Article | July 19, 2016

5 Antimicrobial-Related Trends In Medical Device Design

By Lise Moloney, Sciessent

In the U.S., an average of two million people become ill with antibiotic-resistant infections each year, many of which have high mortality rates. On top of that startling statistic, the Affordable Care Act (ACA) has provisions that financially penalize facilities with high infection rates, and increasingly informed, connected healthcare consumers are using tools like Medicare’s Hospital Compare to make decisions about where to go for quality care.

All of these factors have forced healthcare providers to put pressure on medical device manufacturers and other suppliers to share in the responsibility. Some of the country’s largest health systems are also embarking on pay-for-performance contracts, which significantly impact how (and if) a supplier is paid based on how well its products work. 

These shifts in healthcare have essentially changed the suppliers’ role in the industry – especially when it comes to infection prevention. And, they’ve greatly impacted how both providers and suppliers think about the use of antimicrobials. Let’s review, at the year’s halfway point, some of the biggest ongoing antimicrobial-related trends.

1. Designing For Infection Prevention

Traditionally, the onus of infection prevention has fallen on hospitals. But with the shifting of responsibility within healthcare, medical device manufactures have an increasingly critical role to play – especially since devices are a major source of infection. While many manufacturers have found ways to incorporate antimicrobials into the surfaces of already-designed medical devices, which adds another layer of protection for patients, even more is being done now.  

This year, manufacturers have started to employ infection-prevention strategies much earlier in the product lifecycle. While designing for infection prevention is not a new concept in facility design, it’s fairly new to device design. To play their part in improving patient care, device manufacturers are:

  • Better educating design teams on the infection risks associated with products.
  • Experimenting with the design of easy-to-clean devices and components, including smoother surfaces, curved corners, and fewer crevices.
  • Incorporating more active surfaces (which perform a function) vs. passive surfaces (which promote bacterial attachment).
  • Considering disposable options for reusable devices.  

Responsibility also is falling on material suppliers, who traditionally offer materials in bulk, to provide smaller quantities of polymer compounds to facilitate easier and faster infection-prevention R&D for designers.

2. Antimicrobials And Permanent Implants

While the healthcare industry has recognized the infection risk of permanent implants for some time, it’s taken a while for manufacturers to find the right technologies and gain the regulatory approvals for these types of devices.

This year, the industry has seen an increase in the development of antimicrobial-embedded permanent implants, driven by the available technologies and the increasing rate of infections due to antibiotic-resistant bacteria.

3. Antimicrobial Use In 3D Printing

Personalized medicine has always been cited as the future of healthcare, and the use of 3D printing technologies is making it happen today. And while these technologies provide, at times, better treatment options, these “parts” are not exempt from contributing to dangerous infections.

The use of antimicrobials within the printing materials is on the rise. Whether they are compacted into the surface or blended into the materials, antimicrobials are playing a larger role in ensuring that these customized components do not become gateways for harmful bacteria.

4. Reevaluating the Safety of Reusable Devices

With the high-profile outbreak of healthcare-associated infections (HAIs, also called hospital-acquired infections) linked to endoscopes, and studies showing the presence of HPV on “disinfected” ultrasound wands, healthcare organizations are taking a much closer look at the safety of reusable devices. Testing for the presence of bacteria on reusable devices takes time, and with no instant-feedback options available, a time lag like this is simply unrealistic for healthcare.

With the rise of increasingly deadly strains of bacteria, the use of embedded antimicrobials is being seriously considered for reusable devices – not just in hospitals, but also in doctors’ offices, clinics, and all healthcare settings.

5. Protection Of All Surfaces, Not Just Devices

The use of embedded antimicrobials in medical devices – especially those that are known conduits of infections (catheters, endotracheal tubes, etc.) – has increased in popularity. But the healthcare industry still has a long way to go in terms of protecting all critical surfaces: things like workstations, bed rails, doorknobs, tables, and even ductwork for air conditioning.

In addition to medical devices, it’s been found that the environment can act as a source of contamination. This is due to the manual nature and general human error associated with standard disinfection, as well as (at times) undertrained environmental services firms that often experience high turnover rates.

This year, the incorporation of antimicrobial surfaces in patient rooms, operating rooms, and all other high-traffic locations in the healthcare setting is becoming increasingly common as an additional layer of infection prevention. However, some healthcare providers are proceeding cautiously with antimicrobial surfaces, and rightfully so. They want to see clinical data associated with the antimicrobial technology before they accept them into their facilities.   

About The Author

Lise Moloney is director of business development for the healthcare division of Sciessent, with whom she also has served as a medical device and biotechnology consultant. Moloney possesses a degree in chemical engineering from the University of Connecticut and has industry experience with combination devices, clinical advisory boards, pre-clinical studies, technical collaboration and regulatory submissions.