WHO Mandates New Single-Use Syringe

Marcia Frellick

September 12, 2014

WASHINGTON, DC — Two innovations — a syringe that auto-disables so it can't be reused and a blood test that allows extensive results from a tiny sample — are providing low-cost answers to some of the world's most confounding healthcare challenges.

British inventor Marc Koska created the K-1 (LifeSaver) syringe 20 years ago, but until now, single-use needles were required by the World Health Organization (WHO) only for immunizations, which represent 5% of the global market. The other 95% pertained to the curative market, where there is no global policy governing syringe use.

But that's about to change.

Speaking to a TEDMED 2014 audience here, Koska played a video message from Marie Paule Kieny, WHO assistant director general for health systems and innovation, who said that by 2017, all health systems in the world will have to switch to auto-disable syringes.

Marc Koska

Koska said the directive is "only the third-ever global initiative that the WHO has issued in their 66-year history."

With a WHO mandate, "all parties involved in healthcare — manufacturers, ministers, funders, as well as nurses and patients — will see the scourge of iatrogenic infections end, and healthcare around the developing world will be revolutionized," Koska added in a news release.

He said WHO puts deaths from dirty needles at 1.3 million a year, twice the number of deaths from malaria, making it the ninth leading cause of deaths worldwide. Koska says he became aware of dirty needles' role in spreading AIDS, hepatitis, and other diseases when he was in his 20s and decided to devote his life to inventing a syringe that couldn't be reused.

Cutting Infection

"There is an incredible burden on healthcare workers in the developing world when there aren't the supplies that they need," Koska said.

The K-1 syringe has a tiny locking ring in the barrel. When the plunger is depressed, it passes the ring and can't be pulled out to refill. Forced extraction breaks the device.

Dr. Kieny said, "WHO's new injection safety policy, combined with the work of many partners in implementing the policy, in the next 2 years will usher the world in a new era of safe, single-use syringes and needles for all injections. This will finally bring an end to needless harm to millions of healthcare workers and patients."

Another innovator, Elizabeth Holmes, dropped out of Stanford University to found a consumer healthcare technology company called Theranos in 2003, which has wellness centers in select Walgreens.

The Palo Alto–based company was built on getting quick health information with just a few drops of blood from a finger instead of multiple tubes drawn from the arm.

Elizabeth Holmes

Minuscule Blood Samples

Holmes told the TEDMED audience she aims to change the timeline so that people know what they or their loved ones are facing sooner. Having to present with symptoms should not be a requirement to get information about your own body, she said.

"Today, laboratory information drives 70% to 80% of clinical decision. Yet, until a few months ago, people in many states couldn't even get copies of their own lab results for tests ordered for them by their physicians even if they paid for it," Holmes said.

"Today I can go buy a deadly animal, a venomous viper, but I can't order a blood-based pregnancy test or an allergy test because that could be dangerous," she said.

Holmes says her company has made it possible to run any lab test "for 50% to 90% off of Medicare reimbursement." With their approach, any combination of tests can be run for the same costs as an individual test, she said.

Changing the way blood is drawn helps compliance rates for blood tests, she noted. Patients often find them painful or too expensive, even if they are insured, and they may not have the time to return for multiple appointments.

"When individuals have access to information about their bodies, they can begin to change outcomes," she said.

TEDMED 2014.

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