Complex Medical Devices Research Articles

A model driven approach to data privacy verification in E-Health systems

Last years experienced the growth of new technologies able to remotely monitor health state of persons. This includes both (even complex) Medical devices and all kind of wearable device. In additio...

Evaluating Device Design and Cleanability of Orthopedic Device Models Contaminated with a Clinically Relevant Bone Test Soil.

Reusable medical devices need to be cleaned prior to disinfection or sterilization and subsequent use to prevent infections. The cleanability of medical devices depends in part on the design of the device. This study examined how models of orthopedic medical devices of increasing complexity retain calcium phosphate bone cement, a relevant test soil for these devices. The dye Alizarin Red S and micro-computed tomography (μCT) were used to assess the amount and location of bone cement debris in a series of model orthopedic devices. Testing was performed after soiling and cleaning once, and soiling and cleaning 10 times. The color change of the dye after reacting with the bone cement was useful for indicating the presence of bone cement in these models. High-resolution μCT analysis provided the volume and location of the bone cement. Models that were more complex retained significantly more bone debris than simpler designs. Model devices repeatedly soiled and cleaned 10 times retained significantly more bone debris than those soiled and cleaned once. Significantly more bone cement was retained in the more complex lumen structures. This information may be useful in designing reusable orthopedic devices, and other complex medical devices with lumens.

Design for Usability of Complex Medical Devices: Leading a Technology-Push Innovation Towards User Acceptance

Abstract This study explores the applicability of usability design processes in the development of a complex medical device in order to enhance the marketability and user acceptance of such. In healthcare, risk mitigation and prevention of potential use errors are the prevailing topics that need to be addressed throughout the development processes of medical devices. However, it is also acknowledged that medical device manufacturers ought to go beyond the mere functional and safety-related aspects of the device-to-be since potential customers also consult usability testing results before purchasing such systems. Yet, it remains unclear how and at what development stage manufacturers include the user perspective in their design iterations in order to enhance the system’s usability. Through action research, this study investigates the approach towards product usability applied throughout the development process of a medical device manufacturer. Interdisciplinary usability workshops were conducted, involving designers and application specialists from within the company that represent future users of the device. These so-called user proxies are able to provide the input from a user perspective at several stages of the design process. It was found that device usability is considered as a crucial topic in order to detect and mitigate use errors as early as possible. Including user proxies in the development process is beneficial to receive feedback from internal professionals that come closest to future users of the system. However, it is challenging to translate user proxies’ insights directly into the development process due to the system’s complexity and technical constraints. The study presents an outline of how to make the usability aspects fit into current development processes in order to increase user acceptance. It contributes to academia and practice alike as a starting point to further investigate how to integrate and standardize usability design processes throughout the development of medical devices.

Transition of respiratory technology dependent patients from pediatric to adult pulmonology care.

Recent advances in medicine have allowed children with chronic life-threatening disorders to survive longer than ever before with the use of complex medical device technology (e.g., mechanical ventilation, dialysis, etc.). The care of children with chronic pulmonary disorders and respiratory-technology dependence is often complex, involving a high level of ongoing interaction between caregivers and the health care team. Unmanaged, non-standardized transition of respiratory technology dependent (RTD) patients to adult care potentially increases the risk of adverse outcomes. Pediatric Pulmonary programs at US children's hospitals were surveyed to ascertain whether a standardized process is utilized for transitioning RTD patients from pediatric to adult subspecialty pulmonology care. Pediatric pulmonology programs with Accreditation Council for Graduate Medical Education certification were invited to participate in an electronic survey inquiring about practices and processes used to transition RTD patients from pediatric to adult pulmonology. The majority of respondents, 78.1% (25/32), reported that they do not utilize a standard protocol for transition while 41.4% (12/29) have no process in place. No program surveyed uses a designated transition leader. Referral to an adult pulmonologist within the same health system occurs more frequently than referral to private practice. Forty-three percent are not satisfied with involvement from the adult pulmonology care team. Coordination of care with other specialty services such as adult otolaryngology is provided by 31% of respondents. Of respondents, 13.8% assessed "readiness to transition" to adult pulmonary for RTD patients. Pediatric pulmonary providers are not satisfied with their current practices or involvement from the adult team, and only 24% track the transition process until the first visit with the adult pulmonologist. The survey results highlight a lack of standardized transition programs at US children's hospitals for the transfer of RTD patients from a pediatric to an adult care setting. Improvement in the standardized management of transitions of complex RTD patients from pediatric to adult care may decrease the risk for adverse health outcomes and the stresses associated with changing the health care setting.

