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Necessity to check sterilization of sterile medical materials18744391411/27/2020 7:00:00 AMInfection ControlSouth KoreaKorea Patient Safety Reporting & Learning SystemThis alert describes an incident where a non-sterile compression bandage was used on a patient. Non-sterile medical materials can cause severe harm due an increased risk of infection with their use. Caution and steps to verify the sterility of medical materials is required prior to providing patient care. 12/1/2021 1:58:02 PMIndicateur chimique Agents antithrombotiques Agents antiplaquettaires 3 Prevention & Control (IPAC)
Retained Instruments / Material – Sterilization indicator in vagina1846236024/1/2017 6:00:00 AMObstetrics & GynecologyHong KongHong Kong Hospital AuthorityThis alert briefly describes a patient safety incident of retention of a foreign body following an invasive procedure. A patient underwent a right salpingo-oophrectomy, urinary catheterization and vaginal washing were preformed pre-operatively and the procedure was uneventful. A day after discharge, the patient removed a piece of paper foil from her vagina. The foil was determined to be the sterilization indicator. A vaginal and ultrasound examination revealed no abnormality. Contributing factors were considered to be the following: 1. Unclear role delineation among nurses in checking and discarding the sterilization indicator. 2. The indicator was small in size and could easily adhere to a pile of gauze unnoticed. Recommendations to prevent similar incidents are provided.5/11/2020 2:18:57 AMcorps étranger, objet étranger, cathétérisme, lavage vaginal, stérilité
Review of the Infection Prevention and Control and CSR Sterilization Issues in East Central Health Region1792331447/1/2007 6:00:00 AMInfection Prevention and ControlCanadaHealth Quality Council of AlbertaA rural secondary healthcare facility closure was precipitated by evidence of inadequately sterilized medical equipment and an inability to contain an ongoing spread of Methicillin Resistant Staphylococcus aureus (MRSA). At the request of Alberta Health and Wellness, the HQCA conducted an independent and systematic review with respect to infection prevention and control (IPC) and central sterilization room (CSR) processes. The scope of the review was expanded to include other sites within the same regional health authority. The following themes emerged as contributing factors relating to the inappropriate sterilization of medical equipment in the CSR and inability to contain the MRSA transmission in the hospital. • clarity of authority, accountability, and responsibility of the hospital and the regional health authority and its management • organizational structure and processes to support safety and quality • patient safety culture and impact on planning, operations, decision-making • application and implementation of best practices, standards, policies and procedures and mechanisms to ensure compliance of same • processes to define expectations and evaluate knowledge, competency and skills • support of continuing education, training and professional development • engagement of physicians in safety and quality • equipment and physical plant limitations • human resource requirements for effective infection prevention and control • provincial leadership for infection prevention and control • role of and educational requirements for the board members especially in patient safety and quality leadership A total of 76 recommendations were made; abbreviated versions are presented in this alert.5/11/2020 2:16:38 AMsingle use cautery device, sterilization equipment, washer-disinfector, washer-sanitizer Prevention & Control;Healthcare Associated Infections;Hand Hygiene;Patient Safety Incident
Connectors for Sterilization of all Gastrointestinal Fiberoptic Endoscopes19302VA162/1/2004 7:00:00 AMMedical DeviceUnited States of AmericaNational Center for Patient Safety (Department of Veteran's Affairs - USA)"A VA medical center reports using an incorrect connector to link sterilizing solution to endoscopes during reprocessing (cleaning and sterilizing) procedures. A dual-port or “Y” connector designed to connect to endoscopes incorporating dual ports was connected to endoscopes with single ports. Under this condition an indeterminate amount of sterilizing solution may have been directed to the unconnected port, possibly leading to inadequate sterilization of the endoscope. The Alert describes actions to be implemented by applicable VA facilities. "5/11/2020 2:13:51 AMÉvénements liés aux produits ou aux appareils Safety Incident
Inadvertent Endoscope Contamination Can lead to Patient Infections1864938921/30/2019 7:00:00 AMInfection Prevention and ControlUnited States of AmericaOregon Patient Safety Commission (USA)This alert discusses the potential for patient infections when using endoscopes that have been contaminated. Device reprocessing is an important part of a facility’s infection control program. Both inside and outside endoscope surfaces are exposed to potential contaminants and they can be difficult to disinfect. For example, devices may be heat sensitive, and thus cannot be sterilised with steam, and complex design features (e.g, elevator mechanisms on duodenoscopes) can make for difficult-to-reach surfaces. ECRI identified three risks during this process: - Inadequate drying after high-level disinfection - Recontamination due to mishandling with unclean gloves - Recontamination during transportation or storing During an Infection Control Assessment and Response (ICAR) visit, infection control consultants evaluate device reprocessing. They’ve found than about a fifth of the hospitals assessed don’t allow adequate time for reprocessing and about a fifth of the outpatient facilities assessed haven’t allotted adequate space for reprocessing. They also found that while 90% of hospitals and outpatient facilities provide training when new devices or protocols are introduced, less than 40% routinely audit adherence to reprocessing protocols. Recommendations to prevent infection related to endoscope use are provided in the alert.7/23/2020 3:11:20 AMstockage, distractions, interruptions, espace, stockage, étiquetage, stérilisation, vapeur
