Maintain Compliance and Ensure Safety through Efficient Label Design

Safety labels seem like a basic enough component of a product to not warrant serious consideration, but for medical device manufacturers, that type of thinking could lead to serious consequences. This article will provide a high-level overview of the label development process, including a look at a couple of the organizations setting the standards, the basic elements of label development, and the proper label appearance.

By Jim Heckman

Jim Heckman is a technical consultant for Standard Register. With over 12 years of experience in the design of safety labels, he is the safety label subject matter expert for the company, providing his knowledge of safety label design to their customers to help improve their safety messages. Heckman can be reached at 866-339-3475 or james.heckman@standardregister.com.

Warning labels for medical devices should follow industry standards, such as those set by ANSI (left) or ISO (right).

For medical device manufacturers, safety labels on their products have never been more important. Inadequate warnings could have a wide variety of consequences for the manufacturer as well as its employees, customers, and patientsconsequences that range from non-compliance to lawsuits to minor injuries or even death.Because of the significance of these labels in the manufacturing process, industry standards have been developed. But these standards change every day, with more and more being required of manufacturers to meet the standards and to make certain the labels they design and use are in compliance. With this ever-growing list of standards, the label design issue has become complicated and confusing.

ANSI and ISO

For guidance in the development of safety labels, manufacturers often turn to the American National Standards Institute (ANSI) and the International Organization for Standardization (ISO). ANSI and ISO standards are very similar, and manufacturers in all industries, foreign and domestic, typically use one or both sets of standards on their products. However, manufacturers must note that if a particular industry or segment has its own set of standards (e.g., FDA compliance protocols or testing and instrumentation product compliance requirements), they supersede the standards set by ANSI and ISO.ANSI labels are comprised of four key elements: A signal word panel (CAUTION, WARNING, DANGER)

Hazard identification

Hazard avoidance

Consequences of not avoiding the hazardStandards set by ISO for safety labels include: An optional signal word panel

Hazard pictogram inside a triangle

Yellow background

Optional text outlining the hazard and hazard avoidanceAt the core of both sets of standards is the actual hazard. In order to identify any potential hazards associated with a product, the manufacturer should use some type of hazard analysis or an actual physical review of the product. This will not only help determine the actual hazard but will also give guidance on how to avoid the hazard and the potential consequences of not avoiding the hazard. Once this step is completed, the severity of the hazard can be determined. Both ANSI and ISO use the following to define the severity of hazards: CAUTION: minor or moderate injury may occur (ANSI)

CAUTION: minor or moderate injury could occur (ISO)

WARNING: death or serious injury could occur

DANGER: death or serious injury will occur

Safety Label Design and Development

There are several elements that must go into ANSI- and ISO-compliant safety labels. These include pictorial use; verbiage outlining the hazard, hazard avoidance, and consequences; and layout requirements and consistency.

Pictorials

Pictures are the universal language when it comes to communications, no matter a person’s native tongue or literacy level. Wherever possible, manufacturers should try to use pictorials to accompany their messages so that end users have the opportunity to visualize the hazard and see how to avoid it without needing to read. This is particularly important due to the vast number of foreign languages currently in use, not to mention the many countries which employ multiple dialects. All of this pertains to the United States as well due to the influx of Spanish speaking people and the illiterate. Fortunately, these language barriers can be readily addressed with the use of pictorials.There is a wide variety of standardized pictorials available for use, nearly all of which can be referenced through any number of resources. These resources, many of which are subscription-based, are available to manufacturers to review pictorial standards and databases. Examples of such resources include: ANSI/AAMI/ISO 15223: Medical devices – Symbols to be used with medical device labels, labeling, and information to be supplied1

BS EN 980: Graphical symbols for use in the labeling of medical devices2Use these resources or standards to identify the pictorials best depicting the hazard to be addressed by the safety label as well as pictorials illustrating hazard avoidance – accurately depicting how to avoid the hazard is a key component that is missing in many inappropriately designed safety labels. As pictorials are identified for specific manufacturer products, the development of an in-house pictorial library is highly recommended for quick and easy access to all of the commonly and often used pictorials by the manufacturer.

