Medicine Device Labels for Packaging 101 - Know Everything

Although the labels on the packaging of devices are admittedly not the most thrilling aspect of the creation and design. They aren't as exciting as discoveries in science, the lustre of human-factors design, and even the rigorous testing. As a result, they're usually considered late during the development process and are often viewed as a last resort. However, labels play a crucial function in developing a device. They are essential to the introduction of a new product and its company's long-term financial viability, and also to patients' health and well-being. 

Mandated by the FDA. Labels can create significant issues if they are not accurate. They're consistently listed among the top three or five causes of FDA-issued product recalls.

The causes of mislabeling recalls come from many sources. The most common ones are:

• The auditing process (internal and external FDA).
• Alerting customers and employees.
• Customers who discover inaccurate or inaccurate information.

The problems can be large or small, and even minor ones could trigger significant recalls. For example, a mistake in the version number or part code on packaging labels can trigger the memory or an error in a diagram or explanation. On the other side of the spectrum, there are issues caused by instructions for use printed on labels. For example, a mistake in the user's manual could be reflected on the label and possibly cause improper use of the equipment. 

The outcomes of a few of the nation's most significant product recalls are widely known. In most cases, large companies have been able to fix problems, avoid recalls, and flourish. However, for a smaller manufacturer, places can be disastrous. Reissue and correction time could result in an opportunity to market missed. Certain companies' recalls could lead to the closure of a business or even bankruptcy. 

Consider, for instance, an entrepreneurial company with four employees designing and marketing a class II device. The company launched its product in the marketplace and realized that a lot number printed on a batch product was incorrect. The most crucial aspect of a label is that the lot number is used for traceability. The company, therefore, had to recall the batch to investigate. Unfortunately, this recall resulted in the cost of shipping the product back and revenue loss and losing trust with the early adopters, further decreasing sales. After correcting the issue with the lot number, the company could not regain sales and eventually shut its doors due to the shortage of funds. 

(Related – Medical device Labelling Requirements )

Get It Perfect the First Time 

The positive side is that out of all the steps involved during the design and development of devices, labelling is the one that has the highest chance of getting it right the first time. The FDA's definitive standards, regulations, and timetables provide a clear pathway to an accurate label. In contrast to software, where it's nearly impossible to eliminate every glitch fixed in the first attempt, labels can be created correctly on the first try. Because of the availability of information and simple process, device makers often believe that creating labels is straightforward and then putting it off until the final. The subsequent chaos results in frustration, additional costs, and delays. 

To make sure you do it correctly the first time, be familiar with FDA's guidelines and information for labelling devices. In conjunction with your internal or external manufacturing and quality, staff ensure that all employees integrate labels within the production process. The aim is to complete labels that design's output by the end - after the procedure is frozen and then create them before testing the device. 

Label Standards 

Although they might differ in terms of the label they are on; however, the majority of labels adhere to two fundamental standards: 

• Code of Federal Regulations Title 21: Also known by the name 21 CFR Part 801. This data from the FDA contains information on general labelling requirements and requirements for labelling unique device identifiers, requirements for labelling for devices sold over the counter, and exemptions and specifications for specific devices. Any device manufacturer that sells within the United States must follow 21 CFR Part 801. 
• ISO 15223: The last revision was in 2021. ISO 15223-1 defines the symbols used on labels for medical devices. ISO 15223-2 outlines the process of developing symbols and validation, selection, and development and offers additional details regarding the selection of symbols. 

Although the FDA accepts ISO 15223, it does not require manufacturers to conform to the standard altogether. However, many manufacturers follow the guidelines because it is the best practice in the industry and mandatory from other countries. For example, device makers can employ ISO 15223 symbols without adjacent explanation text. They can also choose a symbol not included within ISO 15223 if they think users will easily understand it. 

(Also read – Most frequently asked questions in Medical Devices Industry )

A Look at the Label 

Knowing the various sections of a typical label for a device and why it's essential to ensure that labelling will be the most efficient is possible. The following information and the diagram define the requirements for labels in the 21 CFR part 801. 

