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Mismatching Medical Devices and Accessories18311PA0883/1/2005 7:00:00 AMMedical DeviceUnited States of AmericaPennsylvania Patient Safety Authority (USA)"This Patient Safety Advisory provides information about injuries patients have sustained as a result of using incompatible device parts during procedures. During the removal of a skin graft, a surgical blade specific for one dermatome device was inserted and used with another dermatome device, which was not recommended by the manufacturer. The incompatible manufacturers' blades led to deep lacerations on the patient's body. In a circumcision patient safety incident, a clamp broke apart due to mismatched parts of different clamps that were assembled during the sterilization procedure. This led to excessive bleeding during the procedure placing the patient at risk. Actions to reduce further risk of injury have been provided. "5/11/2020 2:12:56 AMassociated with the use or function of a device in patient care in which the device is used or functions other than as intended Product or Device Events Safety Incident
Medical Device Alarm Safety in Hospitals1722330824/8/2013 6:00:00 AMMedical DeviceUnited States of AmericaThe Joint Commission (USA)This alert addresses patient safety incidents that can occur when medical devices with alarm systems are not appropriately responded to because of "alarm fatigue". Medical devices which have alarm systems include bedside physiologic monitors that include ECG (electrocardiogram) machines, pulse oximetry devices, blood pressure and other parameters monitoring devices, bedside telemetry; central station monitors; infusion pumps and ventilators. These alarm-equipped medical devices are essential to providing safe care to patients in many health care settings but patient safety incidents can occur when when their alarms create similar sounds, when their default settings are not changed, and when there is a failure to respond to their alarm signals.5/11/2020 2:16:28 AMECG (electrocardiogram) machines, pulse oximetry devices, and monitors of blood pressure Appareils ECG (électrocardiogramme), appareils d'oxymétrie de pouls, moniteurs de pression 5 Safety Incident
Medical Device Alarm – “The WOLF is COMING”1722430817/1/2013 6:00:00 AMMedical DeviceHong KongHong Kong Hospital AuthorityThis alert addresses patient safety incidents that can occur when medical devices with alarm systems are not appropriately responded to because of "alarm fatigue". Medical devices which have alarm systems include bedside physiologic monitors that include ECG (electrocardiogram) machines, pulse oximetry devices, blood pressure and other parameters monitoring devices, bedside telemetry; central station monitors; infusion pumps and ventilators. These alarm-equipped medical devices are essential to providing safe care to patients in many health care settings. There are essentially hundreds of alarm signals per patient which equates to thousands of alarm signals on each unit which further equates to tens of thousands of alarm signals throughout a hospital each day. Because 85 - 99% of alarm signals do not require clinical intervention, clinicians become desensitized to the sounds of medical device alarms and are overwhelmed with the amount of information coming from the alarms; i.e. they suffer from "alarm fatigue". When this happens, they may turn down the alarm volume, turn off the alarm, or adjust the alarm settings sometimes with fatal or serious outcomes. Information from the United States Joint Commission Sentinel Event database indicated that from January 2009 to June 2012 98 alarm related incidents were reported; 80 resulted in death, 13 resulted in permanent loss of function and 5 resulted in unexpected additional care or extended stay. Contributing factors to these incident include the following: 1. Alarm fatigue - the most common cause 2. Alarm settings are not customized to the individual patient or patient population. 3. Inadequate staff training on the proper use and functioning of the equipment. 4. Inadequate staffing to support or respond to alarm signals. 5. Alarm conditions and settings are not integrated with other medical devices. 6. Equipment malfunctions and failures. Recommendations to prevent similar incidents are provided.5/11/2020 2:16:29 AMelectrocardiogram) machines, pulse oximetry devices, blood pressure monitoring devices, bedside telemetry; central station monitors Safety Incident
Medical Device Tubing Misconnections May Result in Serious Harm17719371310/27/2016 6:00:00 AMMedical DeviceUnited States of AmericaOregon Patient Safety Commission (USA)This alert discusses the adverse events that can occur when tubing of medical devices is misconnected. Serious harm or death can result when a medication, substance (such as an enteral feeding) or gas is delivered via the wrong route. The alert identifies major factors contributing to tubing misconnection injuries. International Organization for Standardization (ISO) standards are currently being reworked to prevent misconnections by designing connectors that physically prevent connections with devices used for other medical applications. During the transition to the new ISO standards for tubing connections, healthcare organizations should implement practices to manage the risk of tubing misconnections. The alert provides the Joint Commission risk management tips for clinicians.5/11/2020 2:18:31 AMalimentation entérale, gaz, mauvaise voie, erreurs de connexion, stress, fatigue, distractions, éclairage, facteurs environnementaux, syndrome du spaghetti, retracer, déplacement
