Safe Medical Devices Act of 1990: A Milestone in US History - Essay Sample

Introduction

The Safe Medical Devices Act of 1990 was signed on the 28th November 1990 by the then president of the United States George Bush. Since the Medical Amendment Act of 1976, the Safe Medical Device Act was the first significant device amendment to the Federal Food, Drug, and Cosmetic Act. Indeed this Act was an extension of the Medical Device Amendments of 1976, which imposed rules on the production, distribution, and sales of medical devices to the health facilities.

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The Safe Medical Device Act gave the Food and Drug Administration the legal authority to have a directly participate in regulating the use of medical devices in the healthcare sectors. The provisions in the Act include the specific requirements for the health professionals and hospitals as well as other users of the medical devices within the health sector. The law also demands that the manufactures and the distributors of the Medical devices adopt a system of device tracking for safety and security purposes.

Furthermore, various hospitals and healthcare institutions are expected to corporate with the manufactures and provide information on patients that require permanently implanted devices or life-sustaining devices outside the hospital premises. Having such information is vital in monitoring and evaluation of the utilisation and the effectiveness of the Medical devices. Moreover, the Act also permits the Food and Drug Administration Authority to designate other specific health devices subject to track, especially if the tracking would be significant in the preservation of the health of the patient.

Most importantly, the Safe Medical Devices Act gives the health professionals and the device users the responsibility of reporting the patient's incidents that involve the medical devices particularly to the manufactures and to the Food and Drug Administration Authority. Such reporting should be done in case the device caused severe injuries to the patient or immensely contributed to the injury, death and or adverse experience described by the Food and Drug Administration Authority as Fractures, temporary paralysis among others.

Again, the device users and the manufacturers have the obligation of reporting severe injuries and the deaths that have been caused by the medical devices as well as maintain adverse event files for future references. The act describes a user facility as an ambulatory surgery facility, hospital, nursing home or an outpatient diagnostic facility that is not the physician's office. In the context of the act, however, a medical device refers to any item used for diagnosis, treatment and disease prevention other than a drug or any biologic substance.

Concisely, the Food and Drug Administration has been mandated under the act to order to recall medical devices, carry out user notification as well as temporary suspension of the premarket approval of a machine. They can also impose civil and criminal penalties to enforce the requirements for Medical Reporting. In coming up with sentences, the Food and Drug Administration Authority takes into consideration the nature, extent and the gravity of the violations as well as the ability of the violator to pay such penalties. The history of prior violations is also considered in the determination of the appropriate punishment.

The Essence of the Safe Medical Devices Act to the Management of Medical Equipment

Even though safety of the patients have primarily focused on the errors in medications in the recent past, medical devices have immense contribution to the injuries and deaths reported from patients today. The safe Medical Act encourages the monitoring of the adverse events involving the medical devices thereby promoting timely detection and correction of problems associated with the tools in case they arise. The Act also provides for reporting of device malfunctioning thus contributing to the increased life span of the medical equipment in the hospital or nursing home. The fact that the Safe Medical Devices Act provides for tracking and thorough supervision of the medical equipment within the healthcare facility helps significantly in the management of such devices ranging from the usage to storage and their life span.

An example of a case that is reportable under the Safe Medical device act is a case of removal of the of an intraocular lens because of the severe corneal ulcer in a prolonged wear contact lens for the patients that require hospitalisation. To avoid the penalties associated with poor handling storage and management of the medical devices, health care facilities often tend to adequately adhere to the regulations contained in the Safe Medical Devices Act of 1990.

Furthermore, the Act also tasks the Food and Drug administration with ensuring safety and effectiveness of the manufactured healthcare equipment and devices. Technological devices in healthcare such as the infusion pumps have improved the patient's outcomes in the recent past. However, these devices have severe contributions to the injury and the death of many patients in various health facilities. Therefore, the tracking possibility provided for under the Act also reduces the likelihood of misplacement of the medical devices that could pose health risks to the patients.

Conclusion

In conclusion, medical errors have been viewed in the past as the most significant cause of injuries and death of patients within the clinical environment. However, poor handling of the medical devices and equipment is the great contributor of injuries and sometimes death of the patient. Safe Medical Devices Act places the responsibility on the manufacturers and various stakeholders within the health care sector to ensure efficient handling of the medical devices and equipment.

References

Loob, W. H. (1991). The Safe Medical Devices Act of 1990: Are hospitals ready to deal with the FDA?. Journal of clinical engineering, 16(1), 35-48. https://doi.org/10.1097/00004669-199101000-00011