UDI Expands, Questions Roll In, And Debate Over System Adoption Continues

Jay Crowley was interviewed for an article about the current state of the Unique Device Identification (UDI) program, persistent challenges for companies and what to expect in the year ahead.

Here is a link to the article. You need to be a subscriber or register for a free trial to The Gray Sheet to view the entire article.

As Vice President of the UDI Practice at USDM Life Sciences, Crowley helps medical device manufacturers achieve regulatory compliance as well as internal benefits and competitive advantage with UDI implementation.

Is it Possible to Add Additional Product Data to What is Available Via the GUDID?

Yes, after getting UDI Connect into your Salesforce Org, go to the AppExchange and bring down the desired package. Once this happens, it is possible to add any field, pick lists, and look-ups from the Global UDI Database (GUDID) to the app. The app is highly customizable as USDM does not limiting like other managed packages. The application is flexible and designed in this way because USDM understands that all clients have different processes and practices as well as different intended uses for the application.

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 USDM Help Implement on Platforms Other than Salesforce?

USDM Life Sciences' UDI Connect platform is currently designed to work on Salesforce, and it can be ported to other backend services that support the same level of security and multi-tenancy. Porting involves adapting to the specific requirements and features of the target platform, but USDM can leverage its existing methodology and Workflows, as well as the same mobile application, and apply it to any platform.

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.

Chris Chandler, PharmD. USDM
Lakisha Bowie, MBA, Standards & Interoperability Franciscan Missionaries of Our Lady Health System (FMOL HS) 
Bill Mosser, VP Materials Management FMOL HS

The Franciscan Missionaries of Our Lady Health System (FMOLHS) in Baton Rouge is one of the largest healthcare systems in Louisiana. Bill Mosser, VP of Materials Management brings years of experience to reshape healthcare delivery 'Strategically, our healthcare supply chain leaders are continually challenged by changing environments. It's important that we open our minds to ideas and solutions that have been successful in other industries. In that regard, collaboration with those from outside our own organization offers opportunity for open discussion and learning, understanding the views of our cohorts and building relationships with partners focused on common goals and outcomes’.

Their warehouse and truck delivery network, Logistics One, is a new supply distribution center to provide more efficient delivery for five hospitals and other healthcare organizations across Louisiana, significantly reducing hospital traffic from trucks and vendors to one visit. Its inventory management technology provides real-time flow of information to ensure next-day delivery for the most common supplies stocked in healthcare settings, reducing the demand for storage space. Logistics One is the result of partnership with ROi, the supply chain solution founded by the Sisters of Mercy Health headquartered in St. Louis, bringing together two health systems with similar missions and values. Bill Mosser, VP Materials Management led the team for FMOL HS and estimates it will reduce spending on supplies by two to four percent over the next 24 months (supplies and medications represent approximately 20 percent of costs in a typical hospital).

Mosser recognizes the supply chain plays a critical role to meet the challenge of quality patient care with innovation, stepping out of traditional service lines. To that end he championed work within the Pharmacy Department’s 19 inpatient, clinic and retail pharmacies throughout Louisiana to implement efficient supply chain solutions including a program for compliance with the FDA’s implementation of the Drug Supply Chain Security Act (DSCSA). As the practice of pharmacy focuses on competing priorities in providing clinical support, delivery of medications and ever increasing standards and regulations from the DEA, State Boards of Pharmacy, USP and JC, the supply chain demands to comply with 340B regulations and now compliance with new FDA regulations adds to the growing management burden. Mosser and his team led by Lakisha Bowie brought in training, rolled up their sleeves to evaluate current policies and built new processes with the pharmacy to align at the enterprise level and follow the successful model in FMOL HS Materials Management. In meeting the DSCSA regulation, a compliance assessment strategy continues to fill the gaps in offering further electronic efficiencies and traceability of product information for patient safety. So what’s next? Mosser and his team will extend further successful projects at Logistics One to Pharmacy to support challenges in critical shortages, procure-to-pay, and the ultimate goal of perfect order. Allowing the pharmacy to focus on their clinical support of patient care, supply chain partnerships are critical to a successful program.

