A Summation Of The Safe Medical Devices Act
The SMDA Act is an act that sanctions the progressive reporting as well as tracking the regulations for the use of the medical devices. The medical devices defined under the Act involve the devices classified within the consent of the Medical Device Regulation Act. The Act is responsible for the mandate of reporting the requirements made by the manufacturers of medical devices.
The requirements hold with regards to the safety events as well as the product efficiency of the said devices. Based on the Act, the devices are classified with a substantial equivalence to the class II medical devices (Fekete 605). The amendments to the Acts that pertain to the application of the various devices in the medical field took place in 1990, with the enactment of the then president of the United States President Edward M. Kennedy.
Therefore, the Act focuses on determining the appropriate procedure for the usage, storage as well as the cleaning of the medical equipment. As a result, it is deemed effective about the issue relating to the handling of the medical devices within the health sector of the United States of America (Fekete 605). As a result, it is prudent that the essay focuses on the effects of the SMDA Act on maintenance, and management, the usage, lifespan, as well as the storage of the medical equipment.
The Effects of the SMDA Act on:
The Usage of the Medical Devices
Based on the Act, there is a certain protocol that to govern the manner in which the manufacturer uses the medical devices used within the industry. Every device is manufactured to serve a specific purpose in the health care, and hence the application of the devices must follow the laid out precepts (Fekete 605). The Act exists to ensure that the usage of the medical equipment is within the requirements of the law, as well as for the execution of the intended functions.
Firstly, the SMDA led to the creation of a plan for the usage of the medical equipment. With regards to the acquisition of the new equipment, it was possible to give responsibility to certain regulatory bodies within the health sector to carry out the process. Based on the Act, the medical equipment ranging from syringes, thermometers electrical devices, catheters, and autoclaves must be cleaned after use. After the cleaning process, the equipment is taken for safe storage, and the regulations or the storage and general handling procedures stipulated in the catalogs for the various equipment must be adhered to (Fekete 605).
The manufacturers of the equipment are responsible for putting the procedures in place so that the users of the devices can apply the same procedures to execute the various roles they were meant to, in the health facilities (Fekete 605). Based on the SMDA Act, the medical equipment should be ready for use at any given time, and there are professional protocols that are taught in the medical courses on how to handle the equipment.
The Act also gives the freedom of renting the equipment, as long as they are in good condition, before and after the acquisition from the respective loaner. The rental equipment must have the approval of the chairperson of the departments concerned, for the ease of management, and to enable an easy way of tracing the equipment.
Additionally, in cases of loaning of the medical equipment, there must be proof of safety of the equipment with the certification of the same before the usage of the medical devices (Jyothi, Venkatesh, & Pramod 583). Therefore, it is evident that the SMDA Act has affected the process of the application of the medical devices in the various aspects of the health care services, in a more significant way.
Based on the analysis, the SMDA Act led to the definition of the various protocols to govern the processes that pertain to the application of the medical equipment to serve the various purposes within the industry (Jyothi, Venkatesh, & Pramod 584). There are set committees or leaders within the sector, to oversee the adherence to the laid out regulations of the Act, and to ensure that the usage of the medical devices is satisfactory and bound by the respective requirements of the regulations.
Storage of the Medical Devices
The SMDA Act gave the power to the Food and Drug Administration regulations of medical devices, to define the appropriate storage mechanisms for the storage of the medical devices (Jyothi, Venkatesh, & Pramod 584). Therefore, most of the regulations governing the storage of the medical devices are vested within the power of the regulatory body, and it is responsible for taking any action against the inappropriate storage mechanisms for the devices.
Based on the FDA regulations, the storage of the devices must be based on their condition, as well as the safety of the place of storage (Fekete 605). The place of storage should be free from access by the unauthorized people, as well as capable of preventing burglary attempts. The most important issue on the storage is the safety of the equipment regarding cleanliness, and the safety from stealing by thieves.
Additionally, the FDA regulations also define the appropriate measures that are put in place to safeguard the documents from unsafe situations (Jyothi, Venkatesh, & Pramod 587). The documents that contain the information regarding the purchase, as well as the ownership of such equipment, are placed in safe places, free from access by many people, apart from the few who are allowed access.
Lifespan of Medical Devices
The SMDA Act guaranteed a long life span for the medical devices because, with the maximum adherence to the storage as well as usage measures, the equipment will remain safe. The safety of the equipment is dependent on the safety precautions (Jyothi, Venkatesh, & Pramod 584). If the people handling the equipment are not keen in observing such precautions, then the equipment will last for a short while. However, the keen application of the storage as well as the usage procedures guarantees the safety of the equipment, at all times before and after use. Therefore, by defining the appropriate storage and usage the protocols, the SMDA Act has increased the lifespan of medical devices.
Works Cited
Fekete, Stephanie P. "Litigating Medical Device Premarket Classification Decisions for Small Business: Have the Courts Given the FDA Too Much Deference: The Case for Taking the Focus off of Efficacy." Cath. UL Rev. 65 (2015): 605.
Jyothi, G. V. S. S. N., Venkatesh, M. P., & Pramod Kumar, T. M. (2013). Regulations of medical devices in regulated countries: A comparative review. Therapeutic Innovation & Regulatory Science, 47(5), 581-592.
