Medical Devices & Products Liability

The main issues in this case study are the legality of further sale of medical devices in the presence of safer or more modern units with a lower level of side effects or potential emergency situations associated with their use. This is a problem due to the fact that a large number of deaths or adverse outcomes in medical practice are associated with imperfections of medical instruments. In addition, in many hospitals there is an established tradition of using certain appliances, and the transition to new mechanisms is difficult.

Implicit issues are related to the admission of the patient’s guilt in an unsuccessful outcome. For example, in this case study, the cause of death was not the imperfection of the medical device, but the fact that the patient moved during the procedure. The problem of the need for a universal transition to new devices and the related need to change the current practice has existed for a long time (Medical devices, n. d.). It appeared with the beginning of the active development of medical technologies, as a result of which new more advanced analogues of medical units regularly appear.

Key points of contention are related to the need for fundamental changes in the market of medical products. This can be done with the help of withdrawal of old equipment, or with the preservation of current practice and the gradual introduction of updates. Values of those involved include the preservation of practice traditions on the part of nurses, who will find it difficult to retrain to use new appliances. The values of patients are their life and health, for the preservation of which it is more appropriate to use modern devices, although this will entail certain difficulties for medical personnel.

Standards of practice show that most often there is a practice developed over the years, which is followed in hospitals. Changes towards the use of new devices take a long time and with difficulty (Medical devices, n. d.). Environmental factors which are addressed include, first of all, the management features in the hospital and the structure of the staff.

Older nurses tend to resist the introduction of innovations, just as younger management tends to support modern technology. An important role is played by the amount of funding for hospitals, which allows the purchase of new devices or complicates it. Thus, the standards of practice differ for each specific hospital, but in most cases, more traditional methods of treatment using familiar devices are accepted among the staff.

Consumer and patient rights legislation or healthcare law sate the need to use the treatment method that will be most beneficial for the patient. This is not always the most modern method and the most modern devices, as nurses, as a rule, need time to retrain. In addition, the limited funding of the hospital makes the purchase of life-supporting drugs a higher priority, rather than the constant updating of the technical base (Medical devices, n. d.). In this regard, the most ethical thing for both nurses and patients will be the gradual displacement of old devices from the market and updating them with new ones, rather than a sharp ban on the use of old equipment. The use of this approach will allow nurses to retrain qualitatively, and will also give hospitals the opportunity to manage finances more flexibly.


Medical devices/products lability brief – When do new medical devices render old ones defective? – Hansen v. Baxter Healthcare Corp., 2002 WL 93106

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