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Medical Devices - Is there a well-devised surveillance technology?

Medical Devices - Is there a well-devised surveillance technology?
December 01, 2017

September 24, 2020, has been declared by the FDA as the last compliance date by which the UDI system should be implemented across all medical devices. I intended to use the not-so-familiar date format (YYYY-MM-DD) that FDI mandates in all medical devices as part of the UDI rule for the reason that, although it makes no huge difference from the usually familiar date formats for the human eye, it does make immense difference to system readability. Such is the massive difference that UDI will bring to the technology platforms across all pharmaceutical manufactures and providers.

The UDI implementation has happened in a phased manner from 2014 and is mandated to be completed by 2020. The Unique Device Identifier Final Rule is not just a new FDA regulation, it is also a good business practice. Healthcare customers are embracing the use of unique identifiers. Eventually, the number of customers demanding UDI will be significant, and manufacturers will need to act promptly—this can only be achieved with the help of vendors who will be able to provide this technology upgrade.

From my experience, I can recollect how the ICD-9 to ICD-10 conversion kept the healthcare sector busy with specific deadlines. Similarly, in Life Sciences sector, this is an introduction of a new system and involves more design and development opportunity. Since it is in the initial stages of implementation, it provides opportunities to try innovative concepts.

This new rule has opened product development opportunities in the following (refer Figure 1) areas of Life Sciences and Healthcare sector that will be interesting and challenging area to explore for the technology service providers.

Next generation Unique Device Identifier management system that will best store and track the UDIs of medical devices.

product development  UDI introduction

Figure 1: The technical areas that will need upgrade due to UDI introduction

UDI regulations will improve the accuracy and timeliness of PMS data. More accurate and timely PMS data will indirectly improve patient safety by ensuring more accurate reporting, reviewing, and analyzing of adverse event reports, such that devices with problems can be determined, corrected, and removed in a timely manner. 

Benefits of UDI:

The general benefits of UDI can be listed as follows:

  • Medical device recalls
  • Adverse events reporting
  • Tracking and tracing (reduced counterfeiting)
  • Supply chain security and efficiencies
  • Reduced medical errors
  • PMS
  • An easily accessible source of device information for patients, clinicians, and public
  • Global visibility

Apart from the UDI system being a great aid in device recall, it also offers a number of benefits for the healthcare delivery system like the ability to enhance patient safety, simplify device PMS, and facilitate medical device innovation.

Benefits for Manufacturers:

The March 2011 Edition of Healthcare Purchasing News published an article written by Karen Conway that describes Becton, Dickinson and Company’s (BD) resource optimization and innovation (ROi) experiences while implementing UI (GS1’s Global Trade Identification Number). Dennis Black (BD) and Alex Zimmerman (ROi) describe the positive impact of implementing UI on their businesses. They were able to document a 30% reduction in accounts payable days outstanding. Other findings included:

  • 73% reduction in errors on customer orders
  • Fewer stock outs
  • Fewer calls to customer service
  • Better charge compliance
  • Greater process efficiency

Benefits for Providers

They can now:

  • Improve patient safety by minimizing medical errors
  • Strengthen the electronic medical records initiative by providing a standard method for recording the identity of each device during use in clinical information systems, claim data sources and registries
  • Address counterfeiting and diversion
  • Prepare for medical emergencies and disasters
  • Provide a foundation for a global, secure distribution chain

Impact of UDI Regulations Globally

However, the final rule was drafted by the FDA. The European Union and regulatory agencies around the world are drafting their versions of a UDI regulation. In addition to the benefits of implementing a UDI system in general, a global UDI system would:

  • Allow companies to create globally harmonized labeling with a single UDI worldwide
  • Promote worldwide tracking and tracing of devices for easier recalls
  • Provide another risk control to prevent counterfeiting and diversion of medical devices

Listed below is the compliance deadline for the phased UDI implementation:

Compliance Date Device (Labels and Package) Requirements
September 24, 2014 Class III devices
  • Class III stand-alone software
  • Data for these devices must be submitted to GUDID
  • Dates on labels must be formatted as YYYY-MM-DD
September 24, 2015 Implantable, life-supporting and life-sustaining devices
  • Must have UDI as permanent mark if it is to be used more than once and reprocessed before each use
  • Data for these devices must be submitted to GUDID
  • Dates on labels must be formatted as YYYY-MM-DD
September 24, 2016 Class II devices and Software
  • Must have UDI as permanent mark if it is to be used more than once and reprocessed before each use
  • Data for these devices must be submitted to GUDID
  • Dates on labels must be formatted as YYYY-MM-DD
September 24, 2018 Class I devices and Software
  • Must have UDI as permanent mark if it is to be used more than once and reprocessed before each use
  • Data for these devices must be submitted to GUDID
  • Dates on labels must be formatted as YYYY-MM-DD
September 24, 2020 Non classified
  • Devices that have not been classified as Class I, Class II or Class III must have UDI as permanent mark if it is to be used more than once and reprocessed before each use
  • Dates on labels must be formatted as YYYY-MM-DD

From all that we discussed, we sure know that the answer to the question, ‘is there a well-devised surveillance technology?’ is definitely “yes”. However, what we as a technology service provider need to now ascertain is, ‘is there a well-devised UDI implementation technology that we can advertise?’