Healthcare-associated infections have become a serious matter that medical device designers ignore at their own peril—with a recent Harvard Medical School-led study estimating they cost the U.S. nearly $10 billion a year.
Worse, the bugs are becoming increasingly difficult to treat, because there isn’t a new pipeline of antibiotics to replace the ones that have worn out. (Want to get really scared? Watch the report PBS’ Frontline had on the problem last year.)
“Now we’re facing the consequences of our apathy,” says John Ianonne, technical specialist and program manager at Toxikon.
Iannone and Michael Brady, PhD, director of microbiology services at Toxikon, are scheduled to hold a panel discussion on the problem at MD&M East, June 9 to 12 in New York. They recently shared four ways the industry is responding to the HAI threat:
1. Reducing and Simplifying Surface Area
“Being able to design a device that is easy or easier to clean, disinfect, sterilize, becomes really critical,” Iannone said.
When it comes to reprocessed devices such as endoscopes or surgical forceps, there is an increased to have devices with less surface area for bacteria to attach, and fewer places that are difficult to reach. (Think the area under the burners on older electric stoves.)
“Think about the intricacies of a device. Sometimes these intricacies are helpful for the functionality of a device, but they become the culprit when it comes to fostering that potential for cross-contamination,” Iannone said. “It’s all about the design of the device to minimize the potential for cross-contamination.”
2. Finding New Ways to Sterilize
Manufacturers most commonly use ethylene oxide (EO) sterilization and gamma radiation to sterilize. Health providers on site turn to autoclaves and STERRAD plasma systems.
But as bacteria become more dangerous, there’s a new focus on other sterilization methods involving reactive nitrogen species, oxygen species, microwaves, and ultraviolet light.
“There’s a general trend of using existing technologies in new ways to promote sterile devices,” Brady says. “Each one of these sterilization methodologies—they have certain advantages and disadvantages. And one important component in deciding what’s most important is the materials and the applications.”
3. Antimicrobial Materials
Incorporating antimicrobial materials into devices, especially implanted devices, is also increasingly important.
“Silver is a classic example of an antimicrobial agent used to combat HAIs. Increasingly, we’re seeing similar devices use additional antimicrobials and antibiotics in these combinations. These are not new antibiotics, but they’re new combinations of existing ones that confer these protective properties,” Brady says.
Antimicrobial-embedded catheters are a good example of this trend.
4. New Ways of Doing Things
Iannone also noted there are device designers thinking of ways to change operating room methods to reduce HAI.
For example, a biodegradable pouch laced with antibiotics could be dropped in during a surgery, releasing antibiotics around an implanted device as it degrades. Medtronic early this year announced it had acquired such technology through its purchase of New Jersey–based TYRX.