Our bed/mattress vendor recommends, Joint Commission and CMS mandate that we follow the manufacturer’s instructions for use (MIFUs) for cleaning and disinfecting the mattress. Does the MIFU process achieve an adequate level of disinfection for mattresses?

While following the MIFUs will certainly improve cleaning and disinfection, it may not provide a completely disinfected surface. MIFUs for cleaning and disinfecting mattresses require multi-step processes,40-42 as opposed to the 1-step process used by many facilities and are likely more effective than using UV light since mattresses are soft surfaces.47 But while the FDA Reprocessing Guidance mandates that manufacturers validate their instructions for use for cleaning and disinfection,23 Trinity Guardion is unaware of any published research that shows manual cleaning processes, including following MIFUs, can achieve even low-level disinfection on hospital mattresses. Additionally, the FDA does not require manufacturers to validate their cleaning and disinfection MIFU for C. diff while the Support Surface Standards Initiative (S3I), the standards body for healthcare mattresses in the U.S., admits in their cleaning/disinfection guidance, “Prevention of serious disease transmission may require more aggressive interventions.”39 C. diff is likely the most challenging organism in a facility, as it remains the most common HAI in the United States.50 Peer-reviewed research has demonstrated that both symptomatic and asymptomatic patients contribute C. diff spores to the environment.51-54 Therefore, disinfection protocols should be able to effectively address C. diff with
every cycle.

References

23. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. fda.gov. https://www.fda.gov/media/80265/download. Published March 17, 2015. Updated June 9, 2017. Accessed September 11, 2020.

39. Best Practices for Cleansing, Disinfecting, and Care of Polyurethane Support Surface Covers. National Pressure Injury Advisory Panel. https://cdn.ymaws.com/npiap.com/resource/resmgr/s3i/S3i_NPIAP_Cleansing_Disinfec.pdf. Published 2020. Accessed April 13, 2021.

40. Cleaning and Disinfecting Instruction Video (REV 1). Hillrom. https://www.hill-rom.com/international/Education/education-by/e-learning/cleaning-instructions/. Accessed September 9, 2020.

41. Stryker® Maintenance Manual: Isolibrium™ Support Surface (REV B). Stryker. https://techweb.stryker.com/Support_Surfaces/2971/0815/maintenance/2971-009-002B.pdf. Published 2017. Accessed September 4, 2020.

42. User Manual and Technical Description: Eleganza 5 Positionable Bed for Intensive Care and Opticare Integrated Mattress Replacement System (Version 6). Linet. Published October 2018.

47. UV Lights and Lamps: Ultraviolet-C Radiation, Disinfection, and Coronavirus. fda.gov. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/uv-lights-and-lamps-ultraviolet-c-radiation-disinfection-and-coronavirus. Updated August 19, 2020. Accessed September 4, 2020.

50. Antibiotic Resistance Threats in the United States, 2019: Clostridioides Difficile. cdc.gov. https://www.cdc.gov/drugresistance/pdf/threats-report/clostridioides-difficile-508.pdf. Published 2019. Accessed April 29, 2021.

51. Blixt T, Gradel KO, Homann C, et al. Asymptomatic carriers contribute to nosocomial Clostridium difficile infection: a cohort study of 4508 patients. Gastroenterology. 2017;152(5):1031-1041. doi:10.1053/j.gastro.2016.12.035

52. Donskey CJ, Sunkesula VCK, Stone ND, et al. Transmission of Clostridium difficile from asymptomatically colonized or infected long-term care facility residents. Infect Control Hosp Epidemiol. 2018;39(8):909-916. doi:10.1017/ice.2018.106

53. Riggs MM, Sethi AK, Zabarsky TF, Eckstein EC, Jump RLP, Donskey CJ. Asymptomatic carriers are a potential source for transmission of epidemic and nonepidemic Clostridium difficile strains among long-term care facility residents. Clin Infect Dis. 2007;45(8):992-998. doi:10.1086/521854

54. Worley J, Delaney ML, Cummins CK, DuBois A, Klompas M, Bry L. Genomic determination of relative risks for Clostridioides difficile infection from asymptomatic carriage in ICU patients. Clin Infect Dis. 2020;ciaa894. doi:10.1093/cid/ciaa894