Regulatory Focus™ > News Articles > Regulators Eye Biofilm as Challenge to Medical Device Safety

Regulators Eye Biofilm as Challenge to Medical Device Safety

Posted 23 January 2014 | By Alexander Gaffney, RAC

US regulators are set to take a deep dive into the challenge of biofilms-colonies of microbes which physically adhere to materials, such as a medical device-saying their contributions to infections and other adverse events need to be better understood.

Biofilms are essentially colonies of any bacteria that have adhered to a surface. Oral plaque, for example, is a common biofilm. But while some, like plaque or pond scum, are of little consequence to human health, others present more serious challenges.

As FDA explained in a Federal Registernotice on 23 January 2014, biofilms regularly affect medical devices, including those implanted into the body. The problem, regulators said, is that research has only recently begun to look at the effects these biofilms have on the safety of devices, leaving regulators unsure how to best protect or promote public health through best practices.

FDA said it is keenly interested in discovering and learning more about the roles biofilms play in causing illnesses such as device-related infections and resistant infections.

"Research on the basic science of biofilms may provide insight on device-associated biofilms, ultimately advancing research on technologies that are intended to prevent biofilm formation," FDA wrote. Such research on biofilm formation is "critical for protecting/promoting public health," it added.

To do this, FDA plans to hold a workshop in February 2014 co-sponsored by Montana State University, which runs the Center for Biofilm Engineering. The two groups plan to focus on three major topics, they said:

  1. research on biofilms and their public health impact
  2. challenges faced by the scientific community, clinical community, government, and industry on addressing biofilm contamination of medical devices
  3. critical areas of research that will address the scientific and clinical challenges faced by the stakeholders when developing technologies that are intended to prevent biofilm formation.

The workshop will be held on FDA's main White Oak campus in Silver Spring, MD.


Workshop Notice

Federal Register

Regulatory Focus newsletters

All the biggest regulatory news and happenings.