FDA: New Medical Device Standards
April 30 -- 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."
