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PLoS Medicine 2012Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings.
METHODS AND FINDINGS
We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n = 9), studies of device recalls (n = 8), and surveys of device manufacturers (n = 3). These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys.
CONCLUSIONS
Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting.
Topics: Equipment and Supplies; European Union; Humans; Medical Device Recalls; Product Surveillance, Postmarketing; Social Control, Formal; United States
PubMed: 22912563
DOI: 10.1371/journal.pmed.1001276 -
BMC Medical Informatics and Decision... Sep 2020Modern healthcare devices can be connected to computer networks and many western healthcare institutions run those devices in networks. At the same time, cyber attacks...
BACKGROUND
Modern healthcare devices can be connected to computer networks and many western healthcare institutions run those devices in networks. At the same time, cyber attacks are on the rise and there is evidence that cybercriminals do not spare critical infrastructure such as major hospitals, even if they endanger patients. Intuitively, the more and closer connected healthcare devices are to public networks, the higher the risk of getting attacked.
METHODS
To asses the current connectivity status of healthcare devices, we surveyed the field of German hospitals and especially University Medical Center UMCs.
RESULTS
The results show a strong correlation between the networking degree and the number of medical devices. The average number of medical devices is 25.150, with a median of networked medical devices of 3.600. Actual key users of networked medical devices are the departments Radiology, Intensive Care, Radio-Oncology RO, Nuclear Medicine NUC, and Anaesthesiology in the group of UMCs. In the next five years, the usage of networked medical devices will increase significantly in the departments of Surgery, Intensive Care, and Radiology. We detected a strong correlation between the degree of connectivity and the likelihood of being attacked.The survey answers regarding the cyber security status reveal a lack of security basics in some of the inquired hospitals. We did discover successful attacks in hospitals with separated or subsidiary departments. A fusion of competencies on an organizational level facilitates the right behavior here. Most hospitals rated themselves predominantly positively in the self-assessment but also stated the usefulness of IT security insurance.
CONCLUSIONS
Concluding our results, hospitals are already facing the consequences of omitted measures within their growing pool of medical devices. Continuously relying on historically grown structures without adaption and trusting manufactures to solve vectors is a critical behavior that could seriously endanger patients.
Topics: Computer Communication Networks; Computer Security; Equipment and Supplies; Germany; Health Facilities; Hospitals; Humans; Radiography; Radiology; Risk Assessment; Security Measures
PubMed: 32993623
DOI: 10.1186/s12911-020-01259-y -
Infectious Disease Clinics of North... Dec 2018Treatment of medical device-related infections is challenging and recurrence is common. The main reason for this is that microorganisms adhere to the surfaces of medical... (Review)
Review
Treatment of medical device-related infections is challenging and recurrence is common. The main reason for this is that microorganisms adhere to the surfaces of medical devices and enter into a biofilm state in which they display distinct growth rates, structural features, and protection from antimicrobial agents and host immune mechanisms compared with their planktonic counterparts. This article reviews how microorganisms form biofilms and the mechanisms of protection against antimicrobial agents and the host immune system provided by biofilms. Also discussed are innovative strategies for the diagnosis of biofilm-associated infection and novel approaches to treatment and prevention of medical device-associated infections.
Topics: Bacterial Infections; Biofilms; Equipment and Supplies; Humans
PubMed: 30241715
DOI: 10.1016/j.idc.2018.06.009 -
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 -
FEMS Immunology and Medical Microbiology Aug 2010Biofilms play a pivotal role in healthcare-associated infections, especially those related to the implant of medical devices, such as intravascular catheters, urinary... (Review)
Review
Biofilms play a pivotal role in healthcare-associated infections, especially those related to the implant of medical devices, such as intravascular catheters, urinary catheters and orthopaedic implants. This paper reviews the most successful approaches for the control and prevention of these infections as well as promising perspectives for the development of novel devices refractory to microbial adhesion, colonization and biofilm formation.
