801
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Virginia University of Lynchburg *
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801
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Medicine
Date
Dec 6, 2023
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docx
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2
Uploaded by Lmcrock111
INTRODUCTION The case study pertaining to Health City Cayman Islands highlights notable ethical
considerations surrounding the utilization of recycled medical equipment, a practice that is currently
prohibited in the United States. In order to investigate the concerns that patients may have regarding the
reuse of medical devices and its potential effects on the willingness of both U.S. insurance companies
and patients to participate in this practice, the research inquiry will be addressed through a case study
analysis.
DISCUSSION
In a particular context, the answer is affirmative. Despite the lack of legal permission, it is imperative to
offer patients comprehensive guidance on the numerous factors related to the reutilization of medical
devices. Reusable medical devices are medical equipment that healthcare professionals can employ for
the purpose of diagnosing and treating multiple patients. Surgical forceps, endoscopes, and
stethoscopes serve as prime examples of reusable medical instruments. Reusable medical devices
become contaminated and colonized with bacteria following their use on patients. Reusable medical
devices are defined as those that can be reprocessed and used multiple times by healthcare
professionals, in accordance with the guidelines set forth by the original equipment manufacturer
(OEM). Disposable devices are categorized as products that are explicitly designated by the
manufacturer for either single-use or single-patient use. Reusable medical devices are prone to
contamination and colonization by bacteria after being utilized on patients. Reusable medical devices
undergo a meticulous reprocessing procedure, encompassing a series of steps designed to
comprehensively clean, disinfect, and sterilize the devices.
This process is crucial in reducing the potential for infection that may arise from contaminated
equipment. Reprocessing a medical device enables its safe reuse in either the same patient or multiple
patients, contingent upon strict adherence to reprocessing guidelines following each use of the device.
Proper reprocessing of reusable medical devices is of utmost importance in guaranteeing the safety of
patients. The Food and Drug Administration (FDA), as a public health agency, promotes collaboration and
partnership among diverse stakeholders.
These entities encompass a wide range of stakeholders, such as manufacturers, healthcare institutions
and personnel. Could this factor potentially discourage insurance companies and patients in the United
States from participating in this specific undertaking?
Not at all, Hospitals and external preprocessors, in contravention of the guidelines provided by medical
device manufacturers, procure these devices and subject them to cleaning and sterilization procedures
that entail the use of potentially dangerous chemicals and high temperatures. Subsequently, these
devices are utilized on various patients. Hospitals and preprocessors have successfully accomplished this
feat without any intervention or involvement from the federal government or the pharmaceutical sector.
After acknowledging the aforementioned disclaimer, both insurance companies and patients can now
shift their focus towards the legal aspects surrounding hospital reprocessing and the practice of reusing
medical equipment. This article is to analyze the level of accountability that hospitals bear in cases
pertaining to the practice of reusing materials. It is important to acknowledge that any legal proceedings
regarding the damage caused by reused single-use devices may entail the involvement of various parties,
such as the original device manufacturer, distributors, and hospital physicians who partake in the reuse
practice. Only if Member States opt to authorize the practice through their national legislation, would it
be deemed permissible to engage in the reprocessing of medical devices. Consequently, Member States
have the prerogative to exercise their right to "opt out" of the reprocessing process. Variations may exist
between Member States due to the implementation of national regulations. According to the Medical
Device Regulation (MDR), the party engaged in the reprocessing of a single-use device (SUD) will be
designated as the manufacturer of the reprocessed device, thereby assuming the obligations and
liabilities associated with the manufacturing process, primarily focused on safeguarding patient well-
being. Article 17 of the Medical Device Regulation (MDR) mandates that health facilities involved in the
reprocessing of single-use devices must adhere to compliance requirements.
The Regulation sets forth rigorous standards for the reprocessing of single-use medical devices and
places full product liability on the entity responsible for the pre-processing. In order to adhere to
regulatory requirements, the reprocessed device may necessitate certification from a notified authority,
along with the inclusion of the authority's name and address on the device. This procedure is performed
to determine the safety equivalence between reprocessed devices and the original Single-Use Device
(SUD). Member states are provided with the opportunity to "opt-in" to an exemption that allows
healthcare institutions (and potentially external preprocessors) to deviate from the standard regulations
applicable to producers.
This exemption applies as long as the single-use devices (SUDs) are processed and utilized solely within
the healthcare institution. Only when a healthcare institution or an external preprocessor complies with
established specifications, national regulations, and standardized guidelines, as confirmed by an
accredited organization, will this departure from the Medical Device Regulation (MDR) be authorized.
REFERENCE The U.S. Food and Drug Administration (FDA). The Food and Drug Administration (FDA). 26th
March 2018. Reprocessing of Reusable Medical Devices. Accessed on July 4, 2021. The source of this
information is the official website of the U.S. Food and Drug Administration (FDA), specifically the section
dedicated to medical devices and procedures. The URL for the source is https://www.fda.gov/medical-
devices/products-and-medical-procedures/reprocessing- reusable-medical-devices.
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