Evaluation of Adverse Events Recorded in FDA/USA and ANVISA/Brazil Databases for Medical Devices: Defibrillator, Infusion Pump, Physiological Monitor, Pulmonary Ventilator and Ultrasonic Scalpel

The use of medical technologies has grown steadily in all health fields, offering numerous benefits to patients. However, related adverse events, which may cause severe consequences for patients, also have increased. Technical factors and human aspects that cause dangers to patients may be related to the complexity of the devices, quality control in manufacturing, software used, maintenance procedures, materials, and mode of use. Thereby, our objective is to present the main alerts, dangers, and failures related to medical equipment and ways to attenuate them. For that purpose, we performed an analysis of adverse events reported for medical equipment in the Food Drugs Administration (FDA/USA) and the Brazilian Health Surveillance Agency (ANVISA) databases, since 2016. Finally, we classified the events into different categories, according to similarity. The results show a total of 3,100 cases registered in the FDA for six types of equipment at the study and 75 cases in ANVISA for two of these equipment. Based on the top ten health hazards (2016-2020) provided by the Emergency Care Research Institute (ECRI) we were able to understand which equipment most offers hazards and the main ways to mitigate them. We found that the risks are common to medical devices, therefore, it is crucial that there are preventative measures to avoid them, for example, training users to use the products, maintenance, improving quality, and reporting adverse events to manufacturers.

Is Clinical Engineering an occupation or profession?

In this paper, we examine the practice level of engineers and discuss whether Clinical Engineering is a profession or an occupation. Many think that occupation and profession are synonyms, but are they? One must explore the difference, if it exists, between these terms, and to accomplish that, clarification of these terms is being offered and established first. We conducted a review of the terms and proceeded to identify if the tenants that are expected to be associated with professional standing are included in applying clinical engineering practices and to what level if it is. Engineering is a profession that improves the quality of living and for the common good. The professional education of engineers requires the education to contain a body of specialized knowledge, problem-solving skills, ethical behavior, and good analytical judgment in the service of all people. The engineering education domains aim to form individuals who are intellectually trained, practically adept, and ethically accountable for their work. Especially within the healthcare delivery system, engineering work engages problem-solving dependent upon sufficient body of knowledge to deal with practical problems by understanding the why, knowing how and identifying the when. There are various levels of the expected body of knowledge within the clinical engineering field ranging from engineers with formal academic training at undergraduate and graduate levels to clinical engineering technologists and technicians having graduated from between 1-4 years of academic training. Engineers may further select to publicly proclaim their adequate preparation and mastering of knowledge to conduct their work through a credentialing process that can confer the term professional, registered, or certified engineer if successfully achieved. Once the differences of working characteristics and obligations between occupation and profession are understood, it is clear that clinical engineers must continuously commit to pursue and fulfill these obligations. Therefore, every professional engineer is called on to achieve a certain degree of intellectual and technical mastery and acquire practical wisdom that brings together the knowledge and skills that best serve a particular purpose for the good of humanity. Clinical engineers and technologists are critical for sustaining the availability of safe, effective, and appropriate technology for patient care. It is as important for their associations to collaborate on compliance with professional obligations that their jobs require.

A risk assessment method based on the failure analysis of medical devices in the adult Intensive Care Unit

Backgrounds and Objective: The Intensive Care Unit (ICU) receives patients whose situation demands high complexity tasks. Their recovery depends on medical care, their response to medications and clinical procedures, and the optimal functioning of the medical devices devoted to them. Adverse events in ICU due to failures in the facilities, particularly medical devices, have an important impact not only on the patients but also on the operators and all those involved in their care. The origins of the technological failures seem to be more oriented to the interaction between the equipment and the operator: once the medical equipment is functioning, we must guarantee its correct execution to meet both the clinical service's objectives and the expectations of those involved in care, including the patients themselves. We present an approach to quality management based on failure analysis as the source of risk for medical devices' functioning and operation in the ICU. We decided to address it through a systematic approach by using the Failure Mode and Effects Analysis (FMEA) method and the Ishikawa diagrams' support to obtain the causes graphically. Material and Methods: We used the risk analysis framework as a basis of the methodology. By obtaining the causes and sub causes of technological failures in the ICU for adult patients, we applied the FMEA method and the Ishikawa diagrams to analyze the relationship between cause and failure. The ICU devices came from the Official Mexican Standard and WHO information related to the ICU operation and facilities. The data from the causes of failure came from specialized consultation and discussion forums on medical devices where these topics were addressed; we searched for over five years in Spanish forums. We proposed a calculation of the Risk Priority Number based on the information subtracted from the forums. Then, we defined an indicator showing the priority level that can be used to address the issue. Results: In general, the results showed that most of the medical equipment failure causes have medium and high-risk priority levels and, in some cases, the cause presented as the most prevalent didn't match with the reported in official documents such as technical or operation manuals. The most frequent causes found are related to electrical system issues and operation skills. We presented three study cases: defibrillator, vital sign monitor, and volumetric ventilator, to show the risk level designation. The conclusions inferred from these cases are oriented to training strategies and the development of support material in Spanish. Conclusion: The development of risk management methodologies that aim to monitor and solve potential hazard situations in critical areas is valuable to the health technology management program. The FMEA method showed to be a strong basis for the risk assessment processes, and its application to the ICU medical technology allowed the creation of the evidence supporting the decision-making process concerning strategic solutions to guarantee patient safety

