Co-authored by: Steve Cottrell, President of Maetrics and Madris Tomes, CEO of Device Events
For years, the medical device industry has already been tracking and identifying varying products, however, a global system was missing, meaning there was not one unified way to track device name, model and any other pertinent information about a product. In 2006, the American Hospital Association (AHA) and the Association for Healthcare Resource & Materials Management (AHRMM) pressed the FDA for a compulsory method for unique device identification.
A short while later, congress agreed; it recognized that a standardized medical device tracking system would allow for more accurate and timely detection of adverse events pertaining to medical devices, facilitating product recalls, and enabling strong post market surveillance. In 2007, Unique Device Identification (UDI) was signed into law as part of the FDA Amendments Act 2007, with The Final Rule published the following year. Once The Final Rule had been implemented the FDA set out a series of compliance dates which manufacturers had to meet when implementing UDI into their systems.
Implementing UDI is not always straight forward and does not happen overnight; a lot of effort is required by manufacturers to be in a position to meet all UDI compliance standards. However, there are substantial long-term benefits that come with complying early. Such advantages are improved inventory control, potential increased sales, more time to be able to recognize and troubleshoot differing product issues, improved medical billing accuracy and reduced levels of fraud.
If manufacturers treat UDI as more than just another regulatory compliance process, but rather as an ingression towards global regulatory harmonization then they will benefit much more than their competitors, due to the substantial positive benefits to patient and companies alike.
In order for medical device manufacturers to garner the best results from UDI and to ensure that they meet the remaining deadlines, it’s imperative that they plan for UDI without any delay – particularly because the next compliance deadline for UDI is fast approaching – 24th September 2016.
To help manufacturers to meet the upcoming UDI deadlines, here are 8 important facts to note when it comes to striving for prompt UDI compliance:
When it comes to diagnostic instrument systems, using UDI labels will ensure that the FDA and In Vitro Diagnostics (IVD) manufacturers will be able to see any potential problems with the devices which are being used for clinical purposes. However, the bigger challenges lie in how to label products. For example, blood diagnostic equipment may include the machine, a blood sample container, and the software used to analyze the blood. Therefore, one manufacturer may register the machine as a complete unit, while another may in fact register the machine, the container and the supporting software as separate entities. The jury is still out on clarifying which process is in fact correct.
Exemptions to UDI
After the FDA published the Final Rule, it was clarified that devices which were manufactured and labeled before their compliance dates are exempt from UDI labeling requirements for a total of three years, although the data must be filed with GUDID (Global Unique Identification Database). If a device is in commercial distribution before its compliance date, it is in fact exempt from the UDI requirements. A labeler can request an exemption from the UDI labeling requirements if the requirements are not “technically feasible” or if an alternative would provide more accurate identification. The FDA might choose to exempt devices which are intended for research and other educational purposes, as well as custom and investigational devices. Also, if the FDA stipulates that an alternative label is in the best interest of public health, then this too may exempt the product from UDI requirements.
It is possible that many manufacturers will in fact misinterpret the inventory and labeling exemptions, in order to use it as a way to postpone complying with UDI regulations or because they are trying to by-pass the system completely. There are competitive disadvantages to consider; various healthcare companies and hospitals have restructured their inventory management to meet the requirements of UDI and might not accept a product without a UDI label as it will no longer meet the prerequisites of their new systems.
It is also possible that if the FDA is overwhelmed with requests, they can in fact delay their response. However, if the FDA later denies the exemption request, the labeler will have to act quickly to comply with the UDI compliance deadlines – this is not a process that should be particularly rushed.
Serialization & Submissions
If a high-risk device previously required a serial number, then under the requirements for UDI, it must continue to do so. The healthcare industry is also pushing for more details on re-used devices due to high-profile safety concerns. In response to a series of antibiotic-resistant infections in patients that used contaminated closed-channel duodenoscopes, the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) recommended that Congress require UDIs in insurance claims.
A device manufacturer’s labeler must enter a range of device data for GUDID submission. Required device information includes company name, company contact information, device count, model, device description, commercial distribution status, quantity per package, device status, FDA listing and others.
