What are Healthcare Providers Doing to Implement DSCSA Requirements?

Healthcare providers approach to implementing the Drug Supply Chain Security Act (DSCSA) varies. Some providers have teamed up with a solution provider that helps them to track pharmaceutical information. Others are using manual processes and keeping paper copies of the information. It really varies by organization. However, a paper process in any manner is not sustainable. It's a start. It helps to build the process. It will help the provider to understand the complexity and how having a solution is really going to help them to manage this data much better than a paper process.

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.

If Not Using the Kit Exception, Does the Kit Itself Need a UDI?

The kit exception doesn't work in reverse. So what the kit exception says is that if you have a UDI on the kit (assuming that it's a kit that meets the intent of the UDI Rule and the regulatory definition that's there now) then the device components are exempt from having to have a UDI on them. And we probably should use the term "component". The devices within the kit do not need to have a UDI on them.

The collection of medical devices, or the kit, in this case, is still a medical device and subject to UDI. So even if each of the devices within the kit have their own UDI, the kit itself is still a medical device and still needs its own UDI that identifies the kit itself. So it doesn't work in reverse.

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.

Will There be More Changes in the Expectations for Reporting Adverse Events Based on the Implementation of UDI?

Jean Sargent, Vice President of Healthcare Strategy and Implementation at USDM Life Sciences says adverse events reporting will become more and more imperative for all of the healthcare providers, as well as the medical device manufacturers. The FDA doesn't regulate the hospitals, so they can take it to a certain point. I'll liken it back to 2000. In 2000, being on the central service side, I was very involved when the FDA said "You can no longer manufacture your own product."

The FDA actually did start going into hospitals and making sure that the hospitals were not manufacturing their own product. There's going to be some way that the FDA is going to work with hospitals, to make sure they are capturing this information and therefore, reporting this information.

Now whether they end up using the joint commission or they end up using Medicare that demands having that UDI information for reimbursement - there will be methods that will be coming up down the road that will drive the adoption and implementation of the UDI within the hospitals.

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.

Do All Justifications for Direct Marking on Implants Have to be Submitted to the FDA or Can They be Documented in a Device History File for Inspection by the FDA?

The UDI Rule says that you need to have a permanent UDI on the device itself.

Direct Part Marking (DPM), is a set of technologies that are used both in medical device space, and widely in the DoD space, to apply typically bar codes to often metal or hard surfaces. One of the technologies to apply barcodes to surfaces is laser etching. There’s a number of different technologies that are out there.

But direct part marking is one way to meet the direct mark requirement. Obviously, there are permanent labels, tags, other ways as well, and some of this is discussed as well in the FDA's guidance on the topic.

On the issue of exceptions built into the Rule, I didn't touch on them today, but just like the single-use vice packaging and convenience kit exception, integral to the UDI Rule are a number of direct marking exceptions. They are listed there. And just like the single-use device packaging exception or the convenience kit exception, these exceptions are noted in the DHF of the particular device. So if you decide, for example, that it is not technologically feasible to directly mark your device, this is something you note yourself. All of these exceptions are things, all the exceptions that are integral to the Rule are things that you note yourself and do not have to request from the FDA.

There is an exception and alternative process that is built into the Rule, so if for some reason you believe you can't meet the Rule as we just talked about it and the exceptions that are integral to it are not sufficient, you can request from FDA a specific exception alternative. We've done a number of those for clients. There's some more information on FDA's website. If you have questions about it, please let us know.

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 UDI’s Assumed Application to Class III Medical Devices Connected with Serialization Initiatives?

At this point, there are no serialization or track and trace mandates in the United States that apply to medical devices. There are a number of activities in the pharmaceutical space for drug track and trace, specifically FDA’s Drug Supply Chain Security Act (DSCSA) legislation that requires eventual serialization of pharmaceutical products. There is nothing like this in the realm of medical devices.

Currently, UDI is solely concerned with medical device identification and its associated metadata. All stakeholders throughout the life cycle of the device should utilize UDI, but there is no mandate to either serialize or manage the traceability of the device the way there is within the pharmaceutical space.  If, in the future, serialization initiatives move into the medical device space, UDI could support this.

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.

How Does the UDI Rule Address Subcomponents or Accessories in Regards to the Statement that Every Medical Device Needs UDI?

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.

UDI is Paradigm Shift for Healthcare

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.