Originally Published MPMN November 2006

EDITOR'S PAGE

Warning: Labels Matter

We at MPMN live and work in Los Angeles, the so-called image capital of the world. What you drive, who you wear, which zip code you live in—all these things matter here. It’s not just an LA thing, though. While we might think it shallow to make judgments based on appearance, we do it all the time, no matter where we live.

The same goes for the products we use. We like things that look good. There’s a reason why companies spend a lot of money to design the perfect package.

But what if a promising new product came with a glaring hazard label slapped on it? Would you still use it?

Here’s an example. Recently, engineers at the University of Alberta (Edmonton, AB, Canada) used nanotechnology to create a microsensor that measures and compares osseointegration of a hip implant over time. The device is permanently implanted and periodically transmits data to doctors.

“The ability to monitor and quantify this healing process is critical to orthopedic surgeons in determining a patient’s rehabilitation progress,” says Walied Moussa, who has a lab in the National Research Council’s National Institute for Nanotechnology. “Until now, there has been no quantitative method for assessing osseointegration.”

The sensor will also cut down on the need for x-rays to monitor bone functionality, reducing costs and exposure to radiation, according to Moussa.

But if the Action Group on Erosion Technology and Concentration (ETC Group; www.etcgroup.org) has its way, many doctors and patients might think twice about using it. The group is strongly in favor of a “nanohazard” symbol similar to those for nuclear, bio-, and toxic hazards for products made with nanotechnology. The group has also recently announced a contest inviting people to design and submit such a symbol.

ETC Group explains why it thinks nanomaterials may be hazardous (see its Web site). “Because of their extremely small size and large surface area, nanoparticles may be more reactive and more toxic than larger particles of the same substance.” The group has called for a moratorium on nanoparticle production to allow for a full societal debate and until precautionary regulations are in place.

However, it was made clear at FDA’s recent public meeting on nanotechnology materials that the current guidelines for medical devices are sufficient to ensure that these products are safe and effective. UNESCO agrees. In a report titled “The Ethics and Politics of Nanotechnology,” the organization states that current U.S. regulations are satisfactory for nanomaterials.

Placing a nanohazard symbol on medical devices is unnecessary. Beyond that, and far more critical, it might unduly influence patients and healthcare providers against using them.

Susan Shepard, Managing Editor

Copyright ©2006 Medical Product Manufacturing News