Topics: Biofilms; Catheter-Related Infections; Cross Infection; Equipment and Supplies; Humans; Infection Control; Prosthesis-Related Infections
PubMed: 20412300
DOI: 10.1111/j.1574-695X.2010.00665.x -
Journal of Diabetes Science and... Jul 2018
Topics: Computer Security; Diabetes Mellitus; Equipment Safety; Equipment and Supplies; Humans; Medical Device Legislation; Wireless Technology
PubMed: 29575925
DOI: 10.1177/1932296818763634 -
Emerging Infectious Diseases 2001Microorganisms commonly attach to living and nonliving surfaces, including those of indwelling medical devices, and form biofilms made up of extracellular polymers. In... (Review)
Review
Microorganisms commonly attach to living and nonliving surfaces, including those of indwelling medical devices, and form biofilms made up of extracellular polymers. In this state, microorganisms are highly resistant to antimicrobial treatment and are tenaciously bound to the surface. To better understand and control biofilms on indwelling medical devices, researchers should develop reliable sampling and measurement techniques, investigate the role of biofilms in antimicrobial drug resistance, and establish the link between biofilm contamination and patient infection.
Topics: Biofilms; Catheterization, Central Venous; Equipment Contamination; Equipment and Supplies, Hospital; Heart Valve Prosthesis; Humans; Urinary Catheterization
PubMed: 11294723
DOI: 10.3201/eid0702.010226 -
Diagnostic and Interventional Radiology... Jul 2018Cardiovascular devices and hemodynamic monitoring systems continue to evolve with the goal of allowing for rapid clinical intervention and management. Cardiovascular... (Review)
Review
Cardiovascular devices and hemodynamic monitoring systems continue to evolve with the goal of allowing for rapid clinical intervention and management. Cardiovascular devices including the CardioMicroelectromechanical (CardioMEMS) device, implantable loop recorder, and right ventricular (RV) leadless pacemaker are now widely used for treatment and monitoring of advanced cardiac conditions, as many of these devices have been shown to significantly improve patient outcomes. Additionally, hemodynamic monitoring devices have shown utility in monitoring patients with aortic aneurysms after endovascular aortic repair (EVAR) for early detection of Type I and Type II endoleaks. There is limited published data regarding the imaging features of these devices. As these devices become more widely used, it is important for radiologists to become familiar with the normal imaging features and potential complications. The goal of this review is to summarize the data regarding the use of leadless cardiovascular devices including the CardioMEMS device, implantable loop recorder, and RV leadless pacemaker, and to present cases demonstrating their utility and normal imaging features.
Topics: Equipment Design; Equipment and Supplies; Humans; Monitoring, Physiologic; Pacemaker, Artificial; Radiography; Tomography, X-Ray Computed
PubMed: 30091710
DOI: 10.5152/dir.2018.17462 -
Therapie 2013Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months...
Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson's patients). A round-table held during the XXVIII(th) Giens Workshops meeting focused on the methodology of scientific evaluation of medical devices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative. An update of the multiple regulatory protocols governing medical devices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented.
Topics: Cost-Benefit Analysis; Equipment and Supplies; Evaluation Studies as Topic; France; Humans; Inventions; Medical Device Legislation; Prosthesis Implantation; Surgical Procedures, Operative
PubMed: 23981256
DOI: 10.2515/therapie/2013036 -
Pharmacoepidemiology and Drug Safety Sep 2019Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive-reactive postmarket surveillance (PMS) system.... (Review)
Review
PURPOSE
Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive-reactive postmarket surveillance (PMS) system. Various European Union (EU) national competent authorities have started to focus on strengthening the postmarket risk evaluation. As a consequence, the new EU medical device regulation was published; it includes the concept of a PMS Plan.
METHODS
This publication reviewed Annex III Technical Documentation on PMS and Annex XIV Part B: Postmarket clinical follow-up from the new Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices.
RESULTS
The results of the PMS activities will be described in the PMS plan and will be used to update other related documents. A modular approach to structure the contents of the PMS plan will help to consistently update other PMS information. It is our suggestion that the PMS plan should consist of a PMS plan Core and a PMS plan Supplement. The PMS plan Core document will describe the PMS system, and the PMS plan Supplement will outline the specific activities performed by the manufacturer for a particular medical device.
CONCLUSIONS
The PMS plan may serve as a thorough tool for the benefit-risk evaluation of medical devices. If properly developed and implemented, it will function as a key player in the establishment of a new framework for proactive safety evaluation of medical devices.
Topics: Device Approval; Equipment and Supplies; European Union; Feasibility Studies; Product Surveillance, Postmarketing; Risk Assessment
PubMed: 31318470
DOI: 10.1002/pds.4859