Ensuring Quality Management Amidst Regulatory and Design Technology Changes

ensuring quality managementA regulatory driven, product design tsunami is headed our way, but at least we have an awareness that it is coming and a means of preparing for it. New requirements for destination labeling, brought about by globalization, are on a collision course with the applications of technology that we have become accustomed to. Global UDI initiatives and burgeoning breakthroughs in patient-specific modalities only add to the impact by adding to the complexity of compliant distribution worldwide. It is time to embrace a new paradigm for product design and labeling to maximize efficiency, while meeting compliance requirements for the future. While just-in-time manufacturing is here to stay, on-demand localizable labeling is quickly becoming a reality for companies that wish to remain competitive in a swiftly changing world. But patient-specific product design implies a more focused level of labeling for each unit of production. To make sense of all of this, we need to think in terms of finding a common denominator to solve these challenges. The common denominator is data.

Read the full article from Advantage Business Media.


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.