Newsletter

Complexity and infections
CHPSO reports suggest increased risk of infection with complex devices.

Initial reports suggest that, as medical devices become more complex, the risk of infection and intra-operative problems rise. Preliminary reports from member hospitals raise the possibility of increased infection risk with the use of complex medical equipment (e.g., robotic surgery devices). 

While the reports do not provide sufficient information to draw conclusions, there are enough concerns related to reprocessing challenges to merit further investigation.

Nationally, there is growing awareness that device complexity has brought new risks both during and after procedures — during because of the number of instruments (and associated opportunities for mechanical failure) and the need for extensive training and experience to develop competency, and after due to the complexity of preparing devices for their next use.

The Federal Drug Administration (FDA) is currently working with manufacturers to improve device design and instructions specifically to improve reprocessing reliability. Device reprocessing, which several decades ago was fairly simple, has become highly technical and varied — device manufacturers often have different and sometimes contradictory requirements for disassembly and cleaning. Further complicating matters, manufacturers often use different names for common device parts. Instructions may be difficult to understand, remember and follow.

Last October the FDA and Association for the Advancement of Medical Instrumentation (AAMI) held a summit on medical device reprocessing. AAMI issued a comprehensive follow-up report, which contained seven primary recommendations. The full report is available at www.aami.org/htsi/reprocessing/pdfs/2011_Reprocessing_Summit_publication.pdf.

AAMI’s seven primary recommendations on medical device reprocessing

  1. Gain consensus on adequate cleaning validation protocols.
  2. Create standardized, clear instructions and repeatable steps for reprocessing whenever possible.
  3. Pay attention to reprocessing requirements throughout the device design process.
  4. Make human factors and work environment factors priorities when developing reprocessing requirements.
  5. Broaden the use of best practices in reprocessing.
  6. Improve end user reprocessing competencies.
  7. Create a greater sense of urgency and understanding throughout the health care community about the consequences of inadequate reprocessing.

FDA’s view of the reprocessing challenge

The FDA has identified safety concerns based on its evaluation of reports received and on available literature. A summary of FDA concerns can be found at http://www.fda.gov/medicaldevices/productsandmedicalprocedures/reprocessingofreusablemedicaldevices/ucm454622.htm.

The FDA presents several examples of device design and reprocessing methodology challenges.

Device design

The designs of some types of reusable medical devices, endoscopes in particular, have become more complex. This can make optimal cleaning, high-level disinfection or sterilization more complicated.

The FDA’s evaluation of adverse event reports and other information identified design features that are prone to retaining debris and biological materials, including:

  • Long, narrow interior channels (lumens), including those with internal surfaces that are not smooth, have ridges or sharp angles, or are too small to permit a brush to pass through;
  • Hinges;
  • Sleeves surrounding rods, blades, activators, inserters, etc.;
  • Adjacent device surfaces between which debris can be forced or caught during use;
  • O-rings;
  • Valves that regulate the flow of fluid through a device (stopcocks); and
  • Devices with these or other design features that cannot be disassembled for reprocessing.

Other device-design-related concerns:

  • Post-market design changes that do not take into account how the changes impact the ability to properly clean and disinfect the device.
  • Lack of communication between manufacturers and/or between manufacturers and device users when medical devices used for reprocessing are modified and instructions are revised.

Reprocessing methodology

Reprocessing is detailed, labor intensive, time-consuming, and can be prone to errors.

Each reusable medical device requires specific reprocessing steps or techniques appropriate for that device. Many variables impact the effectiveness of reprocessing reusable medical devices:

  • Reprocessing challenges at individual facilities, such as:
    • Staff responsible for steps in the process
    • Training available to the staff
    • Equipment (e.g. appropriately sized brushes) available for use
  • Quality and completeness of the reprocessing instructions provided by the manufacturer.
  • Access to the manufacturers’ instructions.

These variables are always changing because medical device technology is constantly evolving and reprocessing requires precision, as well as periodic retraining to assure staff competence.

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