Cardiovascular Devices and Latex Gloves Reclassified Court Allows Off-Label Promotion of Medical Devices

1999 ◽  
Vol 24 (6) ◽  
pp. 337-338
Author(s):  
Jay Geller
2018 ◽  
Vol 69 (3) ◽  
pp. 755-757
Author(s):  
Ionut Vida Simiti

Breaking the limits of the risks for the human body, health or even the life of the patient, as assumed by the pharmaceutical producers, by using a drug off label, for its side effects, in another purpose or even against the purpose for which the drug was authorized by the National Agency of Medicine and Medical Devices, is not in itself illegal if the off label use has the common consent of both the doctor and the patient for a treatment and only for a treatment which, although a spread procedure, has little or no scientific support. But if the patient is subjected to unreasonable risks, endangering his body, health or life beyond the possible benefits of the treatment, without being informed about the lack of scientific support, the doctor is liable not only for malpractice (civil medical liability) but also for a criminal offence.


Friction ◽  
2021 ◽  
Author(s):  
Xiaogang Zhang ◽  
Yali Zhang ◽  
Zhongmin Jin

AbstractNumerous medical devices have been applied for the treatment or alleviation of various diseases. Tribological issues widely exist in those medical devices and play vital roles in determining their performance and service life. In this review, the bio-tribological issues involved in commonly used medical devices are identified, including artificial joints, fracture fixation devices, skin-related devices, dental restoration devices, cardiovascular devices, and surgical instruments. The current understanding of the bio-tribological behavior and mechanism involved in those devices is summarized. Recent advances in the improvement of tribological properties are examined. Challenges and future developments for the prospective of bio-tribological performance are highlighted.


2010 ◽  
Vol 3 (5) ◽  
pp. 303-306
Author(s):  
Christopher F. Hyer

Drugs and medical devices obtain specific on-label indications for use by the Food and Drug Administration. Physicians are able to use such devices and drugs off label as part of the practice of medicine, but is this is good thing? This edition of In the Profession examines what it means to be off label in terms of regulations, clinical studies, industry marketing, and common areas of use.


2020 ◽  
Author(s):  
Emilia Anderson ◽  
Simon Poon ◽  
Jonathan Penm

BACKGROUND The use of medical devices is rapidly expanding. Despite this, there is a huge gap in the literature surrounding the use of devices in healthcare and the adverse events occurring. Given that these errors can be life-threatening, it is imperative to have a thorough understanding of the problem in order to improve patient safety. OBJECTIVE To conduct a Rapid Review to identify the frequency, types and causes of medical device-related errors which are reported in published peer-reviewed literature. METHODS Following PRISMA guidelines, a literature search strategy was developed. Databases searched until 23 February 2018 included Pubmed, International Pharmaceutical Abstracts and Cinahl. Articles were included if they: defined medical devices, reported the frequency, causes and types of errors, were published in peer-reviewed literature. Articles were screened and discussed by two authors. RESULTS Database searching yielded 7,559 unduplicated articles. After two rounds of screening, 24 articles were included in the Review. Device types included cochlear implants, defibrillator leads, anaesthetic & intensive care devices, surgical equipment, automated external defibrillators, radiation oncology devices, ambulance stretchers, breast pumps, cardiovascular devices, orthopaedic devices, and patient controlled analgesia devices. The frequency of errors was 3.83-33.0%. The most common causes were user error, malfunction and design error. CONCLUSIONS This Review identified a range of device types associated with errors. The frequency of errors was lower than published literature. User error was confirmed as a leading cause, alongside malfunction and design error. Future research should examine near-miss events and expand the device types studied.


2021 ◽  
pp. medethics-2020-107031
Author(s):  
Daniel B. Kramer ◽  
Efthimios Parasidis

Many high-risk medical devices earn US marketing approval based on limited premarket clinical evaluation that leaves important questions unanswered. Rigorous postmarket surveillance includes registries that actively collect and maintain information defined by individual patient exposures to particular devices. Several prominent registries for cardiovascular devices require enrolment as a condition of reimbursement for the implant procedure, without informed consent. In this article, we focus on whether these registries, separate from their legal requirements, have an ethical obligation to obtain informed consent from enrolees, what is lost in not doing so, and the ways in which seeking and obtaining consent might strengthen postmarket surveillance in the USA.


1999 ◽  
Vol 173 (3) ◽  
pp. 539-542 ◽  
Author(s):  
J J Smith ◽  
L Berlin

PEDIATRICS ◽  
2016 ◽  
Vol 139 (1) ◽  
pp. e20163439 ◽  
Author(s):  
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