Failure Of Medical Devices Research Articles

Medical Device Failures Investigative Series—KFF News

Medical Device Failures Investigative Series—KFF News

Calcium‐dependent antimicrobials: Nature‐inspired materials and designs

Bacterial infection remains a major complication answering for the failures of various implantable medical devices. Tremendous extraordinary advances have been published in the design and synthesis of antimicrobial materials addressing this issue; however, the clinical translation has largely been blocked due to the challenge of balancing the efficacy and safety of these materials. Here, calcium's biochemical features, natural roles in pathogens and the immune systems, and advanced uses in infection medications are illuminated, showing calcium is a promising target for developing implantable devices with less infection tendency. The paper gives a historical overview of biomedical uses of calcium and summarizes calcium's merits in coordination, hydration, ionization, and stereochemistry for acting as a structural former or trigger in biological systems. It focuses on the involvement of calcium in pathogens' integrity, motility, and metabolism maintenance, outlining the potential antimicrobial targets for calcium. It addresses calcium's uses in the immune systems that the authors can learn from for antimicrobial synthesis. Additionally, the advances in calcium's uses in infection medications are highlighted to sketch the future directions for developing implantable antimicrobial materials. In conclusion, calcium is at the nexus of antimicrobial defense, and future works on taking advantage of calcium in antimicrobial developments are promising in clinical translation.

Exploiting phage-antibiotic synergies to disrupt Pseudomonas aeruginosa PAO1 biofilms in the context of orthopedic infections.

Biofilm-related infections are among the most difficult-to-treat infections in all fields of medicine due to their antibiotic tolerance and persistent character. In the field of orthopedics, these biofilms often lead to therapeutic failure of medical implantable devices and urgently need novel treatment strategies. This forthcoming article aims to explore the dynamic interplay between newly isolated bacteriophages and routinely used antibiotics and clearly indicates synergetic patterns when used as a dual treatment modality. Biofilms were drastically more reduced when both active agents were combined, thereby providing additional evidence that phage-antibiotic combinations lead to synergism and could potentially improve clinical outcome for affected patients.

Phase III clinical trial of autologous CD34 + cell transplantation to accelerate fracture nonunion repair

BackgroundWe previously demonstrated that CD34 + cell transplantation in animals healed intractable fractures via osteogenesis and vasculogenesis; we also demonstrated the safety and efficacy of this cell therapy in an earlier phase I/II clinical trial conducted on seven patients with fracture nonunion. Herein, we present the results of a phase III clinical trial conducted to confirm the results of the previous phase studies using a larger cohort of patients.MethodsCD34 + cells were mobilized via administration of granulocyte colony-stimulating factor, harvested using leukapheresis, and isolated using magnetic cell sorting. Autologous CD34 + cells were transplanted in 15 patients with tibia nonunion and 10 patients with femur nonunion, who were followed up for 52 weeks post transplantation. The main outcome was a reduction in time to heal the tibia in nonunion patients compared with that in historical control patients. We calculated the required number of patients as 15 based on the results of the phase I/II study. An independent data monitoring committee performed the radiographic assessments. Adverse events and medical device failures were recorded.ResultsAll fractures healed during the study period. The time to radiological fracture healing was 2.8 times shorter in patients with CD34 + cell transplantation than in the historical control group (hazard ratio: 2.81 and 95% confidence interval 1.16–6.85); moreover, no safety concerns were observed.ConclusionsOur findings strongly suggest that autologous CD34 + cell transplantation is a novel treatment option for fracture nonunion.Trial registrationUMIN-CTR, UMIN000022814. Registered on 22 June 2016.

Improving Corrosion and Stress Corrosion Cracking Performance of Machined Biodegradable Alloy ZX20 by HF-Treatment

The treatment with hydrofluoric acid (HF-treatment) was suggested to be an effective way of improving the corrosion resistance of Mg alloys, including Mg-Zn-Ca (ZX) ones used for biodegradable implants. However, the effect of the HF-treatment on the stress corrosion cracking (SCC) susceptibility of ZX alloys has not been reported yet, although this phenomenon can induce premature brittle failures of the metallic medical devices, and thus, it is critical for their in-service structural integrity. In the present study, the effect of the HF-treatment on the microstructure, cytotoxicity, corrosion rate, mechanical properties, and fracture and side surface characteristics of the as-cast ZX20 alloy were investigated with the use of scanning electron microscopy, immersion, and slow-strain rate tensile testing in Hanks’ solution and indirect cell viability tests. It is found that the HF-treatment exerts no cytotoxic effect and results in a significant reduction in corrosion rate (up to 6 times of magnitude) and SCC susceptibility indexes (up to 1.5 times of magnitude). The observed improvement of corrosion and SCC performance of the alloy by the HF-treatment is found to be attributed to three effects, including (i) formation of the protective surface film of MgF2, (ii) removal of surficial contaminations originating from sample preparation procedures, and (iii) dissolution of surficial secondary phase particles. The mechanism of corrosion and SCC in the specimens before and after the HF-treatment are discussed.

