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.
Life Science News
Tuesday, January 5, 2016
Monday, December 21, 2015
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.
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.
Thursday, December 17, 2015
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.
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.
Wednesday, December 16, 2015
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.
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.
Friday, November 13, 2015
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.
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.
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)
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.
Wednesday, September 9, 2015
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.
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