Sponsored by AUE
By Jim Carr
Most of us were very happy and encouraged by the recent FDA decision to NOT require close regulation of servicing companies, and by the study FDA published that explained the reasoning behind that decision. Last month, I talked about that study and the lessons we should learn from it. Now, I want to bring up what I consider to be a bad decision that was first announced by the Centers for Medicare & Medicaid Services (CMS) in 2011, clarified in a 2013 memo and fully implemented in 2015.
In November of 2015, the State Operations Manual that is used by surveyors (e.g.; auditors such as Joint Commission) was amended to say Alternative Equipment Maintenance (AEM) programs are not allowed on any imaging systems. Hospitals need to pass audits by the Joint Commission or an alternative surveyor in order to receive Medicare and Medicaid payments. That means they are essentially forced to meet the guidelines laid out by CMS, even though many hospitals have evidence that shows their AEM programs on scanners have improved patient safety and decreased their maintenance costs.
AEM programs are plans that imaging service and clinical engineering departments can develop for a specific type of medical device. They specify how often preventive maintenance is scheduled and the procedures that need to be performed during the PMs. AEM plans need to be based on data and risk analysis, and have been used for years by many hospitals in order to reduce their costs and decrease risks to patients on various types of scanners, including ultrasound and MRI systems. When the CMS issued the 2011 memorandum that seemed to say they would not allow AEM for imaging systems, they were surprised when it was met with resistance and anger by many HTM professionals, described at the time as a “large and disappointed response by the CE and biomed community.” The CMS said they were surprised that many administrators and directors were certain that their costs and the risk to patients would actually increase in many cases, if they only do what the manufacturer says to do. CMS put out a questionnaire to gather opinions from the HTM and imaging service community, and AAMI submitted 244 pages regarding the value of evidence-based quality as part of AEM programs in health care facilities. Representatives from CMS met with two large biomedical engineering associations – ASHE and AAMI. Even though they had that input from the HTM and imaging service communities, in 2015 they made a decision to not allow AEM for any imaging systems.
I believe that the decision by the CMS is based on an incorrect assumption. The 2013 memo has a statement that says AEM programs are not allowed if “Other Federal or state law … require adherence to manufacturer’s recommendations and/or set specific requirements.” I do not know of any U.S. or state law that requires manufacturers to specify the frequency or methods for maintaining any imaging systems except those that emit X-rays. The FDA law is very clear that the OEMs that produce scanners with ionizing radiation must provide a schedule and procedure(s) for maintenance (ref: 21 CFR Part 1020).
However, the part of FDA law that covers other scanners – including nuclear medicine, MRI and ultrasound systems – is not as specific. Until recently, many user manuals and service manuals actually had different PM schedules. Since the CMS decision in 2015, many manufacturers have revised service and user manuals to specify less frequent PMs. The most ludicrous example I know of is the SonoSite ultrasound systems. The manuals actually say PMs are not needed – ever. Anyone who has worked on ultrasound systems knows that is absurd; several studies have shown that about 25 percent of the probes in use today have defects that make them unsafe electrically or unable to produce correct clinical results.
The user manuals for most modalities include a large amount of user maintenance, as well, and those user checks would actually reduce risks to patients and costs in many cases. For example, MRI user manuals tell the user to inspect the coils and look for physical damage. Ultrasound manuals often say that probes should be visually inspected every day. Those parts can often be repaired if the damage is discovered early enough. However, it seems the CMS surveyors are focusing on the imaging service departments, and I have not heard of any auditor looking at the user maintenance schedules and procedures. But in some cases the OEM says the user should do more maintenance than is actually needed, or tests that the scanner tech is not equipped or trained to do.
Many hospitals have had AEM programs for several years on imaging scanners. They have proof that they have reduced costs and risks to patients by following them. The imaging service and HTM professionals responsible for the scanners are in the best position to determine what is best for their hospital. Many have changed their terminology and don’t call the testing they do PMs or AEM, hoping they can keep checking the scanners using the procedures and schedule they have determined are best in their situation without running afoul of the CMS. The requirements for implementing AEM are already documented in the State Operations Manual. I urge the CMS to reconsider their decision and allow AEM programs for all diagnostic imaging systems, so long as they require the use of data and risk assessments to develop them.
Jim Carr is Director of Service and International Operations for AUE. He may be contacted via email at JCarr@auetulsa.com.