Medical devices are classified according to the risk they pose to patient safety. If a device – such as elastic bandages – is low risk, then it is subject to less regulatory control, compared to a class III device (an implantable pacemaker for example).
If the Senate HELP committee succeeds in its push to include UDI in claims payment systems it could potentially reduce healthcare fraud. Fraud in the healthcare system is serious business. In 2012, Donald Berwick, a former CMS administrator, and Andrew Hackbarth of the RAND corporation, estimated that fraud added as much as $98 billion to annual Medicare and Medicaid spending, and up to $272 billion across the entire health system. Any effort put forward to reduce fraud would benefit the healthcare industry, the medical device industry and the public.
As part of a UDI implementation plan, medical device manufacturers should incorporate UDI into procedures for complaints, MDR, corrections, recalls, and service reports. This in fact allows the FDA to improve post-market surveillance and recall processes. The MDR initiative links to the public Manufacturer and User Facility Device Experience (MAUDE) MDR database; typically the UDI information in the database is redacted and the reason for the omission has not been disclosed.
Having an up to date repository to track UDI will garner needed benefits – more benefits than just meeting FDA requirements. Better tracking means fewer counterfeit products and better management of “trunk” inventory and consignment products. UDI also enables manufacturers to evaluate individual product portfolios, thus making it far easier to remove a product from their catalog. UDI would also allow for faster and more accurate identification of recalled devices. Hospitals, device manufacturers, and CMS would also receive proper re-imbursement.
When any device is reported to the FDA, Form FDA 3500A must be used and now should also include UDI (if it is available). Medical device manufacturers should also be looking to incorporate UDI into all procedures for MDR as soon as it is required on device labels in order to increase transparency and public safety.
Mergers and Acquisitions (M&A)
Once the initial announcement has been made about a new company acquisition, it is up to all involved parties to conduct their own due diligence. If UDI has already been implemented then it will help towards a seamless transition between the parties. Having access to a definitive list of all products manufactured, plus the annual sales figures for those products would allow the acquiring company to more accurately evaluate the transaction and perform a comprehensive risk assessment.
The key to success is prompt compliance
Meeting varying compliance standards typically involves the collaboration of multiple departments in the business as well as a lot of time, money and extra resources. Being prepared to achieve prompt compliance will ultimately reduce any undue expenses down the road. However, before a manufacturer starts to make any drastic operational or IT changes, they should conduct a proper readiness assessment to see which products are already meeting compliance standards, or will be, by the next compliance deadline. It is advisable to employ experienced external consultants who are well versed in the regulations and can help a company avoid annoying fines, recalls, rejections and other delays.
When UDI is implemented properly, manufacturers will gain significant long term benefits, including: better product traceability, transparency for complaints handling and a system wide reduction in counterfeit products. Even though there are hefty costs involved when first getting started with UDI, the benefits will ultimately outweigh these. In fact, the cost of non-compliance can have serious legal consequences and manufacturers could leave their business open to facing serious fiscal ramifications.
UDI should be treated as an opportunity to restructure operations for maximum benefit; manufacturers who launch a comprehensive UDI implementation plan as soon as possible will reap the biggest rewards
Steve Cottrell, President, Maetrics
Steve Cottrell is the President of Maetrics and is responsible for the client service delivery, growth and overall performance of the company. His experience encompasses leading a wide array of business services within the life sciences sector, including business process outsourcing, strategic sourcing and clinical trial offerings. Mr. Cottrell is a business executive with 25-plus years of experience in the life sciences industry. His career has been dedicated to supporting services in the medical device, pharmaceutical and biotech market segments.
Madris Tomes, CEO and Founder, Device Events
Madris Tomes is CEO and Founder of Device Events – a web-based software platform that is focused on the medical device domain and provider space, to intelligently search large data sets. Prior to founding Device Events, Ms. Tomes worked as a FDA Manager with a strong focus on increasing the value of UDI through its use in EHRs, claims payment systems, and in adverse event reporting. Ms. Tomes is a healthcare IT expert and strategist with over 18 years’ experience focusing on medical device data.