Insights From a Clinically Orientated Workshop on Health Care Cybersecurity and Medical Technology: Observational Study and Thematic Analysis.

Health care professionals receive little training on the digital technologies that their patients rely on. Consequently, practitioners may face significant barriers when providing care to patients experiencing digitally mediated harms (eg, medical device failures and cybersecurity exploits). Here, we explore the impact of technological failures in clinical terms. Our study explored the key challenges faced by frontline health care workers during digital events, identified gaps in clinical training and guidance, and proposes a set of recommendations for improving digital clinical practice. A qualitative study involving a 1-day workshop of 52 participants, internationally attended, with multistakeholder participation. Participants engaged in table-top exercises and group discussions focused on medical scenarios complicated by technology (eg, malfunctioning ventilators and malicious hacks on health care apps). Extensive notes from 5 scribes were retrospectively analyzed and a thematic analysis was performed to extract and synthesize data. Clinicians reported novel forms of harm related to technology (eg, geofencing in domestic violence and errors related to interconnected fetal monitoring systems) and barriers impeding adverse event reporting (eg, time constraints and postmortem device disposal). Challenges to providing effective patient care included a lack of clinical suspicion of device failures, unfamiliarity with equipment, and an absence of digitally tailored clinical protocols. Participants agreed that cyberattacks should be classified as major incidents, with the repurposing of existing crisis resources. Treatment of patients was determined by the role technology played in clinical management, such that those reliant on potentially compromised laboratory or radiological facilities were prioritized. Here, we have framed digital events through a clinical lens, described in terms of their end-point impact on the patient. In doing so, we have developed a series of recommendations for ensuring responses to digital events are tailored to clinical needs and center patient care.

Emerging Digital Technologies in Patient Care: Dealing with connected, intelligent medical device vulnerabilities and failures in the healthcare sector

Emerging Digital Technologies in Patient Care: Dealing with connected, intelligent medical device vulnerabilities and failures in the healthcare sector

Predicting medical device failure: a promise to reduce healthcare facilities cost through smart healthcare management.

The advancement of biomedical research generates myriad healthcare-relevant data, including medical records and medical device maintenance information. The COVID-19 pandemic significantly affects the global mortality rate, creating an enormous demand for medical devices. As information technology has advanced, the concept of intelligent healthcare has steadily gained prominence. Smart healthcare utilises a new generation of information technologies, such as the Internet of Things (loT), big data, cloud computing, and artificial intelligence, to completely transform the traditional medical system. With the intention of presenting the concept of smart healthcare, a predictive model is proposed to predict medical device failure for intelligent management of healthcare services. Present healthcare device management can be improved by proposing a predictive machine learning model that prognosticates the tendency of medical device failures toward smart healthcare. The predictive model is developed based on 8,294 critical medical devices from 44 different types of equipment extracted from 15 healthcare facilities in Malaysia. The model classifies the device into three classes; (i) class 1, where the device is unlikely to fail within the first 3 years of purchase, (ii) class 2, where the device is likely to fail within 3 years from purchase date, and (iii) class 3 where the device is likely to fail more than 3 years after purchase. The goal is to establish a precise maintenance schedule and reduce maintenance and resource costs based on the time to the first failure event. A machine learning and deep learning technique were compared, and the best robust model for smart healthcare was proposed. This study compares five algorithms in machine learning and three optimizers in deep learning techniques. The best optimized predictive model is based on ensemble classifier and SGDM optimizer, respectively. An ensemble classifier model produces 77.90%, 87.60%, and 75.39% for accuracy, specificity, and precision compared to 70.30%, 83.71%, and 67.15% for deep learning models. The ensemble classifier model improves to 79.50%, 88.36%, and 77.43% for accuracy, specificity, and precision after significant features are identified. The result concludes although machine learning has better accuracy than deep learning, more training time is required, which is 11.49 min instead of 1 min 5 s when deep learning is applied. The model accuracy shall be improved by introducing unstructured data from maintenance notes and is considered the author's future work because dealing with text data is time-consuming. The proposed model has proven to improve the devices' maintenance strategy with a Malaysian Ringgit (MYR) cost reduction of approximately MYR 326,330.88 per year. Therefore, the maintenance cost would drastically decrease if this smart predictive model is included in the healthcare management system.

