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Journal of the American College of... Jan 2017Infective endocarditis is defined by a focus of infection within the heart and is a feared disease across the field of cardiology. It is frequently acquired in the... (Review)
Review
Infective endocarditis is defined by a focus of infection within the heart and is a feared disease across the field of cardiology. It is frequently acquired in the health care setting, and more than one-half of cases now occur in patients without known heart disease. Despite optimal care, mortality approaches 30% at 1 year. The challenges posed by infective endocarditis are significant. It is heterogeneous in etiology, clinical manifestations, and course. Staphylococcus aureus, which has become the predominant causative organism in the developed world, leads to an aggressive form of the disease, often in vulnerable or elderly patient populations. There is a lack of research infrastructure and funding, with few randomized controlled trials to guide practice. Longstanding controversies such as the timing of surgery or the role of antibiotic prophylaxis have not been resolved. The present article reviews the challenges posed by infective endocarditis and outlines current and future strategies to limit its impact.
Topics: Aged; Anti-Bacterial Agents; Endocarditis; Equipment and Supplies; Humans; Male; Practice Guidelines as Topic; Stroke
PubMed: 28104075
DOI: 10.1016/j.jacc.2016.10.066 -
Journal of Wound Care Feb 2020
Topics: Clinical Protocols; Equipment and Supplies; Humans; Practice Guidelines as Topic; Pressure Ulcer
PubMed: 32067552
DOI: 10.12968/jowc.2020.29.Sup2a.S1 -
Best Practice & Research. Clinical... Oct 2021Hospitals face catastrophic financial challenges in light of the coronavirus disease 2019 (COVID-19) pandemic. Acute shortages in materials such as masks, ventilators,... (Review)
Review
Hospitals face catastrophic financial challenges in light of the coronavirus disease 2019 (COVID-19) pandemic. Acute shortages in materials such as masks, ventilators, intensive care unit capacity, and personal protective equipment (PPE) are a significant concern. The future success of supply chain management involves increasing the transparency of where our raw materials are sourced, diversifying of our product resources, and improving our technology that is able to predict potential shortages. It is also important to develop a proactive budgeting strategy to meet supply demands through early designation of dependable roles to support organizations and through the education of healthcare staff. In this paper, we discuss supply chain management, governance and financing, emergency protocols, including emergency procurement and supply chain, supply chain gaps and how to address them, and the importance of communication in the times of crisis.
Topics: COVID-19; Civil Defense; Crew Resource Management, Healthcare; Equipment and Supplies, Hospital; Humans; Personal Protective Equipment
PubMed: 34511225
DOI: 10.1016/j.bpa.2020.11.007 -
The American Journal of Bioethics : AJOB Aug 2020
Topics: Commerce; Equipment and Supplies; Ethics, Business; Health Care Sector; Humans; Marketing
PubMed: 32757913
DOI: 10.1080/15265161.2020.1782643 -
Paediatric Respiratory Reviews Sep 2020There are significant logistical challenges to providing respiratory support devices, beyond simple oxygen flow, when centres run out of supplies or do not have these... (Review)
Review
There are significant logistical challenges to providing respiratory support devices, beyond simple oxygen flow, when centres run out of supplies or do not have these devices at all, such as in low resource settings. At the peak of the COVID-19 crisis, it was extremely difficult to import medical equipment and supplies, because most countries prohibited the medical industry from selling outside of their own countries. As a consequence, engineering teams worldwide volunteered to develop emergency devices, and medical experts in mechanical ventilation helped to guide the design and evaluation of prototypes. Although regulations vary among countries, given the emergency situation, some Regulatory Agencies facilitated expedited procedures. However, laboratory and animal model testing are crucial to minimize the potential risk for patients when treated with a device that may worsen clinical outcome if poorly designed or misused.
Topics: Betacoronavirus; COVID-19; Continuous Positive Airway Pressure; Coronavirus Infections; Device Approval; Education, Professional, Retraining; Equipment Design; Equipment and Supplies; Humans; Medical Device Legislation; Noninvasive Ventilation; Pandemics; Personnel Staffing and Scheduling; Pneumonia, Viral; Respiration, Artificial; Respiratory Distress Syndrome; Respiratory Insufficiency; SARS-CoV-2; Spain; Ventilators, Mechanical
PubMed: 32690356
DOI: 10.1016/j.prrv.2020.06.015 -
Orthopaedics & Traumatology, Surgery &... Feb 2016Patient safety requires speedy detection of any medical device malfunction; this is known as "materials vigilance". It entails the need to be able to trace back the... (Review)
Review
Patient safety requires speedy detection of any medical device malfunction; this is known as "materials vigilance". It entails the need to be able to trace back the life-long pathway of a device; this is "traceability". European regulations enact free circulation of medical devices throughout the European Union, with each member state being responsible for safety within its own territory. Medical devices are divided into 3 categories of increasing risk. CE marking mandatory for medical devices distributed within the EU, and count as market authorizations. They are delivered with 5-year validity by what is known as a "notified body". Health authorities are responsible for monitoring the market and any incidents. New regulations are presently being drawn up to improve efficiency and transparency. Materials vigilance is founded on mandatory declaration of medical device incidents. At local level, it comprises local reporters responsible for informing the National Health Products Safety Agency (Agence nationale de sécurité du médicament et des produits de santé [ANSM]) of any incidents and taking all necessary precautions. At national level, the ANSM assesses the safety, efficacy and quality of healthcare products; it centralizes and assesses materials vigilance reports and takes the requisite decisions. Materials vigilance is further organized at the European and international levels, to harmonize legislation regarding medical devices. Traceability is intended to rapidly identify medical device bearers in case of product recall. Each center is to organize the traceability of its devices; manufacturers' obligation of traceability ceases with the healthcare establishment or user. CE marking involves strict labeling rules to ensure safety of use. A change in the organization of traceability is presently underway, in the form of international Unique Device Identifiers, with harmonized label data, barcodes and standardized terminology. A European and later international database will be set up. The objective is to make Unique Device Identifiers mandatory within the EU by 2017.
