What are your top 3 takeaways for this article? A US Food and Drug Administratio

Question

What are your top 3 takeaways for this article?

A US Food and Drug Administration (FDA) public health announcement, released to physicians in October 2008, highlighted concerns associated with the use of licensed mesh devices in the minimally invasive surgical repair of pelvic organ prolapse and stress urinary incontinence. The announcement reported serious complications resulting from the use of licensed devices from nine manufacturers, and pointed out that some of the complications led to significant decrease in patient quality of life with ongoing symptoms. The FDA memorandum stressed the need for surgeons to seek specialized training for each type of technique, to be vigilant about adverse events and complications, and highlighted the importance of informing patients about the potential for adverse events with possible long-term unpleasant effects on quality of life [1]. The information in the FDA announcement was reiterated in 2010 by the Health Canada Marketed Health Products Directorate [2]. These unusual announcements underline the dangers associated with the adoption of new licensed medical devices, and provide a reminder that the responsibility for patient outcome lies not only with regulators and device manufacturers, but also with policy makers and surgeons, and that patient should be active in the decision to have surgery performed.

The decisions surrounding the choice of medical device to approve (by device regulators), fund (by health care funding bodies) or adopt into clinical practice (by hospital authorities and clinicians) are affected by many different motivators and barriers, such as perceived effectiveness, safety (as highlighted by the FDA and Health Canada [1, 2]), and also ethical and economic considerations. The research described in this protocol will examine specifically how ethics and economics influence stakeholders' decisions about adopting new devices, particularly when full information on effectiveness and safety may not be available.

In Canada, the licensing and use of new medical devices occurs within a health care system in which the adoption of new technologies is guided by ethics and economics as well as by clinical investigation: assuming that there is evidence that a new device is effective, the adoption of that device is subject to ethical and economic choices at all levels of the health care system. Ethics influences such decisions, seeking assurance that the device will benefit patients while not doing them disproportionate harm, that individuals are fully informed before they make decisions about adopting a new device, and that risks and benefits of a new treatment (or from withdrawing access to an older one) are fairly and reasonably distributed [3]. Economic theory offers further insights into the decision-making process, suggesting that in situations of limited resources, choices are necessary about which technologies should be adopted and which services should be sacrificed in order to free up resources [3, 4, 5, 6]. Thus both ethics and economics are concerned with making good choices in adopting new health technologies, and may even be considered inseparable [3, 4, 5, 6]. They are as fundamental to decisions about licensing and adopting new clinical devices, as considerations of clinical effectiveness and safety.

Explanation / Answer

The following are the top 3 takeaways from this article:

1. FDA had announced to the physicians as there is a probelm in a license device for a surgical repair of the pelvic organ and stress urinary incontinence, where nine manufactures found that the device less on quality to be used for the patient.

2. The FDA stress on the surgeons to train their patients to take on their decision of health and surgery after explaining on the quality, as where the patient must be active towards their decision. So that safety would be a major concern which would focus more on ethics.

3. Ethics and economics plays a major role in the clinical industry as where ethics encourages on new device adoption as where there will not be any harm towards the device and which benefit on the health of the patients. The economic provides on the choice of technology for the patients towards improvising their health and consideration on their safety and quality.

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