The importance of Equipment Integrity used in Brachytherapy Treatments1890741754/1/2021 6:00:00 AMDeviceUnited States of AmericaThis bulletin discusses patient safety incidents related to faulty brachytherapy equipment integrity. Equipment involved included applicators, transfer tubes and catheters. A commonality across reported incidents relates to the assumed integrity of accessories including applicators and catheters that have direct contact with the patient. Reprocessing may result in equipment damage and pre-treatment quality checks should be in place. Recommendations to ensure equipment integrity are provided.2/25/2022 9:36:11 PMsoins de courte durée, radiothérapie, imagerie diagnostique, retraitement, fabricants d’ intégrité présumée, retraitement, stérilisation, base de données MAUDE, contrôle de
OPSC Review of Unintended Retained Foreign Objects1891441817/13/2021 6:00:00 AMSurgeryUnited States of AmericaOregon Patient Safety Commission (USA)This alert discusses the findings of the Oregon Patient Safety Commission (OPSC) of a review of retained foreign objects related to orthopedic surgery during 2020 to 2021. 23 reports met the criteria and the alert provides information on where the events occurred, the type of events and contributing factors. A summary of the strongest action plans are presented.2/25/2022 9:36:20 PMinstrument fragments, whole instruments, sponges, guidewires médicaments, soins infirmiers, stérilisation, fournisseurs de dispositifs médicaux
Retained instruments18150329712/1/2014 7:00:00 AMSurgeryAustraliaVictoria Department of Health (Australia)This alert discusses a patient safety incident of retention of a foreign body in a patient undergoing surgery. In this incident, a patient underwent multiple laparoscopic procedures. A blunt curette was utilised and counted into the surgical field for the first procedure as the required rectal probe was not available. The laparoscopic procedures continued with a single and final surgical count declared correct at the end of the last procedure. The surgery was concluded and the patient was subsequently transferred to the recovery room. The surgical instruments were returned to the central sterilizing services department (CSSD) for the cleaning and sterilizing process. During the scanning of the instrument set, the staff noticed one supplementary curette absent on what was supposedly a complete surgical set. The incident was not reported to the operating room staff as it was assumed the notification would be unhelpful. A search for a missing curette was conducted within the sterilizing unit but the instrument was not found. Three days post-operatively, the patient was discharged but subsequently presented to the emergency department with severe stomach pain. The instrument was identified in the patient’s body requiring surgical removal. Contributing factors to this incident included the following: - Lack of availability of the required instrument resulted in an additional curette being added to the surgical count and opportunity for subsequent count failure. - Communication breakdown within surgical team to ascertain whether additional probing instruments used had been removed and/or appropriately counted. - The surgical count procedure was not followed. There was no count made specifically for the second/third operation sites. The follow up process for tracking of instruments identified as missing within the sterilizing unit was not effective. The alert provided recommendations to reduce the risk of similar patient safety incidents.5/31/2017 7:45:11 PMchirurgical définitif, nettoyage, stérilisation, panne de communication, formation, suivi 3
Retained Bioburden On Surgical Instruments After Reprocessing: Are We Just Scraping the Surface?1836136886/1/2017 6:00:00 AMInfection Prevention and ControlUnited States of AmericaPennsylvania Patient Safety Authority (USA)This alert helps to inform healthcare facilities about the prevalence of inadequate reprocessing of surgical instruments. The design of medical devices, equipment, and instruments can provide ideal spaces for bioburden accumulation and subsequent development of surface biofilms, especially if compound hinges, gaps, channels, or lumens are present. Many outcomes related to the use of poor-quality instruments are likely to go unrecognized, especially if the result of an event is latent in a patient’s course. Review of relevant incident reports for the period of January 1, 2005, through December 31, 2015 showed an increase in the number of reported events over time, both in the number of reports per year and as a rate per 1,000 procedures. The alert provides information on problematic themes that contributed to problems with surgical instrument reprocessing and use. To combat the trend of increased bioburden prevalence, a quality improvement initiative in surgical instrument reprocessing may need to occur. Efforts should be considered to unify reprocessing departments and the operating room as well as processes around the care and maintenance of mission-critical items, such as surgical instruments, devices, and equipment.5/11/2020 2:18:38 AMscissors, hinge pin, straight Hibbs chisel, Pratt-Smith hemostatic forceps (Pratt microbienne, débris microscopiques, stérilisation, articles critiques, matériel biologique
Automatic Endoscope Reprocessors18167NJ076/1/2009 6:00:00 AMMedical DeviceUnited States of AmericaNew Jersey Department of Health and Senior Services (USA)"During an evaluation of medical equipment in the endoscope unit, two areas of concern were noted with near-miss patient safety incidents. It was discovered that the cycle used to disinfect equipment was significantly shorter than the manufacturer's suggested time plus staff were unable to determine if optimal temperatures for proper disinfection of equipment was reached during the disinfection process, as only a light indicated temperatures but no gauges for more accuracy. A break down of the evaluation findings revealed several pertinent issues: improper initial set-up of the equipment by the manufacturer, lack of adequate staff training on interpreting and understanding the computer printouts, no instruction manual available for the equipment users and no visual temperature gauge. Further actions to reduce risk have been included in this alert."5/11/2020 2:12:21 AM"Patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the healthcare facility Décès ou grave invalidité d'un patient Safety Incident