US regulators have finalized a new set of recommendations intended to make infusion pumps safer and more reliable.
In the US, medical devices can come to market in a variety of different ways. Some low-risk devices, known as Class I medical devices, need only to adhere to established standards for a device to be able to be legally marketed. On the opposite spectrum, high-risk, Class III medical devices must undergo a thorough review process in which they need to show clinical evidence of safety and efficacy prior to approval.
In the middle, however, is FDA's premarket notification process, also known as its 510(k) process. The process is intended to allow medical devices to obtain market "clearance" through an abbreviated process. Instead of requiring extensive clinical data, FDA requires devices to show they are substantially equivalent to an already-marketed "predicate" device, and then assesses the impact of any differences between the two devices.
To assist manufacturers looking to bring products to market through the 510(k) process, FDA regularly releases new guidance documents outlining best practices for the content of marketing submissions. Some of those documents are intended to help clarify an otherwise difficult or confusing applications process; others are intended to help improve the safety of devices.
FDA's newest guidance document, Infusion Pumps Total Product Life Cycle, is in the latter category.
As FDA explains in the guidance, "The FDA has evaluated a broad spectrum of infusion pumps across manufacturers and has encountered problems with device software, human factors, reliability and manufacturing. Based on an evaluation of reported adverse events and recalls, FDA believes that many injuries and adverse events may be avoided by improving the design verification and validation processes for these devices."
In other words, there are problems—easily correctable ones in the eyes of regulators—and manufacturers need to start reforming their design verification and validation processes to help fix them.
What are infusion pumps? Under the US Food and Drug Administration's (FDA) regulatory definitions (21 CFR 880.5725), the pumps are any device "used in a healthcare facility to pump fluids into a patient in a controlled manner." FDA already subjects several types of the pumps and their supporting devices to its Class II performance standards, including:
|MEA||Patient controlled analgesia (PCA) infusion pumps|
|MEB||Elastomeric infusion pumps|
|LZG||Insulin infusion pumps|
|OPP||Insulin bolus infusion pump s|
|LZH||Enteral infusion pumps|
|MRZ||Infusion pump accessories|
|PHC||Infusion Safety Management Software|
FDA's guidance on infusion pumps is somewhat unusual in that it calls for sponsors of infusion pump applications to submit information about substantial equivalence through a "safety assurance case" (safety case) framework.
The case is essentially a "structured argument" supporting an "organized case" that a pump is safe and is designed in such a way as to mitigate and address any hazards associated with its use or its environment. "Any newly developed device should have its own unique safety case," FDA added. Modifications to infusion pumps without a developed safety case must include a safety case.
At a high level, each safety case must include a claim about a characteristic of the device, an argument supporting the claim, and evidence supporting the argument.
FDA's guidance also calls on sponsors to conduct a hazard analysis of each device and its potential errors, performance testing on the device, and information about the use of alarms and safety control mechanisms.
Infusion Pumps Total Product Life Cycle (FR)