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Today, surgical devices’ marketing takes place without sufficient evidence as to whether they are safe and effective to use by humanity. This has taken root almost in the entire planet. The industrial marketing is happening with the aim of money making, not considering the outcomes linked to such business. The selfish merchants are so drawn into money making that they rarely consider the negative consequences that may come about. Patients being handled by surgeons have all the rights to be provided with the finest details concerning the level of understanding of a device usage by the later. Current paper discusses the ethical issues that are associated with surgical devices’ marketing without prior sufficient evidence of effectiveness and safety.
The industry has to work very close with physicians appropriately in order to be certain of devices that are new before they are taken out for consumption. Balanced presentations of safety and evidence of new products have to be made available to the concerned parties. The evidence presentation would be a foundation with which safety will be enhanced in the application of a new technology in new devices. Whenever surgeons are making use of any device, they should make attempts to become familiar with the technology behind it. Understanding the effectiveness and safety connected to their usage plus competent and proper training are real ways of sure certainty of devices’ effectiveness. Surgeons should take steps to see that patients acquire information sufficient for evaluating the evidence available (Goldim, 2009). Patients also require information in an honest way that complications may arise as a result of usage of new devices, as well as experiences a surgeon has. This way, evaluation becomes possible for patients and they come up with finality to reject or accept the offered services. On acceptance, there would be psychological preparation in cases of complications.
Health institutions responsible in matters of practice regulation should make a review for economic impacts, effectiveness and device safety before putting them to use. Surgeons new in the usage of the newly introduced devices should have rules regulating and limiting their use so that the patients’ lives are not risked. The idea here being the insurances that competence in training and practice for perfection is done to surgeons. Having strict rules in the industrial consumption is a vital factor that has to be fully considered, so that each stakeholder in the end gets fully satisfied. Surgeons would never enjoy working if numerous complications arise in their line of working. Patients too would lose trust in surgeons’ work. Human beings will see risks instead of solutions to the medical problems that they have. The persons and institutions that are have the responsibility of developing, licensing, and the usage of surgical devices that are new to make sure that they target higher standards of ethics in the profession. By practicing ethics in the industry, safety and health of patients requiring surgery will never be at stake. Without doubt, this is what all persons like.
The minimum universal standards of ethics would require device manufacturers to make provisions of timely and accurate information concerning the safety, as well as the efficacy of the products they produce. The on time information will not only be useful to surgeons, but also to patients needing surgery services. Both parties will have opportunities to make evaluation of information considered to be significant before surgery due to the available evidence. Manufacturers’ usage finer details to surgeons would see that the devices would not be put to use in a manner that has no base. User manuals would inform surgeons of the likely negative outcomes as a result of usage of new developed surgery devices. The effect for this would be lifesaving and tricky technicality avoidance. Complications would in turn become minimal in the medical industry since the usage of such technology would be within control.
The technology related to surgical device production is now a modern miracle. The devices are getting sophisticated day by day. The change of the devices’ technology is being worked on to come up with solutions to the new problems and the old ones that have never been solved. The developed devices are falling in the hands of surgeons who put them to use in nontraditional setting. There is a point that is worth noting. Decisions concerning medical device regulation for the aim of effectiveness and safety by physicians in center of medication cannot be put into use when addressing problems of a ninety years old person (Freemont & Kitney, 2012). A device that is manufactured for doing surgery to babies has to be different from those of adults and those who have aged. These are diverse patients; hence they have to acquire services of surgery that are unique in some way. As a result of poor control, all persons regardless of their age are subjected to similar device in surgery.
Another ethical issue in Bioengineering is the benefits and risk weighing to determine effectiveness and safety of devices. Surgical devices are manufactured and consequently marketed without benefit cost analysis. It means that there are possible cases in which risks are more than benefits when it comes to surgery. In such cases, life matters have to be considered. Before the board related to regulation allows the usage of any device, the benefits have to be more than the risks (Rinčić & Muzur, 2012). There was anesthesia machine case from a certain manufacturer, where the knobs for increasing gas went opposite the usual direction. It followed that turning such knobs in the usual direction by surgeons increased gas supply to a patient when it was not needed, and lowering the same when increased quantities were desired. The result of the usage of this device was many deaths that would have never occurred if evidence was good before the device was put to use.