Medical Device Recalls for Electronic Components

Through the advancement of technology, an ever-increasing number of medical devices contain electronic components and sensors. As a result of these technological advances, smaller devices need more memory, sensors, processing power, and increased energy requirements. Ultimately, the performance of many medical devices is directly dependent on the functionality of these interconnected electronic components. In this article, medical device recalls are examined for malfunctions of electronic systems and components with respect to what system or component specifically did not perform as intended. From this examination, recalls related to electronic medical device systems and components are identified and grouped into common themes. By alerting the Food and Drug Administration to medical device failures, clinical engineering staff can help make manufacturers aware of issues that can be used to make future design changes or mitigations that can ultimately improve the performance and reliability of electronic medical devices.

Sol-Gel Synthesis of Caffeic Acid Entrapped in Silica/Polyethylene Glycol Based Organic-Inorganic Hybrids: Drug Delivery and Biological Properties

The failure of medical devices, such as bones prosthesis, is mainly due to inflammatory and infectious phenomena. Entrapping anti-inflammatory and antimicrobial agents inside the biomaterial matrix could avoid these phenomena. In this context, inorganic/organic silica (S)/polyethylene glycol (P)/caffeic acid (A) hybrid systems were synthesized via the sol-gel method with different weight percentages of P and A. Fourier-transform infrared (FT-IR) revealed that caffeic acid undergoes an oxidizing phenomenon in the sol-gel synthesis condition. Additionally, the formation of a hydroxyapatite layer on hybrid surfaces was demonstrated by employing the Kokubo test and analyzing the samples using scanning electron microscopy, X-ray diffraction, and FT-IR. Moreover, further characterization of the antimicrobial activity of the synthesized biomaterials was carried out using the Kirby–Bauer test. Finally, UV-Vis measurement was useful to evaluate the caffeic acid kinetic release in simulated body fluid (SBF) at 37 °C. The kinetic study disclosed that the hybrid materials without polyethylene glycol had faster release rates than the ones obtained without the organic polymer.

Medical Device Failure Predictions Through AI-Driven Analysis of Multimodal Maintenance Records

Medical Device Failure Predictions Through AI-Driven Analysis of Multimodal Maintenance Records

Systematic Review and Narrative Synthesis of Randomised Controlled Trials Supporting Implantable Devices for Vascular and Endovascular Procedures

