Unique Device Identification - A Hot Topic in Healthcare

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 pharmaceuticals 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 addition to unique ID data capture requirements proposed under Meaningful Use (MU) Stage3, 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 Stage3 requirements for Electronic Health Records will provide the software enhancements to make this possible implanted devices as well as document in registries and support value analysis. The industry as a whole needs to be better informed on what's 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 their 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.

How Can ISBT 128 be Used Within Radio-Frequency Identification (RFID) and Other Automated ID Technologies?

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.

Can ISBT 128 be Used for Both Human Cells, Tissues, and Cellular Tissue-Base Product (HTC/Ps) That are Regulated as Biologics and HTC/Ps That are Regulated as Devices? Does It Work the Same Way?

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.

Is ISBT 128 Always in 2D Data Matrix?

No, Code 128 linear symbols may be used, but it leads to a very long barcode and such long barcodes may not fit on the labels of human cells, tissues, and cellular tissue-based products (HTC/Ps). The recommendation is to use 2D, especially in a case where a system is just being set up because it is more efficient.

Another consideration is what code will be best for those receiving the product with the label. Those receiving the product must be able to understand and utilize the data included in a way that is useful to them.

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.

Have Vendors of Technologies Begun Modifying Their Systems to Take Advantage of Standardized Unique Device Identification (UDI) and ISBT128 Tracking of Devices?

Yes, technologies have started adapting to automatic IDs and capabilities associated with tissue storage and blood banking. The Eye Bank Association of America has just mandated ISBT 128 for international distribution of products for their accredited facilities beginning in 2017. For many reasons, software development companies are starting to become interested in ISBT 128 and a tracking system that can be built around it. In regards to blood banking systems, there are issues because the FDA 510(k) clearance for blood bank software does not include other uses. Software developers need to use the same principles, but many need to create separate systems for tissue and cells.

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.

GCP Investigators: Do Regulations Require a CV to be Periodically Updated?

FDA does not require updates to CVs. Initial submission of documentation of training and experience on a CV is adequate. However, a sponsor may require CV updates. USDM Life Sciences recommends you adhere to sponsor requirements that are provided during the trial.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.

Does the UDI Extension for Some Implantable Devices Apply to Implants Distributed in Sterile Form?

The Unique Device Identification (UDI) extension for some implantable devices only applies to devices distributed that are intended to be taken out of their package and sterilized before use, for example sets, trays and caddies.  Implants that remain in their sterile packing (class II and II) until use still have their original compliance deadlines.

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.