adding web services capabilities. Also announced were Direct Marking guidance (which incidentally was released during the conference), and the opening of the GUDID after January 1, 2016 to Class II products that are not implantable, life-supporting, and life-sustaining devices. The biggest news from FDA is that Terrie Reed is coming back.

AIM (Global trade association for the Automatic Identification and Data Capture (AIDC) industry) presented a session demonstrating the way that technologies using unique device identification (UDI) are being employed to meet recent U.S. compliance rules. The takeaways from the 2015 UDI Conference are that: various types of direct marking technologies are available and some are a better fit than others depending upon the particular medical device, vision inspection is a very useful tool to help with addressing the accuracy required for the new data elements on the labels, and software was demonstrated that can handle master data management (using information pulled from other systems in real-time), regulatory data upload, label management and printing anywhere in the world via browser using a single solution.

The key takeaway from the track concerning UDI in the supply chain is that medical device manufacturers need to be concerned with getting data all of the way through to the providers. The important thing about GMDN is that terms will change and it is up to you as labeler to make sure you keep pace and keep the GMDN information in your GUDID records up to date. The most salient point from the session on understanding efforts that are similar to UDI around the globe is that harmonization is not taking place to the extent that one might hope. Surmise that there may be some challenges and budget accordingly.


What Do Software Validation Services Entail?

During the course of software engineering, testing and software project management, validation refers to the process of verifying that a software solution meets required specifications. This is a formalized process and is required within the life sciences. Software validation will ensure that your software solutions comply with requirements. Failing to do so can result in your company being issued a 483. If a computer system is used to provide information to a regulatory body (such as under FDA 21 CFR Part 11), or meet requirements for the regulatory body, the system must be validated. Continue reading


Medical Device Labeling Guidelines

Medical device labeling guidelines have been updated by the U.S. Food and Drug Administration (FDA) with the aim of clarifying the ways in which medical devices may be labeled in order to prevent confusion for caregivers, patients and medical staff.

The FDA’s final rule has established a system for the unique identification of medical devices that is based on their use and means of distribution. As the system becomes fully implemented, device labels will carry a unique device identifier (UDI). Companies responsible for device labelling are also required to submit certain information pertaining to each device to the FDA’s Global Unique Device Identification Database (GUDID) so that the public can search for and download this information. Continue reading

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Understanding the FDA UDI Final Rule

The U.S. Food and Drug Administration (FDA) released the final rule on a Unique Device Identifier (UDI) system on September 20, 2013. The system, along with the Global Unique Device Identification Database (GUDID) was 10 years in the making and is a vital step toward increasing the safety of medical devices. One of the most significant changes is the elimination of the requirement that all implantable medical devices—such as pacemakers and heart valves—have the UDI printed on the device itself. Originally the proposed rule required manufacturers to mark the UDI directly onto the following types of  devices: Continue reading

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