Episode 241  |  26:54 min  |  01.05.2022

Understanding the UDI System for Medical Devices

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This is a podcast episode titled, Understanding the UDI System for Medical Devices. The summary for this episode is: <p>Do you understand how the Unique Device Identification (UDI) system in the medical device industry works? The overall concept can be best understood by learning how it is used and why it exists.</p><p>TIn this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mark Rutkiewicz, VP of Quality at Innovize, Founder of Consiliso LLC, and author of Medical Device Company In A Box. Listen to Jon, Etienne, and Mark discuss key points every medical device professional should know about the UDI system.</p><h3><strong>Some of the highlights of this episode include:</strong></h3><ul><li>The FDA requires the UDI to adequately identify medical devices that are manufactured, distributed, sold, and used by patients.</li><li>According to the FDA, labels on most medical devices will include a UDI in readable forms to improve patient safety, modernize postmarket surveillance, and facilitate innovation.</li><li>UDI eliminates mistakes. If a patient is prescribed something, you scan everything that they do. If somebody makes a mistake, they know right away.</li><li>The UDI is stored in a worldwide central database. Different countries have different requirements. In the United States, medical device manufacturers can use three different types of identifiers (GS1, HIBC, and blood banking).&nbsp;</li><li>For Bills of Materials (BOMs), it’s important to understand the rules of interchangeability to set medical device products apart and determine whether to assign different codes.</li><li>A data matrix and quick resource (QR) code are intermixed and both are two-dimensional. Mark explains how to visually tell the difference between the two and the three components required.</li><li>Integrating UDIs and codes into databases represents levels of complexity that are added to medical devices.</li><li>The UDI is intended for the hospital user. So, a sellable product needs to have a UDI that can be scanned and validated. When parts are too tiny, the UDI will be placed elsewhere on the product packaging.</li></ul><h3><strong>Memorable quotes from Mark Rutkiewicz:</strong></h3><p><em>“Every part that you use in the hospital room has a barcode on it.”</em></p><p><em>“If this patient was prescribed something, then you scan everything that they do. If somebody made a mistake, they would catch it right away.”&nbsp;</em></p><p><em>“Nobody's really standardized."&nbsp;</em></p><p><em>“You can scan it to make sure that you are using the right product with the right other products and with the right patient.”&nbsp;</em></p><h3><strong>Links:</strong></h3><p><a href="https://www.linkedin.com/in/mark-rutkiewicz-598a992" rel="noopener noreferrer" target="_blank">Mark Rutkiewicz on LinkedIn</a></p><p><a href="https://twitter.com/consilisomark" rel="noopener noreferrer" target="_blank">Mark Rutkiewicz on Twitter</a></p><p><a href="https://www.innovize.com/" rel="noopener noreferrer" target="_blank">Innovize</a></p><p><a href="https://www.consiliso.com/" rel="noopener noreferrer" target="_blank">Consiliso LLC</a></p><p><a href="https://www.amazon.com/dp/1599328615/ref=cm_sw_r_cp_ep_dp_dP54zb3V0F00B" rel="noopener noreferrer" target="_blank">Medical Device Company In A Box: The Case For Consiliso</a></p><p><a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system" rel="noopener noreferrer" target="_blank">FDA - Unique Device Identification System (UDI System)</a></p><p><a href="https://eumdr.com/" rel="noopener noreferrer" target="_blank">European Union Medical Device Regulation (EU MDR)</a></p><p><a href="https://mdic.org/" rel="noopener noreferrer" target="_blank">Medical Device Innovation Consortium (MDIC)</a></p><p><a href="https://www.iso.org/iso-13485-medical-devices.html" rel="noopener noreferrer" target="_blank">ISO 13485 - Medical Devices</a></p><p><a href="https://www.greenlight.guru/academy" rel="noopener noreferrer" target="_blank">Greenlight Guru Academy</a></p><p><a href="https://virtual-summit.greenlight.guru/" rel="noopener noreferrer" target="_blank">The Greenlight Guru True Quality Virtual Summit</a></p><p><a href="https://www.greenlight.guru/podcast-mtqs" rel="noopener noreferrer" target="_blank">MedTech True Quality Stories Podcast</a></p><p><a href="https://www.youtube.com/channel/UCYfQsPqHW8H8mZ4xpM4gn1Q" rel="noopener noreferrer" target="_blank">Greenlight Guru YouTube Channel</a></p><p><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank">Greenlight Guru</a></p>

Do you understand how the Unique Device Identification (UDI) system in the medical device industry works? The overall concept can be best understood by learning how it is used and why it exists.

TIn this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mark Rutkiewicz, VP of Quality at Innovize, Founder of Consiliso LLC, and author of Medical Device Company In A Box. Listen to Jon, Etienne, and Mark discuss key points every medical device professional should know about the UDI system.

Some of the highlights of this episode include:

  • The FDA requires the UDI to adequately identify medical devices that are manufactured, distributed, sold, and used by patients.
  • According to the FDA, labels on most medical devices will include a UDI in readable forms to improve patient safety, modernize postmarket surveillance, and facilitate innovation.
  • UDI eliminates mistakes. If a patient is prescribed something, you scan everything that they do. If somebody makes a mistake, they know right away.
  • The UDI is stored in a worldwide central database. Different countries have different requirements. In the United States, medical device manufacturers can use three different types of identifiers (GS1, HIBC, and blood banking). 
  • For Bills of Materials (BOMs), it’s important to understand the rules of interchangeability to set medical device products apart and determine whether to assign different codes.
  • A data matrix and quick resource (QR) code are intermixed and both are two-dimensional. Mark explains how to visually tell the difference between the two and the three components required.
  • Integrating UDIs and codes into databases represents levels of complexity that are added to medical devices.
  • The UDI is intended for the hospital user. So, a sellable product needs to have a UDI that can be scanned and validated. When parts are too tiny, the UDI will be placed elsewhere on the product packaging.

Memorable quotes from Mark Rutkiewicz:

“Every part that you use in the hospital room has a barcode on it.”

“If this patient was prescribed something, then you scan everything that they do. If somebody made a mistake, they would catch it right away.” 

“Nobody's really standardized." 

“You can scan it to make sure that you are using the right product with the right other products and with the right patient.” 

Links:

Mark Rutkiewicz on LinkedIn

Mark Rutkiewicz on Twitter

Innovize

Consiliso LLC

Medical Device Company In A Box: The Case For Consiliso

FDA - Unique Device Identification System (UDI System)

European Union Medical Device Regulation (EU MDR)

Medical Device Innovation Consortium (MDIC)

ISO 13485 - Medical Devices

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

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