Open Letter about NEMA/MITA 2-201X Requirements for Servicing Medical Imaging Equipment

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By John Garrett

There is something subtly sinister about the NEMA/MITA 2-201X. It is written in seemingly logical and reasonable language to ensure quality imaging is maintained. It has a stated purpose of ensuring imaging quality throughout the country. However, it is an attempt to get people that don’t know anything about medical imaging to create laws that will have a disastrous impact to most hospitals.

There is no reason for this type of legislation to exist. There are already quality controls built into all of the guidelines that CMS has in place. There is no national dilemma that needs to be addressed. There is simply an attempt to manipulate rules and regulations that benefit manufacturers.

One interesting section is 7.4 Service Activities. Requiring worn parts to be replaced for a variety of circumstances. One of these is if it could cause indirect harm to the patient. There is no definition as to what indirect harm could mean. Do rescheduled studies, emotional stress, or delay of imaging count? If so, what is enough to qualify? What standards are used to determine what might happen? In short, it is an avenue for the manufacturer to have more parts replaced more often for a nice increase in sales. It has nothing to actually do with improving quality.

In an attempt to prevent anyone but the manufacturer from selling parts, Section 6 is an interesting read. If you are using an Independent Service Organization (ISO) the parts they provide will be considered Non-Qualified. Even though many ISOs may have a higher quality parts due to more stringent quality control practices, being able to label it as “non-qualified” leaves a lot of room for lawyers to get involved and run everyone out of business. You can, in theory, have a qualified part as a non-manufacturer entity. The way to have validation as a qualified part is under section 4.4 and is vague enough that the manufacturers will tell you how to do that later. Perhaps it would be more accurate to say, “Manipulate it later to ensure that only manufacturers can have qualified parts.”

This is only a small sampling of the attempt to drive ISOs out of business and drive the cost of maintaining medical imaging equipment up by significant amounts – all to benefit manufacturers. There is nothing in the document that will significantly improve outcomes for patients. It only creates a higher cost for health care, with arguably reduced quality, as medical systems cost for ownership will increase dramatically. With reduced reimbursement, that means cuts will have to be made somewhere.

If you care about medical imaging, the cost of health care, and really improving quality of service to the patient, find out more about NEMA/MITA 2-201X. Then, find all the ways you can help prevent it from ever being more than a bold grab by the manufacturers for a monopoly on service.


– John Garrett has 20 years experience in imaging service including general radiation, mammography, CT and nuclear medicine. He has worked for third-party service companies, manufacturers, sales companies and in-house imaging teams.

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