By Stuart C. Gardner and Kris K. Hughes
Although it is only a fraction of the PACS purchasing and operational process, the task of choosing data-storage solutions continues to be muddied by misunderstood or misrepresented regulatory concerns, as well as an ongoing turf battle among PACS and storage-technology vendors. However, a recent Food and Drug Administration clarification obtained by SG&A Consulting may change all that.
For several years now, the PACS industry has been touting the benefits of the integrated healthcare enterprise, including strategies that would result in enterprise-wide data management, storage, disaster recovery, and business continuity solutions. Unfortunately, many of the industry’s leading manufacturers have failed to actively join the movement on a truly practical level.
Some PACS firms tell potential customers that deploying a "foreign-vendor" storage-area network (SAN) or networked-attached storage (NAS) for the archiving/business continuity element of PACS would run afoul of FDA medical device regulations concerning the vendor's 510(k) clearance. Also, the idea of integrating PACS-generated images into a preexisting archive can be problematic for many vendors.
A recent FDA-issued opinion, however, assists purchasers by increasing the available options for archive strategy implementation. Furthermore, end users will enjoy the benefit of a more open market as they begin to purchase storage solutions directly from the storage-technology vendors and their resellers.
Although there may be skeptics in the PACS vendor market that are unwilling to change existing marketing and sales strategies, the well-educated end user will no longer be forced to capitulate to those vendors who would claim regulatory violation as the reason for limiting purchase options.
Sensitive to the frustrations of healthcare organizations facing ardent resistance from numerous vendors, SG&A Consulting filed an official advisory opinion request with the FDA on August 12, 2002, pursuant to 21 C.F.R § 10.85. We sought clarification on the FDA's regulation of archiving technologies, device classifications, related matters of device alteration, the relevance of the type of information stored in the archive, and any subsequent requirements on the part of the healthcare provider organizations.
Many PACS vendors today tell clients that they must purchase any expanded storage upgrades from the vendor, stating that their PACS is a regulated Class II medical device. Not all end users, however, are knowledgeable enough to argue the point, and therefore concede to the uninformed interpretation of the regulations.
Such statements have cost end users untold millions of dollars in the aggregate, and have forced them into storage strategies designed by the vendor, which are not necessarily in the end user’s best interests.
In guidance material published in July 2000, the FDA attempted to provide clarification for manufacturers with respect to medical image management devices. According to the guidance text, sections 892.2010 (medical image storage devices) and 892.2020 (medical image communications devices) are:
"intended to include all medical image management devices whose principal functions are communications or storage. Classification 892.2050 is intended to cover devices that have not been included in the other medical image management device classifications (i.e. 892.2010-2040). There has been some confusion regarding the applicability of 892.2050 because the term ‘PACS’ has commonly been used to refer to all types of image management devices. The classification 892.2050 -- Picture Archiving and Communications System is not intended to include products whose principal function is medical image communications and/or storage.
In many cases it is difficult to decide if a device should be classified as a Medical Image Communications Device, a Medical Image Storage Device, or as a Picture Archiving and Communications System. In such cases the classification is determined by the additional functions performed by the device.
Simple manipulations which do not alter the image data, such as window and level, pan and zoom, and image annotation are considered to be within the scope of the communications and storage functions, and do not preclude a system from these classifications. However, image-processing functions, which are intended to alter the image data (e.g. filtering, multiplanar reconstruction, and 3-D reconstruction), are considered to be outside the scope of the storage and communications functions.
Also, complex quantitative functions (e.g. arterial stenosis evaluation, ventricular volume classifications, and calcium scoring) are not considered to be communications and storage functions. Devices which incorporate such functions are treated as picture archiving and communications systems, which are Class II devices and premarket notification is required."
The FDA requires manufacturers to submit premarket notification (510(k)) applications for certain types of medical devices. Generally, class I devices are exempt from 510(k) requirements, while Class II devices are not.
However, even in the case of a Class II device, such as a PACS (as defined by 21 CFR 892.2050), the information required on a manufacturer’s 510(k) regarding the "storage component" is quite minimal.
