HOW ARE THE
CHALLENGES
ADDRESSED?
SOME OF THE MAJOR ALERTS by manufactureRs, the FDA and other International Public Health AUTHORITIES
CURRENT CLEANING PROCEDURES:
THE MAIN PROBLEM
In cleaning guidelines, hydrogen peroxide21-27 and Puristeril19 are recommended as the products of choice for maintenance of water-based HCUs.
Puristeril is irritating to eyes and mucous membranes of the respiratory tract and skin. It causes lacrimation, extreme discomfort and irritation to the upper respiratory tract in humans after exposure to it for only 3 minutes.19
Chronic exposure to high concentrations of Puristeril causes haemorrhages, oedema and consolidation of the lungs with moderate signs of respiratory tract irritation. Because of the toxicity of Puristeril, the maintenance process should be performed in a dedicated, well-ventilated area near the operating room to avoid long transport routes for the HCUs. Unfortunately, not all hospitals have the possibility to dedicate a space to the maintenance of HCUs.19
Manufacturers cleaning guidelines are not only inadequate at eradicating M. chimaera but also put hospital staff at high risk of exposure to toxic disinfectants.19
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FDA Safety Communication. Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices: FDA Safety Communication. http://wayback.archiveit. org/7993/20170722215713/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm466963.htm. Published 2015.
Sorin Group Deutschland GMBH. Field Safety Notice: Cardiac Surgery Mycobacterium Risks Disinfection and Cleaning of Sorin Heater Cooler Devices.; 2014.http://www.livanova.sorin.com/products/cardiac-surgery/perfusion/hlm/3t#product_download_area.
Sorin Group Deutschland GMBH. Field Safety Notice: Cardiac Surgery Mycobacterium Risks Disinfection and Cleaning of Sorin Heater Cooler Devices.; 2014.http://www.bfarm.de/SharedDocs/Kundeninfos/EN/12/2014/04000-14_kundeninfo_en.pdf?__blob=publicationFile&v=3.
FRANCE SG. INFORMATION IMPORTANTE Risques de Mycobactéries En Chirurgie Cardiaque Risques de Mycobactéries En Chirurgie Cardiaque Désinfection et Nettoyage Des Générateurs Thermiques Sorin Désinfection et Nettoyage Des Générateurs Thermiques Sorin. Vol 33.; 2014. https://www.ansm.sante.fr/S-informer/Informations-desecurite-Autres-mesures-de-securite/Generateurs-thermiques-CEC-SORIN-Information-de-securite.
SWISSMEDIC (Swiss Agency for Therapeutic Products). Announcements: Measures for improved patient safety in cardiac surgery. https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/archive/measures-for-improved-patient-safety-in-cardiac-surgery.html. Published 2014.
Public Health England. Mycobacterium chimaera: infections linked to heater cooler units: Guidance for healthcare professionals on infection control and clinical aspects of M. chimaera infection associated with cardiopulmonary bypass. www.gov.uk/government/collections/mycobacterial-infections-associated-with-heater-cooler-units. Published 2015.
FDA Executive Summary: Nontuberculous Mycobacterium (NTM) Infections Associated with Heater-Cooler Devices (HCD) during Cardiothoracic Surgery. (/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvi%0AsoryCommittee/ CirculatorySystemDevicesPanel/UCM505732.pdf).
FDA. Executive Summary Prepared for the June 2-3, 2016 Meeting of the Circulatory Devices Panel of the Medical Devices Advisory Committee: Nontuberculous Mycobacterium (NTM) Infections Associated with Heater-Cooler Devices (HCD) during Cardiothoracic Surgery.; 2016. https://www.fda.gov/media/98191/download.
HPRA (Health Products Regulatory Authority) IRELAND. HPRA Safety Notice: SN2014(34) Medical Devices: Heater Cooler Unit. Priority 2 - Warning.; 2014.doi:10.1111/j.1365-2044.1996.tb07839.
LivaNova Deutschland GmbH. FIELD SAFETY NOTICE UPDATE: Cardiac Surgery Mycobacterium Risks Disinfection and Cleaning of Sorin Heater Cooler Devices.; 2016. https://www.hsa.gov.sg/content/dam/HSA/HPRG/Medical_Devices/Updates_and_Safety_reporting/Field_Safety_Corrective_Action/FSN/2017/January/HSA 6004101-299-17-01_25 FSN_Redacted.pdf.
Centers for Disease Control and Prevention. CDC Advises Hospitals to Alert Patients at Risk from Contaminated Heater-Cooler Devices Used during Cardiac Surgery. HAN-00397.; 2016. https://emergency.cdc.gov/han/han00397.asp.
FDA Safety Communication. UPDATE: Mycobacterium Chimaera Infections Associated with LivaNova PLC (Formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler System: FDA Safety Communication.; 2016. http://wayback.archive-it.org/7993/20171115052210/https://www.fda.gov/MedicalDevices/Safety/ AlertsandNotices/ucm520191.htm.
