Medical Alarm Evaluation Prior to Purchase

Adhering to HFE principles during initial design stages of a medical alarm is essential. However, human factors analysis should also be incorporated into the institutional decision to acquire a new medical alarm or software program.3 Alarm purchasers should strongly consider institution-specific human factors testing. Usability testing at the institutional level establishes built-in redundancies to capture any design problems missed by manufacturers. Furthermore, the users and environments at individual institutions will differ, possibly in important ways, from the users and environments in which the device or program was initially designed and tested. It is important for an institution to be aware of who the intended users of the device or software will be, as well as where and when they plan to use the device. The information for such evaluations may be obtained from vendors, from an in-house analysis, or from independent organizations.

Vendors must be able to prove to the FDA that the user will be able to operate the medical alarm in the way in which it was intended.10 As companies are required to collect human factors analysis data, it is important that institutions wishing to purchase a new medical alarm, device or software receive and carefully review this information. Gosbee provides a list of questions to ask a vendor before a purchase, which include: "How long does it take to learn to operate the system? How long does it take to complete typical set-up tasks? What are the types and frequency of errors that could happen, and the systems to thwart them?"3

It is also important to consider the environment in which a device will be used. Idiosyncratic features of the environment, such as excessive noise or poor lighting, and differences in user skill or acuity due to fatigue or otherwise, may affect safety and the device's in-house usability.
Some institutions have developed in-house usability labs, in order to rigorously test any device before purchasing. The Mayo Clinic uses simulations to test the usability of medical software before purchasing.17 By carefully measuring user performance with the software they are able to uncover latent errors in the design. The usability lab is also able to measure the time necessary to learn to use the new software. This important information can help predict the device's or software's influence on workflow as well as its predilection for operator misuse.
Even without sophisticated usability laboratories, an institution can use basic human factors techniques to evaluate a product before purchase.3 Powerful techniques such as cognitive walk-through can be easily utilized at any institution. This involves observing the end-users of a product interact with the product. As they attempt to use the device, they are instructed to "think out loud." Careful observation of the user's actions and comments can identify potential design flaws that might make it difficult to utilize the device or software.

Independent organizations are another potential source of information on device safety. Unfortunately, most independent sources do not make clear to what degree HFE principles were used in product evaluations, although they do provide some assessment of safety. One such organization is ECRI (formerly the Emergency Care Research Institute), a nonprofit international health services research agency. Another is the Institute of Safe Medical Practices (ISMP). Both release newsletters and publications regarding product safety. By searching these and similar databases, institutions can gather additional information concerning product safety prior to purchasing a device. ERCI also publishes articles specifically geared to the institutions that might wish to purchase a medical device or software.

Regardless of the level of pre-procurement testing, some unsafe designs will not be detected until after the product is in use.3 Therefore, it is important for institutions to continuously evaluate these products to ensure safety.

From www.ahrq.gov