1. Device diagram 

Although not mandatory, diagrams help identify and separate when devices are available in different sizes or lengths. It also helps medical professionals recognize the items they require faster. 

2. UDI 

A Unique Device Identifier (UDI) is required for all labels on devices. The two most widely employed methods of imprinting information on bar codes (or QR codes) are the ones that are part of Global Standards 1 (GS1) and the Health Industry Business Communications Council ( HIBCC). The FDA recognizes any one of these formats to be the UDI. GS1 is a UDI-issuing organization with a standardization system that creates a global strategy to capture, identify and exchange information about the product. The HIBCC has established alphanumeric Health Industry Bar Code (HIBC) standards and formats for data that are uniform adaptable, global compatible, and supported by the industry. 

Logically, putting the UDI in the middle of the label and making sure it is not overshadowed by other information makes it easier to scan. 

3. Manufacturer 

The manufacturing symbol signifies the company is accountable for design or production, or production. It is not necessarily the one that constructs or packages the device. Many firms use contract development, design, and manufacturing companies for medical devices. After the device has been placed in the market and is sold, the contract companies handle any concerns. In these instances, it is common for the "manufacturer" name and contact details on the label could be listed by the following words "Manufactured to (name of the company responsible)," "Distributed by (name of the business accountable)," or "Packaged to (name of the business accountable)." 

The label should also contain the name and address of the business for the company (manufacturer distributor, manufacturer, and packer). Only the state and city must be included for the address if the business is in a telephone directory. 

4. Part Number Revision Number 

It's recommended to show the part's number and the revision level on the device's label. This will ensure that it is an authentic, adequately controlled document developed within a simple process for quality control. 

5. REF Number 

The ref could refer to the catalogue number commercial product code, storage unit for stock, reference code, or reorder number. It is the only number that can identify the medical device manufactured by the manufacturer. 

6. Lot Number 

Displaying the correct lot code is vital for traceability. If a manufacturer experiences complaints, they should identify the device to the specific lot. A quality management system can ensure complete documentation and the capability to link a device to its lot number by production sterilization (if needed) and packing. 

7. Dates: Manufacturing and Use By 

In the case of sterile devices, the "day of manufacturing" is when devices are sterilized. The expiry date starts on that date. For non-sterile devices, the manufacturing date is when the whole device is finished manufacturing. 

"Use By" date is the "use of" date is usually defined as the precise number of years after the manufacturing date. Based on shelf-life studies, the number of years typically ranges from one to five. For a shelf life longer than five years, device manufacturers face significantly higher costs in testing for speedy ageing. 

8. The Symbols used for Medical Device Labels 

Other symbols, which are included within ISO 15223, are available to signify specific applications of the item. Examples include: 

• One-time use only 
• Do not sterilize. 
• Only for prescription use 
• Keep dry 
• Do not expose yourself to the sun. 
• Non-pyrogenic 
• Limits to humidity and temperature for storage and shipping 
• Method of sterilization (e.g., steam gamma, ethylene oxide) when the device is entirely sterile 

The addition of the appropriate symbol to "consult the instruction on usage" (IFU) should be strongly advised when using medical equipment. Because the IFU document is the primary instrument to reduce the risk of a device, directing users to read the IFU before making use of the device will lower risk and increase effectiveness. 

Also, including an acetate sheet with peel-off stickers in a set of devices with the lot number could be beneficial to the process of labelling. The provider could then put the sticker on a patient chart, making it easier to identify any possible issues later. 

Conclusion 

Labelling medical devices always take longer than the developers believe it will. Although simple, labelling isn't always straightforward and can pose significant risks. For example, suppose you're handling the labelling process internally or with consultants or a contract quality specialist. In that case, it is essential to begin early and take the time to ensure each symbol, word, and diagram on the label of your device is accurate and precise. Look up the International Medical Device Regulators Forum's Label and Instructions to Use for the guidance document. 

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