The health effects of 3D printing

Basic steps you can take to protect your patrons and staff

3D printing closeupAs makerspaces and fab labs increase in popularity, more and more libraries are adding 3D-printing capabilities. According to a 2015 American Library Association (ALA) report, 428 public library branches have made this technology available. Some potential issues of 3D printing, such as the threat of printing weapons and copyrighted works, are often considered. However, discussion of the health hazards associated with 3D printing is rare.

Ultrafine particles and volatile organic compounds
Several studies have shown that 3D printers produce high amounts of ultrafine particles (UFPs) and volatile organic compounds (VOCs) while in use, and that these particles and vapors are detectable for many hours after the printers have been shut off. UFPs have been linked to adverse health conditions, such as asthma and cardiovascular issues, because they can pass through the lungs and travel to other organs. They can also transfer toxic material into the body, including blood and tissue cells. The US Environmental Protection Administration has classified many VOCs as toxic air pollutants. Exposure to certain VOCs, such as benzene and methylene chloride, has been linked to cancer.

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How 3D printing can revolutionise the medical profession

Groundbreaking 3D printing and scanning techniques are improving access to fully customisable artificial limbs

Cambodian woman Leakhena Laing being fitted for a new device at CSPO private clinic, where 3D PrintAbility training has been taking place, in Phnom Penh.Before the vehicle that she was travelling in flipped over and trapped her right leg, Leakhena Laing was a happy teenager who enjoyed climbing trees and playing football with friends. After her limb was amputated, she could only sit and watch.

“It was difficult to even get a glass of water. I felt hopeless, very sad and embarrassed to be around other people,” says Laing, who was forced to abandon school after the accident nearly four years ago.

She used crutches for two years, before receiving a below-knee (transtibial) prosthetic plaster limb, which improved the quality of her life, although it meant regular visits to a clinic in Phnom Penh, Cambodia’s capital, nearly 30 miles away from her home in Borset district, for refittings.

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A vision for 3D printing in Pharma manufacturing

Three-dimensional (3D) printing—a type of additive manufacturing (AM)—has the potential to be the “next great step” in pharmaceutical manufacturing, enabling fabrication of specialty drugs and medical devices, said Emil Ciurczak, Doramaxx Consulting and CPhI expert panel member, in the 2016 CPhI Annual Industry Report. 3D printing could be used for personalized or unique dosage forms, more complex drug-release profiles, and printing living tissue, noted Ciurczak in the report.

Because 3D printing builds an object layer by layer, it could be used to print drug tablets with a personalized dosage, possibly combining multiple drugs into a single dose. Printing a barrier between APIs in a multilayer tablet could facilitate targeted and controlled drug release. Ciurczak proposed some applications where 3D printing could be of benefit. Orphan drugs, for example, may be limited because their market is too small to justify production costs, but a 3D printing process could minimize the cost. Another possible use is for making tablets to calibrate dissolution testers for United States Pharmacopeia testing. Ciurczak suggested that 3D printing could allow these tablets to be made in smaller lots, as needed, rather than once every few years, which could improve reproducibility. Products that would benefit from the lack of high compressive forces in 3D printing of tablets, such as abuse-proof tablets, may be another opportunity.

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The evolving regulatory landscape of 3D printed medical products

Over the past year, my email inbox has been consistently pinged by law firms advertising seminars and workshops that promise to help medical professionals understand what is noteworthy for 3D printed medical products, ranging from regulatory to IP concerns.  Some of these have been quite alarming, seeming to indicate that as disruptive as 3D printing promises to be, there must be a corresponding disruption to how we work on regulatory compliance to protect our assets.

But if we step back and look at the actual Food and Drug Administration (FDA) communications, the pace of adoption of 3D printing and real intersections of 3D printing and business processes, it appears that little has changed. The only disruption is when 3D printing revolutionizes a commercial process.

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