Background: A recent survey of in-hospital reprocessing in Tanzanian hospitals identified bag-valve masks (BVM) as a commonly reused single-use device. In low- and middle-income countries (LMIC), in-hospital reprocessing supports neonatal resuscitation strategies by helping to maintain adequate supplies of BVM. However, there is a need for device-specific protocols defining reprocessing procedures and inspection criteria to overcome variations in reprocessing practices between hospitals. The purposes of this study were: 1) to complete a comprehensive design review and identify challenges to reprocessing BVMs; and 2) to investigate three different residual bioburden analysis methods for assessing the efficacy of decontaminating a disposable BVM. Methods: New, unused bag-valve-masks were contaminated with Staphylococcus epidermidis and Artificial Mucus Soil to simulate the worst case soiling conditions. Devices underwent one of five disinfection protocols, including one currently used in a LMIC hospital. Three analytical (two quantitative and one qualitative) methods were selected to evaluate residual bioburden on the device following decontamination. Results: Of all protocols tested, only the positive control and the Soap and Bleach protocols met disinfection targets. Most cleaning outcomes were consistent from trial to trial for each protocol. However, cleaning outcomes varied greatly for the Alcohol Wipe protocol. For the residual bioburden analyses, the two quantitative methods produced similar results, but the qualitative measurement exhibited increased variability. Conclusion: While this study revealed positive disinfection outcomes for the Tanzanian hospital decontamination protocol, more studies are required to support these findings. Design features of the BVM mask presented challenges to cleaning and drying during different decontamination protocols, as seen in the variability in the Alcohol Wipe protocol performance. These findings support the case for a device-specific protocol for the BVM. Given proper hospital personnel training and available resources, in-hospital reprocessing could support neonatal resuscitation strategies and other demands for manual resuscitation by helping to maintain adequate supplies of BVM.
KeywordsReprocessingLow-ResourceBag Valve MaskSingle-Use DeviceLow-and Middle-Income Countries
Food and Drug Administration, Center for Devices and Radiological Health (2006) Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices. UCM071441, Rockville, MD.
Council of the European Union (2007) European Council Directive 2007/47/EC of 5 September 2007 Amending Council Directive 93/42/EEC Concerning Medical Devices. Official Journal of the European Union, L247, 21-55.
Therapeutic Goods Administration (2011) Australian regulatory Guidelines for Medical Devices (ARGMD): Part 2 Pre-Market. Department of Health and Ageing, Australian Government, Woden, ACT, Version 1.1.
Alberta Health and Wellness Department, Public Health Division (2008) Standards for Cleaning, Disinfection and Sterilization of Reusable Medical Devices for All Health Care Facilities and Settings. Alberta Health and Wellness Department, Edmonton.
US Government Accountability Office (US GAO) (2008) Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased and Available Information Does Not Indicate that Use Presents an Elevated Health Risk. GAO-08-147, Washington DC.
Alfa, M.J. and Castillo, J. (2004) Impact of FDA Policy Change on the Reuse of Single-Use Medical Devices in Michigan Hospitals. American Journal of Infection Control, 32, 337-341. https://doi.org/10.1016/j.ajic.2004.03.003
Cowling, T. and de Léséleuc, L. (2015) Reprocessing of Single-Use Medical Devices: A 2015 Update. Canadian Agency for Drugs and Technologies in Health, Environmental Scan, Ottawa, No. 48.
Thiede, B. and Kramer, A. (2013) Evaluation of Reprocessing Medical Devices in 14 German Regional Hospitals and at 27 Medical Practitioners’ Offices within the European Context: Consequences for European Harmonization. GMS Hygiene and Infection Control, 8, 1-14.
Amarante, J.M., Toscano, C.M., Pearson, M.L., Roth, V., Jarvis, W.R. and Levin, A.S. (2008) Reprocessing and Reuse of Single-Use Medical Devices Used during Hemodynamic Procedures in Brazil: A Widespread and Largely Overlooked Problem. Infection Control and Hospital Epidemiology, 9, 854-858. https://doi.org/10.1086/590357
Hargett, Z.T., Harman, M.K., Zemitis, S.E. and Dean, D. (2018) Reprocessing and Reuse of Single-Use Medical Devices in a Low-Resource Setting: Initial Results from an On-Site Survey of Three Hospitals in Tanzania. J HealthcEng (In Review).
Hussain, M., Balsara, K.P. and Nagral, S. (2012) Reuse of Single-Use Devices: Looking Back, Looking Forward. The National Medical Journal of India, 25, 151-155.
Newborn Resuscitation
Koh, A. (2005) Kawahara K. Current Practices and Problems in the Reuse of Single-Use Devices in Japan. Journal of Medical and Dental Sciences, 52, 81-89.
