HIGHPOWER’s test methodology is based on methods outlined in ANSI/AAMI HE75. Some reusable medical devices require human factors testing in order to assure proper and safe use by health care personnel.
According to ANSI/AAMI HE75:2009, “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.”
Successful development of safe and usable medical devices is a concern of device manufacturers and the FDA. Since coming out with a guidance document in June of 2011 on human factors usability engineering in medical device design, the FDA has increased their request from medical device manufacturers seeking 510K approvals for this sometimes challenging set of data.
Let HIGHPOWER validate the effectiveness of your risk analysis and subsequent device labeling. Our new State-of-the-art facility is set up to mimic both the Central Sterile and OR Departments within healthcare facilities.
With multiple healthcare facilities in the area, HIGHPOWER has a deep pool of hospital participants available to be part of your devices HFE study. HIGHPOWER can not only provide the facility, but the participants and staff required to complete your devices usability assessment and will document the results for review by the FDA and other regulatory bodies.
- Human Factor Testing of Medical Devices
- Human Factor Testing of Sterilizers
- Human Factor Testing of Washers
- Human Factor Testing of Ultrasonic Cleaners
- Human Factor Testing of Rigid Containers and Rigid Containment Systems
Please feel free to contact us at email@example.com with any questions you may have.