LivaNova Deutschland GmbH. FIELD SAFETY NOTICE - UPDATE Cardiac Surgery Mycobacterium Risks Disinfection and Cleaning of Sorin Heater Cooler Devices. BfArM: Federal Institute for Drugs and Medical Devices. http://www.bfarm.de/SharedDocs/Kundeninfos/EN/12/2016/10412-16_kundeninfo_en.pdf?__blob=publicationFile&v=1. Published 2016.
ANSM: Agence nationale de securite du medicament et des produits de sante. Information Importante – Risques de Mycobactérie Nettoyage Des Générateurs Thermiques Sorin.; 2016. https://www.ansm.sante.fr/S-informer/Informations-de-securite-Autres-mesures-de-securite/Generateurs-thermiques-CEC-SORIN-Information-de-securite.
European Centre for Disease Prevention and Control. RAPID RISK ASSESSMENT: European Centre for Disease Prevention and Control. Invasive Cardiovascular Infection by Mycobacterium Chimaera Associated with 3T Heater -Cooler System Used during Open-Heart Surgery – 18 November 2016.; 2016. https://ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/RRA-mycobacterium-chimaera-November-2016.pdf.
Maquet Cardiopulmonary GmbH. Urgent Field Safety Notice. Revised Disinfection Procedure for Heater-Cooler Unit HCU 40.; 2016.
Maquet Cardiopulmonary GmbH. Urgent Field Safety Notice (FSN). Revised disinfection procedure for Heater-Cooler Unit HCU 40. BfArM: Federal Institute for Drugs and Medical Devices. http://www.bfarm.de/SharedDocs/Kundeninfos/EN/12/2016/10716-16_kundeninfo_en.pdf?__blob=publicationFile&v=2. Published 2016
ANSM: Agence nationale de securite du medicament et des produits de sante. Information Importante – Risques de Mycobactérie Nettoyage Des Générateurs Thermiques Sorin.; 2016. https://www.ansm.sante.fr/S-informer/Informations-de-securite-Autres-mesures-de-securite/Generateurs-thermiques-CEC-SORIN-Information-desecurite.
Colangelo N, Giambuzzi I, Moro M, et al. Mycobacterium Chimaera in heater – cooler units : new technical approach for treatment, cleaning and disinfection protocol. Perfusion. 2018:1-5. doi:10.1177/0267659118814691.
Perkins KM, Lawsin A, Hasan NA, Al. E. Notes from the Field: Mycobacterium chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery — United States. Morb Mortal Wkly Rep US Dep Heal Hum Serv Dis Control Prev. 2016;65(40):1117-1118.
Romano-bertrand S, Evrevin M, Dupont C, Frapier J, Sinquet J. Persistent contamination of heater - cooler units for extracorporeal circulation cured by chlorhexidine e alcohol in water tanks. J Hosp Infect. 2018;99(3):290-294. doi:10.1016/j.jhin.2018.01.005.
FDA Safety Communication. Update: Availability of Deep-Cleaning Service of Certain LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler Systems in the U.S.: FDA Safety Communication. 2018https://www.fda.gov/medical-devices/safety-communications/update-availability-deepcleaning-service-certain-livanova-plc-formerly-sorin-group-deutschland-gmbh.
FDA Safety Communication. Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater- Cooler Systems. https://www.fda.gov/medical-devices/safety-communications/updated-information-reduce-potential-cardiac-surgery-infection-risks-associated-livanova-3t-heater . Published 2018
LivaNova Deutschland GmbH. LivaNova Field Safety Notice: Potential Cardiac Surgery Infection Risk Reduction Measure. Hydrogen Peroxide Concentration Monitoring. BfArM: Federal Institute for Drugs and Medical Devices. doi:CP-MUN-2018-005
ANSM: Agence nationale de sécurité du médicament et des produits de santé. Générateur thermique de CEC - Générateur thermique 3T, Heater/Cooler System 1T - Livanova SAS - Information de sécurité. https://www.ansm.sante.fr/S-informer/Informations-de-securite-Autres-mesures-de-securite/Generateur-thermique-de-CEC-Generateur-thermique-3T-Heater-Cooler-System-1T-Livanova-SAS-Information-de-securite . Published 2018
Ministero della Salute. OGGETTO: Indicazioni Operative Riguardanti Gli Aspetti Di Laboratorio in Merito Ai Casi Di Infezione Da Mycobacterium Chimaera in Italia e Aggiornamento Delle Informazioni Disponibili.; 2019. http://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2019&codLeg=68845&parte=1 &serie=null.
FDA Safety Communication. Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater- Cooler Systems. https://www.fda.gov/medical-devices/safety-communications/updated-information-reduce-potential-cardiac-surgery-infection-risks-associated-livanova-3theater. Published 2018.