According to the guidance documentation, "In cases where standard, general-purpose equipment is utilized, it is only necessary to provide the manufacturer, trade-name, form of storage (analog or digital), and type of storage medium (e.g. solid state, floppy or hard disc, magnetic tape, optical disc)."
This is further indication of the FDA’s position regarding general-purpose devices that are not marketed for "medical use." Although a PACS may be deemed a Class II medical device when considered as a whole, the individual general-purpose devices incorporated into the whole are not necessarily considered medical devices.
The guidance for submission of premarket notifications for medical image management devices very clearly states that manufacturers of general-purpose image management products (e.g. software, communications devices, storage devices, TV monitors, scanners, frame grabbers), that are not labeled or promoted for medical use, are exempted from registration, listing, and premarket notification.
"The original manufacturer is not responsible for the medical use of the device. This is the responsibility of the manufacturer of the medical image management system," the guidance states.
"Use" versus "marketing"
A significant concept to understand with regard to the FDA’s regulation of medical devices is the distinction between use and marketing. It is important to note that the FDA regulates manufacturers of products intended for medical use. These regulations, however, do not apply to a healthcare provider or provider organization actually utilizing the regulated manufacturer’s products, unless the provider organization intends to market a device in interstate commerce.
For example, a provider organization that purchased a PACS from a certain vendor may understand that the organization’s projected growth will, at some point, require additional storage capability -- perhaps for data generated by an anticipated hospital information system. The vendor may claim that no information, other than that generated by the PACS itself, may be archived in the existing PACS archive since it would "alter" a medical device.
Accordingly, the vendor might attempt to preclude either information integration or an upgrade to a third-party archive vendor’s product that was sought and purchased independently by the provider organization. The FDA’s recent response to us, however, clearly indicates that the type of information contained therein does not affect device status.
Instead, the status of a device is determined by its intended use when marketed. This leaves the provider organization free to use the general-purpose archive to store whatever data it deems necessary and appropriate.
While a manufacturer of archiving technology may not claim that its product is intended for "medical use" -- unless it has complied with the necessary Class I medical device requirements (which include device registration and Good Manufacturing Practice requirements) -- it may nonetheless market its general-purpose device to a healthcare facility for the general purpose for which the product was manufactured -- to store data.
As stated in the FDA’s recent opinion letter to SG&A, "the nature of the data contained in an information archive has no bearing on whether the manufacturer falls under the purview of the Good Manufacturing Practices, 510(k) requirements, or related medical device regulations."
One might argue that calling a general-purpose archive or storage technology a medical device when it is marketed to store healthcare information that could include medical images would be analogous to similarly designating a common metal filing cabinet that stores hard copies of patient images as a medical device.
Market impact
What does this mean for the marketplace? It is a testament to the benefits of an educated end user. In addition, understanding the impact of these regulations and the FDA’s relative position opens up many opportunities for healthcare provider organizations and their respective information management departments. True enterprise-wide information management and the industry’s laudable goal of integrating the healthcare enterprise can be achieved.
End users no longer have to accept the argument that to integrate additional information into an existing storage environment is in violation of FDA regulations. Furthermore, by recognizing that the FDA’s medical device regulations were not intended to regulate general-purpose storage devices, the type of information stored in any general-purpose storage device, or the consumers operating those devices, end users will now be free to pursue the most appropriate and cost-effective storage and archiving strategies available on the market.
By Stuart C. Gardner and Kris K. HughesAuntMinnie.com contributing writers
July 24, 2003
Stuart Gardner is the president of PACS consulting firm, SG&A Consulting of Arlington, TX. Kris Hughes is general counsel and is the director of HIPAA services at SG&A Consulting.
Related Reading
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PACS provides push for paperless, June 9, 2003
RIS/PACS integration -- what is it and what are its benefits?, June 6, 2003
PACS brings benefits, with caveats, May 22, 2003
Separating HIPAA facts from fiction, May 12, 2003
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