In addition to announcing and explaining the final UDI rule, presenters at the conference offered a wealth of advice for medical device manufacturers preparing to comply with the regulation. For those of you who were unable to attend the conference, we’ve selected some highlights for you:
Terrie Reid, Associate Director for Informatics, who has worked incredibly hard to create the infrastructure for the Global Unique Device Identifier Database (GUDID, pronounced, “Good-ID”), cited these keys to UDI implementation:
1. Act now – the sooner implementation begins, the lower the overall costs are likely to be.
2. Advocate for change – know the benefits of UDI and share them widely among colleagues.
3. Build a great team – this will ensure that implementation goes smoothly.
4. Partner with all key stakeholders – and communicate constantly and clearly with all of them.
In his presentation, Ken Koldan, co-chair of the AIM North America UDI Committee and CEO of FLEXcon, laid out five simple steps to UDI compliance:
1. Identify which accredited issuing agency from whom you are going to acquire codes (GS1, HIBCC and ICCBA are the only accredited agencies)
2. Reformat your Product Identifier (PI) to match UDI requirement.
3. Mark your products with you Automatic Identification Code (AIDC) technology
4. Register the device with the FDA Database
5. Ship out the device
We’re grateful to all of the presenters for sharing their thoughts about UDI. We’d also like to commend the UDI team on their exceptional work to create a regulation that will have such a positive impact on public health. We look forward to providing AIDC and data submission solutions to manufacturers as they work to implement these important changes.
Tuesday, September 24, 2013
UDI Final Rule: Timeline and Exceptions
by Foster Sayers
As noted in my last blog post, the final rule for Unique Device Identification (UDI) was published today, September 24, 2013, to the Federal Registry. Which means the clock is now ticking.
Within one year (by September 24, 2014) all Class III medical devices must bear a UDI.
There are some exceptions. The industry has been given three years to make existing inventory compliant. Class I devices do not need to include production identifiers and thus will not require dynamic printing/packaging. Shipping containers are exempt. Individual single use devices, such as ones that come in shelf packs, are exempt.
One of the most notable exemptions was related to kits and combination products. If there is a UDI on a kit or combination product then the constituent parts are exempt from having UDI.
There is no longer any reason to delay. The time to begin implementing UDI is now. If you’re in search of a solution or would like to understand more, please contact us.
As noted in my last blog post, the final rule for Unique Device Identification (UDI) was published today, September 24, 2013, to the Federal Registry. Which means the clock is now ticking.
Within one year (by September 24, 2014) all Class III medical devices must bear a UDI.
Within two years (by September 24, 2015) Class II and Class I implants and life-sustaining devices must bear a UDI.
Within three years (by September 24, 2016) remainder of Class II devices must bear a UDI.
Within five years (by September 24, 2018) Class I devices must bear a UDI.
There are some exceptions. The industry has been given three years to make existing inventory compliant. Class I devices do not need to include production identifiers and thus will not require dynamic printing/packaging. Shipping containers are exempt. Individual single use devices, such as ones that come in shelf packs, are exempt.
One of the most notable exemptions was related to kits and combination products. If there is a UDI on a kit or combination product then the constituent parts are exempt from having UDI.
There is no longer any reason to delay. The time to begin implementing UDI is now. If you’re in search of a solution or would like to understand more, please contact us.
Friday, September 20, 2013
UDI Final Rule
by Foster Sayers
At 8:45 this morning the FDA pre-published the long anticipated final rule on Unique Device Identification.
Jay Crowley, the architect of the Global Unique Device Identification Database and leader of the UDI initiative made the announcement at the UDI conference in Baltimore to much applause.
The final rule will allow many organizations to move forward with their UDI projects with the certainty needed in order to ensure their efforts will lead to compliance.
As of now, the rule is available in PDF format only. Crowley announced at the conference that he expected the publication would appear in it's official final format on the Federal Register's website by Tuesday, September 24.
In my next blog post I will touch on some of the key differences between the proposed rule and the final rule published this morning.
At 8:45 this morning the FDA pre-published the long anticipated final rule on Unique Device Identification.
Jay Crowley, the architect of the Global Unique Device Identification Database and leader of the UDI initiative made the announcement at the UDI conference in Baltimore to much applause.
The final rule will allow many organizations to move forward with their UDI projects with the certainty needed in order to ensure their efforts will lead to compliance.
As of now, the rule is available in PDF format only. Crowley announced at the conference that he expected the publication would appear in it's official final format on the Federal Register's website by Tuesday, September 24.
In my next blog post I will touch on some of the key differences between the proposed rule and the final rule published this morning.