ObjectiveTo identify implantable devices currently used for vascular and endovascular procedures, to ascertain how many have randomised controlled trial (RCT) evidence available, and to assess the quality of that evidence.Data SourcesMEDLINE, Embase, DARE, PROSPERO, clinical trial registries, and Cochrane databases.Review MethodsA list of current devices used in both vascular and endovascular procedures was generated by searching conference proceedings, manufacturer catalogues, and websites. MEDLINE, Embase, DARE, PROSPERO, clinical trial registries, and Cochrane databases were searched from inception up to June 2020. The primary outcome was the availability of RCTs to support the use of a vascular implantable device. RCTs were then quality assessed using the Cochrane risk of bias tool.ResultsA total of 116 current vascular implantable devices were identified. The systematic literature review identified 165 RCTs. Eighty-three of the RCTs (50.3%) applied to 33 of the 116 (28.4%) current implantable devices. When grouped by device type, eight of the 13 types (62%) had at least one RCT performed. There was a high risk of bias across the majority of the RCTs, with only nine (5.4%) deemed to be at low risk of bias. Only 22 (13.3%) RCTs had a clear safety outcome.ConclusionSixty-two per cent of implantable device types for use in vascular and endovascular interventions had at least one RCT available to show equivalence to previous devices or safety. RCTs were generally of low quality and are decreasing in frequency with time. With medical implantable device failure being increasingly recognised as causing significant harm to patients worldwide, there is a clear need for a more robust implantable device regulation and approval systems. ObjectiveTo identify implantable devices currently used for vascular and endovascular procedures, to ascertain how many have randomised controlled trial (RCT) evidence available, and to assess the quality of that evidence. To identify implantable devices currently used for vascular and endovascular procedures, to ascertain how many have randomised controlled trial (RCT) evidence available, and to assess the quality of that evidence. Data SourcesMEDLINE, Embase, DARE, PROSPERO, clinical trial registries, and Cochrane databases. MEDLINE, Embase, DARE, PROSPERO, clinical trial registries, and Cochrane databases. Review MethodsA list of current devices used in both vascular and endovascular procedures was generated by searching conference proceedings, manufacturer catalogues, and websites. MEDLINE, Embase, DARE, PROSPERO, clinical trial registries, and Cochrane databases were searched from inception up to June 2020. The primary outcome was the availability of RCTs to support the use of a vascular implantable device. RCTs were then quality assessed using the Cochrane risk of bias tool. A list of current devices used in both vascular and endovascular procedures was generated by searching conference proceedings, manufacturer catalogues, and websites. MEDLINE, Embase, DARE, PROSPERO, clinical trial registries, and Cochrane databases were searched from inception up to June 2020. The primary outcome was the availability of RCTs to support the use of a vascular implantable device. RCTs were then quality assessed using the Cochrane risk of bias tool. ResultsA total of 116 current vascular implantable devices were identified. The systematic literature review identified 165 RCTs. Eighty-three of the RCTs (50.3%) applied to 33 of the 116 (28.4%) current implantable devices. When grouped by device type, eight of the 13 types (62%) had at least one RCT performed. There was a high risk of bias across the majority of the RCTs, with only nine (5.4%) deemed to be at low risk of bias. Only 22 (13.3%) RCTs had a clear safety outcome. A total of 116 current vascular implantable devices were identified. The systematic literature review identified 165 RCTs. Eighty-three of the RCTs (50.3%) applied to 33 of the 116 (28.4%) current implantable devices. When grouped by device type, eight of the 13 types (62%) had at least one RCT performed. There was a high risk of bias across the majority of the RCTs, with only nine (5.4%) deemed to be at low risk of bias. Only 22 (13.3%) RCTs had a clear safety outcome. ConclusionSixty-two per cent of implantable device types for use in vascular and endovascular interventions had at least one RCT available to show equivalence to previous devices or safety. RCTs were generally of low quality and are decreasing in frequency with time. With medical implantable device failure being increasingly recognised as causing significant harm to patients worldwide, there is a clear need for a more robust implantable device regulation and approval systems. Sixty-two per cent of implantable device types for use in vascular and endovascular interventions had at least one RCT available to show equivalence to previous devices or safety. RCTs were generally of low quality and are decreasing in frequency with time. With medical implantable device failure being increasingly recognised as causing significant harm to patients worldwide, there is a clear need for a more robust implantable device regulation and approval systems.

Case Series

Health technology managers play a vital role in medical device safety for pediatric patients in the neonatal intensive care unit and the pediatric intensive care unit. Medical device malfunctions and failures can contribute to potential for harm and adverse events. These patients are especially vulnerable to harm when these incidents occur. When health technology managers provide their expertise on medical device malfunction reports, their valuable input can provide a more complete view of the safety concerns to the US Food and Drug Administration and the device manufacturer. The examples in this article are from medical device reports submitted to the US Food and Drug Administration's MedSun program and illustrate how health technology managers' input has advanced US Food and Drug Administration's understanding of medical device safety concerns and contributed to subsequent recalls and other safety actions for devices used in the neonatal intensive care unit and pediatric intensive care unit.

Cardiovascular Medical Device Failure: Using Five-Week Moving Averages To Assess Adverse Event Report Data

The COVID-19 pandemic had a variety of effects on the healthcare system, including the interruption of regular cardiology practices. We examined the pandemic’s effects on cardiovascular medical device failure by investigating trends in the number of reports of adverse events of several cardiovascular medical devices over the span of three years, including the first year of the pandemic. Specifically, we used data from the FDA’s MAUDE database, calculating the five-week moving average of adverse events associated with both implantable cardioverter defibrillators and coronary drug-eluting stents. We previously reported a 46% decrease in reported deaths attributed to ICDs and a 27% decrease in reported injuries attributed to coronary DES. We use a five-week moving average and confirm a 46% decrease in reported deaths attributed to ICDs, report a 9.8% increase in ICD-attributed malfunctions, and confirm a 27% decrease in reported injuries attributed to coronary DES. The different effects of the pandemic on these adverse event report trends, even within one device, show there are more factors to consider than explanations such as underreporting which would be expected to affect most medical devices relatively homogeneously.

