Doctors scale down devices for kids
Improvise isn't a word parents want to hear from their kid's doctor. Yet pediatric specialists too often have to figure out care. That's because many of the medical devices needed to treat sick children were built for adults.
Part of the problem is size.
Here's how doctors fixed Alice de Pooter's faltering heartbeat. They wedged an adult pacemaker into a baby's body. But the device's large battery bulged badly under her rib cage. She struggled to sit upright until her first birthday.
It's also an engineering problem. Children aren't just mini adults. Their bodies are growing and changing. Adult devices haven't been formally studied in children. So using them in youngsters can raise safety questions.
"It affects patient care. We need to find a resolution," Dr. Matthew Oetgen. He is chief of orthopedic surgery and sports medicine at Children's National Health System. He made this statement at a recent grants competition. It was hosted by the Washington hospital. The hospital wants to spur development of innovative pediatric devices.
There's little financial incentive to create and test pint-sized devices. That's because children overall are healthier than adults. They also make up a fraction of the treatment market.
But families are starting to demand solutions.
A birth defect left Miyah Williams with one leg missing at midthigh. She received a prosthetic leg as a toddler. But it came with a painful socket. A rigid cup connected the leg to her thigh. It was too painful and she refused to wear it. Her mother eventually found a small San Francisco company. The company designed a softer, adjustable socket able to grow some as Miyah does.
Miyah is now 3. She dances to show off her leg. It is comfortable enough to wear all day.
"She told them earlier today that her bone no longer hurts," said Tamara Williams.
The industry acknowledges medical devices designed specifically for children often lag behind devices for adults. The lag time can be five years to 10 years. The Food and Drug Administration statistics illustrate the disparity. In 2013, eight of the 38 novel or higher-risk devices FDA approved were labeled for use by patients younger than 22. In 2014, six of 33 such device approvals were for pediatric use. Two devices for rare disorders were allowed to sell under a special fast-tracking program.
Consider pacemakers. Children account for only about 1 percent of pacemaker implants, said Dr. Charles Berul. He is co-director of Children's National Heart Institute. Adult pacemakers can save lives, but improvising has drawbacks, he said.
Adults typically have a pacemaker's electrical leads, or wires. They are easily threaded into the heart through a vein. But babies require open-chest surgery to attach them to the outside of the heart, explained Berul. Faster child heartbeats wear out the batteries more rapidly. The leads can stretch out of place as tots grow.
Alice is now 3 and has a well-functioning heart. While the battery's outline remains visible in her belly, "she's running and happy," said her mother.
Manufacturers are developing a tiny wireless pacemaker for adults. If it works, Berul hopes eventually that could be adapted for children, too. Meanwhile, he's developing a less invasive way to place today's wires in a tot. He gets aid from a tiny camera normally used in the urinary tract.
It's an example of the partnerships between doctors and bioengineers. These partnerships are springing up at numerous children's hospitals and universities. They are sparked in part by 2007 legislation establishing an FDA program. The program has a small budget to help fund early pediatric device development. This year, FDA awarded $3.5 million to eight such consortia. Some experts argue more far-reaching incentives are needed. These include tax credits and patent exclusivity. Both have spurred an increase in medications for rare diseases.
Another incentive: Make a device that works first in kids. Then "absolutely there will be benefit for the adult population. It's not as easy the other way around," said Dr. Vasum Peiris. He's the FDA's new chief medical officer for pediatric devices.
Doctors point to some successes. The Berlin Heart child-sized implantable pump was approved through a special FDA program. The approval in 2011 helped children survive the wait for a heart transplant. This is an option long available for adults. OrthoPediatrics Corp. of Warsaw, Indiana, recently created a device to repair a common knee injury. The device repairs a torn ACL. It does not damage a young child's still-growing bones.
Last month's competition by Children's National's innovation institute highlighted early prototypes attempting to wind through the pipeline. The prototypes included a device by Ireland's AventaMed to implant ear tubes in youngsters. This device does not require full anesthesia. Another innovation is a test by Prospiria Inc. in Galveston, Texas. It shows if breathing tubes are inserted properly.
The ideas don't have to come from pediatricians: "Just ask patients what they want," said Dr. Andrew Pedtke. He's an orthopedic surgeon who co-founded LIM Innovations. He founded the company after seeing adult amputees struggle with painful sockets.