By Rick Schrenker
First, a sample of the soup. (Sorry for all the TLAs—or three-letter acronyms)
- CFR: Code of federal regulations
- HDO: Healthcare delivery organization
- MDDS: Medical device data system
- MDM: Medical device management
- MEMP: Medical equipment management plan
- QM: Quality manual
- QMS: Quality management system
- QSR: Quality system regulation
- SOP: Standard operating procedure
- SOUP: Software of unknown provenance (Yes, there is soup in the soup.)
Other than intellectual curiosity, a practical reason you may want to learn a bit more about QMSs, QMs, and even the QSRs is because there are proposals floating around in various CE/HTM forums suggesting departments adopt a QMS, e.g., as a replacement for the MEMP. This is not a new issue, as some from the MDM side have long questioned why they must comply while others offering the same services need not (and as far as I’m concerned, it’s a reasonable question).
My introduction to this world goes back to the beginning of the 2010s. Some of you may recall that the FDA instituted a rule that required HDOs to register with the FDA and list any MDDSs that they had developed, in essence treating those HDOs as equivalent to MDMs.
I won’t delve into that story any more deeply here other than to note that (1) the FDA abandoned that requirement by the middle of the decade, and (2) in the meantime, I worked to register three MDDSs we’d developed and were using here at MGH and then jumped down the rabbit hole into the wonderland of learning what it would require to comply with the regulation. Ultimately, we removed our devices from the listing and ended our efforts to develop an FDA-compliant program.
Developing a system to meet FDA requirements led us to develop and institute a QMS to meet the requirements of 21 CFR Part 820 FDA Quality System Regulation (if interested, you can delve into the sparse details of Part 820 here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820). That effectively led us to create a draft QM. Since the FDA regulated MDDSs as Class 1 devices (low risk), we were only required to implement design controls as defined by the regulations. However, a project I was working on was considering creating Class 2 devices that potentially could have been evaluated in human studies, so we went ahead and engaged a consultant to help us develop a QM that addressed sections of the regulation in addition to design controls.
Our draft QM and 12 SOPs cited 16 regulatory references, 53 defined terms, and 41 acronyms. I’ll touch on one aspect of the QM and a few others of the SOPs here, but I want to note that my personal professional interest at the time was risk management, and I will focus on that in my next column. (Interestingly, Part 820 mentions risk management only once [in 820.30(g)], although its rather lengthy preamble touches on safety and risk a good bit more.).
Got all that? Any questions? Besides “So what?” I mean…
Part 820 as it has existed for the last couple of decades arguably bears strong resemblance to the generic ISO 9001 quality system standard. But outside the United States, much of the rest of the world relies on the voluntary standard ISO 13485: Medical devices—Quality management systems—Requirements for regulatory purposes. There are at least three things you should know about 13485:
- As you would expect, it essentially covers the same quality management topics as the QSRs.
- Even so, it is more explicitly focused on risk management.
- The FDA is in the process of harmonizing 13485 with the QSR.
Tying this all together, if an argument can be made that CE/HTM departments should adopt QMSs as MEMPs (and the ones I’ve seen more or less do), and MEMPs should align in intent and spirit with the regulations placed on MDMs, should MEMPs be grounded in some manner with 13485?
I’ll drop that provocative statement right here for others to argue and move on to a brief, light touch on some of the components of the QSRs for which we created our draft QM and SOPs:
- Quality manual: For the most part, the QM served as an introduction to and integration point for the SOPs. But in addition, it made “the buck stops here” role of top management explicit, requiring top management to be actively engaged with the quality program, including monitoring the program on a regular basis and documenting the intent and results of all related efforts. (All QMs I’ve seen include provisions for this.)
- Design controls: Strictly in terms of medical devices, this is probably beyond the scope of CE/HTM.But in terms of a broader scope, e.g., system development and integration, the focus on requirements, specifications, risk management, verification, and validation associable with this topic may be useful. Reminder: If HDOs were still required to list MDDSs, HDOs would be required to implement design controls.
- Supplier and purchasing controls: If you don’t buy all your parts and supplies from sources recommended by the device manufacturer, how do you qualify them?
- Document and records controls: Are all of your documents and records systems organized and managed? How do you ensure everyone is using valid versions?
- Control of nonconforming product: Do you segregate devices that are not to be used? If so, how?
- Corrective and preventive action: How do you identify and manage issues that require corrections and/or prevention?
- Complaint handling and medical device reporting: Because of SMDA, you probably have MDR under control. But what about complaints from your customers?
- Internal and external audits: Do you audit your own systems? How, and how frequently?
In my next column, I’ll move to ISO 14971: Medical devices—Application of risk management to medical devices—which is really what I wanted to write about in the first place.
Rick Schrenker is a systems engineering manager for Massachusetts General Hospital. Questions and comments can be directed to chief editor Keri Forsythe-Stephens at [email protected].
- Iduri B, Bankuru R, Yamevic R. “Applying QMS principles to a medical equipment management program.” Biomed Instrum Technol. 2019;(53)5:342–346.
- Grimes S. “The case for a auality management system standard for HTM.” Biomed Instrum Technol. 2019;(53)1;24–29