DSCSA Requirement	Activity Description
Authorization- Check supplier license and expiration	•        New Vendor Letter and Survey •         Authorized Supplier Listing maintained on SharePoint (compliance, ability to correct T3 and electronic/ ASN capability)
Verification- Inspection,  T3 match and Store T3	•        Draft GDP Policy •        Training/Communication Plan- internal and external •        Shared Data Retention Folders
DSCSA Compliance	Implementation Plan Weekly Meetings •        T3 Compliance •        Audits- TBD every month to visit each location at least 2x/year •        Impact- Dispenser-to-dispenser transactions, Product Recall Process
Improved Process-T3	Electronic System- not required until 2017 however paper burden at 27 pharmacy control points =  3+FTEE for the enterprise •        Electronic Transaction Vendor Requirements Building, Selection
Master Data Management	Relating T3 Master Data- build a Pharmacy Item Master

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 Basics of the Unique Device Identifier (UDI) in Healthcare

Bar code scanning in our everyday lives is natural except when it comes to healthcare. This article provides a high level overview of the Unique Device Identifier and what adoption in healthcare means to patient safety.

Read The Basics of the Unique Device Identifier (UDI) in Healthcare
(AHRMM Membership Required to Access Article)

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.

Attention Hospitals: Time to Clean Your Data House!

 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 (link to Healthcare Practice page).

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.

Recognizing Supply Chain Thought Leaders

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!

What Does ISBT128 Utilization Look Like for Those Receiving Products from Manufacturers, for Instance for Blood Banks or Departments Within Hospitals?

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/inventory management systems and interfaces to the GUDID.

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.

Does FDA Require the Investigator to Complete an FDA 1572 for Conducting Clinical Investigations of a Medical Device?

For clinical investigations of medical devices, an FDA 1572 is not required.  However, an investigator agreement is required for clinical investigation of medical devices.  An investigator agreement is not a specific form, it’s an agreement of the PI to conduct the trial according to regulations.

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 All Class II (FDASIA) Devices?

The extension for some implantable devices does not apply to all class II (FDASIA) medical devices.  The extension only applies to devices that are classified as FDASIA implants and distributed non-sterile.  It’s a limited subset of all FDASIA devices that have been granted this label extension to 2016.

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 There a Checklist for GCP Audits?

There are a number of GCP audit checklists, some of them are available for free online.  An Internet search for “GCP audit checklists” will provide you with many checklists to choose from.  The auditors at USDM Life Sciences recommend including a checklist as part of your quality assurance process – don’t wait until you get an audit notice to prepare.

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 All UDI Requirements?

The extension for some implantable devices does not apply to all Unique Device Identification (UDI) requirements.  The extension only applies to the label requirement.  Requirements to collect, store, normalize, validate and submit data to the Global UDI database (GUDID) must be met by September 24, 2015.

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.

Should Validation Services and Training be Included in a Request for Proposal?

It’s important to be very clear in a Request for Proposal (RFP).  If you want validation or training services, specify exactly what you are looking for in the request.  For example, some companies have validation staff, but may not have a validation leader.  You may want to specify that you only need a validation team leader.  If you will need training services, include who will need to be trained.  You may only need help training the trainers or you may need training for an entire department.

USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.

Does the UDI Extension for Some Implantable Devices Apply to All UDI Requirements?

The extension for some implantable devices does not apply to all Unique Device Identification (UDI) requirements.  The extension only applies to the label requirement.  Requirements to collect, store, normalize, validate and submit data to the Global UDI database (GUDID) must be met by September 24, 2015.

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.

When to Establish Requirements for New LIMS/Lab System?

It’s important to understand the capabilities of the new LIMS and develop a baseline of requirements at the beginning of the project.  It’s a good idea to have representatives from every department that will use the new LIMS participate in establishing the baseline of requirements, because departments within a company often have different requirements.  Kathleen Warner, Vice President of Project and Program Management at USDM Life Sciences says requirements for one particular LIMS project she worked on had to be revised four times because company representatives learned about new capabilities of the lab system during the project.

USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.