Medical Devices Lag in iPod Age - Patients' Safety Is At Risk, Experts Say

 December 29, 2008    The Boston Globe; By Carolyn Y. Johnson

A 32-year-old woman was on the operating table for routine gall bladder surgery, and doctors needed a quick X-ray. To keep her chest still while the image was shot, her ventilator was switched off. But the anesthesiologist, distracted by another problem, forgot to turn the breathing machine back on. The woman died.

The case is an extreme example of the kind of error that could be prevented if medical devices were designed to talk to each other, says Dr. Julian Goldman, a Massachusetts General Hospital anesthesiologist who has compiled such instances from across the United States to highlight the need for medical device "connectivity." In this case, he says, synchronizing the X-ray machine with the ventilator, so the image was automatically timed to a natural pause in breathing, would have made it unnecessary to turn it off.

As technology moves forward, people expect the electronic devices of everyday life to work together, from cellphones that can call or text-message other phones, to computers that interconnect with a slew of gadgets. But in the medical world, where the stakes are higher, such flexible interconnection is rare. Each device operates in its own silo.

"It is really unacceptable, and it's one of the reasons we're unable to make dramatic improvements in patient safety," said Goldman, a leader in calling for a new generation of medical devices that talk to each other.

Now the push for greater connectedness in hospital electronics is gaining momentum. The goal is devices that can not only plug into one another, but can also "understand" each other and automatically identify potential life-threatening problems sooner than they would have been caught by busy nurses and doctors.

In October, a task force - including Partners HealthCare, Mass. General, Johns Hopkins Medicine, Kaiser Permanente, and the Boston-based Center for Integration of Medicine and Innovative Technology - released sample language that hospitals can incorporate into contracts with vendors of medical devices, requiring that manufacturers create products capable of communicating with other devices using agreed-upon standards.

"My bank can notify me via text message if my account has a low balance, but medical devices can't let me know if my patient is having a critical event," says Dr. Jesse Ehrenfeld, a Mass. General anesthesiologist.

The administration of pain medication is one area where the ability to connect could save lives, advocates say.

A case reported in the Canadian Journal of Anesthesia, for example, describes a 19-year-old patient who accidentally received too much pain medication through an IV pump and died. Such pumps have safety features intended to guard against overdoses, but in most cases they are not hooked up to the monitors tracking the patient's vital signs. That means a dosage error or unexpected reaction that causes the patient to decline could escape notice.

A study published this month in the Joint Commission Journal of Quality and Patient Safety looked at the safety of patient-administered pain medication and found that it is four times more likely to result in patient harm than other medication errors.

At a recent conference, Goldman's Medical Device Plug and Play Interoperability Program demonstrated how problems with such medication systems could be addressed. It presented a series of circuits that could patch together monitors and, when needed, automatically shut off the pump administering pain medication, and call the nurses station.

Dr. Marc J. Bloom, director of perioperative technology at New York University's Langone Medical Center, calls the clutter of wires and cords in operating rooms "malignant spaghetti."

"We work with a lot of high technology in a very tight space," he said. "For us to connect all the devices, you have to run a wire. So if you have 10 devices, you'd have to run not just 10 wires but 100, to interconnect everything in the room. Add to that the fact that if you do connect them all together, they don't speak the same electronic languages."

Ehrenfeld pointed out another danger: increased costs. He's seen a patient come in with an MRI scan saved on a CD, but in a proprietary file format that can't be easily viewed, meaning that another MRI is ordered at considerable cost.

So why hasn't greater connectivity in medical devices been developed before now? There are a variety of reasons.

"At a certain point of development, it's understandable because the vision of the value of connectivity is not really there as the technology is still being developed," said Goldman. On top of that, there has been little demand because "doctors and nurses don't realize things can be better than they are today."

And medical device companies have been slow to change so far, according to Tim Gee, a principal at Medical Connectivity Consulting. Adding interconnectivity could increase companies' liability and costs, and open them up to new competition from other companies, he said.

But companies participate in annual Connectathons, and greater connectivity has become a priority, according to Jeffrey Secunda, associate vice president of technology and regulatory affairs for AdvaMed, a medical device trade association.

"Clearly, the patient benefit is there, and therefore there will be a competitive benefit for companies to pursue this," Secunda said.

Sandy Weininger, senior biomedical engineer at the US Food and Drug Administration, which regulates medical devices, said the agency has been working on the issue of interoperability for about four years, with safety a priority because medical devices are held to a higher standard than consumer electronics.

"Typically, no one is going to die from their phone not working. But they will die if their ventilator or heart-lung machine hiccups or freezes because of interoperability," Weininger said.

Gee, the consultant, predicts that interoperability is likely to emerge from companies that find ways to connect devices, instead of requiring hospitals to replace thousands of functioning units with new, integrated systems.

The turning point may be the arrival of the first truly revolutionary application, such as a medical version of an iPod, that changes people's expectations of their devices. That is what it will take to make "everyone clamor," Weininger said. "As soon as you get the iPod . . . it just mushrooms."

© Copyright 2008 Globe Newspaper Company.