In the current regulatory environment, with agencies such as US FDA demanding complete lifecycle traceability of every product, accurate labelling is a necessity. It is time for medical device companies of every size to accept the next regulatory era and put in place robust, highly integrated processes for printing and verifying label creation that minimise the risk of compliance failure whilst also providing the required complete lifecycle audit.
The compliance landscape for any organisation involved in the life sciences industry has changed radically over the past decade. From pharmaceutical companies to medical equipment manufacturers, organisations now face stringent demands for complete product lifecycle traceability and auditability.
The reasons are clear: failure to accurately label these critical devices can be life- threatening. This is demonstrated by examples such as the Class I Orthodontics Buccall SS tubes that were mislabelled as nickel-free, risking allergic reaction in patients; or the pediatric tracheal tubes manufactured with an internal diameter smaller than indicated on the label.1
In addition to damaged reputation associated with information inaccuracy, poor processes can result in huge fines from local regulators such as US FDA or the UK Medicines and Healthcare Products Regulatory Agency, product recall and even complete operational shut down.
With labels undergoing multiple revisions during the product lifecycle in response to regulatory demands, medical companies recognise the need to implement incredibly robust processes for design and print of labels. Yet with information typically being pulled from multiple systems, often globally, ensuring the imagery matches the words and that both comply with local regulations is both highly intensive and time-consuming.
Processes are typically highly manual, somewhat convoluted and require multiple authorisations and multiple scans of both labels and products. With information pulled from multiple disparate systems there is a risk of overlap, duplication and information discrepancy – i.e. two versions of the truth.
As a result, despite the manually intensive effort, most companies accept a certain level of problems, such as incurring tickets for noncompliance from US FDA on an annual basis. Many companies also endure repeated failure of label printing, discarding swathes of labels that have been produced with the wrong text, imagery or unreadable quality.
This approach is not sustainable in today’s regulatory environment. How can a business continue to invest heavily in innovative product design and high standards of manufacturing, yet still risk warning letters and penalties from US FDA due to poor processes for product labelling? How can an organisation that exploits real time online communication to streamline production and transform the supply chain, still rely on paper-based authorisation for this critical aspect of the operation?
Integrated and verified
Traditional processes for label production, i.e. understanding what was sent vs. what was printed, are no longer fit for purpose. And many companies recognise this fact, with growing numbers exploring systems to undertake postprint verification to ensure no errors have crept into the process as a result of print problems, for example. But for many organisations the issue comes before verification—just how many can confidently confirm that the information sent to the printer is 100% accurate every single time?
To achieve a solution that can be validated for final destination labels, medical device manufacturers need to embrace a fully integrated electronic print and validation solution that includes auditable security protocols and lifecycle documentation. By integrating information from the multiple source systems into a dedicated solution to ensure one version of the truth, a manufacturer removes the element of chance from the process and ensures information from production is delivered to the label at the time of print.
Combining this single source of the truth with an in-built approval process—review, approve, print, reconcile—means that only approved imagery and data can be placed on the label. With this in place, an integrated print verification solution such as Prisym ID's Medica Vision undertakes an automated audit on the print process, ensuring the print process has occurred correctly.
Taking this approach removes the chance of label errors, reducing tickets, minimising wastage and avoiding duplication; whilst also delivering the complete lifecycle traceability demanded by US FDA and enabling rapid action to be taken should a product recall be required.
Of course, despite widespread awareness of the problem, many companies are hoping to stay under US FDA’s radar, assuming the current emphasis on enforcing regulation for the top tier of organisations will continue. But with improvements in the available technology and the increasingly accessible nature of these solutions, the onus is now on organisations of all sizes to ensure that they adopt robust, highly integrated labelling processes that can reduce ticketing incidents as much as possible.
Furthermore, while hard to measure, there is no doubt that health service procurement is also taking into account the quality of labelling. With every health service globally looking to reduce incidents of malpractice and the escalating legal bills, those companies that contribute to a problem with a patient due to poor labelling are likely to be rapidly removed from the list of approved suppliers. Add in feedback from surgeons regarding the usability of devices—which by default will include the ease with which the device can be identified by its labelling—and good, accurate labelling also plays a key commercial role.
This is a critical component of the business. Industry legislation for medical device labelling and packaging is constantly evolving. And while many companies still argue the traditional approach is working; it isn’t. For organisations making huge investments in research and development, streamlined production and excellent customer service, is it really worth jeopardising business success by waiting for a major US FDA investigation or public lambasting before bringing product labelling up to standard?
1) www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=... - 8k
http://www.fda.gov/Safety/MedWatch/ucm167079.htm?utm_campaign=Google2&ut... device recall label&utm_content=20
is Senior Vice President, Global Sales, Prisym ID