Noteworthy News

FDA Clarifies Convenience Kit Unique Device Identification Requirements and Exceptions

April 24, 2019

The U.S. Food and Drug Administration clarifies a more narrow scope of what is considered a Convenience Kit for the purposes of exception to UDI marking of the individual medical devices contained within a Convenience Kit.

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FDA announces new steps to help reduce risks associated with surgical stapler for internal use and implantable staples

April 23, 2019

The U.S. Food and Drug Administration announced on April 23rd, 2019 a proposed increase in regulatory classification for surgical staplers and implantable staples from Class I to Class II device. This would require baseline mechanical testing of the devices prior to being brought to market.

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FDA orders manufacturers to stop selling all surgical mesh devices intended for transvaginal repair of pelvic organ prolapse

April 16, 2019

The U.S. Food and Drug Administration today ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the U.S. immediately. The order is the latest in a series of...

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FDA flags breathing tube shortage tied to sterilization plant closing

April 15, 2019

FDA Friday alerted healthcare providers and caregivers to a temporary shortage of a tracheostomy tube made by Smiths Medical resulting from the recent closure of a large ethylene oxide (EO) sterilization plant in Willowbrook, Illinois.

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FDA Chief Calls For Release Of All Data Tracking Problems With Medical Devices

March 27, 2019

FDA Commissioner Scott Gottlieb announced in a tweet Wednesday that the agency plans to release hundreds of thousands, if not millions, of previously unpublished injury and malfunction reports tied to about 100 medical devices. “We’re now prioritizing making ALL of this data available,” Gottlieb tweeted.

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FDA braces for medical device shortages: 9 things to know

March 27, 2019

The FDA is taking several steps to help combat medical device shortages after a major medical device sterilization facility closed. Nine things to know:...

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8 common supply chain blunders

March 15, 2019

Healthcare organizations face many challenges in managing their supply chains. But there are a few problems that supply chain managers can avoid to improve inventory management, standardization and efficiency to save money for their organizations. Below are some of the top all-too-common blunders in the supply...

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FDA takes steps to help reduce risks associated with surgical staplers and implantable staples

March 8, 2019

Today, the U.S. Food and Drug Administration issued a Letter to Health Care Providers to alert them that the agency is aware of an increasing number of medical device reports associated with the use of surgical staplers for internal use and implantable surgical staples—common devices used in many surgeries—and...

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Generic drug approvals soar, but nearly half the meds aren't for sale in US

February 7, 2019

Although there has been a jump in FDA generic drug approvals in the last two years, nearly half of the medications are not sold in the U.S., according to a Kaiser Health News report. Since January 2017, more than...

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Fragile pharmaceutical supply chain increases costs, compromises care

January 15, 2019

The average unit price of drugs in shortage in 2016 increased 23.4%, according to a new report. And 1 in 4 hospitals had to cut staff to mitigate budget pressures.

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GS1 US White Paper: Non-Sterile Orthopedic Implants & UDI Capture: Options, Challenges, Benefits and Next Steps

December 06, 2018

The Workgroup set out to conduct a detailed analysis of data and device process flows, observe live surgeries, and analyze the various options. Their work highlighted and reinforced the complexity of the OR, and the challenges associated with managing these devices efficiently and effectively to support the safety...

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FDA to overhaul more than 40-year-old process for approving medical devices that some say puts consumers at risk

November 26, 2018

The Food and Drug Administration is overhauling the most common way medical device manufacturers bring their products to market in an attempt to advance new technologies.

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Medical device rules need 'drastic change' to protect patients

November 26, 2018

Urgent and drastic changes to the rules around medical devices, such as pacemakers, are needed to protect patients, according to the Royal College of Surgeons. It wants a register of every device in every patient set up so doctors know if new innovations are causing harm.

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Consolidation is hurting hospitals’ supply costs, not helping them

October 19, 2018

When health systems merge, one of the goals is to gain economies of scale, lowering costs through the bargaining power that comes from being a bigger player. Yet despite a consolidation wave in hospitals, it appears that they are paying more for supplies than they did a year ago.

