The US Food and Drug Administration (FDA) today unveiled an ambitious campaign to improve the safety of external infusion pumps, which have triggered 56,000 FDA adverse event reports linked to more than 500 deaths and 87 product recalls from 2005 through 2009, according to the agency.
The campaign mostly affects the makers of external infusion pumps, which may find FDA inspectors visiting their plants to ensure that safe manufacturing and testing processes are in place.
The initiative addresses safety problems in infusion pumps across the spectrum, whether they deliver insulin, antibiotics, chemotherapy drugs, or pain killers. The agency has concluded that many pump mishaps stem from faulty design and engineering, particularly in terms of software and user interface. In the past, the FDA has responded to infusion-pump failures on a case-by-case basis, but the number and severity of recalls have continued to rise, prompting the agency to take a more systemic approach.
"The initiative we're announcing today represents a major shift in FDA's approach to medical device safety," Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said at a press conference today. "Instead of responding to problems one by one, manufacturer by manufacturer, we're taking comprehensive steps to prevent problems by fostering the development of safer and more effective infusion pumps industry wide."
One common problem with infusion pumps, said Dr. Shuren, is "key bounce," in which the device interprets a single keystroke as multiple keystrokes. Dr. Shuren said a woman died after receiving 10 times the prescribed dose of heparin from an infusion pump because key bounce added an extra 0 to the dosage.
Dr. Shuren noted that when he punches in a number on his cell phone, he does not get an extra digit. "We should have the same expectation from infusion pumps," he said.
Confusing or unclear screen instructions also have contributed to user errors. For example, a device may not specify whether a patient's weight should be entered as kilograms or pounds. Still other mishaps are mechanical or electrical in nature — a battery overheats and dies prematurely, or a component breaks from routine use.
Pump Makers Will Face More Rigorous Approval Process
As part of its infusion pump initiative, the FDA today released a first draft of agency guidance — a prelude to binding regulation — recommending that manufacturers submit additional design and engineering information during premarket review of their devices. Manufacturers should explain the steps they have taken to reduce the risk of their device at each stage of its life cycle, from design to actual operation, according to the preliminary guidance document.
Furthermore, tests of infusion pumps should be conducted in the environment for which they are intended — hospital or home, for example — to account for real-life issues. In a home setting, such issues may involve an inexperienced user or a family pet, Dr. Shuren noted Friday.
Another portion of the proposed agency guidance puts pump manufacturers on notice that the FDA will tighten a process called 510(k) premarket clearance notification that it uses to allow devices to enter the marketplace. With a 510(k) clearance, a manufacturer need only prove that its product is basically the same as another product already approved by the FDA. This process is far easier and less expensive than premarket approval, the other process the FDA uses to okay a product. In a premarket approval, the manufacturer must demonstrate that its product is safe and effective.
The draft guidance released today reminds manufacturers that the FDA has the authority to withhold 510(k) clearance for an infusion pump until it inspects the company's facility.
"We are now for the first time exercising that authority across an entire class of devices because we've seen such rampant problems in this technology," Dr. Shuren said.
During these plant visits, FDA inspectors would be looking at the company's processes and documents "to make sure they've got a good quality system in place so they would have detected problems and followed up on it," said Dr. Shuren. "You want to eyeball that. You don't want to do that from a distance."
On a less confrontational note, the FDA is inviting manufacturers to voluntarily submit their pump software code to the agency before premarket review for expert analysis that could detect dormant problems. In addition, the FDA is encouraging manufacturers to participate in the Generic Infusion Pump Project, a collaboration between the agency and outside researchers that has developed an open-source software safety model. Manufacturers can use the model to fine-tune their infusion pump software.
FDA Asks Clinicians to Take Extra Precautions
The FDA initiative on infusion pumps targets not only manufacturers but also clinicians. The agency is asking them to practice extra vigilance in using the devices either on an inpatient or outpatient basis. The FDA recommends that they should, among other things:
* Draft plans for how they will respond to a pump failure. For example, how will they go about rounding up a replacement pump in a hurry?
* Label infusion pump channels and tubing with the name of the medication or fluid if the pump does not display the name.
* Monitor pump settings and patients alike for signs of underinfusion or overinfusion.
* Report any pump problems to the FDA.
For more information, visit a new section of the FDA's Web site on its so-called Infusion Pump Improvement Initiative.
