The European Commission defines a medical device as being any instrument, apparatus, appliance or material that can be used to diagnose, prevent, monitor, treat, investigate or alleviate disease, injury or handicap, among several other functions.
With this in mind, it is no surprise that the sector is a significant one within the healthcare industry, covering everything from surgical equipment to life-supporting products and fulfilling an essential role that contributes greatly towards the public’s well-being and ability to combat ailments.
According to the Association of British Healthcare Industries (ABHI), the medical device field is in a healthy state, comprising over 2,000 organisations, of which more than 80 per cent are small and medium-sized enterprises.
These businesses collectively employ nearly 50,000 people, and support the occupations of an estimated 250,000 more. The ABHI says the UK exports more medical devices than it imports and is therefore trade-positive, and recognises this as a “key contributor to the UK economy”.
However, this doesn’t only apply to the UK. In its Global Medical Device Industry 2012-2017: Trend, Profit, and Forecast Analysis report on the worldwide market, Lucintel found the industry is expected to experience “significant growth” between 2012 and 2017.
The organisation predicted that by 2017, the market will be worth around $302 billion (£198.5 billion), growing by an average of 6.1 per cent every year.
This finding has been further supported by Research and Market’s study into the global portable medical device sector, which covers instruments such as blood glucose meters and weight scales. Here, the industry is expected to achieve a compound annual growth rate of 8.19 per cent between 2014 and 2019.
However, the greater demand for such products means that - perhaps more than ever before - medical device manufacturers need to be aware of their responsibilities with regards to compliance.
Labelling plays a key part of this, and this whitepaper will therefore look to explore the issue of medical device labelling; how it can improve health and safety across the healthcare sector; and how manufacturers can ensure the labelling methods they are investing in will do the job required without being compromised by the conditions their devices are routinely subjected to.
Labelling clearly plays a critical role in the use of medical devices. Considering the sector that these products serve, mislabelling can have severe - and even fatal - consequences.
This is demonstrated in the Medical and Healthcare Products Regulatory Agency’s (MHRA’s) report, ‘Medicines & Medical Devices Regulation: What You Need To Know’. Here, the organisation cites a case in which a coroner requested the wording of labels on a specific type of urinary catheter intended for use by women be made clearer, after the device was inadvertently used on a man. The coroner ruled that this oversight had unfortunately contributed to his death.
As the US Food and Drug Administration points out, high-quality labelling is becoming even more important given the growing number of patients using complex medical devices in their own home. Not only must labels provide healthcare professionals with all the necessary information, but they must also be easily understood by any average member of the public.
However, the way a message is communicated on the label is only one of many potential considerations that manufacturers should be making before their products go to market. Often, the greatest risk comes from how well the label is able to withstand the wear and tear of everyday use.
There are plenty of potential hazards that medical devices might be exposed to that could compromise the quality of their labelling. Sterilisation is a key issue, with hospitals and similar environments needing to keep their equipment free from bugs and bacteria - so labels often need to be protected against being regularly wiped down with alcohol or solvents.
A similar issue is the human factor. In hospital rooms where there are likely to be visiting members of the public, the devil makes work for idle hands - and it is possible that at some point labels will have to withstand attempts to pick them off the surface they have been applied to.
With this in mind, simply ensuring the label is present at the time the device is sold just isn’t good enough; in an industry where matters of life and death occur every day, manufacturers need to be certain that what they are putting to market will survive the long haul.
In addition to the moral implications, the financial consequences can be significant. Recalling a product can have a major impact on several key areas of a business, including ROI, efficiency and productivity, while regulatory fines that can be levied as a result of noncompliance - along with the potential reputational damage - will also have a knock-on effect.
What information might need to be included on medical device labelling?
Because of the wide range of devices on the market - all of which serve a variety of purposes - there is no single rule that covers the labelling requirements of all products. Nevertheless, the European Commission’s guidance on medical device labelling indicates that information provided should include:
- The name (or trade name) and address of the manufacturer
- Instructions for use
Naturally, while some information can be included on outer packaging, it is necessary for particular data to be available on the device itself. In the aforementioned case of the catheter, the MHRA requested after the coroner’s verdict that all associated manufacturers amend their labelling so it would be possible to differentiate between the different types of products once they have been removed from their packaging.
Serial numbers are also likely to be a necessity, for identification and inventory purposes.