Advanced Electronic Packaging Options for Miniaturization of Complex Medical Devices

Electronics packaging for complex medical devices demands innovation and advanced capabilities, but achieved in a manner which ensures reliability and performance. The evolution of

Design, Fabrication and Computational Characterization of a 3D Micro-Valve Built by Multi-Photon Polymerization

We report on the design, modeling and fabrication by multi-photon polymerization of a complex medical fluidic device. The physical dimensions of the built micro-valve prototype are compared to those of its computer-designed model. Important fabrication issues such as achieving high dimensional resolution and ability to control distortion due to shrinkage are presented and discussed. The operational performance of both multi-photon and CAD-created models under steady blood flow conditions was evaluated and compared through computational fluid dynamics analysis.

Challenges to validation of a complex nonsterile medical device tray.

Validation by steam sterilization of reusable medical devices requires careful attention to many parameters that directly influence whether or not complete sterilization occurs. Complex implant/instrument tray systems have a variety of configurations and components. Geobacillus stearothermophilus biological indicators (BIs) are used in overkill cycles to to simulate worst case conditions and are intended to provide substantial sterilization assurance. Survival of G. stearothermophilus spores was linked to steam access and size of load in the chamber. By a small and reproducible margin, it was determined that placement of the trays in a rigid container into minimally loaded chambers were more difficult to completely sterilize than maximally loaded chambers.

Specific stressors in endonasal skull base surgery with and without navigation.

The goal of modern organizational psychology is to recognize, anticipate and finally avoid stress situations. The aim of this study was to measure objectively the mental and physical demands during transnasal surgery with and without the aid of a navigation system. Forty endonasal surgeries (20 with and 20 without navigation, not blinded and not randomized) done by four different experienced rhinosurgeons (>250 FESS procedures done) were included. The heart rate, the heart rate variability, the respiratory frequency and the masseter tone were monitored as biometrical parameters by the surgeons during the whole surgery for the quantification of mental demand. Stress situations could be identified during the procedures by an increase in the heart rate and a decrease in the heart rate variability. Stress level in procedures with navigation did not significantly differ from procedures without navigation. Interestingly, in 10 % of the cases a navigation system would have been helpful, although the surgeon stated before the procedure that such a system would not be necessary. Other stressors could be identified like time pressure, students or colleagues speaking with the surgeon or chatting in the OR and system failure of medical devices, i.e. navigation, sinus drill, electrocautery or shaver. Surgical stressors blurred vision due to diffuse bleeding and drill out procedures in the sphenoid sinus. Calming situations were a quiet atmosphere in the OR (i.e. closed doors) and the participation of another experienced colleague, especially a neurosurgeon. Stress situations occur when complex medical devices like the navigation do not work. For their proper function it is important that the whole OR-team is trained with it. Unqualified or unmotivated OR personnel create stress for the surgeon and disharmony in the team, which then ends in inadequate behaviour.

Comparison of Raman spectroscopy vs. high performance liquid chromatography for quality control of complex therapeutic objects: Model of elastomeric portable pumps filled with a fluorouracil solution

This study compares the performance of a reference method of HPLC to Raman spectroscopy (RS) for the analytical quality control (AQC) of complex therapeutic objects. We assessed a model consisting of a widely used anticancer drug, i.e., 5-fluorouracil, which was compounded in a complex medical device, i.e., an elastomeric portable infusion pump. In view of the main objective, the two methods provided excellent results for the analytical validation key criteria, i.e., trueness, precision and accuracy, ranging from 7.5 to 50mg/mL and in either isotonic sodium or 5% dextrose. The Spearman and Kendall correlation tests (p-value<1×10−15) and the statistical studies performed on the graphs confirm a strong correlation in the results between RS and the standard HPLC under the experimental conditions. The selection of a spectral interval between 700 and 1400cm−1 for both the characterization and quantification by RS was the result of a gradual process optimization, combining matrix and packaging responses. In this new application, we demonstrate at least eight benefits of RS: (a) operator safety, (b) elimination of disposables, (c) elimination of analysis waste, which contributes to the protection of the environment, (d) a fast analytical response of less than 2min, (e) the ability to identify the solubilizing phase, (f) reduction of the risk of errors because no intrusion or dilution are needed, (g) negligible maintenance costs and (h) a reduction in the budget dedicated to technician training. Overall, we indicate the potential of non-intrusive AQC performed by RS, especially when the analysis is not possible using the usual techniques, and the technique's high potential as a contributor to the safety of medication.

