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There is an exception pertaining to the packaging of single use devices. The exception states that if you put a Unique Device Identifier (UDI) on the next higher level of packaging you do not need to put the UDI on each individual single use device.

For example, within a package of 10 bandages each individual bandage is packaged as well. Each bandage is individually labeled and under normal circumstances a UDI would be included on the label. Due to the exception, if the device is stored and distributed in a box, shelf pack, or other type of container then a UDI on the higher level of packaging is sufficient for the purposes of visibility and traceability. There are other devices distributed in similar boxes where the single use device exception is not applicable. If the device is not a single use device then it will most likely require a UDI label on the individual device in addition to the next higher level of packaging.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

It is hard to believe that it has only been 2 years since I announced the publication of the UDI final rule on September 24, 2013 at the UDI Conference – it feels like a lifetime ago. So much has happened in the intervening 2 years – so many unexpected issues (accessories, labelers), so many complex device issues, so many UDIs. We all continue to learn and refine our understanding of UDI, how it can and should apply to a myriad of device types, and how the GUDID data should be populated and used.

It is interesting that this year marks the compliance data that we did not originally envision – but rather was legislatively mandated in FDASIA (2012). Though the premarket risk class of (most) devices is fairly obvious – determining whether a device is subject to this year’s compliance date (what we call the FDASIA devices – all class II and I implants and life-supporting/life-sustaining devices) is a bit more of a challenge. As always, we encourage you to check FDA’s website to determine whether your device, based on its product code, is subject to the UDI requirements this year.

And finally, the guidance document that FDA published on August 14, 2015 “Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015” has created some confusion. Due to a security vulnerability in GUDID, on August 7, 2015 FDA decided to take the system offline to develop and implement a patch. Though it came back on-line relatively quickly, due to the temporary unavailability of the GUDID system, FDA intends to exercise enforcement discretion to extend the September 24, 2015 GUDID submission compliance date to October 24, 2015. That is, ONLY the GUDID submission requirement is subject to this enforcement discretion – all of the other UDI requirements are still due September 24, 2015.

Jay Crowley is the Vice President of UDI Services and Solutions at USDM Life Sciences. Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

It is hard to believe that it has only been 2 years since I announced the publication of the UDI final rule on September 24, 2013 at the UDI Conference – it feels like a lifetime ago. So much has happened in the intervening 2 years – so many unexpected issues (accessories, labelers), so many complex device issues, so many UDIs. We all continue to learn and refine our understanding of UDI, how it can and should apply to a myriad of device types, and how the GUDID data should be populated and used.

It is interesting that this year marks the compliance data that we did not originally envision – but rather was legislatively mandated in FDASIA (2012). Though the premarket risk class of (most) devices is fairly obvious – determining whether a device is subject to this year’s compliance date (what we call the FDASIA devices – all class II and I implants and life-supporting/life-sustaining devices) is a bit more of a challenge. As always, we encourage you to check FDA’s website to determine whether your device, based on its product code, is subject to the UDI requirements this year.

And finally, the guidance document that FDA published on August 14, 2015 “Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015” has created some confusion. Due to a security vulnerability in GUDID, on August 7, 2015 FDA decided to take the system offline to develop and implement a patch. Though it came back on-line relatively quickly, due to the temporary unavailability of the GUDID system, FDA intends to exercise enforcement discretion to extend the September 24, 2015 GUDID submission compliance date to October 24, 2015. That is, ONLY the GUDID submission requirement is subject to this enforcement discretion – all of the other UDI requirements are still due September 24, 2015.

Jay Crowley is the Vice President of UDI Services and Solutions at USDM Life Sciences. Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

There are other countries that are not too far behind the United States in developing medical device identification regulations. It’s important to keep in mind that each country will likely have different requirements.

Europe, like Canada, has indicated a desire to follow the International Medical Device Regulators Forum (IMDRF) guidance. Jay Crowley, Vice President of UDI Services and Solutions at USDM Life Sciences recommends reviewing a copy of the guidance. It is very similar to the UDI Rule in the U.S. with subtle differences. IMDRF guidance limits some things that the Food and Drug Administration (FDA) does not and vise versa. IMDRF guidance represents a globally harmonized approach. Countries like Singapore and Korea have been preparing for UDI or UDI-like systems and have expressed a desire to follow the globally harmonized approach.

There may be some disagreement and variability regarding certain details surrounding concepts such as exceptions and definitions, but we expect the core data set surrounding the brand name of the product and what the product is to remain consistent. There will be local or national requirements in terms of local contact or national registration numbers that will be dependent upon how the product is on market in a particular country leading to differences in regulation.

The global landscape must be taken into consideration when thinking about data. In the U.S., the UDI Rule is only focused on device identification and its associated metadata. Other countries aspire to use UDI to fulfill other needs such as, traceability and reimbursement needs. Requirements from other countries will be coupled with UDI and these other needs; therefore other data associated with the new, particular regulatory aspect will be required.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

By Chris Chandler, PharmD, Vice President of Healthcare, USDM Life Sciences

With deadlines under UDI and DSCSA, and proposals under Meaningful Use Stage 3 to use unique identification for implant information, hospitals should seize the opportunity to manage the incredible amounts of data housed in their various information systems. Savvy hospitals are realizing that they can do more than just accommodate unique data codes in their systems. The nation's top hospitals are harnessing the data to realize benefits across their system that extend beyond operational efficiencies, such as value analyses and measuring comparative effectiveness and outcomes. Download Article: Is Your Data House in Order?