Verbiage

While pictorials provide the important visual component of the hazard, the verbiage included on the safety label provides more finite detail around the hazard, hazard avoidance, and consequences. At this point in the label development process, a manufacturer has already provided the initial verbiage needed for the labelsignal words CAUTION, WARNING, or DANGER. The next step is to put the identified hazard into words and describe how do avoid the hazard.For example, a particular piece of equipment could present a hazard of pacemaker failure. The label would display the signal word “DANGER” with the identification of the hazard reading, “MAGNETIC HAZARD!” Following would be avoidance text: “Stay clear. If you have a pacemaker or other similar implanted device, please tell the technician.” This text informs the end-user of the steps necessary to avoid the hazard.

The remaining verbiage is a description of the consequences of not avoiding the hazard. In the example, the text would read, “Failure to comply could result in death or serious injury.” All of this verbiage would be coupled with pictorials illustrating the magnetic hazard and the avoidance action.

To develop effective verbiage for safety labels, wording must be succinct and use a headline-style format. Label designers must avoid using excessive, unnecessary words (e.g., the) while presenting the text in easy-to-read upper and lower case letters. Note that it is acceptable to use all upper case letters in short phrases requiring impact, like MAGNETIC HAZARD.

Next, be mindful of the font size of the text and the space available on the label. Manufacturers need to determine the proper distance to view the safety label and avoid the hazard. ANSI has a set of font size guidelines that can be referenced for this very purpose.

Layout and Consistency

When designing a safety label, ANSI standards indicate it can be laid out in either a vertical or horizontal format. Both orientations are acceptable design layouts and can be determined by a manufacturer’s corporate standards, the area where the label will go, or personal preference.Overall design consistency must be maintained. Through label design consistency, manufacturers will help ensure the recognition of hazard and avoidance pictorials by using the same pictorials outlined in ANSI and ISO stylebooks. It also ensures that a consistent message is delivered across entire product lines and between different products.

It is also a good practice to keep layout styles consistent across different labels. Generally, manufacturers want to keep the signal word panel, the pictorials, and the verbiage in the same location within various labels when possible. This will allow end users to recognize safety messages quickly.

Final Label Design and Production

Once all of the elements are in place, take a final look at the safety label to make sure the artwork is clean and that the label accurately describes the hazard and avoidance steps. It is encouraged to test the labelfor example, gather a group of individuals to critique the label on symbol recognition and messaging.During this testing, it is important for manufacturers to remember that safety labels are not the “end-all be-all” for identified hazards. The labels are there to remind the users of what they should have reviewed in the Operator’s Manual or learned during product training. It is always the responsibility of the user to read the manual and attain training before operating any piece of equipment.

After the label passes the test, work with a proven label supplier to produce the finished product, making certain to provide size requirements and any special instructions to the supplier. In addition, while there are no set standards for the type of material on which the label should be printed, there are special conditions that should be considered by the manufacturer. It is recommended to inform the supplier if the label will be exposed to extreme conditions, such as abrasion or chemicals.

All of these factors will play a role in determining which adhesive, base material, and over-laminate (if applicable) are best to use. Other items to be addressed with the supplier are the surface to which the label is being applied: Is it curved or flat?

Is the surface powder coated or enamel paint?

Does it have a smooth or rough texture?A good supplier is willing to work with the manufacturer throughout the entire label development process, offering full design capabilities, translation services, and a thorough knowledge of industry standards and compliance requirements.

References

1 Association for the Advancement of Medical Instrumentation (AAMI)

2 British Standards and European Committee for Standardization (SB EN)

Online

For additional information on the technologies and products discussed in this article, see MDT online at www.mdtmag.com or Standard Register at www.standardregister.com.