Healthcare Technology Is on the Move

Healthcare Technology Is on the Move

Reporting standards for adverse events after medical device use in the peripheral vascular system

New York, NY;Phoenix, Ariz; Houston, Tex; London, Ontario, Canada; Delhi, India; Silver Spring, Md; and Lewiston, MeAdverse event reporting after medical device implanta-tion is essential to understanding the safety and perfor-mance of a device. Standardization of reporting attainsgreat importance when comparing different devices andfor the ongoing surveillance of a marketed device.Although some work has been done to standardize adverseevent reporting for medical devices, a single reference withrecommendations that span investigational and postmarketuse does not exist.Standardization of nomenclature for reporting vascularconditions is one of the objectives of the Society forVascular Surgery (SVS) in its Bylaws.

G56(P) How to Construct Hi-Fidelity Online Medical Device Simulators

ObjectivesI set out to investigate how the workings of a complex medical device could be visually represented and documented on paper, and then be translated into computer code to produce...

Pharmacovigilance as a tool for safety and monitoring: a review of general issues and the specific challenges with end-stage renal failure patients.

Pharmacovigilance is instrumental in helping to ensure patient safety for both newly released drugs and those that are well established in the market. However, while pharmacovigilance procedures are strictly regulated in the clinical trial setting, post-marketing adverse event reporting is not well implemented or enforced. As such, the underreporting of adverse events, in relation to drugs that are on the market, is estimated to be in the region of 90%. The identification of drug safety issues in patients with complex diseases and extensive comorbidities is therefore particularly challenging. Dialysis patients – those with end-stage renal disease and often other comorbidities such as diabetes, hypertension, and cardiovascular disease – are a population with significant treatment challenges. Patients receive dialysis using complex medical devices (eg, a peritoneal dialysis home cycler) and also receive a range of pharmaceutical agents as part of dialysis itself (eg, peritoneal dialysis solutions). Many of the pharmaceutical agents used to treat these patients have been developed in populations without these complications and, therefore, an extensive knowledge of potential problems and contraindications in the dialysis population is lacking. It is important that the nephrology community understands the concept of pharmacovigilance – the pharmacologic science relating to the detection, assessment, understanding, and prevention of adverse effects, particularly long-term and short-term side effects, of medicines. Health care professionals (HCPs) and providers, pharmaceutical companies, global regulatory agencies, and the patients themselves all play unique and critical roles in this process. This review defines the science of pharmacovigilance and the process of adverse event reporting, highlights the new directions that pharmacovigilance has taken, and provides insight for HCPs managing dialysis patients into the important role that they play in helping to shape the understanding of a drug’s safety profile in order to continually enhance patient safety.

Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States

The incorporation of complex medical device technologies into clinical practice is governed by critical oversight of the United States Food and Drug Administration. This regulatory process requires a judicious balance between assuring safety and efficacy, while providing efficient review to facilitate access to innovative therapies. Recent contrasting views of the regulatory process have emphasized the difficulties in obtaining an optimal balance. Mechanical circulatory support has evolved to become an important therapy for patients who have advanced heart failure with the advent of more durable, implantable ventricular assist devices. The regulatory oversight of these new technologies has been difficult owing to the complexities of these devices, associated adverse event profile, and severity of illness of the intended patient population. Maintaining a regulatory environment to foster efficient introduction of safe and effective technologies is critical to the success of ventricular assist device therapy and the health of patients with advanced heart failure. Physicians representing key surgical and cardiology societies, and representatives from the Food and Drug Administration, National Heart Lung, and Blood Institute, Centers for Medicare and Medicaid Services, Inter-agency Registry of Mechanically Assisted Circulatory Support, and industry partners gathered to discuss relevant issues regarding the current regulatory environment assessing ventricular assist devices. The goal of the meeting was to explore innovative ways to foster the introduction of technologically advanced, safe, and effective ventricular assist devices. The following summary reflects opinions and conclusions endorsed by The Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, Heart Failure Society of America, International Society for Heart and Lung Transplantation, and Interagency Registry of Mechanically Assisted Circulatory Support.