Quality assessment of emergency corrective maintenance of critical care ventilators within the context of COVID-19 in Sao Paulo, Brazil

This technical report presents the quality assessment process for the emergency corrective maintenance of critical care ventilators in a node, IPT-POLI, of a voluntary network that is part of the initiative +Maintenance of Ventilators, led by the National Service of Industrial Training (SENAI) and its Integrated Manufacturing and Technology Center (CIMATEC) to perform maintenance on unused mechanical ventilators in the context of the COVID-19 pandemic in Brazil. A procedure was established for the quality assessment of equipment subjected to corrective emergency maintenance, covering the essential aspects of the three primary standards (ABNT NBR IEC 60601-1: 2010+A1:2016, ABNT NBR ISO IEC 62353: 2019, and ABNT NBR ISO 80601-2-12:2014) for performance and safety assessment. A set of nine critical care ventilators was evaluated considering the following parameters: leakage current, protective ground resistance, control accuracy, delivered oxygen test, and alarms. The evaluated ventilators underwent corrective emergency maintenance before performance and safety assessments. In the electrical safety tests, all equipment presented values prescribed for the standard. However, the assessment of ventilator parameters revealed that their performance was below the standard. Finally, quality assessment reports were sent to the clinical engineering departments at hospitals. Thus, it can be concluded that criteria selection for the quality assessment in critical care ventilators is crucial and of great significance for future pandemic scenarios, such as the situation experienced during the COVID-19 pandemic.

Lean and Computerized Management System for Non-Hospital Owned Medical Equipment in Hospital

Many challenges exist in the management of non-hospital-owned medical equipment. This paper proposes implementing a novel kind of lean and computerized management method, including the management policy, procedures, agreement signing, equipment installation, acceptance and maintenance, and exit procedure. The result shows that the Lean and computerized management system can improve oversight and assure the safe integration of non-hospital-owned equipment to reduce liability exposure and increase compliance with regulations.

A multi-platform information management system of total life cycle for medical equipment

Objective: To establish a total life cycle information management system for medical equipment based on our hospital’s actual situation. Methods: Per the definition of the total life cycle for the particular item of medical equipment, the function modules were designed and distributed according to different staff postings and then implemented on the WeChat public account-a series of API and services to develop custom features, a mobile app, and a computer web browser. Results: After implementation, the system can cover a series of management stages of the entire life cycle for medical equipment and the information exchanged among various stages. The relevant staff in different posts can operate the medical equipment management information on any of the three platforms. Conclusion: The improvement and efficiency aid staff in various settings in managing medical equipment and medical behaviors and patient safety is increased.

Evaluation and optimization of CES performances: application of Pareto principle to KPIs

In recent times the approach to health care has been mostly influenced by the growing number of biomedical equipment used in hospitals, which needs the presence of the Clinical Engineering Service (CES). The aim of this work is to suggest a methodology to improve the performance of a CES through the application of Pareto principle to main Key Performance Indicators (KPIs). The methodology is applied by focusing on the use of KPIs that represent a quantifiable measure of achieving goals set by an organization. In this study five KPIs are considered: Uptime, MTTR (mean time to repair), PPM (percentage preventive maintenance), MTBF (mean time between failures) and the COSR (cost of service ratio). The first three indicators express the measure of CES efficiency in ensuring regular maintenance. The first step consists in retrieving data related to work orders for the years 2015-2016 on 6000 installed devices, carried out by a management software. The second step is to get the results through the use of an environment for numerical calculation and statistical analysis. In order to identify the main critical issues that may be present, three indicators (Uptime, MTTR and MTBF) are analyzed by applying the Pareto principle (i.e. 20% of the causes produce 80% of the effects). Considering the totality of work orders, therefore, it is possible to concentrate on only 20% of them in order to focus on a small group to understand the correlations between them. Identifying these characteristics means identifying the main critical issues that are present, on which action must be taken, and which affect 80% of the overall behavior. The COSR and PPM indicators, instead, suggest distribution models that allow to focus attention on the most critical devices. In conclusion, the way to analyze the results is obtained, when possible, by applying Pareto principle. Therefore, a CES will be able to focus on a few causes of poor performance. The achievement of these results could allow the standardization of the method used, enabling it to be applied to any healthcare system.