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Although the words “accessory” and “component” are often used as generic terms when discussing devices, they each have regulatory definitions. From a regulatory perspective, “accessories” are specific objects that work with finished medical devices and are therefore regulated devices in their own right and subject to UDI. “Components” are defined as objects that manufacturers acquire or build and then use to create medical devices. These are not put into commercial distribution. Therefore, UDI does not apply to components. UDI applies to finished medical devices and accessories that are put into commercial distribution, sold, and distributed.

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 a new year and the healthcare world is ever evolving. The UDI Rule is in progress with manufacturers working to comply including submitting information to the GUDID. Meaningful Use Stage 3 was presented in October indicating the EHR software is to be capable of accepting the UDI. Use of the UDI within the healthcare provider is gaining adoption through means of software providers, clinicians, supply chain and information technology. The metadata associated with the use of the UDI is becoming more apparent and open for discussion on how to best manage and utilize the information.

The metadata will be collected from multiple systems across an organization using key terms to synchronize the data and generate meaningful reports in regards to purchase history, recalls, patient outcomes and reimbursement.

All that we do in regards to use of the UDI is patient safety focused. The paradigm shift requires implementation of a strategy by segment bringing together the stakeholders, discussing the influences, testing and proving the concept is possible to implement.

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.

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.

Jean Sargent, Vice President of Healthcare Strategy and Implementation at USDM Life Sciences, has been speaking with numerous solutions providers in order to understand where they are in relation to capabilities to transact with the UDI data. From the perspective of the supply chain, most of the large supply chain solution providers already have the capabilities to handle the capabilities built into their systems. If this capability is not on a built in version, solution providers have determined a path that allows the utilization of this information using subfields. When there is an upgrade all of the information will be in the correct fields and this information can then be used for transactions.

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.

It has been over a year since the Food and Drug Administration (FDA) required that class III devices were to be labeled with Unique Device Identification (UDI). Despite the common sentiment that labeling regulation can cause a great deal of reorganization and work, the packaging label is valuable. If you already have a packaging string built into your Item Master, you simply associate each UDI with that packaging string. The UDI for a 4by4 will have a different number for the package, box, and case. Use of this information within the Item Master ensures orders will transact utilizing the correct UDI with the associated product.

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.

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.

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.

It is very important to do your own assessment beyond the notice of violation or Form 483 (483) to determine if there are any broader or systemic issues. If you address only the issues outlined in the Establishment Inspection Report (EIR), 483, or notice of violation it is possible that the Food and Drug Administration (FDA) or another regulatory body will find other issues that are still existent in your system. This key milestone should be a precursor to completing the remediation plan. The remediation plan should include all of the commitments and responses to the FDA as well as items identified through the internal assessment.

Including the internal assessment in your response shows that you are taking the situation seriously and that you have done all of your due diligence. It demonstrates that you did not just look myopically at the issues raised by the FDA and that you have done a very thorough root cause analysis.

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.

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.

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.

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