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A successfully designed medical device is one that will perform the duty of relieving minor irritations and rectifying life threatening situations. However, the sustainability of the device may be compromised if certain legal procedures of practice are not adhered to. These include the FDA Good Manufacturing Practices (GMPs), the FDA Investigation Device Exemption (IDE), Safe Medical Devices Act of 1990 and Medical Device Reporting Act of 1984.
FDA Good Manufacturing Practices (GMPs)
The U.S. FDA is a body that regulates all medical devices that are sold in the U.S.Complex devices in Class II and Class III are materials that interact with the body at close proximity. In order to enhance the sustainability of these devices in the market, an understanding of the FDA GMPs regulation and adherence is crucial.
The purpose of the GMPs is to ascertain that the manufacturers of the medical devices come up with a device that can design, control, install and service these devices (ISO 9000 certification). Some changes on medical devices may be necessary and may be executed without prior notification to the FDA (FDA, 1997). However, the FDA has controls that regulate any changes effected on the devices.
FDA International Device Exemption (IDE)
The IDE regulations allow the inception of a clinical pre-trial to test for the effectiveness and efficiency of devices that have considerable risk. The decisions reached by the FDA are based on the regulations defined by the FDA. As a result, a decision maybe an ‘Approval’ or ‘Disapproval’. When an application is approved, the sponsor may start subject enrolment based on the benchmarks stipulated by the FDA as described in the decision letter. Also inclusive are the number of subjects to enroll and the investigation centre.
On the other hand, if an application is ‘Disapproved’, the sponsor may not be allowed to initiate the clinical pre-trial until the sponsor provides an amendment that addresses the inadequacies pointed out in the FDA’s letter. Later on, the sponsor may begin the investigation after receiving another approval letter from the FDA that approves the clinical investigation.
Safe Medical Devices Act of 1990
This Act gives the FDA the authority to regulate medical devices by checking for any faulty devices and getting rid of such devices from health care facilities. It also enables the FDA to legally regulate the handling of medical devices and necessitates health practitioners to report incidences were medical devices contribute to or causes an injury, death or other unpleasant experiences (fractures, temporary paralysis, loss of hearing,concussions,burns).This aspect of the law is known as user reporting. The hospital is also mandated to be part of tracking medical devices that are potential in causing serious health ramifications.
Medical Device Reporting Act of 1984.
This Act was enacted by the U.S congress to boost the amount of information that FDA and the medical device manufacturers receive regarding problems with medical services. Underreporting of the device inefficiencies lead to the development of the Safe Medical Device Act of 1990 as discussed above.
It is noteworthy that the regulations designed and implemented by the FDA consider the design of a medical device as important. This is because future deficiencies in the device can be avoided if the nitty gritties of the plan and design of the devices are thoroughly checked; future modifications will be possible if these initial stages of making the device are properly done. In adhering to these regulations, manufacturers prevent incurring any losses and ensure sustainability and longevity of shelf-life of medical devices.