Cooperation with respect to the delivery of A.I.A.T. information for radiation emitting devices is required by 21 C.F.R. Parts 820.170 and 1020.30. Nonetheless, the standard (though replete with references to 21 C.F.R. citations for the sections to be imposed on servicers) is barren of reference to regulatory obligations for manufacturer responsibilities and is also silent with respect to following the requirements of accrediting organizations such as the Joint Commission.

Analyzing the language of the proposed standard
The MITA standard sets forth service provider responsibilities on audit, document control, service process control, test equipment, tools, parts and supplies, personnel, software based service processes, evaluation of suppliers, contractors and consultants, training procedures, calibration standards, installation of equipment, preventive maintenance, service reports, analysis of service reports, operational testing, complaints, corrective and preventive action, risk management and statistical techniques.



The compliance challenges become more evident as one delves into the standard, and nowhere is this more apparent than in the Equipment Maintenance section. Section 3.8.5 requires that each service provider shall "ensure that all equipment used in the service process meets ‘specified requirements’ and is appropriately designed, constructed, placed and properly installed to facilitate maintenance, adjustment, cleaning and use.” "Specified requirements" is not a defined term in the standard and presumably means requirements established by the manufacturer. However, if the manufacturer does not provide the manuals etc., it is not at all clear how the servicer may achieve this requirement.

The "inspection" requirement in the Equipment section of the standard further imposes specific duties upon the service provider that cannot be easily met when it requires: “[e]ach service provider shall conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules. No definition of "established procedures" is provided in the standard. It is not clear from this section how the servicer meets the "specified requirements" or follows the "established procedures".

The servicer is confronted with a similar challenge with regard to the "complaint management" section as the service provider is both required to have a system in place for managing device complaints and sharing such information with appropriate parties, such as the manufacturer. Parenthetically the definition is nearly identical to the broad definition of complaint in the regulation applicable to the manufacturer. Were there any doubt MITA wishes to impose the manufacturer standard on the servicer, MITA has inserted the specific regulatory reference underneath the definitions to be absolutely clear as to the scope. It defines a complaint as any written electronic or oral communication of alleged "deficiencies". Nowhere in the complaint section is there a method for how a servicer undertakes a "root cause analysis" of the alleged deficiencies if the manufacturer declines to share equipment specifications information.

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