Failure mode effect and criticality analysis of ultrasound device by classification tracking

BackgroundMedical ultrasound device has been more and more widely used in the hospital and Its safety risk is significantly increased when failures occur. However, there is a lack of quantitative risk assessments of different types of failure modes for medical ultrasound device. This study utilizes a failure mode, effect and criticality analysis (FMECA) approach for quantitative risk evaluation of different failure modes for ultrasound devices.MethodsThe 4216 medical ultrasound device failure records at various hospitals were investigated. A failure mode and effect analysis method was developed for the quantitative evaluation of the risks of different failure modes. Visual correlation analysis was conducted for all categories to identify the causes of various failure modes. Based on the severity, occurrence and detectability of the failure causes determined, the risk priority number (RPN) for each failure mode was back-calculated through the obtained tracking diagram.ResultsThe failure modes of unclear images, unable to power on and dark shadows on an image had the highest RPNs. One failure mode could be caused by various factors, and the failure location was not necessarily related to the cause of the failure.ConclusionsThis quantitative approach more accurately evaluated the risks of different failure modes, and the results of the corresponding analysis of failure modes and causes could support the rapid determination of the causes of failures in clinical practice.

Prevention of medical device infections via multi-action nitric oxide and chlorhexidine diacetate releasing medical grade silicone biointerfaces.

The presence of bacteria and biofilm on medical device surfaces has been linked to serious infections, increased health care costs, and failure of medical devices. Therefore, antimicrobial biointerfaces and medical devices that can thwart microbial attachment and biofilm formation are urgently needed. Both nitric oxide (NO) and chlorhexidine diacetate (CHXD) possess broad-spectrum antibacterial properties. In the past, individual polymer release systems of CHXD and NO donor S-nitroso-N-acetylpenicillamine (SNAP) incorporated polymer platforms have attracted considerable attention for biomedical/therapeutic applications. However, the combination of the two surfaces has not yet been explored. Herein, the synergy of NO and CHXD was evaluated to create an antimicrobial medical-grade silicone rubber. The 10wt% SNAP films were fabricated using solvent casting with a topcoat of CHXD (1, 3, and 5wt%) to generate a dual-active antibacterial interface. Chemiluminescence studies confirmed the NO release from SNAP-CHXD films at physiologically relevant levels (0.5-4× 10-10 mol min-1 cm-2 ) for at least 3 weeks and CHXD release for at least 7 days. Further characterization of the films via SEM-EDS confirmed uniform distribution of SNAP and presence of CHXD within the polymer films without substantial morphological changes, as confirmed by contact angle hysteresis. Moreover, the dual-active SNAP-CHXD films were able to significantly reduce Escherichia coli and Staphylococcus aureus bacteria (>3-log reduction) compared to controls with no explicit toxicity towards mouse fibroblast cells. The synergy between the two potent antimicrobial agents will help combat bacterial contamination on biointerfaces and enhance the longevity of medical devices.

Dopamine Assisted Self-Cleaning, Antifouling, and Antibacterial Coating via Dynamic Covalent Interactions.

The rapid accumulation of dead bacteria or protein on a bactericidal surface can reduce the effectiveness of the modified surface and alter its biocidal activity by shielding the surface biocide functional groups, promoting microbial attachment and subsequent biofilm formation. Thus, the alteration of biocidal activity due to biofilm formation can cause serious trouble including severe infection or implant or medical device failure leading to death. Therefore, developing a smart self-cleaning surface is of great interest. Ideally, such a surface can not only kill the attached microbials but also release the dead cells and foulants from the surface under a particular incitement on demand. In this project, a sugar-responsive self-cleaning coating has been developed by forming covalent boronic ester bonds between catechol groups from polydopamine and a benzoxaborole pendant from zwitterionic and cationic polymers. To incorporate antifouling properties and enhance the biocompatibility of the coating, bioinspired zwitterionic compound 2-methacryloyloxyethyl phosphorylcholine (MPC) was chosen and benzoxaborole pendant containing zwitterionic polymer poly(MPC-st-MAABO) (MAABO: 5-methacrylamido-1,2-benzoxaborole) was synthesized. Additionally to impart antibacterial properties to the surface, a quaternary ammonium containing cationic polymer poly(2-(methacryloyloxy)ethyl trimethylammonium (META)-st-MAABO)) was synthesized. These synthesized polymers were covalently grafted to a polydopamine (PDA) coated surface by forming a strong cyclic boronic ester complex with a catechol group of the PDA layer endowing the surface with bacteria contact-killing properties and capturing specific protein. After the addition of cis-diol containing competitive molecules, i.e., saccharides/sugars, this boronic ester complex with a catechol group of PDA was replaced and the attached polymer layer was cleaved from the surface, resulting in the release of both absorbed protein and live/killed bacteria electrostatically attached to the polymer layer. This dynamic self-cleaning surface can be a promising material for biomedical applications avoiding the gathering of dead cells and debris that are typically encountered on a traditional biocidal surface.

