Human Factors in Critical Cleaning

“To err is human, to forgive divine,” Alexander Pope (1)

To err is not an option in critical product cleaning. The stark reality for manufacturers is that error leads to low yields, unsatisfied customers, lost business. Error, often resulting from ineffective or avoided critical product cleaning, can jeopardize patients, passengers, and mission-critical operations.

Understanding Human Factors can keep human errors to a minimum. Human factors play a crucial role in product design, product manufacturing and product utilization. Read on to understand why considering human factors must be part of your critical cleaning process.

The concept of human factors, or Human Factors Engineering, encompasses all aspects of interaction between a product and the people who design, manufacture and use that product. Both humans and machines perceive information (input), process the information, and use that process to control actions (output). If machines, including cleaning systems, are designed and maintained correctly, they ought to perform the same way, time after time. The field of Human Factors considers the fact that people are variable, with a range of capabilities and limitations. Some factors include physical, sensory, emotional, and intellectual.

Interfaces
Consider interfaces between humans and devices where information is passed from a device to a person and vice versa. For example, suppose, based on the reading on a gauge, a person must decide whether or not to press an emergency off switch. If the information on the gauge is incorrect or is difficult to decipher, the person may not be able to make an unambiguous decision. If the switch is not clearly visible or readily accessible, the person may not be able to press it in time.

Human factors in critical cleaning
Human Factors Engineering should be part of cleaning processes for products at all stages from product design, through manufacture and ultimate use. Clear communication is essential in minimizing errors associated with Human Factors. Designers and manufacturers must communicate. Otherwise, there may be an impractical design that cannot be readily built or cleaned. Cleaning equipment and the cleaning process itself should factor in the operators. People have to be able to understand both what the equipment can do and equipment limitations. Cleaning equipment designers should consider not only the ideal operator but also the specifics of a given workforce. Operating instructions to manufacturing assemblers must be clear and understandable. They need to take into account differences in language, training and experience.

Any chemical and any process can be used in a manner that harms either the product being built or the people who are building it. An effective Chemical Product Services (CPS) program (2) includes Human Factors engineering. One example is the SAFECARE™ system for managing cleaning solvents used in vapor degreasing(3).

Cleaning Medical Devices
Using a product correctly can be more complex than reading a gauge and pressing an emergency off switch.

When the product is a medical device, particularly a reusable medical device, Human Factors can include many parameters. For more than a decade, the FDA has required that Human Factors Engineering be a part of medical device design and validation (4). This includes making sure that the design allows the device to be readily used as intended, accounting for a range of differences in language, education, training, experience, and real-life situations where the device might be used.

It’s important to design reusable medical devices so that they can be cleaned effectively. The cleaning processes have to be really effective and simple. Cleaning processes that are appropriate to the realities of intended use should be designed into the IFUs. For example, if a device is used in emergency situations, verbiage mandating that the device be cleaned “immediately” might benefit from considering situational Human Factors. Emergency personnel, faced with simultaneously attempting to save the lives of multiple people, might not clean the device immediately.

One way to minimize human error is to envision how a message might be misinterpreted. This can be a message from a person to a device, or a message from a device to a person. Especially, it can be messages from one person to another. Ask if the message is unambiguous? Are there nuances in the language that might mean one thing to someone and another thing to someone else? Then, figure out how to word that message so that the unambiguity disappears.

References

    1. Alexander Pope, An Essay on Criticism, 1711, (first published anonymously)
      https://www.britannica.com/topic/An-Essay-on-Criticism
    2. B. Kanegsberg and E. Kanegsberg, “Cleaning Perspective – parts2clean Part II, Clean Source, August 2020. https://bfksolutions.com/cleaning-perspective-parts2clean-part-ii/
    3. T. Pennington, “Closing the Cleaning Loop,” Products Finishing Magazine, Sept. 2011. https://www.pfonline.com/articles/closing-the-cleaning-loop
    4. https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/medical-devices-current-good-manufacturing-practice-cgmp-final-rule-quality-system-regulation

Note: Dr. Virginia Lang, HirLan, Inc discussed many aspects of “The Human factors in getting through the FDA” at MedTech Monday, August 3, 2020, Her comments provided the impetus to apply the topic of Human Factors to critical cleaning.

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