Guidelines for User-Friendly Medical Equipment Operation

Vantage MedTech, a leading specialist in usability engineering for medical devices, offers expert insight into medical device usability. The company is renowned for its robust services in electromechanical medical device development, design, and manufacturing.

The importance of usability in medical device design, development, and manufacturing cannot be overstated. Usability refers to the ability of a human to interact easily and relatively error-free with a system or product. Vantage MedTech ensures that medical devices are not only safe and effective but also user-friendly.

Usability testing, a comprehensive process, takes many potential use errors into account. This testing is crucial, considering the reported annual number of deaths caused by medical error is approximately 250,000. All individuals involved in the user testing process must be the intended users, such as doctors and nurses.

Some device testing takes place in a real environment, known as 'actual use testing'. This type of testing is particularly important for devices whose proper use cannot be simulated, such as hearing aids or prosthetic limbs. 'Actual use testing' is usually conducted with devices to ensure that they function as intended in real-world scenarios.

Vantage MedTech maintains compliance with a variety of regulations during the production process and usability testing phase. These include MDR, IEC 62366, IEC 60601-1-6, ISO 13485, ISO 9001, ISO 14971, FDA, and MDD. The company's adherence to these standards ensures that the developed medical device is up to standard and ready to be safely adopted by practitioners and patients alike.

The international standard IEC 62366 is crucial for human factors engineering and usability risk management. It works in conjunction with another international standard, ISO 14971, which encompasses the broader standard of risk management as it applies to medical devices.

Obtaining ISO 14971 and IEC 62366 certifications are necessary steps in fostering the adoption of a medical device in various markets. The British Standards Institution (BSI) has defined usability, and the Food and Drug Administration (FDA) has a guidance document of usability engineering guidelines.

International standards such as ISO 13485 for medical device quality management and ISO 9241 for human-centered design are particularly important for the human-factors-oriented design and manufacture of medical devices. These standards ensure that devices are safe, effective, and user-friendly.

The process of usability testing is accompanied by a comprehensive documentation process to prove that a satisfactory level of testing has been conducted. Vantage MedTech's robust services ensure that a medical device will get to market faster than competitors and free of design errors. As a trusted provider for electromechanical medical device development, design, and manufacturing, Vantage MedTech is at the forefront of ensuring medical devices are not only safe and effective but also user-friendly.