Initial remarks: This blog is a supplement to a more complete article (click here to read it) that discusses this topic in the context of endoscope reprocessing and infection control.
Blog: The current good manufacturing practice (CGMP) requirements of the FDA’s Quality System (QS) regulation mandate that manufacturers of medical devices that are sold in the U.S. develop and employ a quality system (unless the device is exempt from this regulation).
A quality system helps to ensure that the manufactured device consistently meets the device’s design specifications.
Among other activities, the employed quality system is required to establish and maintain procedures to manage and control the designs of medical devices, known as “design controls,” including any changes to their designs. This “design control” requirement applies to most medical devices and, in part, is intended to ensure the proper execution of a design change—namely, that a modified device is consistent with the device’s changed design specifications (i.e., that the “total finished design output”14 conforms to the device’s “design input requirements”8).
According to the FDA, “design controls” are “based upon quality assurance and engineering principles” and are “an interrelated set of practices and procedures that are incorporated into the design and development process, i.e., a system of checks and balances.”
The CGMP requirements of the FDA’s QS regulation apply to all medical devices, no matter whether it is a class 1, class 2, or class 3 device.8 While applying to all class 2 and class 3 devices, however, this regulation’s provisions requiring that manufacturers control the device’s design (and changes to its design) apply only to a few class 1 devices. (Please click here to read the FDA’s “Design Control Guidance for Medical Device Manufacturers,” which lists those class 1 devices that are sujbect to design controls.)
Class 1 devices (e.g., examination gloves) pose a low risk of patient harm and are generally exempt from pre-market review; class 2 devices (e.g., GI endoscopes) pose a moderate risk and usually receive a 510(k) clearance; and class 3 devices (e.g., implantable pacemakers) pose a high risk and require a pre-market approval.8,9
As a sidebar, “control” in the QS regulation refers to, among other activities, the manufacturer’s review, approval, documentation, verification and, as required, validation of a device’s design and any changes to its design. Verification confirms that a change conforms to the device’s design specifications, whereas validation confirms that the change is consistent with the device’s intended uses.8
Further, the FDA’s QS regulation requires that a manufacturer’s quality system establish and maintain procedures to manage and control the device’s documentation, which includes its labeling, instructions for use (or, IFUs), and, if the device is reusable, its reprocessing instructions. An example of a manufactured device that lacks design control, displays faulty translation of its design specifications, and does not comply with the QS regulation—and, therefore, according to the FDA, is adulterated11,13—would be a reusable instrument whose design specifications require that the device withstand steam sterilization, but that was discordantly manufactured using plastic materials that are melted by heat.
A reusable instrument whose design specifications require that the device withstand steam sterilization, but that was discordantly manufactured using plastic materials that are melted by heat, is an example of a manufactured device that self-evidently lacks adequate design control and does not comply with the QS regulation would be
Germane to a more complete article on this topic, which may be read by clicking here, the FDA’s QS regulation similarly requires that changes to a reusable device’s documentation – which includes its labeling, instructions for use (or, IFUs), and, if the device is reusable, its reprocessing instructions – like changes to the device’s design, also be managed and controlled to ensure the device’s quality, safety, and effectiveness.
A labeling change may be minor requiring limited control, including the manufacturer’s review, approval, and verification (and, as required, validation) of the change; or, the change may be significant, or “major,”9 with the potential to adversely affect the device’s safety and effectiveness.9 Unlike minor ones, significant labeling changes—an example would be a change to the device’s intended uses—require additional control, including that the device receive a new 510(k) clearance (or a new premarket approval) to be legally marketed in the U.S.9,11,13
Click here to read the FDA’s “Design Control Guidance For Medical Device Manufacturers.”
Whether a specific change to a device’s labeling is minor or sufficiently significant to require a new 510(k) clearance may not always be obvious. One manufacturer may interpret to be minor and insignificant a device’s revised reprocessing instruction that another may conclude invalidates its current 510(k) clearance. The elimination of the use of detergent during bedside cleaning may be such an example of a change to the device’s labeling that the FDA may, or may not, deem significant.
To avoid a device becoming adulterated and misbranded, its manufacturer may judiciously consider applying for a new 510(k) clearance whenever there is the reasonable possibility that the FDA would conclude that a specific change to the device’s labeling is significant.
Click here to read Dr. Muscarella’s peer-reviewed article, “Medical errors, infection-control breaches and the use of adulterated and misbranded medical devices.”