Monday, September 16, 2013
RossPPD to Exhibit at UDI Conference Later This Week
by Foster Sayers
RossPPD is pleased to be exhibiting at the UDI conference this week in Baltimore on the 19th and 20th. This conference will be the place to find out all of the final guidance on what the new FDA mandate on Unique Device Identification will require of your organization.
While the final rule on UDI has not yet been published, it has been submitted to the Office of Management and Budget (OMB). There is a chance it will be published in time for the conference. However, if it is not published then the rule is final enough that it can be discussed in depth and guidance can be given. Jay Crowley, the architect behind UDI, will be presenting in order to provide everyone with guidance on implementing the rule.
If you’re going to attend, be sure to come by our booth to see a demo of MDDTrack, RossPPD’s comprehensive solution for UDI submissions to the GUDID, electronic instructions for use, and item level risk management.
Ross will partner with your organization to guide not only regulatory, but also packaging, IT and marketing through the process of getting set up to implement your UDI solution. If you’d like to understand how, please come see us at our booth, 13 A, on the UDI conference exhibition floor.
RossPPD is pleased to be exhibiting at the UDI conference this week in Baltimore on the 19th and 20th. This conference will be the place to find out all of the final guidance on what the new FDA mandate on Unique Device Identification will require of your organization.
While the final rule on UDI has not yet been published, it has been submitted to the Office of Management and Budget (OMB). There is a chance it will be published in time for the conference. However, if it is not published then the rule is final enough that it can be discussed in depth and guidance can be given. Jay Crowley, the architect behind UDI, will be presenting in order to provide everyone with guidance on implementing the rule.
If you’re going to attend, be sure to come by our booth to see a demo of MDDTrack, RossPPD’s comprehensive solution for UDI submissions to the GUDID, electronic instructions for use, and item level risk management.
Ross will partner with your organization to guide not only regulatory, but also packaging, IT and marketing through the process of getting set up to implement your UDI solution. If you’d like to understand how, please come see us at our booth, 13 A, on the UDI conference exhibition floor.
Monday, September 9, 2013
Introducing the RossPPD Product Suite
by Brittany Sutton
Ross PPD is focused on solutions for biomedical companies by offering products that provide supply chain management, paper instructions for use, and medial adherence. Their product line includes MDDTrack, IFUTrack, and PharTrack.
MDDTrack: Track and Trace Products Individually
The FDA' proposed ruling on Unique Device Identifiers (UDI) should be finalized by the UDI Conference this September. MDDTrack will help companies comply with the regulation by linking a QR code (the physical UDI) on the packaging to a unique URL. This allows items to be tracked through every step of the supply chain.
MDDTrack also allows a company to address a product recall down to the specific item or lot using the UDI, which allows you to micro-target the recall in real time to solve the issue faster and more efficiently.
IFUTrack: Eliminate Paper and Save Money
In March of 2013, the European Commission began allowing electronic instructions for use instead of paper IFUs. This ruling allows companies to save enormous amounts of printing costs and time, and allows the consumer to access the eIFU in their native language more easily. IFUTrack is a simple user-friendly interface and allows you to download your eIFUs by scanning the QR code on the packaging.
PharTrack: PBMs and Medical Adherence
Medical Adherence is a worldwide problem that reduces the revenue Pharmacy Benefit Managers receive. PharTrack helps increase medical adherence and therefore gives more revenue to the PBM through unique URLs on prescriptions
PharTrack allows patient to quickly scan their code and click a button to record they’ve taken their daily dose. This will help PBMs capture revenue lost when patients do not adhere to medication schedules, and it will also keep patients healthier and refilling on time.
Find out more about Ross’ solutions at rossppd.com/products.
Ross PPD is focused on solutions for biomedical companies by offering products that provide supply chain management, paper instructions for use, and medial adherence. Their product line includes MDDTrack, IFUTrack, and PharTrack.
MDDTrack: Track and Trace Products Individually
The FDA' proposed ruling on Unique Device Identifiers (UDI) should be finalized by the UDI Conference this September. MDDTrack will help companies comply with the regulation by linking a QR code (the physical UDI) on the packaging to a unique URL. This allows items to be tracked through every step of the supply chain.
MDDTrack also allows a company to address a product recall down to the specific item or lot using the UDI, which allows you to micro-target the recall in real time to solve the issue faster and more efficiently.
IFUTrack: Eliminate Paper and Save Money
In March of 2013, the European Commission began allowing electronic instructions for use instead of paper IFUs. This ruling allows companies to save enormous amounts of printing costs and time, and allows the consumer to access the eIFU in their native language more easily. IFUTrack is a simple user-friendly interface and allows you to download your eIFUs by scanning the QR code on the packaging.
