An editorial by Robert J. Kerwin
IAMERS General Counsel

The Medical Imaging Technology Alliance (“MITA”), a division of the National Electrical Manufacturers Association, has circulated for formal balloting and public comment its proposed national standard for servicing of diagnostic imaging equipment.

This follows MITA’s advocacy on Capitol Hill and before the FDA for regulation of independent servicers.

If approved as a standard by the American National Standards Institute (“ANSI”) or by the FDA, the MITA servicing standard would serve to establish the minimum elements of a quality management system for all service providers of medical imaging equipment.



While IAMERS is a strong proponent of quality management systems and indeed conditions membership on adherence to IAMERS’ Best Practices, the MITA standard is troubling and largely unachievable for independent servicers who are routinely denied access by manufacturers to manuals, service keys and training. It's our belief that it is all well and good to establish standards for training, calibration and testing, but the common issue of a manufacturer’s "withholding of important equipment information" necessary to implement these standards continues to be the "elephant in the room" that is being sidestepped.

Independent servicers should email their concerns about this standard to MITA during the MITA comment period (December 8 deadline) not simply because the standard contains a bevy of unachievable or ambiguous provisions, but because it quite deliberately sidesteps obligations of the manufacturer to provide equipment manuals, passwords or service keys.

MITA has advised of its intention to share the standard publicly, but as of this writing it does not seem to be available through access to the MITA website.

The International Association of Medical Equipment Remarketers and Servicers (IAMERS), which I represent, has raised concerns with MITA about the withholding of passwords, equipment manuals and service keys, and was variously informed that MITA does not seek to regulate the behavior of its members on this issue, and that manufacturer obligations do not belong in a servicing standard.

MITA’s explanations seem like sidesteps especially when one considers that MITA informed Congress earlier in the year, and the FDA last year, that its objective in seeking servicer regulation is to ensure all service providers provide the same level of quality and safety. Despite the reports of ECRI and other respected commentators that there is no data in FDA Maude reports of systemic issues, MITA submitted photos of ostensibly unsafe workmanship of nameless independent servicers to make its case for the need to improve patient safety.

If the goal of the MITA standard was truly patient safety, why was there no attempt in either the MITA standard or in the creation of any corollary consensus document to deal with the elephant in the room? Could the reason for this sidestepping possibly have its real genesis in competitive origins to exclude independent diagnostic imaging servicers from undertaking certain servicing contracts? We welcome being disabused of this concern.

A standard potentially unattainable for ISOs
We also hope that the American National Standards Institute (ANSI) and other interested parties take notice that there are substantial issues of dominance, openness and balance contrary to the Essential Requirements of ANSI. See ANSI Essential Requirements: Due Process requirements for American National Standards.



IAMERS elected to be an observer in this process. While ANSI requirements require consensus, it is challenging to build a consensus when open and obvious standards requirements are dismissed in favor of watered-down language. An example of this is "training" on the equipment. Since a comprehensive ‘training’ provision would plainly require access to equipment information and such was unpalatable, putting in a substitute provision that training must be "as determined by the owner of said device" was a half measure.

In this era of reduced regulatory activity, standards, when approved or incorporated into health care procurement programs may well have, for practical purposes, the force of law. One only needs to note ISO quality standards such as ISO 9001 and 13485 to observe they often serve as a framework for many medical device businesses. In the case of the MITA imaging standard for servicers, the proposed standard would require servicers to assume many of the responsibilities currently imposed on manufacturers by the FDA quality management regulation, 21 C.F.R. 820 et. seq. without any defined path toward access to the information necessary to achieve the standard. Indeed, the manner in which MITA sidestepped this area during months of drafts by the insertion of ambiguous terms such as "specified requirements", "established procedures" and adherence to "intended purposes" or "applicable authorities", removes doubt that MITA purposely did not address how independent servicers would achieve the many benchmarks established without manufacturer cooperation.

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.

The section on software-based service processes, as with many other sections, imposes obligations which likely cannot be met without cooperation. Section 3.8.6 provides that “when non-original manufacturer software or another device is added or connected to the system for servicing purposes, the service provider shall validate the computer software or other device for its intended use according to an established protocol.” While such a protocol seems readily adoptable, it is almost impossible to the extent that the manufacturer of the software withholds this information.

What is the actual goal?
IAMERS continues to receive reports that manufacturers decline to assist in providing A.I.A.T. and other information notwithstanding this longstanding elephant in the room. Little wonder that the Joint Commission early this year imposed an accreditation requirement that this type of information would need to be available to the hospital.



If a mutual goal is truly patient safety, why would there be a problem in providing this information to service providers of equipment owned by hospitals and group medical practices? Why would there be no reference in the MITA standard or any corollary document to providing passwords, service keys and manuals? It is worthy to note that many of the major manufacturers service under multi-vendor programs, so they are no doubt aware that they too need this information when servicing equipment they do not manufacture.


Perhaps it is time to adopt a business model of cooperation and spend time in the development of standards that support this model? Perhaps equally worthy to ponder: why take all this time (ostensibly for patient safety concerns) to devise a standard that can’t always be met because of a lack of cooperation?

ABOUT THE AUTHOR: Robert J. Kerwin has served as general counsel to the International Association of Medical Equipment Remarketers and Servicers Inc. for over twenty years.