Statement Regarding the Pre and Post Market Assessment of Durable, Implantable Ventricular Assist Devices in the United States: Executive Summary

The incorporation of complex medical device technologies into clinical practice is governed by critical oversight of the US Food and Drug Administration. This regulatory process requires a judicious balance between assuring safety and efficacy, while providing efficient review to facilitate access to innovative therapies. Recent contrasting views of the regulatory process have emphasized the difficulties in obtaining an optimal balance. Mechanical circulatory support has evolved to become an important therapy for patients with advanced heart failure with the advent of more durable, implantable ventricular assist devices. The regulatory oversight of these new technologies has been difficult owing to the complexities of these devices, associated adverse event profile, and severity of illness of the intended patient population. Maintaining a regulatory environment to foster efficient introduction of safe and effective technologies is critical to the success of ventricular assist device therapy and the health of patients with advanced heart failure. Physicians representing key surgical and cardiology societies, and representatives from the Food and Drug Administration, National Heart Lung, and Blood Institute, Centers for Medicare and Medicaid Services, Interagency Registry of Mechanically Assisted Circulatory Support, and industry partners gathered to discuss relevant issues regarding the current regulatory environment assessing ventricular assist devices. The goal of the meeting was to explore innovative ways to foster the introduction of technologically advanced, safe, and effective ventricular assist devices. The following summary reflects opinions and conclusions endorsed by The Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, Heart Failure Society of America, International Society for Heart and Lung Transplantation, and the Interagency Registry of Mechanically Assisted Circulatory Support.

Statement Regarding the Pre and Post Market Assessment of Durable, Implantable Ventricular Assist Devices in the United States

The incorporation of complex medical device technologies into clinical practice is governed by critical oversight of the US Food and Drug Administration. This regulatory process requires a judicious balance between assuring safety and efficacy, while providing efficient review to facilitate access to innovative therapies. Recent contrasting views of the regulatory process have emphasized the difficulties in obtaining an optimal balance. Mechanical circulatory support has evolved to become an important therapy for patients who have advanced heart failure with the advent of more durable, implantable ventricular assist devices. The regulatory oversight of these new technologies has been difficult owing to the complexities of these devices, associated adverse event profile, and severity of illness of the intended patient population. Maintaining a regulatory environment to foster efficient introduction of safe and effective technologies is critical to the success of ventricular assist device therapy and the health of patients with advanced heart failure. Physicians representing key surgical and cardiology societies, and representatives from the Food and Drug Administration, National Heart, Lung, and Blood Institute, Centers for Medicare and Medicaid Services, Interagency Registry of Mechanically Assisted Circulatory Support, and industry partners gathered to discuss relevant issues regarding the current regulatory environment assessing ventricular assist devices. The goal of the meeting was to explore innovative ways to foster the introduction of technologically advanced, safe, and effective ventricular assist devices. The following summary reflects opinions and conclusions endorsed by The Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, Heart Failure Society of America, International Society for Heart and Lung Transplantation, and Interagency Registry of Mechanically Assisted Circulatory Support.

Statement Regarding the Pre and Post Market Assessment of Durable, Implantable Ventricular Assist Devices in the United States

The incorporation of complex medical device technologies into clinical practice is governed by critical oversight of the US Food and Drug Administration. This regulatory process requires a judicious balance between assuring safety and efficacy, while providing efficient review to facilitate access to innovative therapies. Recent contrasting views of the regulatory process have emphasized the difficulties in obtaining an optimal balance. Mechanical circulatory support has evolved to become an important therapy for patients who have advanced heart failure with the advent of more durable, implantable ventricular assist devices. The regulatory oversight of these new technologies has been difficult owing to the complexities of these devices, associated adverse event profile, and severity of illness of the intended patient population. Maintaining a regulatory environment to foster efficient introduction of safe and effective technologies is critical to the success of ventricular assist device therapy and the health of patients with advanced heart failure. Physicians representing key surgical and cardiology societies, and representatives from the Food and Drug Administration, National Heart Lung, and Blood Institute, Centers for Medicare and Medicaid Services, Interagency Registry of Mechanically Assisted Circulatory Support, and industry partners gathered to discuss relevant issues regarding the current regulatory environment assessing ventricular assist devices. The goal of the meeting was to explore innovative ways to foster the introduction of technologically advanced, safe, and effective ventricular assist devices. The following summary reflects opinions and conclusions endorsed by The Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, Heart Failure Society of America, International Society for Heart and Lung Transplantation, and Interagency Registry of Mechanically Assisted Circulatory Support.

