Since coming out with a guidance document in 2011 on human factors usability engineering in medical device design, the FDA has stepped up their request from medical device manufacturers for this sometimes-challenging set of data. When it comes to using products, particularly complex medical devices, user error can be a common occurrence. Even easy-to-use devices can still have a learning curve, and it is vital that medical device developers can account for these possibilities, referred to as human factors. At HIGHPOWER, we want to ensure that every medical device manufacturer has the resources they need to gather key data about their device. As such, our human factor testing services experiment with a vast array of potential situations and real-life factors in the medical environment. Here is what you need to know about our capabilities and offerings.
HIGHPOWER’s test methodology is based on methods outlined in the ANSI/AAMI HE75 and AAMI TIR:55 standards and as well as other American and International standards. According to ANSI/AAMI HE75, “Human factors engineering (HFE) is the application of knowledge about human capabilities (physical, sensory, emotional, and intellectual) and limitations to the design and development of tools, devices, systems, environments, and organizations. HFE might also be called, “human factors, ergonomics, human engineering, usability engineering, or human–computer interaction (HCI).” HFE involves the use of behavioral science and engineering methodologies in support of design and evaluation.”
Some reusable medical devices require that human interactions be verified through human factor testing in order to ensure proper and safe use by health care personnel. Without this reassurance, it is easy for healthcare staff to incorrectly use the device, leading to potentially harmful results for themselves or their patients. We test for a series of HE75 human factors and can work with a wide range of instrument and equipment types, including sterilizers, rigid container systems, orthopedic, general surgical, and dental devices.
Regardless of the device being developed, we have access to the resources necessary to test for many common causes of human error. With input from our clients, we take the process a step further by anticipating potential problems with an in-depth understanding of overall human psychology and demographics.
At HIGHPOWER, we work hard to anticipate possible user errors and run an array of defined user steps to gain an accurate idea of how our clients’ devices perform under simulated use conditions.
With multiple healthcare facilities in the area, HIGHPOWER has a deep pool of hospital participants available to be part of your devices’ HFE study. We not only provide the facility but also the participants and staff required to complete your device’s usability assessment and will document the results for review by the FDA and other regulatory bodies.
Tests:
| Test Code | Test Name |
|---|---|
| HFACTOR | Human Factor Testing of:
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With several decades of experience as a life sciences lab, HIGHPOWER is just the resource needed to test a client’s IFU for clarity, performance, and safety. Please feel free to contact us at clientservices@highpowervtls.com with any questions you may have and to learn more about our human factor testing capabilities.