CE test for Product Evaluation and Purchasing: A Review for Clinicians

The Centers for Disease Control and Prevention (CDC) recommends specific products by name in its product assessment framework tool.

There is no difference between a medical device being FDA-cleared and FDA-approved.

The manufacturer and user facility device experience (MAUDE) is a database within the FDA that houses medical device reports that come from the end user such as a hospital, clinic, manufacturer, patient or consumer.

It is not important for disinfectant products used in hospitals to be registered by the Environmental Protection Agency (EPA).

It is critical to follow the manufacturer’s instructions for use when cleaning and disinfecting a medical device or other item used for patient care.

An evidence-based, clinical practice guidance is the highest level of evidence in the evidence pyramid.

The National Institutes of Health defines the goal of clinical trials as determining if these treatment, prevention, and behavior approaches are safe and effective.

Countermeasures are not considered to be products that may be used to treat, prevent, or diagnose conditions associated with emerging infectious diseases.

It is not imperative that clinicians (end users) receive education and training around how to use new products and technologies that are introduced into the healthcare institution.

Evidence-based, unbiased reviews of products are not generally helpful to the product evaluation and purchasing process in the healthcare setting.