Topics: Equipment Failure; Equipment and Supplies; European Union; Humans; Patient Safety; Product Labeling; Prostheses and Implants; Reference Standards
PubMed: 26822532
DOI: 10.1016/j.otsr.2015.05.013 -
Environmental Microbiology Sep 2018The use of medical devices in modern medicine is constantly increasing. Despite the multiple precautionary strategies that are being employed in hospitals, which include... (Review)
Review
The use of medical devices in modern medicine is constantly increasing. Despite the multiple precautionary strategies that are being employed in hospitals, which include increased hygiene and sterilization measures, bacterial infections on these devices still happen frequently. Staphylococci are among the major causes of medical device infection. This is mostly due to the strong capacity of those bacteria to form device-associated biofilms, which provide resistance to chemical and physical treatments as well as attacks by the host's immune system. Biofilm development is a multistep process with specific factors participating in each step. It is tightly regulated to provide a balance between biofilm expansion and detachment. Detachment from a biofilm on a medical device can lead to severe systemic infection, such as bacteremia and sepsis. While our understanding of staphylococcal biofilm formation has increased significantly and staphylococcal biofilm formation on medical devices is among the best understood biofilm-associated infections, the extensive effort put in preclinical studies with the goal to find novel therapies against staphylococcal device-associated infections has not yet resulted in efficient, applicable therapeutic options for that difficult-to-treat type of disease.
Topics: Biofilms; Equipment and Supplies; Humans; Staphylococcus
PubMed: 29633455
DOI: 10.1111/1462-2920.14129 -
Expert Review of Medical Devices Sep 2019: Cardiac arrest remains a worldwide health problem with very poor outcome. In the absence of bystander resuscitation, survival rates decrease by 10% per minute of... (Review)
Review
: Cardiac arrest remains a worldwide health problem with very poor outcome. In the absence of bystander resuscitation, survival rates decrease by 10% per minute of arrest and global ischemia. Even the best manual chest compressions, however, can only produce a fraction of normal cardiac output and blood flow to vital organs. Physiological principles and current evidence for the use of mechanical devices to increase survival and quality of life after cardiac arrest are highlighted in this review article. : Mechanical adjuncts such as the Active Compression Decompression device, automated chest compressors and the use of a negative pressure valve (Impedance Threshold Device) can synergistically aid in improving quality of CPR and increasing cardiac output and vital organ perfusion. : The current conclusions that the use of mechanical adjunct devices in a preclinical setting is not recommended or neutral at best, need to be reevaluated, especially with regard to new advanced and promising treatments that require prolonged high-quality CPR during the transport to a hospital to improve the outcome of patients.
Topics: Brain; Cardiopulmonary Resuscitation; Electric Impedance; Equipment and Supplies; Heart Arrest; Humans; Prostheses and Implants
PubMed: 31353970
DOI: 10.1080/17434440.2019.1649135 -
Inquiry : a Journal of Medical Care... 2021We developed and tested the effectiveness of an algorithm to prevent medical device-related pressure injuries in intensive care unit patients. It was developed in four... (Review)
Review
We developed and tested the effectiveness of an algorithm to prevent medical device-related pressure injuries in intensive care unit patients. It was developed in four stages: literature review and analysis of medical records; preliminary algorithm development; validation of the preliminary algorithm by experts in two rounds; and practical feasibility verification of the revised algorithm by 109 intensive care unit nurses. To verify the algorithm's effectiveness, we compared the incidence of medical device-related pressure injuries between 324 patients without algorithm application (control group) and 312 patients with algorithm application (experimental group). The outcomes were skin inspection of the medical device attachment, pressure injury evaluation, and implementation of pressure injury-preventive nursing care, based on the medical device type. The incidence rates were 1.46 per 100 devices (control group) and 1.19 per 100 devices (experimental group). Since there was no homogeneity in the previous score of the Braden scale in the experimental and control groups, the results regarding the incidence of pressure damage after applying the algorithm should be interpreted with care. Applying this algorithm was a safe intervention that helped prevent medical device-related pressure injuries in this population.
Topics: Algorithms; Humans; Incidence; Intensive Care Units; Pressure Ulcer; Risk Factors
PubMed: 34672226
DOI: 10.1177/00469580211050219 -
Indian Journal of Medical Ethics 2019The report by the International Consortium of Investigative Journalists (ICIJ) on the international medical device industry adds to the growing documentation of health...
The report by the International Consortium of Investigative Journalists (ICIJ) on the international medical device industry adds to the growing documentation of health scandals in India in recent years. A comprehensive picture emerges of manufacturers selling untested products at usurious rates; criminally negligent doctors and medical establishments; and a regulatory system focused on the industry's growth with little regard for patient safety.
Topics: Equipment and Supplies; Ethics, Business; Ethics, Medical; Government Regulation; Humans; Industry; Patient Safety
PubMed: 30919806
DOI: 10.20529/IJME.2019.002