The NEMA XR-29 standard went into effect earlier this year and yet there are many unanswered questions about compliance, auditing and regulatory aspects of proposed solutions.
MITA estimates that one-third of the current CT install base would not meet XR-29 requirements and those facilities will face penalties of 5% this year and 15% thereafter. Now, facilities that use these CT scanners must decide whether to pay these penalties, replace existing scanners or choose a third-party solution to comply with XR-29 standards.
The first question that is always asked is whether a 3rd party XR-29 compliance solution requires FDA-clearance.
The FDA has made it clear in numerous publications that any system that connects to a medical device such as a CT scanner and affects, interferes or interrupts its clinical operation, shall be considered as a Class II Medical Device and therefore requires FDA clearance.
XR-29 Dose Check function, by design, prevents and/or stops a scan if the estimated dose level is higher than a pre-defined threshold. Furthermore, the Dose Check function can cause adverse events in certain CT procedures (e.g. interventional), and an accidental interruption of a scan could result in extra radiation delivered to a patient. There’s very little doubt that any XR-29 solution requires FDA clearance as a Class II device.
Some providers claim that their XR-29 solutions do not require FDA clearance. Some claim that a Class I listing, used for simple devices such as elastic bandages and examination gloves, is sufficient. This approach is suspect at best. In fact, I strongly believe that they are misleading their customers. If the FDA inspects a facility or learns of the device’s improper marketing, they may order a corrective action or even a removal of the subject device.
Auditing is another area that requires clarification. The law requires that XR-29 compliance shall be verified as part of the periodic accreditation. Without clear instructions on how such verification is performed, CT operators rely on the Certificate of Compliance that is provided by the vendor (3rd party or OEM). If the accreditation agency fails to approve non-FDA cleared devices, who will take responsibility for CT scans that were wrongly reported and reimbursed?
I implore CT operators to demand evidence from the FDA and not just accept the opinions of vendors, consultants or advisors.
The big question is what to do in the meantime? On one hand the FDA has been very clear about the need for approval for XR-29 solutions and on the other hand the FDA has remained silent about un-cleared devices that are currently being offered and carry the aforementioned potential risks. Someone needs to step up to the plate and make it clear for all concerned.