Sign In

 

 

Potential for Error – failure to sterilise instruments18608VIC0453/1/2006 7:00:00 AMMedical DeviceAustraliaVictoria Department of Health (Australia)"During the second last procedure on the operating list, the instruments failed. A second set of instruments were opened and the procedure completed. Both sets of instruments were sent to central sterilising for reprocessing. The last patient on the operating list was having a similar procedure that required the same instrumentation. Staff retrieved a complete set of instruments, manually cleaned them and 'flash' sterilized them. A second staff member removed the instruments and did not notice that the steriliser had not functioned properly and the unsterilised instruments were used on the patient. A number of incidents involving the incorrect use of and documentation associated with 'flash' sterilisers. The major contributing factors to this incident were inappropriate use of the 'flash' steriliser, failure of the documentation/notification processes, staff unfamiliar with sterilisation procedures and equipment, lack of documented responsibilities for staff in relation to instrument sterilisation, and unplanned instrument requirements. This alert describes actions to reduce risk. "5/11/2020 2:14:34 AMwith the use of contaminated drugs, devices, or biologics provided by the healthcare Product or Device Events Décès ou grave invalidité d'un patient par suite de l'utilisation d' https://www.patientsafetyinstitute.ca/en/NewsAlerts/Alerts/Lists/Alerts/AllItems.aspxFalsePatient 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 5https://www.patientsafetyinstitute.ca/en/NewsAlerts/Alerts/Lists/Alerts/AllItems.aspxFalsePatient Safety Incident
Failure to check of infusion pump flow18751JP01312/1/2007 7:00:00 AMMedical DeviceJapanJapan Council for Quality Health CareThis alert describes two patient safety incidents where the flow rate during use of infusion pumps was not checked when replacing a drug product or IV fluid with another one. In the first case, a blood product was administered by syringe pump at a rate of 50 mL/hr. After the administration, another drug was planned to be administered at 5 mL/hr,using the same syringe pump, but the flow rate was not confirmed and changed. The alarm of the syringe pump sounded, and it was noticed the wrong flow rate was identified. In the second case, while using an infusion pump, solution X was switched to solution Y. After the administration of solution X at 125 mL/hr was finished, the administration of solution Y at 20 mL/hr was planned, using the same infusion pump. However, the flow rate was not confirmed and changed. Later, another care giver visited the patient's ward and noticed that the flow rate had not been changed.5/11/2020 2:15:03 AMpatients hospitalisés, patients externes, urgence, soins ambulatoires pompe de perfusion, pompe à seringue https://www.patientsafetyinstitute.ca/en/NewsAlerts/Alerts/Lists/Alerts/AllItems.aspxFalsePatient Safety Incident
Failure to resume ventilator without releasing "standby" mode18775JP03712/1/2009 7:00:00 AMMedical DeviceJapanJapan Council for Quality Health CareThis alert discusses patient safety incidents where mechanical ventilation for the patient is interrupted as a result of the ventilator being left on "standby mode". In one incident, the patient was connected to a ventilator (Servo-i) to support spontaneous breathing. Nurse A switched the mode of the ventilator from "on" to "standby" in order to change the patient's body position with the help of Nurse B. Then, Nurse A left the patient room; the mode of the ventilator had not been switched from "standby" to "on." Later, Nurse A returned to the patient room and recognized that the mechanical ventilation was not being carried out. In another incident, patient temporarily removed the ventilator (Servo-i Universal) to go to a toilet, and switched to nasal oxygen administration. At that time, Nurse C turned the ventilator mode to "standby." When the patient returned, Nurse D performed sputum suction for the patient, and attached the ventilator. The mode of the ventilator was not switched from "standby" to "on."5/11/2020 2:15:08 AMhttps://www.patientsafetyinstitute.ca/en/NewsAlerts/Alerts/Lists/Alerts/AllItems.aspxFalsePatient Safety Incident
