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Unique Device Identification (UDI) took center stage at this year’s AHRMM 15 Conference. In the hallways and in sessions, including my panel session on the topic, hospitals, regulators, solution providers and suppliers discussed the obvious benefits of having consistent, accurate and unique identifiers for devices and pharmaceuticals to ensure better tracking throughout the healthcare supply chain to reduce counterfeiting, speed recalls and improve post-market surveillance. With the UDI regulation for devices, FDA’s implementation of the Drug Supply Chain Security Act (DSCSA) and The Joint Commission tissue tracking all in full force this year, in addition to unique ID data capture requirements proposed under Meaningful Use (MU) Stage 3, many hospitals and suppliers are working hard to not only comply, but excel in this incredible time of technology and change. The industry is in the midst of transformation as it learns to harness and hone tremendous amounts of data to propel accuracy, safety and security in the nation’s healthcare system, while also meeting tight regulatory deadlines.

Those who incorporated the UDI into their information systems for last year’s Class 3 implant requirements are reaping the benefits of accurate, consistent product information. Others still have to catch up. AHRMM attendees stated, for example, that they are not aware of all the UDI requirements, even the ones providers are responsible for, such as storage of the entire UDI, including production identifiers, for retrieval in adverse event reporting. Proposed MU Stage 3 requirements for Electronic Health Records will provide the software enhancements to make this possible for implanted devices as well as document in registries and support value analysis. The industry as a whole needs to be better informed on what's in the UDI regulation, who and which items are affected and when the deadlines are. USDM Life Sciences will publish more details around this topic, including upcoming blogs about which products require UDI and how hospitals can use Master Data Management as a strategy to make sense of all their data. In the meantime, you are not in this alone.

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.

A single use device is not required to have a UDI on the package if it meets the following criteria:

  • Device is distributed inside a package with more of the same devices. (The package that contains multiple single use devices is required to have a UDI.)
  • Device is intended to be stored in the package with more of the same products until use
  • Device is not intended for distribution
  • Device is not considered an implant by the FDA (Check this list to see if the FDA considers your device an implant.)

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.

  1. No annual review of Environmental Monitoring data and assessment of the continued appropriateness of current action and alert limits.
  2. Environmental monitoring programs which do not establish investigations or actions for a number of alert limit excursions which occur during a discrete time period.
  3. Supplier qualification processes which are based criticality of supplier on annual procurement $ spend rather than GxP criticality dimensions such as safety, quality, identity, purity or potency.
  4. Supplier qualification processes which allow too long a time period between initial qualification audits and subsequent re-qualification audits.
  5. Supplier qualification processes which do not take into account supplier performance history and the need for adjustments to defined audit frequencies.
  6. Process qualification of critical quality attribute ranges which are not scientifically justified based upon DOE or other science based rationale.
  7. Computer systems validation of key systems used to support quality or production systems which does not include a periodic review process following initial validation to evaluate the collective impact of change controls and the maintenance of the validated state of control.
  8. Recall procedures which do not include provisions for a mock recall to verify lot genealogy/traceability.
  9. IT back-up processes which utilize automated tools/utilities with no manual review of backup logs to verify that there were no failures or files skipped. No process for investigation or escalation of backup failures to IT management.
  10. Failure of cleaning validation to consider limit of detection, limit of quantification, various materials of construction and risk parameters such as worst-case model compound, solubility, number of difficult to clean areas and total product contact area.

About the Author:
Robert (Bob) Lesnefsky is the Global Vice President of Quality Assurance and Regulatory Compliance and Auditing at USDM Life Sciences. He is a seasoned quality assurance and regulatory compliance professional with 30+ years of experience in quality assurance and regulatory compliance in the pharmaceutical, biotechnology, medical device, nuclear and petrochemical industries. Bob is sought out as the GMP/DEA compliance expert in providing compliance opinions and interpretations of cGMP to manufacturing, operations, quality and client services to ensure compliant drug product manufacturing operations.

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.

USDM Life Sciences has quite a bit of experience with this. Let’s say you chose to move to GS1 standards, you're effectively changing the label. You would have to sunset, retire, and create a new record associated with the GS1 standard as your device identifier.

There are some ways to do this that are a bit more flex, if you haven't already submitted the record, that we've helped some clients with. So if you've already submitted, then you're going to have to end date and then create a new record. If you haven't submitted, then take advantage of the primary and secondary DIs that are associated with the product so that you don't have to create new records downstream.

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.

Clinical Enterprise Content Management (ECM) solutions can be leveraged in many different ways, which is one of the big advantages. ECM systems can be leveraged for SOP management, regulatory submissions, regulatory affairs, records information management, as well as by commercial and manufacturing.

To have a comprehensive content management solution that goes across all areas of a pharma or biotech CRO. And, there are many companies that implement stand-alone solutions for each of their business units or content management solutions which then drive up costs of ownership because they're implementing various solutions that don't end, and you've got to have support for each of those, and you've got to have an investment from an infrastructure perspective, or long term solution. You're paying insane costs, things like that. Absolutely they can be and should be an operation across other functional areas.

The USDM Life Sciences Clinical Services and Solutions team provides our clients (from start-up Biotech to large Pharma/Device) with the latest technology, processes and strategies to assist with efficiency, quality and compliance in any scenario and offers our clients a cost-effective, proactive and unified partnership in goal achievement.

 

Generally, the information that's coming from the distributor is very well-managed by the distributor through to the hospitals, but using a solution is still a benefit. Where providers have more difficulty with keeping up with the documentation is for their orders that go direct to the smaller companies. That's where the magnitude comes up, but it's probably an 80/20. They order most of their product through a distributor, so it's covered, but they can order from up to 50 smaller manufacturers. They have to have a process in place with each individual manufacturer, and that is very cumbersome.

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 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.

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.

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.

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.

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    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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