Data drives business intelligence and therefore must be reliable. Data errors can cause catastrophic consequences for patients, as data feeds automated solutions such as pumps, dispensing cabinets and barcode medication administration. How can providers recognize and pull good data from multiple disparate information systems, and use that data to drive excellence in operations and analytics? Hospitals that incorporate a Master Data Management (MDM) strategy that connects many of the different information systems it uses, and synchronizes the internal and external sources of data that fuel those systems, are better off in the long run because they are maximizing their technology investments while minimizing long-standing interoperability issues, and also getting more strategic use out of the master data.

With both technology and regulation in place, the healthcare industry is primed to use synchronized data to improve patient safety and care quality, increase efficiencies and reduce costs. Implementing an MDM strategy is a great way to start.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.

At this year's AHRMM Conference, Brent T. Johnson received the prestigious George R. Gossett Leadership Award. Brent has worked in the supply chain field for over 30 years, with the last 10 at Intermountain Healthcare as the Vice President of Strategic Sourcing. Brent is a member of several organizations where thought leaders in supply chain strategy come together to implement efficiencies in healthcare supply chain. One of the organizations is Healthcare Transformation Group (HTG) who works to adopt use of standards, including UDI and DSCSA, providing the groundwork for others to mimic. Brent was one of the developers of a great video that describes the dichotomy between healthcare and food bar code scanning What if data standards in grocery stores worked like in healthcare?, which has also been translated into French. Brent's leadership also contributed to Intermountain Healthcare being recognized by Gartner as a Top 25 Healthcare Supply Chain. Brent was recently named the CEO of Amerinet, Inc. Congratulations Brent!

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.

Blood banks are very familiar with ISBT128 for blood products. When blood banks handle tissue, they will often use software built around ISBT128. When departments other than the blood bank handle tissue, they are likely to be just learning about ISBT128.

Through an educational system, it is important to try to inform departments within hospitals, dental offices, and clinics of the importance of the donation identification number on the ISBT128 label. It is essential for traceability if a product is recalled. 

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/enventory management systems and interfaces to the GUDID.

Unique Device Identification (UDI) took center stage at this year's AHRMM 15 Conference. In the hallways and in sessions, including my panel session on the topic, hospitals, regulators, solution providers and suppliers discussed the obvious benefits of having consistent, accurate and unique identifiers for devices and pharmaceutials to ensure better tracking throughout the healthcare supply chain to reduce counterfeiting, speed recalls and improve post-market surveillance. With the UDI regulation for devices, FDA's implementation of the Drug Supply Chain Security Act (DSCSA) and The Joint Commission tissue tracking all in full force this year, in additition to unique ID data capture requirements proposed under Meaningful Use (MU) Stage 3, many hospitals and suppliers are working hard to not only comply, but excel in this incredible time of technology and change. The industry is in the midst of transformation as it learns to harness and hone tremendous amounts of data to propel accuracy, safety and security in the nation's healthcare system, while also meeting tight regulatory deadlines.

Those who incorporated the UDI into their information systems for last year's Class 3 implant requirements are reaping the benefits of accurate, consistent product information. Others still have to catch up. AHRMM attendees stated, for example, that they are not aware of all the UDI requirements, even the ones providers are responsible for, such as storage of the entire UDI, including production identifiers, for retrieval in adverse event reporting. Proposed MU Stage 3 requirements for Electronic Health Records will provide the software enhancements to make this possible for implanted devices as well as document in registries and support value anaysis. The industry as a whole needs to be better informed on what's in the UDI regulation, who and which items are affected and when the deadlines are.

USDM Life Sciences will publish more details around this topic, including upcoming blogs about which products require UDI and how hospitals can use Master Data Management as a strategy to make sense of all thier data. In the meantime, you are not in this alone.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.

The coding system is independent of the delivery mechanism and can be used within any delivery mechanism, including RFID technologies. The Blood Center of Wisconsin conducted a long study using ISBT 128 within RFID. The largest issue with Radio-Frequency Identification (RFID) is return on investment, so it has not been implemented in blood banks in the US. For cellular therapy products, it must be proven safe due to the minor amounts of radiation that could possibly do harm to the products. It is important to conduct tests to ensure that RFID is compatible with certain Human Cells, Tissues, and Cellular Tissue-Base Products (HTC/Ps).

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Yes, ISBT 128 may be used for all HCT/Ps regardless of how they are regulated. When labeling HCT/P regulated as a device, you must follow device labeling guidelines that require a Device Identifier (DI) and a Product Identifier (PI). With biologics, you may use either this format or follow the format used for cellular therapy products and blood. It's the same information but organized a little differently. Tissue banks can choose between the two systems for biologics. It's the same information either way---it's just organized into different data structures.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

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