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Hospitals have an unrealized $25.4 billion supply chain opportunity

October 18, 2018

Hospitals can save $25.4 billion if they improve their supply chain operations and harness data, according to a new...

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The Business Case for the UDI Work Group Report

March 30, 2018

The work group recommends that HCOs standardize product identification in the item master using the DI (device identifier) portion of the UDIs from the U.S. Food and Drug Administration’s Global UDI Database (GUDID), and regularly update this information to ensure it is accurate and complete...

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The Three Pillars of Supply Chain Savings

February 8, 2018

U.S. hospitals are struggling to remain financially viable, margins are thin and reimbursements are being reduced at an incredible rate. We need to reduce costs and improve quality of care to survive…

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Eskenazi UDI Capture Case Study

January 12, 2018

Eskenazi Health’s unique device identification (UDI) journey started many years ago when healthcare began discussing the use of GS1 Global Location Numbers (GLNs) for location identification and device identifiers (DIs) for product identification, as well as barcode standards.

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FMOLHS UDI Capture Case Study: Automation of Product Data Capture in the Electronic Health Record

January 12, 2018

FMOLHS is a pioneer in healthcare data standards implementation. Previous case studies have documented the organization’s journey over the past seven years.

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Transmitting the UDI from the Point of Use to Insurance Claims: Changes in Workflows and Information Systems

May 1, 2017

Recent recalls of medical devices and our changing health care system have highlighted the inadequacies of current methods for monitoring the performance, use, and safety of implanted devices.

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University Health Network UDI Capture Work Group Case Study

April 11, 2017

UHN initiated a supply chain technology transformation project throughout its 40 operating rooms (ORs) and two sites with a goal to achieve clinical time efficiencies, patient safety and surgeon cost data for improved decision making and savings.

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University of Tennessee Medical Center UDI Capture Work Group Case Study

April 11, 2017

Physician preference cards contain a list of supplies that hospital staff member’s think a surgeon may use during a procedure.

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Stanford Health Care UDI Capture Work Group Case Study

March 15, 2017

Accurately and efficiently capturing product information at the point of use for patient billing, inventory management, adverse event reporting, and recall management is critical to improving cost, quality, and outcomes in healthcare, but it is no easy task.

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Beaver Dam Community Hospital UDI Capture Work Group Case Study

March 15, 2017

Jordan Noyes, Contract Operations Specialist at BDCH, describes his organization’s work to use device identifiers (DIs) as a “visionary movement,” noting how the 60-bed, acute-care rural hospital is tackling the same challenges around product data standardization similar to other leading health systems across the U.S.

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AHA Fact Sheet: Implementing the Unique Device Identifier

January 31, 2017

Device makers are currently phasing in a new unique device identifier (UDI) for all of their medical devices. The UDI holds promise to improve medical device safety and create supply chain efficiencies. The transition to the UDI will require significant changes to hospital operations and information systems.

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Why most hospitals aren't using unique device identifiers to their full advantage

September 27, 2016

FDA's unique device identifier (UDI) system is supposed to help providers track medical devices, but few hospitals have implemented the technology necessary to leverage the information, Adam Rubenfire and Joseph Conn write for Modern Healthcare.

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Why Healthcare Needs Value-Based Supply Chain Management

February 9, 2016

The ongoing shift away from fee-for-service into the value-based reimbursement realm should intensify healthcare providers’ focus on supply chain management.

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Mercy Receives FDA Award for Medical Device Tracking

November 18, 2015

A project at Mercy to track thousands of implanted medical devices and improve patient safety now has the financial backing of the U.S Food and Drug Administration (FDA).

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Brains over brawn is the key to reducing supply costs

March 10, 2015

With reimbursements falling and expenses growing, hospitals and health systems are feeling the squeeze, and cutting supply chain costs is one of the first things systems are doing to handle the unprecedented margin pressure they're facing.

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