Medical devices adverse events

Form FDA 3500 Voluntary reporting of adverse events (reactions, failures, malfunctions) with drugs or devices by medical personnel... 

All adverse events with medical devices of which the manufacturer becomes aware must be recorded. The detailed legal requirements in relation to recording and reporting are, curiously, more onerous in relation to MDs than AIMDs. However, the Commission s guidance is that they should be treated the same in practice. In general, a manufacturer of general medical devices should report, and a Member State record and evaluate,... 

Accepts reports from consumers and health professionals about products regulated by the FDA, including drugs and medical devices, through Med-Watch, the FDA s safety information and adverse event reporting program. (800) 332-1088... 

Samore MH, Evans RS, Lassen A, Gould P, Lloyd J, et al. Surveillance of medical device-related hazards and adverse events in hospitalized patients. JAMA, 2004 291 325-34, (http //www.ncbi.nlm.nih.gov/ entrez/query.fcgi cmd=Retrieve db=pubmed dopt= Abstract8dist uids-14734595). 

Risks from drugs and other medical products generally fall into four categories (Fig. 9-4). Most injuries and deaths associated with the use of medical products result from their known adverse effects. Some adverse effects are unavoidable, but others can be prevented or minimized by careful product choice and use. It is estimated that more than half the adverse effects from pharmaceuticals are avoidable. Other sources of preventable adverse events are medication or device errors. 

Adverse event or experience Any untoward medical occurrence in a patient treated with a pharmaceutical product/device, reported from any source. This does not imply that a casual relationship exists with this treatment... 

Adverse Events. The Safe Medical Devices Act of 1990 included a provision by which both users and manufacturers (and distributors) of medical devices are required to report adverse patient events that may be related to a medical device. Manufacturers must report to the FDA if a device (a) may have caused or contributed to a death or serious injury, or (b) malfunctioned in such a way as would be likely to cause or contribute to a death or serious injury if the malfunction were to reoccur. Device users are required to notify the device manufacturer of reportable incidents, and must also notify the FDA in case of a device-related death. In addition, the FDA established a voluntary program for reporting device problems that may not have caused an untoward patient event, but which may have the potential for such an occurrence under altered circumstances. 

Baker, N., Tweedale, C. and Ellis, C.J. (2002) Adverse events with medical devices may go unreported. British Medical Journal, 325(7369), 905. 

Medical device manufacturers are required to report adverse events related to their devices as per 21 CFR 803 under the definition of MDR. Adverse events can be reported directly to device manufacturers or reported to the FDA. The MDR database is searchable and open to the public. In some instances, MDR can provide safety signals for devices that can provoke actions to ensure patient safety such as product recalls. 

Food and Drug Administration (FDA) Surveillance System. This was developed and is managed by the FDA. As part of this system, all adverse events reports concerning medical products after their formal approval are submitted to the FDA. In the case of medical devices, the device manufacturers report information on items such as deaths, serious injuries, and malfunctions. Furthermore, the device user facilities such as hospitals and nursing homes are required to report deaths to both the FDA and manufacturers and also serious injuries to device manufacturers. In regard to drug-related adverse events, reporting is mandatory for all manufacturers, but it is voluntary for physicians, consumers, and so on [2]. 

Lin, L., Vicente, K. J., Doyle, D. Patient Safety, Potential Adverse Drug Events, and Medical Device Design A Human Factors Engineering Approach, Journal of Biomedical Informatics, Vol. 34, No. 4,2001, pp. 274-284. 

The United States Eood and Drug Administration (EDA) states that any serious adverse event should be reported to the EDA and defines such an event as any undesirable experience associated with the use of a medical product in a patient. The event is said to be serious when the patient outcome is death, life-threatening, hospitalization (initial or prolonged), disability or permanent damage, congenital anomaly/birth defect, required intervention to prevent permanent impairment or damage (devices), and other serious important medical events (e.g., allergic bronchospasm, serious blood dysaasias, or seizures or convulsions that do not result in hospitalization). 

Samore MH, Evans RS, Lassen A, Gonld P, Lloyd J, Gardner RM, Abonzelof R, Taylor C, Woodbnry DA, Willy M, Bright RA. Snrveillance of medical-device-lelated hazards and adverse events in hospitalised patients. JAMA 2004 291 325-... 

The duties of EU manufacturers with respect to adverse-event notification and evaluation have been regulated in the Product Safety Directives, but for the operation of a vigilance system to enhance patient safety, there are only guidelines and no law. In practice, this means that EU manufacturers are obliged to notify any adverse event to the competent authority of their country (e.g., the medical device agency of the National Health Inspectorate). The... 

The number of adverse events appears to be irrelevant. In daily practice few medical device failures lead to patient damage. They are rarely encountered within the same hospital and therefore often experiences as bad luck. There is no obligation for doctors to report device failure, which often remains unrecognised due to lack of experience of how to assess and to confirm a typical device failure. 

The risk of failure of medical devices in general and for each device in particular should be considered acceptable. When good performance and absence of adverse events can be predicted with sufficient certainty, the outcome can be discussed with the patient in order to allow him to balance risks and benefits. 

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