Advantages of Working with the Device Evaluation Program
What device manufacturers can expect when working with ECRI
Approximately 50% of U.S./Canadian hospitals, in addition to numerous international facilities, trust ECRI's Device Evaluations to aid in selection and purchasing of medical devices by providing ratings. These FAQs provide advantages of working with ECRI.
What makes Device Evaluations unique?
Each Evaluation is conducted using a test methodology developed by clinical reviewers, manufacturers, and internal experts. All participating vendors can comment on testing methodology, and the methodology is applied equally to all evaluated devices to produce a fair comparison. Results are presented using our five-star rating scale, and are obtained through hands-on testing by engineering staff at ECRI laboratories, as well as through review of available clinical evidence. All results, findings, and judgments are reviewed externally by clinicians and participating manufacturers before publication.
Do you certify medical products?
No. We do not test to IEC or ISO standards (such as ISO 13485), and we do not offer any certification or product labels as a result of our testing.
Who can see the published results?
Evaluations are accessible by clients who are members of ECRI's Device Evaluation, Device Evaluation Plus, and Capital Guide programs.
Does ECRI charge manufacturers to participate?
No. We do ask manufacturers to loan or provide access to equipment and accessories free of charge.
How can manufacturers use the results?
Permitted use: Suppliers can inform customers that their product has been evaluated and that the content is posted on the ECRI website. Suppliers may mention the title and date of the posting, and provide a link (note: access is available only to members of certain ECRI programs).
Prohibited use: Suppliers or their representatives may not selectively quote from Device Evaluation content when communicating with customers. Suppliers also may not make any statements that imply that ECRI endorses their product or that a special or preferential arrangement exists.
Suppliers may not quote from, paraphrase, or reproduce ECRI's findings, logos, taglines, or banners in advertisements or in promotional or marketing literature, without prior written approval of ECRI.
What are the steps in an Evaluation?
- Medical device technologies are selected based on input from ECRI's experts, who track industry developments and routinely respond to members' requests for technology advice. The products we evaluate include mature and new technologies.
- Once the medical device technology is chosen, a project engineer is assigned, who refines the scope of the study and develops a set of criteria. The scope and criteria are reviewed and fine-tuned with experts at ECRI.
- Manufacturers that have a device within the scope of the Evaluation are formally invited to review and comment on the proposed criteria/test methods. The project engineer also sends the proposed criteria to external experts for review. These experts are usually clinicians who use the device, along with other relevant experts (e.g., academics, researchers).
- For testing, we ask manufacturers to loan us capital equipment (including required accessories and computer servers), or provide sufficient samples of consumables, at no cost to ECRI. If testing devices at ECRI is impractical, other options may be pursued (e.g., testing at a manufacturer or clinical facility).
- Prior to testing, we ask the manufacturer to demonstrate their product and to train ECRI staff as they would train a new user.
- During testing, we are in regular contact with the manufacturer and will discuss any unexpected findings or major deficiencies and retest if necessary.
- Based on the device's performance against our test criteria, we identify advantages and disadvantages and assign a rating, ranging from five stars (excellent choice for most facilities) to one star (poor choice; most facilities will find the product unsatisfactory).
- An individual Evaluation is written, containing a description and the significant findings for that device. Draft Evaluations are sent to each participating manufacturer and to external reviewers, who review and comment on the Evaluation findings and ratings, and also verify factual information.
- Manufacturers may request a meeting at ECRI to discuss any concerns. All comments are considered, and any significant changes are discussed with the manufacturer before publication.
What if our company declines to participate in an Evaluation?
ECRI understands that some companies may not see an advantage to participating in an Evaluation. In our mission to inform the healthcare community, we reserve the right to pursue other options (e.g., test equipment at a healthcare facility, rent, or purchase a model).
Can we withdraw from the Evaluation?
At any time, you may ask us to return the equipment, and decline to participate further in the process. We will most likely complete our Evaluation based on the results we've already obtained, or by testing units from sources other than the supplier.
Call (610) 825-6000, ext. 5891 or e-mail firstname.lastname@example.org.