Incident: Wrong Lens Inserted During Cataract Surgery at NHS.

Published Date: 2018-11-15

Postmortem Analysis
Timeline 1. The software failure incident happened between March 2015 and December 2017 [Article 77578].
System unknown
Responsible Organization unknown
Impacted Organization unknown
Software Causes 1. Unknown
Non-software Causes 1. Surgeon error in using information regarding the wrong eye during the operation [77578] 2. Lack of proper precautions taken during the cataract operation [77578] 3. Human error in inserting the wrong lens during the surgery [77578]
Impacts unknown
Preventions 1. Implementing proper software validation processes to ensure that the correct information is used for each patient's procedure [77578]. 2. Enhancing the software used for cataract operations to include additional checks and prompts to prevent the insertion of the wrong lens [77578]. 3. Regularly updating and improving the existing computer software used in cataract surgeries to minimize the occurrence of such errors [77578].
Fixes 1. Implement stricter verification processes for selecting the correct lens information in the software used for cataract operations to prevent human errors like using the wrong data [77578]. 2. Enhance the software used in cataract surgeries to include built-in checks and validations to ensure that the correct lens strength is being selected for each patient [77578]. 3. Conduct regular audits and reviews of the software system to identify any potential weaknesses or areas for improvement that could lead to the insertion of the wrong lens during surgeries [77578].
References 1. Healthcare Safety Investigation Branch (HSIB) [Article 77578] 2. Royal College of Ophthalmologists [Article 77578] 3. Department of Health and Social Care [Article 77578] 4. Medicines and Healthcare products Regulatory Agency [Article 77578]

Software Taxonomy of Faults

Category Option Rationale
Recurring unknown The articles do not mention any specific software failure incident happening again at either the same organization (one_organization) or at multiple organizations (multiple_organization). Therefore, the information related to the software failure incident recurrence is unknown based on the provided articles.
Phase (Design/Operation) design, operation (a) The software failure incident related to the design phase is evident in the article. It mentions that despite the introduction of measures to improve safety, including computer software, the event of inserting the wrong lens during cataract surgery continues to occur. This indicates that there may have been contributing factors introduced by the system development or updates that have not effectively prevented the error from happening [77578]. (b) The software failure incident related to the operation phase is also highlighted in the article. The report from the Healthcare Safety Investigation Branch (HSIB) made recommendations to help reduce the number of incidents where the wrong lens is implanted during cataract surgery. This suggests that there were contributing factors introduced by the operation or misuse of the system that led to the errors in surgery [77578].
Boundary (Internal/External) within_system (a) within_system: The software failure incident related to the wrong lens being inserted during cataract operations can be categorized as within_system. The article mentions that despite the introduction of measures to improve safety, including computer software, the event of inserting the wrong lens still continues to occur. This indicates that the failure is attributed to factors originating from within the system, such as issues with the software used in the operation procedures [77578].
Nature (Human/Non-human) human_actions (a) The software failure incident occurring due to non-human actions: - The article does not mention any software failure incident occurring due to non-human actions. Therefore, it is unknown. (b) The software failure incident occurring due to human actions: - The article mentions that despite the introduction of measures to improve safety, including computer software, the event of inserting the wrong lens during cataract surgery continues to occur. This indicates that human actions, such as errors in using the software or not following proper procedures, could contribute to the software failure incident [77578].
Dimension (Hardware/Software) software (a) The article does not provide information about a software failure incident occurring due to contributing factors originating in hardware or a hardware-related failure. (b) The article mentions a software failure incident related to the insertion of the wrong lens during cataract operations. Despite the introduction of measures to improve safety, including computer software, the event of inserting the wrong lens continues to occur. The Healthcare Safety Investigation Branch's report highlighted that this software-related failure persists even with the implementation of safety measures and software solutions [77578].
Objective (Malicious/Non-malicious) non-malicious (a) The articles do not mention any malicious software failure incident related to the cataract operation errors reported in the NHS. Therefore, there is no information to suggest that the software failure incident was due to contributing factors introduced by humans with the intent to harm the system [77578]. (b) The software failure incident related to the cataract operation errors in the NHS is described as a non-malicious failure. The failure was attributed to inserting the wrong lens during a cataract operation, which was considered a 'never event' - incidents believed to be 'wholly preventable' when proper precautions are taken. The mistake of using the wrong lens was identified as a common error in the healthcare system, and despite measures to improve safety, including computer software, such events continue to occur [77578].
Intent (Poor/Accidental Decisions) unknown The articles do not provide information about a software failure incident related to poor decisions or accidental decisions.
Capability (Incompetence/Accidental) unknown The articles do not provide information about a software failure incident related to development incompetence or accidental factors.
Duration unknown The articles do not provide information about a software failure incident related to the duration of the failure being permanent or temporary.
Behaviour crash, omission, value, other (a) crash: The software failure incident related to the wrong lens being inserted during cataract operations can be categorized as a crash. The incident involved a failure in the system losing its state and not performing its intended function of ensuring the correct lens was implanted during the surgery. This resulted in the wrong lens being inserted into patients' eyes, leading to serious consequences [77578]. (b) omission: The software failure incident can also be categorized as an omission. The system omitted to perform its intended function of verifying and ensuring the correct lens information was used during the cataract operations. This omission led to the wrong lens being implanted in multiple cases, highlighting a failure in the system's validation and verification processes [77578]. (c) timing: The software failure incident is not directly related to a timing issue. The issue was not about the system performing its intended functions too late or too early but rather about the system failing to ensure the correct information was used during the cataract operations [77578]. (d) value: The software failure incident can be categorized as a value failure. The system performed its intended function of inserting a lens during cataract operations but did so incorrectly by using the wrong lens information. This incorrect performance led to adverse outcomes for patients who received the wrong lens implant [77578]. (e) byzantine: The software failure incident is not related to a byzantine behavior where the system behaves erroneously with inconsistent responses and interactions. The issue in this case was more about a systematic failure in ensuring the correct information was used during the cataract operations, rather than erratic or inconsistent behavior of the system [77578]. (f) other: The software failure incident can be further described as a failure in the system's validation and verification processes. The system failed to adequately validate and verify the information used during the cataract operations, leading to the insertion of the wrong lens in multiple cases. This highlights a critical flaw in the system's quality control mechanisms [77578].

IoT System Layer

Layer Option Rationale
Perception None None
Communication None None
Application None None

Other Details

Category Option Rationale
Consequence death, harm (a) death: The article mentions a case where a patient died due to a surgical error caused by the insertion of the wrong lens during a cataract operation [77578].
Domain health The failed system in the reported incident was related to the **health** industry. The software failure incident occurred during cataract operations within the NHS, where surgeons inserted the wrong lens during the procedure, leading to serious errors and patient safety concerns ([Article 77578]).

Sources

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