Insufficient Confirmation Concerning Medical Devices Implanted into the Patient's Body1717831231/1/2012 7:00:00 AMMedical DeviceJapanJapan Council for Quality Health CareThis alert discusses patient safety incidents of near misses of harm involving patients who were scheduled for MRI examinations and for whom inadequate information about their medical implant devices was communicated. The incidents involved the following medical devices: pacemaker, cochlear implant, implantable cardiac-defibrillator, ventricular shunt with a variable pressure valve as well as the clips used in cerebral aneurysm surgery and internal fixation plates. Two incidents are described. In the first incident, the patient experienced lower limb muscle weakness after a pacemaker insertion and sought consultation in the orthopedic department. When ordering a lumbar MRI, the physician failed to check whether or not the patient had a pacemaker. Before the examination, with the patient's family member in attendance, the radiological technologist checked that the patient had not brought in any metal objects, such as a wallet, and then commenced the examination. During the examination, the patient's family member said that the patient had had surgery to implant a pacemaker, so the radiological technologist halted the examination immediately. In the second incident, when carrying out an MRI examination of a patient with a hearing impairment, the section of the MRI ordering screen asking about metal objects stated "None", but the ward nurse told the MRI nurse during the handover that the patient used a hearing aid. The hearing aid was removed from the patient's right ear before entering the room but when the patient went into the gantry, s/he complained "My head hurts. My cochlear implant...", so the MRI examination was halted immediately. When the staff checked, it was revealed that the patient had a cochlear implant in his/her left ear, but this had not been communicated to the surgeon who requested the examination. Recommendations for prevention of similar incidents are provided.5/11/2020 2:16:16 AMMRI, pacemaker, cochlear implant, implantable cardiac-defibrillator, ventricular shunt with a variable pressure valve, clips used in cerebral aneurysm surgery and internal Safety Incident
Electro-magnetic Interference (EMI) from the use of two-way hand held radios/ walkie-talkies in close proximity to medical devices.18514VA2211/1/2004 7:00:00 AMMedical DeviceUnited States of AmericaNational Center for Patient Safety (Department of Veteran's Affairs - USA)"A VA medical center reported that oxygen concentrators in the nursing home unit alarmed and sometimes shut down, requiring a reset when two-way radios were keyed to transmit from approximately 10 feet away. Although the medical center has a policy in place to address radio interference, it was not diligently enforced. Hand-held radios are one of the most common causes of radiated Electromagnetic Interference (EMI) in healthcare facilities. As more electronics and wireless devices are used in hospitals, EMI risks continue to increase. Several factors influence EMI risk including: o device design o distance between devices o signal strength o other interference sources Of all these, distance and transmitter management are the most controllable and effective. Suggestions are provided for the consideration of applicable VA facilities. "5/11/2020 2:13:55 AM"soins de longue durée, services aux hospitalisés Product or Device Events Événements liés aux produits ou aux appareils Safety Incident
Educational Support for Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents1811138207/31/2019 6:00:00 AMMedicationCanadaInstitute for Safe Medication Practices CanadaThis bulletin provides information on recent educational resources to support the Protecting Canadians from Unsafe Drugs Act, also known as Vanessa’s Law, intended to increase drug and medical device safety in Canada by strengthening Health Canada’s ability to collect information and to take quick and appropriate action when a serious health risk is identified. It will be mandatory for hospitals to report serious adverse drug reactions (serious ADRs) and medical device incidents (MDIs) to Health Canada, effective December 2019. The mandatory reporting requirements for hospitals apply to therapeutic products, including pharmaceuticals (prescription and nonprescription drugs), biologic drugs, radiopharmaceutical drugs, disinfectants, and medical devices.3 Hospitals will be required to report a serious ADR or MDI to Health Canada within 30 calendar days of first documentation of the event within the hospital. These materials provide information about the new regulatory requirements for mandatory reporting, describe reporting processes, offer strategies to promote and support reporting, and describe Health Canada’s review and communication of safety findings. The bulletin explains that there are 4 PowerPoint modules that contain core content intended for use by hospitals, health care professionals, educators, and patients and their families, to explain, describe, or promote the reporting of serious ADRs and MDIs: Module 1: Overview of Vanessa’s Law and Reporting Requirements Module 2: Reporting Processes to Health Canada Module 3: Strategies to Promote and Support Mandatory Reporting Module 4: Health Canada’s Review and Communication of Safety Findings The modules are intended to inform both health care providers and patients, to raise awareness of Vanessa’s Law, and to support reporting and learning. They are available for use by hospitals, health care educators, professional associations, regulatory colleges, training institutions for health care workers, as well as patients and consumer organizations. Updated modules are available from: Resources/Vanessas-Law/Pages/default.aspx7/9/2020 3:36:57 PMmedical devices prescription and nonprescription drugs, biologic drugs, radiopharmaceutical drugs, disinfectants Protéger les Canadiens contre les médicaments dangereux, la Loi de
