FDA: New Medical Device Standards

Tens of thousands of Americans are killed every year by medical errors and many more are injured.

The Food and Drug Administration says medical devices are a big part of the problem. The agency says many products aren't designed with the users in mind, and it is requiring firms to pay more attention. Devices Designed Without Environment in Mind

The agency has been showing a video about medical device design flaws, so manufacturers and health-care professionals become more aware of where errors may arise.

The video highlights what happens time and again in medical situations:

A doctor turns away from a patient to look at a monitor.

Drug vials look similar but contain very different medications.

Machines have very complicated controls.

All these things happening simultaneously in a noisy, crowded operating room.

"When a devices is designed in isolation where the user's needs and requirements haven't been considered, that device is potentially unsafe," says Dr. Matthew Weinger, professor anesthesiology at the University of California, San Diego, School of Medicine.

"Usability affects safety and if I can't use a device in a crisis situation effectively, then I'm not able to respond to the patient's needs."

Tangled Tubes

Tangled cords and tubing, such as from an IV drip, or from the mess of wires or cables in an operating room, can create hazards, too.

"The large number of cables and wires are not only a tripping hazard, but its not uncommon to forget to plug something in and the battery runs out or to plug the wrong thing to attach to the wrong device or the wrong cable," Weinger says.

"The patient after heart surgery is on 10 different infusions through six different pumps," he adds. "Figuring out which drug is being administered through which infusion pump can be difficult."

Packaging also poses problems.

"One of the problems is a packaging … where you have to pull it open and then you're supposed to drop it onto the sterile table … " says Mary Martin, a registered nurse with the San Diego Veterans Administration Medical Center. "[The packaging, however] makes it very difficult to dispense the item onto the table without contaminating it."

FDA Changing Its Policy

The FDA showed the footage at a teleconference in February for health-care professionals, asking for feedback from experts.

"You see all these different devices and all these users that are trying to interact with them, yet when we actually evaluate devices, we're only looking at the device," says Bob Gatling, a spokesman from the FDA's office of device evaluation.

But the agency will be changing its policy: Manufacturers now must demonstrate usability when they apply for product approval. Once manufacturers become aware of problems with existing products, they are also responsible for correcting them.

Jack Penland is a reporter with Science and Technology News Network .

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