Popp, W., Rasslan, O., Unahalekhaka, A., Brenner, P., Fischnaller, E., Fathy, M., Goldman, C. and Gillespie, E. (2010) What Is the Use? An International Look at Reuse of Single-Use Medical Devices. The International Journal of Hygiene and Environmental Health, 213, 302-307. https://doi.org/10.1016/j.ijheh.2010.04.003
Cabrini, L., Antonelli, M., Savoia, G. and Landriscina, M. (2011) Non-Invasive Ventilation Outside of the Intensive Care Unit: An Italian Survey. Minerva Anestesiologica, 77, 313-322.
Davies, J.D., Costa, B.K. and Asciutto, A.J. (2014) Approaches to Manual Ventilation. Respiratory Care, 59, 810-824. https://doi.org/10.4187/respcare.03060
Kamenir, S.A. (1997) Neonatal Resuscitation and Newborn Outcomes in Rural Kenya. Journal of Tropical Pediatrics, 43, 170-173. https://doi.org/10.1093/tropej/43.3.170
Lassi, Z.S., Middleton, P.F., Crowther, C. and Bhutta, Z.A. (2015) Interventions to Improve Neonatal Health and Later Survival: An Overview of Systematic Reviews. EBio-Medicine, 2, 985-1000. https://doi.org/10.1016/j.ebiom.2015.05.023
Newton, O. and English, M. (2006) Newborn Resuscitation: Defining Best Practice for Low-Income Settings. Transactions of the Royal Society of Tropical Medicine and Hygiene, 100, 899-908. https://doi.org/10.1016/j.trstmh.2006.02.012
Lawn, J., Shibuya, K. and Stein, C. (2005) No Cry at Birth: Global Estimates of Intrapartum Stillbirths and Intrapartum-Related Neonatal Deaths. Bulletin of the World Health Organization, 83, 409-417.
Wall, S.N., Lee, A.C., Niermeyer, S., English, M., Keenan, W.J., Carlo, W., Bhutta, Z.A., Bang, A., Narayanan, I., Ariawan, I. and Lawn, J. (2009) Neonatal Resuscitation in Low Resource Settings: What, Who, and How to Overcome Challenges to Scale Up? International Journal of Gynecology & Obstetrics, 107, S47-S64. https://doi.org/10.1016/j.ijgo.2009.07.013
World Health Organization (1999) Basic Newborn Resuscitation: A Practical Guide. WHO/RHT/MSM/98.1.
Danesi, V., Cristofolini, L., Stea, S., Traina, F., Beraudi, A., Tersi, L., Harman, M. and Viceconti, M. (2011) Reuse of Explanted Osteosynthesis Devices: A Reliable and Inexpensive Reprocessing Protocol. Injury, 42, 1101-1106. https://doi.org/10.1016/j.injury.2011.02.006
van Drongelen, A.W. and de Bruijn, A.C.P. (2008) Reprocessing of Medical Devices: Possibilities and Limiting Factors. National Institute for Public Health and the Environment, RIVM Letter Report 360020004.
World Health Organization (2012) Self Inflating Bag: Manual Resuscitator. https://www.newbornwhocc.org/ONTOP-DATA/Equipment-PDF/Resusciation-bag/Resuscitation-Bag-Reading-Material.pdf
Laerdal Medical (2016) Laerdal Silicone Resuscitators: User Guide. http://cdn.laerdal.com/downloads/f4012/lsr_user_guide_(en).pdf
O’Donnell, C.P., Davis, P.G. and Morley, C.J. (2004) Positive Pressure Ventilation at Neonatal Resuscitation: Review of Equipment and International Survey of Practice. Acta Paediatrica, 93, 583-588. https://doi.org/10.1111/j.1651-2227.2004.tb02981.x
Patel, A., Pope, J. and Neilson, M. (2012) Design Considerations for Medical Device Manufacturers. AAMI Horizons, Springer, Berlin, 73-75.
Sferrazza Papa, G.F., Di Marco, F., Akoumianaki, E. and Brochard, L. (2012) Recent Advances in Interfaces for Non-Invasive Ventilation: From Bench Studies to Practical Issues. Minerva Anestesiologica, 78, 1146-1153.
Haug, R.H. (2012) Microorganisms of the Nose and Paranasal Sinuses. Oral & Maxillofacial Surgery Clinics of North America, 24, 191-196.
John, J.F., Davidson, R.J. and Low, D.E. (1998) Staphylococcus Epidermidis and Other Coagulase-Negative Staphylococci. In: Yu, V.L., Merigan, T.C. and Barriere, S.L., Eds., Antimicrobial Therapy and Vaccines, Williams & Wilkins, Baltimore. http://www.antimicrobe.org/b234.asp
ASTM F3208-17 (2017) Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices. ASTM International, West Conshohocken. http://www.astm.org https://doi.org/10.1520/F3208-17
Rutala, W.A. and Weber, D.J. (1999) Infection Control: The Role of Disinfection and Sterilization. Journal of Hospital Infection, 43, S43-S55.