Failure to Reopen All Clamps on a Cerebrospinal Fluid Drainage Circuit17363320910/1/2013 6:00:00 AMMedical DeviceJapanJapan Council for Quality Health CareThis alert discusses the patient safety incidents where there was excess drainage of cerebrospinal fluid in patients connected to a cerebrospinal fluid drainage circuit due to incorrect operation of the device. Failure to open the air inlet when opening the clamp on a cerebrospinal fluid drainage circuit created negative pressure, and led to over-drainage. Two cases are described. In one case, the four clamps on the cerebrospinal fluid drainage circuit were closed before changing the patient's position. After the position was changed, only two of the clamps on the cerebrospinal fluid drainage circuit (one on the patient's side and one on the drain side) were opened. An hour later, the patient's blood pressure reached the 200 mmHg mark and 200 mL of bloody discharge emerged. Recommendations to prevent similar patient safety incidents are provided5/11/2020 2:16:51 AMcircuit de drainage du liquide céphalorachidien entrée d'air, pression négative, drainage excessif, formation, éducation https://www.patientsafetyinstitute.ca/en/NewsAlerts/Alerts/Lists/Alerts/AllItems.aspxFalsePatient 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 https://www.patientsafetyinstitute.ca/en/NewsAlerts/Alerts/Lists/Alerts/AllItems.aspxFalsePatient Safety Incident
Latent Failures Identified with CADD® Pump Error Analysis18695ISMCP099/1/2004 6:00:00 AMMedical DeviceCanadaInstitute for Safe Medication Practices CanadaThe Bulletin describes a medication incident where a patient received an overdose of hydromorphone that was administered subcutaneously by a CADD-Legacy® PCA Model 6300 pump. Contributing factors and recommendations are also provided.5/11/2020 2:11:59 AMProduct or Device Events "narcotics/opiates, IV, transdermal, and oral Événements liés aux produits ou aux appareils "patient tolérant aux opiacés, formation, groupes d'ordonnances https://www.patientsafetyinstitute.ca/en/NewsAlerts/Alerts/Lists/Alerts/AllItems.aspxFalsePatient Safety Incident
Distractions in the Operating Room1734332266/1/2014 6:00:00 AMSurgeryUnited States of AmericaPennsylvania Patient Safety Authority (USA)This alert discusses the patient safety incidents that can occur in the operating room due to distractions and/or interruptions related to human communication, equipment such as surgical alarms or technology (e.g. phone calls, pagers). Distraction is a threat to patient safety in the operating room (OR). Analysis of events reported through the Pennsylvania Patient Safety Reporting System from January 2010 through May 2013 revealed 304 reports of events occurring in the OR in which distractions and/or interruptions were indicated as contributing factors. Attention is warranted to all events impacted by distraction in the OR regardless of frequency, due to their high potential to result in serious patient harm. Distraction is particularly detrimental to performance of complex tasks that require higher levels of cognitive processing, such as those frequently encountered in the OR. With regard to case-irrelevant communications (CICs), defined as communication not relevant to the surgical procedure in progress. Half of all CICs consisted of “small talk.” Although surgeons initiated and received the greatest number of CICs, visitors to the OR (defined as external staff not belonging to the OR team involved in the current surgical procedure) initiated CICs with the highest levels of observable distraction (i.e., causing team members to pause, disrupting workflow). Communications directed to nurses and anesthesia providers resulted in higher levels of distraction than communications directed to surgeons. Distraction from computers and personal electronic devices (PEDs) is also a growing concern for OR teams. The widespread use of computers in clinical settings, along with the recent rapid growth in the use of cell phones and smartphones, has contributed to a heightened focus on the potential for error and harm caused by distractions that result from the use of these devices, particularly within the OR environment. “Distracted doctoring” is a term coined by the media to describe this phenomenon. Distraction from smartphones and other mobile devices was identified as one of the top 10 health technology hazards for 2013 by ECRI Institute. The following are examples of