PharTrack: PBMs and Medical Adherence
Medical Adherence is a worldwide problem that reduces the revenue Pharmacy Benefit Managers receive. PharTrack helps increase medical adherence and therefore gives more revenue to the PBM through unique URLs on prescriptions
PharTrack allows patient to quickly scan their code and click a button to record they’ve taken their daily dose. This will help PBMs capture revenue lost when patients do not adhere to medication schedules, and it will also keep patients healthier and refilling on time.
Find out more about Ross’ solutions at rossppd.com/products.
Monday, September 2, 2013
FDA Guidelines on Electronic Records
by Foster Sayers
For medical device manufacturers Part 11 requires them to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are either required to be maintained by the FDA predicate rules or used to demonstrate compliance to a predicate rule. A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11.
To date, Part 11 has already been impacting manufacturers that are creating instructions for use electronically and taking other paper records to a digital format.
As UDI approaches, Part 11 will be operative as companies prepare the electronic submissions of data that will go to the FDA. MDDTrack is fully compliant with Part 11 and helps organizations ensure that audit trails and all relevant documentation fully follows all FDA guidelines.
Friday, August 30, 2013
Moving Instructions For Use (IFUs) Online: A Path to Improved Care
Last year, the Pharmaceutical and Biomedical Device industries generated a combined total of $850 billion in revenue. Our partnerships in the industry have revealed that companies consistently spend one one-thousandth of their revenues on printing. This means that the two industries allocated an estimated $850 million to printing IFUs in one year alone. Imagine what could be done with a sum like this across the industry: price cuts on existing products, additional job creation, more attention to quality control, or any number of measures that would help accomplish the end goal of healthcare efforts—improving quality of life and saving life-years of patients.
How can we cut these costs and enable companies to reallocate resources to more critical areas? The answer is simple: we can allow them to replace printed IFUs with electronic ones (eIFUs). The European Union has already issued a regulation (207-2012), effective since March of 2013, permitting the use of eIFUs for certain devices.
Unfortunately, regulation 207-2012 only allows eIFUs to replace printed instructions for very specific use cases: the eIFU must be intended exclusively for a healthcare provider and the device to which it refers must be implantable, contain a built-in system that visually displays instructions for use, or be stand-alone software.
Though the regulation affects a limited number of products, this legislation is setting precedent for digital distribution of information that was previously required in print. In addition to reducing costs, the move towards digital distribution has numerous benefits to biomedical manufacturing companies and the end users of their products. These benefits include:
-Increasing the speed at which devices get to market.
-Reducing the risk of lost IFUs, which can result in improper use of devices.
-Reducing carbon emissions associated with the preparation and distribution of products.
We applaud companies like Medcomp, Abbot Vascular, and Medtronic that have already made their IFUs available online. Not only are they ensuring that patients and their healthcare providers have constant access to the most updated information about their medications or devices, but they are positioning themselves to eliminate paper instructions when the FDA inevitably follows the EU Commission’s lead and permits a full replacement.
RossPPD offers a cloud-based eIFU management system. If you are looking to move your IFUs online, find out more at http://www.rossppd.com/products/ifutrack.
How can we cut these costs and enable companies to reallocate resources to more critical areas? The answer is simple: we can allow them to replace printed IFUs with electronic ones (eIFUs). The European Union has already issued a regulation (207-2012), effective since March of 2013, permitting the use of eIFUs for certain devices.
Unfortunately, regulation 207-2012 only allows eIFUs to replace printed instructions for very specific use cases: the eIFU must be intended exclusively for a healthcare provider and the device to which it refers must be implantable, contain a built-in system that visually displays instructions for use, or be stand-alone software.
Though the regulation affects a limited number of products, this legislation is setting precedent for digital distribution of information that was previously required in print. In addition to reducing costs, the move towards digital distribution has numerous benefits to biomedical manufacturing companies and the end users of their products. These benefits include:
-Increasing the speed at which devices get to market.
-Reducing the risk of lost IFUs, which can result in improper use of devices.
-Reducing carbon emissions associated with the preparation and distribution of products.
We applaud companies like Medcomp, Abbot Vascular, and Medtronic that have already made their IFUs available online. Not only are they ensuring that patients and their healthcare providers have constant access to the most updated information about their medications or devices, but they are positioning themselves to eliminate paper instructions when the FDA inevitably follows the EU Commission’s lead and permits a full replacement.
RossPPD offers a cloud-based eIFU management system. If you are looking to move your IFUs online, find out more at http://www.rossppd.com/products/ifutrack.
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