UDI compliance – What hospitals need to know to stop living dangerously

While the fate of the ACA hangs in the balance, one thing in healthcare is certain: patient safety and quality of care will continue to drive change in the US healthcare market.

UDI regulations support this objective and deadlines for implementation are looming. Many hospitals don’t yet have a way to implement the requirement which mandates the tracking of specific product information such serial and UDI numbers.

The FDA’s unique device identification (UDI) regulation already requires that Class II and Class III devices, including implantable, life-supporting and life-sustaining devices have labels and packages. Also, Class III devices must include a UDI as a permanent marking on the device itself, if it’s intended for reprocessing and reuse. By September 2018, the regulations will require a UDI as a permanent marking on Class II devices and by September of 2020, all classes of medical devices will require this.

Compliance and reimbursement risks for providers who lack the ability to manage tracking and real-time serial and UDI data are real. Smaller hospitals may have trouble meeting implementation deadlines and larger providers may comply but certainly won’t be optimized with easily searchable inventory databases for recalled devices. This is because operations, IT and supply chain departments are behind in adjusting to the new UDI rules, frequently lacking clarity regarding who owns the responsibility for such things as UDI. On top of this, a recent survey found that 78 percent of the medical professional respondents were still manually counting inventory in parts of their supply chain, as well as manually capturing implant data in the operating rooms. It appears that some hospitals may need a checkup of their own.

In order to achieve compliance, hospitals should evaluate their supply chain management capabilities to make sure they have an automated system that can capture medical device data required by the UDI regulations. Improved quality of care can be achieved by providing real-time tracking data for product all the way from the warehouse to the OR.

Here are 6 steps hospital supply chain managers can take now to ready themselves for UDI implementation.

1. Identify who in the hospital oversees the UDI implementation initiative in order to establish a timeline with objectives and milestones
2. Review any current/existing inventory-management systems and identify areas for better cost efficiencies and greater visibility
3. Implement business process changes by considering up-to-date platforms to track hospital supplies and medical devices for better UDI compliance
4. Select an inventory-management system that offers track and trace capabilities with easy data capture including UDI, serial, batch and lot numbers, as well as expiration date, to ensure better compliance.
5. Acutely focus on change management. One of the most frequent mistakes made is not realizing that technology can only help if accompanied by the right amount of change management.
6. Recognize that, in order to elevate the supply chain to the strategic platform required to take advantage of all the changes taking place today, operations will need to be drastically different. Achieving buy-in and support from the hospital leadership to push for those operational changes is key.

Many benefits of UDI implementation are expected, including better inventory control, more efficient management of item recalls and greater patient safety. What many don’t realize, is that there are also cost benefits for providers who optimize for UDI regulation with enhanced inventory tracking platforms. Specific ways that integration with the supply chain and care delivery process leads to increased cost savings and better patient outcomes include:

• Ability to capture data that will inform “Cost per procedure”. CFO’s have more visibility into true costs and can make informed decisions to improve margins. In some cases, they can reduce the amount of lost/wasted/expired product by as much as 20% in supply costs.
• Medical supplies for the OR can represent as much as 80% of the entire inventory value and are often managed inefficiently. Applying the right tracking platform could save as much as $400K per surgeon per year, while significantly reducing clinical staff time dedicated to supplies management
• Outdated surgeon preference cards are a key source of waste. Tracking items opened but unused during a medical procedure, can help to reduce future wastage.
• Having the right supplies immediately available means that patient procedures can be streamlined ensuring reduction in treatment time and scheduling.
• Improved visibility into consignment inventory

As healthcare organizations keep focused on extracting the maximum efficiency from their value chain, it will be imperative that the way they focus on supplies changes. Historically, hospitals have spent a large amount of effort managing low cost supplies while allowing the highest value stock (i.e. surgery and cath lab supplies) to be treated very differently, in most cases with no inventory management system to control it.

Automated, integrated technology offering full visibility and point of care traceability for devices and supplies can help hospitals optimize their supply chain system to come into compliance, cut high healthcare costs and improve patient care.

As providers and suppliers consider how to best take advantage of the new mandates and the data that is being made available, resistance to change must be overcome. The time to question how we currently manage supplies is here. There are better and more efficient ways to do it.

The views, opinions and positions expressed within these guest posts are those of the author alone and do not represent those of Becker's Hospital Review/Becker's Healthcare. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them.

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