Medical Equipment Liability Lawsuits Continue to Grow
Liability is an individual’s responsibility for his or her conduct for failure to meet a standard of care or for failure to perform a duty that causes harm to the client. Strict liability differs in that liability may be proved without demonstrating fault. Product liability is the liability for a manufacturer or vendor for injury to a person by a given product.
What constitutes a medical device or medical equipment? Medical device is a broad term encompassing such items as implants, single use disposable devices, instruments, machines, apparatus, and reagents. Medical devices are essential for safe and effective prevention, diagnosis, treatment and rehabilitation of illness and disease. The achievement of health-related development goals, including the Millennium Development Goals depends upon proper manufacturing, regulation, planning, assessment, acquisition, management and use of medical devices which are of good quality, safe and compatible with the settings in which they are used. As outlined in the World Health Assembly resolution WHA60.29, the WHO Department of Essential Health Technologies (EHT), Diagnostics Imaging and Medical Devices Team (DIM) aims to ensure improved access, quality and use of safe and appropriate medical devices in line with Primary Health Care Reform.
The Safe Medical Devices Act of 1990 (SMDA) provides rules and regulations for the safety and reporting of medical devices. Under the DMDA, healthcare facilities must report serious or potentially serious device-related injuries or illnesses of patients and /or employees to the device’s manufacturer if death from a device has occurred, it must be reported to the Food and Drug Administration (FDA).
Individual responsibility for continuing education and keeping up to date is of the utmost importance. Competence is the ability to provide a level of care according to a standard of care and according to the professions code of ethics. Incompetence is the failing of moral commitment in upholding the code of ethics. Incompetence jeopardizes patient safety and well-being. Furthermore colleagues are placed at risk when they are unable to depend on a team member. When a caregiver identifies incompetence he or she should report it to the proper channels. Incompetence must not be tolerated.
The number of medical equipment liability lawsuits continues to grow, especially in the era of advance technology and the increased use of healthcare devices and equipment. Injury from a device or medical equipment may involve a primary caregiver, organization, and/or equipment manufacture Several recent nation and statewide cases have found manufacturers of medical equipment guilty of many different activities that have resulted in deaths and injuries. Manufacturers and even marketers of these faulty products are all legally responsible for the safety of their products. Because of its very nature, medical equipment laws are especially stringent and protect patients and others from unreasonable harm. These laws include protection from malfunction, misuse, cost, and several others.
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