Particle-Mediated Histotripsy for the Targeted Treatment of Intraluminal Biofilms in Catheter-Based Medical Devices.

Objective. This paper is an initial work towards developing particle-mediated histotripsy (PMH) as a novel method of treating catheter-based medical device (CBMD) intraluminal biofilms. Impact Statement. CBMDs commonly become infected with bacterial biofilms leading to medical device failure, infection, and adverse patient outcomes. Introduction. Histotripsy is a noninvasive focused ultrasound ablation method that was recently proposed as a novel method to remove intraluminal biofilms. Here, we explore the potential of combining histotripsy with acoustically active particles to develop a PMH approach that can noninvasively remove biofilms without the need for high acoustic pressures or real-time image guidance for targeting. Methods. Histotripsy cavitation thresholds in catheters containing either gas-filled microbubbles (MBs) or fluid-filled nanocones (NCs) were determined. The ability of these particles to sustain cavitation over multiple ultrasound pulses was tested after a series of histotripsy exposures. Next, the ability of PMH to generate selective intraluminal cavitation without generating extraluminal cavitation was tested. Finally, the biofilm ablation and bactericidal capabilities of PMH were tested using both MBs and NCs. Results. PMH significantly reduced the histotripsy cavitation threshold, allowing for selective luminal cavitation for both MBs and NCs. Results further showed PMH successfully removed intraluminal biofilms in Tygon catheters. Finally, results from bactericidal experiments showed minimal reduction in bacteria viability. Conclusion. The results of this study demonstrate the potential for PMH to provide a new modality for removing bacterial biofilms from CBMDs and suggest that additional work is warranted to develop histotripsy and PMH for treatment of CBMD intraluminal biofilms.

Predicting Corrosion Delamination Failure in Active Implantable Medical Devices: Analytical Model and Validation Strategy.

The ingress of body fluids or their constituents is one of the main causes of failure of active implantable medical devices (AIMDs). Progressive delamination takes its origin at the junctions where exposed electrodes and conductive pathways enter the implant interior. The description of this interface is considered challenging because electrochemically-diffusively coupled processes are involved. Furthermore, standard tests and specimens, with clearly defined 3-phase boundaries (body fluid-metal-polymer), are lacking. We focus on polymers as substrate and encapsulation and present a simple method to fabricate reliable test specimens with defined boundaries. By using silicone rubber as standard material in active implant encapsulation in combination with a metal surface, a corrosion-triggered delamination process was observed that can be universalised towards typical AIMD electrode materials. Copper was used instead of medical grade platinum since surface energies are comparable but corrosion occurs faster. The finding is that two processes are superimposed there: First, diffusion-limited chemical reactions at interfaces that undermine the layer adhesion. The second process is the influx of ions and body fluid components that leave the aqueous phase and migrate through the rubber to internal interfaces. The latter observation is new for active implants. Our mathematical description with a Stefan-model coupled to volume diffusion reproduces the experimental data in good agreement and lends itself to further generalisation.

Medical device error and failure reporting: Learning from the car industry

BackgroundImproving the design of technology relies in part, on the reporting of performance failures in existing devices. Healthcare has low levels of formal reporting of performance and failure of medical equipment. This paper examines methods of reporting in the car industry and healthcare and aims to understand differences and identify opportunities for improvement within healthcare.MethodsA literature search was carried out in Pubmed, Medline, Embase, Engineering Village, Scopus. NHS England and MHRA publications and guidelines were also reviewed. Focus was placed on the current system of reporting in both industries, known degree of patient harm, initiating factors, barriers, quality and methods of incident investigation and their validity. The findings were used to compare error reporting system in the two industries.ResultsDerivation of healthcare incident data from different sources means the full extent of patient harm is not known. For example, in 2012 there were 13,549 and 38,395 incidents reported by MHRA and NRLS (National Reporting and Learning System) respectively leading to uncertainties on the extent of the problem. The car industry emphasises the role of reporting source in ensuring data quality. Utilising some aspects of this approach might benefit healthcare reporting. These include a specific reporting system that stresses the importance of organisational learning in improving safety and recognises the limitations of root cause analysis.ConclusionsLearning from reporting systems within the car industry may help the healthcare sector improve its own reporting, aiding healthcare performance.