Use of Impregnated Chemical Disinfectant Wipe Systems for Reusable Medical Devices1744231321/24/2014 7:00:00 AMInfection Prevention and ControlAustraliaNew South Wales Department of Health (Australia)This Safety Notice provides advice and direction to health services in the use of Impregnated Chemical Disinfection Wipe Systems, using active ingredients such as isopropryl alcohol, chlorhexidine gluconate, chlorine dioxide and dimethyl oxazolidine, for high-level disinfection of non-lumened reusable medical devices (RMD). Some wipes are used in high-level disinfection of non-lumened medical devices - including nasendoscopes; transoesophageal cardio probes; trans-vaginal and trans-rectal ultrasound transducers; GI high resolution manometry catheters; and ophthalmic devices - that cannot be fully immersed in liquid disinfectant or sterilants and cannot be sterilised by heat. The wipes with the active ingredients listed above are not intended for use on critical medical devices which must be sterilised prior to use on a patient. Unlike automated reprocessing systems which have a measured dosage of chemistry and a validated reprocess cycle, impregnated chemical disinfection wipe systems rely on the manual (human) process of applying each wipe in the recommended sequence. This assumes that each and every part of the device has been contacted consistently for the specified period of time. The devices for which impregnated chemical disinfection wipe systems are intended are not easily stabilised aseptically, which makes it very difficult to ensure and verify that all parts of the device have been contacted by the disinfecting agent consistently at the required concentration for the required time. Recommendations to minimize risk of incomplete disinfection are provided to prevent patient safety incidents.5/11/2020 2:17:06 AMnon-lumened medical devices nasendoscopes transoesophageal cardio probes trans-vaginal and ultrasound transducers GI high resolution manometry catheters ophthalmic devices Prevention & Control;Healthcare Associated Infections;Hand Hygiene;Patient Safety Incident
Managing risks during the transition period to new ISO connectors for medical devices1762634213/27/2015 6:00:00 AMMedical DeviceUnited KingdomNHS Commissioning BoardThis alert addresses the potential for patient safety incidents when using various medical devices and a variety of connectors or adapters resulting in a misconnection and wrong route errors. The source of the alert provides information on introduction of new enteral feed administrations fitted with new connectors and describes how the phased in implementation will proceed. Risks during the transition period are also described. The alert identifies that different types of medical devices can easily be connected using Luer connectors. For example, an inflation tube of a blood pressure monitor can be connected to an intravenous catheter; an enteral feed administration set can be connected to a tracheostomy tube. In the UK and worldwide, such wrong route errors have resulted in patient injury and death. To reduce the risk of misconnections, the International Organization for Standardisation (ISO) has developed a series of new International Standards for small bore connectors in a range of medical devices (ISO 80369). The standards define the design of the connectors for these applications so that the risk of misconnections with other connectors in the series is reduced. Recommended action items are identified for all organizations impacted by this change.5/11/2020 2:18:09 AMsystems, limb cuff inflation devices, neuraxial devices, gravity transitition giving set, pump jeu d'administration d'alimentation entérale, raccord Luer, tube de gonflage Patient Safety;Patient Safety Incident
Improving infusion device safety18861NPSA0355/20/2004 6:00:00 AMMedical DeviceEngland and WalesNational Health Service Commissioning Board (England and Wales)This Safer Practice Notice discusses patient harm that has occurred with infusion devices where there was no fault with the equipment. The contributing factors that have been determined from these incidents include: 1. trusts have a wider range of infusion device types than they need and too many with a higher specification than is necessary; 2. staff training is not a priority or competency-based; and 3. devices of the same type have multiple configurations and react differently under the same circumstances. The NPSA has developed a toolkit to help the review of device management systems. Through the use of this toolkit and implementation of provided actions to reduce risk, patient harm can be reduced.5/11/2020 2:15:24 AMgénie médical, génie clinique, matériel de perfusion, bibliothèque de matériel, formation Safety Incident