Symbols on medical device labels
The use of symbols on medical device labels has become essential in order to accommodate all the information manufacturers are expected to provide to an international audience.
The International Organization for Standardization (ISO) is responsible for the identification of such symbols, and these are covered in the ISO 15223-1:2012 standard. This is an area that is constantly being revised, and previous versions include ISO 15223-1:2007 and EN 980:2008.
Symbols can be used to communicate information ranging from whether or not a device can be used more than once, to its use-by date, how it should be sterilised and if there are any elements (heat, water or radiation, for example) that it should be kept away from.
Clearly this is a lot of information to take in, and manufacturers need to be aware of what they are legally required to display on their products before procuring the services of a label and/or marking solutions provider.
How Fine Cut can help
The important role of medical device labelling highlights the need for durability in the labels themselves. The length of time between a product’s commercial use and its ultimate obsolescence and replacement can span several years; indeed, a Medicines and Healthcare Products Regulatory Agency report noted that some of the devices it observed had been in use for 15 to 20 years, and had eventually failed through fatigue.
However, due to the wide range of products available on the market, there isn’t a single solution to achieve all-round optimum performance when it comes to ensuring information will last for a long time without losing clarity or being removed altogether.
Keith Parkin, Fine Cut Business Development Manager, says it’s a case of “recommending a suitable solution for each application”. Our process of creating labels or marking a product for the first time ensures the best possible solution can be determined accurately.
Our approach ensures we listen to the client and allow them to fully explain their needs, applications and requirements before we recommend a method that will not only be a good fit, but that will enhance the look of the product. Our care during this process creates a trusting and long-lasting relationship that grows into solid partnerships.
At Fine Cut, between 40 and 50 per cent of our business derives from the medical devices industry - a sector we have catered to for over 30 years. As a result, we have a wealth of experience and a variety of options for labelling, engraving or marking to suit any product within the industry.
A wealth of experience
Keith says his 20 years spent in the industry - coupled with the extensive experience of other members of the Fine Cut team - are crucial in determining the best course of action for our customers to ensure they get the best value for money with what they are trying to achieve.
“Fine Cut enjoy working on a consultative approach with clients to find a suitable solution and a process that will deliver a quality product at an affordable price,” he explains. “Our development of ideas ensures that involvement is nurtured from an early stage enabling a clear and transparent path to a recommended end goal. This approach keeps clients involved and creates an awareness of the stages and procedures necessary to achieve the ‘right first time’, ‘on time’ service critical for building lasting client relationships.
“Progression through the years has driven Fine Cut to become a fore runner for print and product marking benchmarks. Our ability to offer the latest in direct product marking and label printing gives us an edge over our competitors and offers client’s options they may not have previously thought possible. Laser marking, digital printing and improvements in label materials, adhesives and finishing techniques provide the customer with a wealth of methods to consider for their product identification. Fine Cut are in an enviable position where they have in excess of 100 years of combined experience for putting forward recommendations for all requirements.”
We have a proven track record of serving the medical device industry over three decades, which we put to good use - as demonstrated by the recommendations and return custom we receive from so many of our existing clients.
“We offer a quality product that gives good performance and durability. Customer loyalty and support through the years tells us we’re doing a good job.”
Keith Parkin, Business Development Manager
Investing in the future
When Fine Cut first started out, traditional printing methods were slow but produced very durable results, however, as a company committed to staying at the forefront of our field we have continually invested in the latest technology to ensure that the business moves forward. The printing industry has changed significantly down the years, with methods such as screen printing and hot foil blocking being complemented by more recent innovations like laser engraving and direct product marking via state of the art digital presses.
Our commitment can be demonstrated by the acquisition of the SwissQ digital press and a bank of laser marking machines, this enables us to offer market-leading solutions. These new technologies provide a more consistent, durable finished product and allow us to offer customers more choice. What’s more, they are more efficient than older solutions, which ultimately allows us to deliver the finished item to customers quicker.
Our strategy of looking to the future will only benefit our ability to serve the medical devices sector as it continues to expand and looks for more durable and flexible processes for identifying smaller and smaller products.
If you want to find out more about how Fine Cut can help your organisation to meet its labelling needs, then get in touch today by calling 01903 751666 or emailing email@example.com or firstname.lastname@example.orgDownload Whitepaper