Serious Events (i.e., events involving patient harm) reported and associated with distraction in the OR: —— Wrong-side surgery —— Wrong-site surgery —— Transfusion of the wrong blood to the wrong patient —— Failure to remove a piece of resected bowel, requiring a return to the OR —— Injection of a patient using an unlabeled syringe and needle previously used on another patient —— Failure to notice a significant loss of evoked potential from a patient’s arm during spinal surgery —— Inflation of a tourniquet applied to a patient’s leg for longer than intended, resulting in neurovascular changes Studies examining the impact of distraction in the OR setting, along with guidelines and tools developed by perioperative professional associations and patient safety agencies to limit and/or ameliorate the negative impact of distraction are discussed (e.g., application of the “sterile cockpit” concept from aviation, reducing distractions from technology and noise, use of surgical safety checklists and briefings, teamwork training). Engagement of surgeons and multidisciplinary teams is necessary to address the problem of distractions in the OR.7/22/2015 5:51:59 PMsurgical equipment alarms, smart alarms, beepers, pagers, cell phones, smartphones, needles, sponges, tourniquet alarme de matériel chirurgical, alarmes intelligentes 3https://www.patientsafetyinstitute.ca/en/NewsAlerts/Alerts/Lists/Alerts/AllItems.aspxFalseSurgical Care Safety;Surgical Site Infection (SSI);Surgical Incidents;Retained Foreign Object;Patient Safety Incident;Surgical Safety Checklist
Cold Storage Devices Risks1723730704/1/2013 6:00:00 AMMedical DeviceHong KongHong Kong Hospital AuthorityThis alert addresses patient safety incidents that have occurred related to the malfunction of cold storage devices (e.g blood refrigerator, drug fridge, deceased body storage). Cold storage devices are critical to the preservation of blood components, stem cells, cord blood, drugs, vaccines, reagents and deceased patients in the hospitals. Flaws in the management and maintenance of the cold storage devices could lead to irreversible damage or wastage of the stored contents. In managing incidents related to malfunctioning of cold storage devices, the usual practical difficulty is the inability to ensure prompt and attentive response to infrequent equipment failure events. The alert provides common incidents related to alarm management, equipment management, cleaning and sanitation and access control. Recommendations to prevent incidents with cold storage devices are provided.5/11/2020 2:16:31 AMblood refrigerator, drug fridge, deceased body cold storage units réfrigérateur à sang, réfrigérateur à médicaments, unités d’entreposage à froid de corps https://www.patientsafetyinstitute.ca/en/NewsAlerts/Alerts/Lists/Alerts/AllItems.aspxFalsePatient Safety Incident
Failures in the Diagnostic Process When Assessing Suicidal Intent44697406610/31/2018 6:00:00 AMSuicideUnited States of AmericaPennsylvania Patient Safety Authority (USA)This article discusses the challenges of correctly identifying suicidal intent in patients as valid and reliable objective measurements and physiologic testing in the diagnostic process are lacking. Potential failures in the diagnostic process were identified were identified in 70 events reported from May 1, 2015, through April 30, 2018. 20% of suicide-attempt event reports mentioned the patient had been assessed as being at low risk of suicide. The article stresses that a complete assessment explores not just the patient's first statements of suicidal ideation but delves deeper into other plans that the patient may have been withholding and the evolution of those plans over time. In addition, information gathering for patient assessment appeared to be inconsistent or incomplete in several event reports. Improving information gathering at all stages of the patient's crisis and ensuring that relevant data is communicated throughout the continuum of care can contribute to a more accurate diagnostic process. Several risk mitigation strategies are provided.2/25/2022 10:02:52 PMmneumonic devices, handheld technology santé comportementale, médecine, médicament, soins infirmiers, travail social mesures objectives, tests physiologiques, tentative de suicide https://www.patientsafetyinstitute.ca/en/NewsAlerts/Alerts/Lists/Alerts/AllItems.aspxFalse