Statement Regarding the Pre and Post Market Assessment of Durable, Implantable Ventricular Assist Devices in the United States: Executive Summary

The incorporation of complex medical device technologies into clinical practice is governed by critical oversight of the US Food and Drug Administration. This regulatory process requires a judicious balance between assuring safety and efficacy, while providing efficient review to facilitate access to innovative therapies. Recent contrasting views of the regulatory process have emphasized the difficulties in obtaining an optimal balance. Mechanical circulatory support has evolved to become an important therapy for patients with advanced heart failure with the advent of more durable, implantable ventricular assist devices. The regulatory oversight of these new technologies has been difficult owing to the complexities of these devices, associated adverse event profile, and severity of illness of the intended patient population. Maintaining a regulatory environment to foster efficient introduction of safe and effective technologies is critical to the success of ventricular assist device therapy and the health of patients with advanced heart failure. Physicians representing key surgical and cardiology societies, and representatives from the Food and Drug Administration, National Heart, Lung, and Blood Institute, Centers for Medicare and Medicaid Services, Interagency Registry of Mechanically Assisted Circulatory Support, and industry partners gathered to discuss relevant issues regarding the current regulatory environment assessing ventricular assist devices. The goal of the meeting was to explore innovative ways to foster the introduction of technologically advanced, safe, and effective ventricular assist devices. The following summary reflects opinions and conclusions endorsed by The Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, Heart Failure Society of America, International Society for Heart and Lung Transplantation, and the Interagency Registry of Mechanically Assisted Circulatory Support.

Software Verification and Validation : The Role of IEC 60601-1

When biomedical engineers begin to conceptualize a new medical device, verification and validation (V&V) is usually at the forefront of their thoughts. They want to start the effort well by making sure that they have the right tools and processes in place for “building the product right,” and they want to be able to conclude their efforts by demonstrating that they’ve “built the right product” for their customers. Standards have always played a role in V&V, but part of the third edition of IEC 60601-1—the standard on medical electrical equipment— deals with the V&V of increasingly complex medical devices in a whole new way. The complexity of medical devices has grown in almost unfathomable leaps and bounds from the likes of primitive tools used for trepanation, as shown in Figure 1a, a painting by Hieronymus Bosch circa 1488-1516, to the likes of modern computer-to-brain interfaces, such as BrainGate (Figure 1b), developed in 2008 by Cyberkinetics and Brown University. Arguably one of the most influential technologies in driving system complexity has been software. Software can introduce a level of product capability that begins to approach that of the human brain, and product complexity that begins to parallel that of human thought processes. If not designed with great care, software can also induce system failures, such as erratic operation or incorrect processing of data, which have uncanny parallels to conditions of the human brain, such as schizophrenia and bipolar disorder. While many debate the definition of software, the medical device community has agreed that a software product, which may by itself be considered a medical device, is a “set of computer programs, procedures, and possibly associated documentation and data.” Just as human physical and emotional health are intertwined and must be managed together, as system complexity grows, managing medical device complexity holistically becomes paramount to ensuring system health. Addressing both these systematic flaws and random faults (e.g., short-circuit caused by conductive pollution) becomes one of the primary means of ensuring that the medical device will do what it is intended to do and not do that which is not intended. As stated in its introduction, the third edition of IEC 60601-1 has changed in some very fundamental ways. First, the concept of “safety” has been broadened from the “basic safety” About the Author

Medical Devices — Balancing Regulation and Innovation

The FDA approval system cannot assure the safety and effectiveness of increasingly complex medical devices. The Institute of Medicine has recommended eliminating a process that permits approval of a device based on its “substantial equivalence” to an existing device.