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07/19/2016

Halyard Health Releases Statement on Sterility Maintenance of Sterilization Packaging Systems

Halyard Health has released “Consensus Statement on Sterility Maintenance of Sterile Packaging Systems in the Hospital Setting.” The consensus statement is authored by six leaders in central services and infection prevention who participated in a roundtable discussion held this past April in San Antonio, Texas about the implications of a recent study that explored the efficacy of sterilization wrap versus rigid containers.

The statement outlines the participants’ perspectives on a recent study on sterility maintenance of sterilization packaging systems published in the 2015 December issue of American Journal of Infection Control (AJIC). The study, titled, “Sterility maintenance study: Dynamic evaluation of sterilized rigid containers and wrapped instrument trays to prevent bacterial ingress” was conducted by Applied Research Associates and examined the ability of rigid containers and sterilization wrapped trays to maintain the sterility of their contents post-sterilization, during transport and handling, until use in the operating room. The results demonstrated that:

  • Rigid containers, both used and unused, failed to maintain barrier performance under the test conditions: 87 percent (97 out of 111) of the rigid containers failed to maintain barrier performance, allowing ingress of the challenge microorganism. 72% of the unused containers failed to maintain sterility.
  • Sterilization wraps provided no detectable ingress of bacteria: 100 percent (161 out of 161) of the wrapped trays using sterilization wrap maintained barrier performance, preventing any bacterial ingress and protecting sterility.

As a result of the study’s broad implications for healthcare professionals and patients, the discussants provided the following four calls-to-action for healthcare professionals, professional groups/associations, standards and accreditation bodies, and federal regulators:

  • Enforce proper maintenance and handling of sterile packaging systems (SPS) 
  • Foster collaboration among the sterile processing department (SPD) or central supply (CS) professionals, infection preventionists, surgeons and other professionals/divisions within the hospital regarding best practices for maintaining and handling SPS
  • Increase rigor of SPS protocols and guidelines 
  • Achieve consensus across healthcare provider and patient safety associations

Industry leaders participating in the roundtable discussion who contributed to the consensus statement include: 

  • Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT; president and CEO of Seavey Healthcare Consulting, LLC
  • Mark Duro, CRCST, FCS; manager, Central Services Center, New England Baptist Hospital; executive board member IAHCSMM
  • Dr. William Jarvis, MD, FAAP, FIDSA, FSSHEA; president and co-founder of Jason and Jarvis Associates; previously held numerous leadership positions at the CDC
  • Sharon Greene-Golden, CRCST, FCS; manager, Bon Secours Depaul Medical Center; past president, IAHCSMM
  • Peg Luebbert, MS, MT, CIC, CHSP, CBSPD; Infection preventionist at Nebraska Orthopaedic Hospital; owner and consultant at Infection Interventions, Inc.
  • Harry Shaffer, MS, Sterilization Consulting Services LLC; sterility maintenance study lead author

The statement, which can be found at www.halyardhealth.com/patientsafety/, discusses industry leaders’ reactions and insights to the findings outlined in the recent study conducted by Applied Research Associates. The panelists address how the study calls into question the assumption that rigid containers prevent bacteria from entering post-sterilization, throughout transport and handling, until use in the OR.