AAMI TIR55, “Human factors engineering for processing medical devices,” has just been released. You can get a copy from Document Center Inc. in paper format, for pdf download and as part of our multi-user Standards Online subscription service. This new release will help you understand the impact of human factors engineering during the full processing lifecycle of reusable medical devices.
Why should a medical device company be concerned? Device usability and safety are essential features of products designed for the healthcare environment. Using a standardized approach across your organization can facilitate successful strategies for instructions and training of personnel involved in the everyday use of your products. And it can help encourage medical device design that includes processing requirements that can be implemented successfully in the real world.
What is a processing lifecycle? This is the period from the point-of-use at the end of the patient procedure to the delivery to the point-of-use for the next patient. As we have discovered from recent media coverage, failures during this cycle can bring unwanted outcomes and spread fear regarding the safety of various procedures and devices.
Where in the organization can the AAMI TIR55 have an impact? The standard addresses human factors concerns in product design, in developing process instructions for use, for design of training programs, and the development, verification and validation of the device processing process itself.
What does this Technical Information Report actually cover? You’ll get the usual scope and definition clauses at the beginning of the publication. Then Clause 3 provides you with an overview of human factors engineering and the design controls approach that’s being used here for device processing. Next come a series of clauses covering specific design requirements: the design of devices for processing, the design of the processing procedures, and the design of the processing instructions.
The last two clauses cover education, training and competency assessment tools, and validation. Not only will you get a complete overview of the considerations essential to developing a system that promotes correct processing of your devices, but you’ll also get suggestions on how to confirm that your efforts are realistic and can be implemented successfully. A one-page bibliography finishes the publication.
Now to get a copy for yourself and your team. You can order online at the Document Center webstore, www.document-center.com. Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’ve been working with companies like yours to help maximize your compliance efforts. Make us your Standards Experts!
