From the November 2011 issue of HealthCare Business News magazine
by David Kuehn

This article originally appeared in the November 2011 issue of DOTmed Business News

There are few industries where the quality and engineering of replacement parts is more important than that of the medical equipment industry. Among medical equipment offerings, imaging equipment systems and parts manufacturers of CT, fluoroscopy and nuclear medicine devices are under particular scrutiny. Exacting replication of system specifications is of the essence- patient safety and diagnostic accuracy and confidence center on it.

With the FDA’s recent Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging and other drivers, patient radiation dosing and safety has become a hot topic. The last two RSNAs and ECRs have hosted heavy coverage and multiple sessions on the subject. The health care media, especially radiology publications, have turned their attention to the issue of patient dosing with a focus largely on the issue of unnecessary radiation exposure above what is regarded as optimal to achieve clinical goals. Higher doses may enhance image resolution but can approach upper limits of what is considered safe, levels which are constantly questioned and reevaluated.

This has not been necessarily a bad discussion as it has created a healthy dialog among radiologists, regulators, patient safety organizations/advocates, radiation physicists, hospital administrators and manufacturers. It has also stimulated work among manufacturers to develop devices that can deliver equivalent or better resolution with lower doses. This is progress and something the industry can take credit for.

While most of the discussion has focused on excess dosage, less attention has been paid to dosage that does not achieve the desired image which could just as well be on the low side. If a dose is too low, it is likely to result in a poor image that is unusable clinically and/ or could lead to an inaccurate diagnosis. Patient dose can actually be worse if it falls below manufacturer specifications than if it rises higher. This is because a low-quality image may require additional imaging procedures to get the proper image — a true argument for quality over quantity.

Therefore, patient doses which are too high or too low can each pose clinical and radiation dilemmas. Radiologists in particular need to be reassured that imaging equipment replacement parts- especially those that emit ionizing radiation- are engineered to be precise in form, fit and function and undergo rigorous, verifiable testing. Ideally, the testing should be done by an independent, outside company.

November 2011 Magazine

Read more stories from the November 2011 issue

More Voices