Early this year, the Association for the Advancement of Medical Instrumentation (AAMI), with heavy involvement from FDA along with representatives from the medical device industry and healthcare organizations incorporating health information technology (IT), has been in the process of developing draft standard, AAMI SW87, Application of Quality Management System concepts to Medical Device Data Systems (MDDS). It is expected to be finalized within the June 2012 timeframe.
On February 15, 2011, FDA published the Medical Device Data System (MDDS) regulation to address the regulatory status of systems and software that interface medical device data output from medical devices to lab and hospital information systems as potential input to patient electronic health records (EHR). The FDA MDDS regulation, promulgated as 21 CFR Part 880.6310, classifies an MDDS as a device that transfers, stores, converts a data format to a preset specification, or displays medical device data without controlling or altering the functions or parameters of any interfaced medical devices. If the device is used for active patient monitoring it falls under a higher risk category and cannot be classified as an MDDS type medical device.Typical components of an MDDS can include software, electronic or electrical hardware such as wireless hardware, modems, interfaces, and communications protocols. Although the MDDS is exempt from 510(k) clearance requirements, manufacturers of MDDS are not exempt from the FDA 21 CFR Part 820, Quality System Regulation (QSR), or other medical device–related FDA regulations such as the 21 CFR Part 803 Medical Device Reporting (MDR) regulations.
FDA has identified MDDS manufacturers to include not only firms that develop and supply MDDS-type products for sale, but also healthcare organizations that modify or label general purpose IT equipment and software and/or develop their own custom systems and software that are intended to interface medical device data per the MDDS regulation. These manufacturers were required to register with FDA as an establishment subject to FDA inspection and list devices subject to a May 18, 2011, deadline. To date, FDA has indicated that fewer than 100 entities, including only approximately four hospitals, have registered as MDDS manufactures with FDA. In addition, by April 18, 2012, all MDDS manufacturers were required to implement a compliant quality system per the FDA 21 CFR Part 820 QSR and begin reporting adverse events per the 21 CFR Part 803 MDR.
The current good news is that FDA has indicated that there is no active FDA compliance policy at this time to inspect MDDS manufacturers to the FDA QSR. Although it appears that most healthcare providers and IT equipment/software suppliers either are unaware or are ignoring their status as MDDS manufacturers, FDA is attempting to reach out and provide education via conferences, webinars and their strong participation with AAMI and the AAMI SW87 standard to identify key aspects of the FDA QSR for MDDS manufacturers to address.
Generally, FDA appears to recognize that the methods for meeting the QSR requirements for an MDDS manufacturer may have a different focus than for traditional medical device manufacturers of non-MDDS products. For example, MDDS-type devices potentially could have more design changes; the risk could be more difficult to assess since the risk depends on what medical devices and associated medical device data are interfaced within the MDDS; and the MDDS may not even be a tangible physical product (for example, purchased IT equipment with associated software configured at a hospital that provides MDDS functionality).
AAMI SW87 has been developed to provide a focus for IT equipment/software suppliers and hospitals or other healthcare organizations that are MDDS manufacturers to initiate implementation of a quality system capable of meeting FDA expectations. In addition, AAMI SW87 is intended to be a primer in basic quality system implementation for those MDDS organizations that have not previously been involved in the medical device industry, typically with no expertise or experience with the FDA QSR. Five key quality system processes per the FDA QSR have been identified per the draft standard:Management—to include quality planning, identification of responsibilities, adequate resource allocation, and review of the effectiveness of the quality system.
- Document and Records Control—including effective implementation of configuration management, revision and change control.
- Design Controls—as a major area of focus including risk management and traceability to MDDS requirements, design, verification, and validation.
- Supplier and Purchasing Controls—since major sections of the MDDS, or the entire system, could be purchased.
- Corrective and Preventive Action (CAPA)—for addressing complaints and other sources of defects and as potential input to MDR analysis and continual quality system improvement.
The following areas of the FDA QSR requirements are not as applicable to MDDS manufacturers and, thus, have not been addressed specifically as a focus in the AAMI SW87 standard:
- Production and Process Controls
- Equipment and Facility Controls
In addition, the AAMI SW87 standard does not specifically appear to address significant guidance toward adverse event reporting per FDA MDR requirements as tied to CAPA.
In summary, the FDA MDDS regulation has been a requirement for more than one year, and a limited number of device manufacturers or healthcare organizations have registered as FDA MDDS manufacturers. The deadline for MDDS manufacturers to implement a quality system compliant with the FDA QSR has passed. However, FDA has adopted a more lenient stance regarding MDDS registration and compliance to the QSR to date. In addition, FDA has been working with AAMI in developing the SW87 standard in order to reach out to MDDS manufacturers to provide education and an emphasis toward implementation of the most important identified aspects of the FDA QSR. The time to initiate implementation of the FDA QSR, using the AAMI SW87 standard as a starting point for guidance, for those registered MDDS manufacturers is now, before FDA changes its more lenient stance on compliance with the QSR, as the deadline has passed.
Dennis Rubenacker is co-founder and senior partner of the consulting firm of Noblitt & Rueland, which provides consulting and training services for medical device and IVD manufacturers. Rubenacker specializes in software validation, FDA electronic recordkeeping, design control, risk management, software development, and software quality management for the medical device industry. He can be contacted by phoning 888 892-4664 or via e-mail at firstname.lastname@example.org.