Post on 15-Jun-2021
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How to Overcome Regulatory and Ethical
Challenges Regarding Medical Device
Dr. Nancy Agnes, Head, Technical Operations, Pubrica, sales@pubrica.com
In Brief
Biotechnological advancements in medical devices
can intensify risks and introduce new types of risk,
despite their potential to greatly benefit health.
Therapeutic products control is our primary tool for
handling these threats. As these developments
advance, the current regulatory approach is likely to
be called into question.
Keywords: Therapeutic products regulation,
regulatory writing, standardised devices, Healthcare
research, medical data collection.
I. INTRODUCTION
The below are the top ten ethical questions, in order of
priority, as viewed by the participants:(1)Equity of
resources, (2) Patients' Rights, (3Patient Safety, (4) )
Confidentiality of the patients, (5)Ethics of
privatisation, (6)Conflict of Interests, (7)Dealing with
the opposite sex, (8)Informed Consent, (9) Beginning
and end of life, and (10) Healthcare team ethics.
II. ETHICS AND THE PURPOSE OF
THERAPEUTIC GOODS REGULATION
Therapeutic products regulation has two roles, which
are often at odds with one another. Control strives to
preserve the public's health and welfare while enabling
or also promoting useful technologies to enter the
market as soon as possible. The expectation that
suppliers show proof of a product's protection and
efficacy is a significant part of how modern systems
meet these goals. On the one side, this safeguards
people from consuming goods that are harmful or
ineffective. On the other hand, it implies that market
success must be founded on sound science, with quality
creativity rewarded.
If evidentiary expectations are too uncertain, regulators'
ability to protect patients may be endangered; if they
are too high, patients may be denied access to new
developments unnecessarily.
III. PROBLEMS OF EVIDENCE ABOUT DEVICES
The immense ethical challenge with consumer
regulation is that we currently tolerate a high risk
during the business acceptance period due to data
gathering issues and the operational requirements of a
regulatory report writing framework related to products,
not that the stakes have been measured appropriately.
Another hand, many buyers conclude that the
commodity on the market has been adequately tested
for protection and efficacy.
IV. NEW CHALLENGES
Emerging innovations add to the complexity of these
already complicated problems. I'll write to two of them.
1. First, machines are becoming more computerised, with many, such as pacemakers and insulin pumps,
incorporating automation into their operations. It
has various advantages, including automation of
tasks for smoother management; improved
calibration of equipment to patients' needs; a
collection of physiological data of therapeutic
significance; and remote, therefore more effective,
system modification.
The use of software in or as a diagnostic system
exacerbates current problems while also adding new
ones. It ensures that devices may be updated ever more
regularly. These changes can affect the functionality of
devices already in use by patients or even implanted in
their bodies. It would become much more challenging
to ensure the technologies remain secure and
prosperous as they grow.Manufacturers will be held
more responsible for device functionality in the long
term. Software introduces additional types of risks,
such as predicting how functionality will be
compromised when used in combination with various
technical technologies and when applied to multiple
clinical scenarios.Another significant and relatively
recent danger concerns cybersecurity: the threat of
computers being compromised and used to damage
their owners.
Customisation, once again, creates new problems.
Given the unparalleled simplicity with which this
manufacturing method can be used, it could be
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impossible for regulators to keep track of all
applications.
2. Increased system customisation, especially by 3D printing and computer-aided design, is a second
evolving possibility. Implants often used, such as
artificial hips, can now be designed in proportions
more closely matched to individual conditions.
Personalised models can even be explicitly
modelled on patient physiology. It seems to help
patients on the surface; however, gathering
rigorous proof of protection and usefulness for
custom devices is much more complex than
standardised devices. Customisation is profoundly
at odds with the most substantial evidence for
regulatory purposes, created from populations of
study subjects that undergo a standardised
intervention. As a result, customisation exacerbates
the difficulty of finding good data for devices.
Custom instruments have typically been used by
testing laws or legal exemptions in the past. The
more customisation is used, the less suitable this
becomes.
V. QUESTIONING CURRENT APPROACHES
If technological advancements continue to pressure the
existing system, it's worth considering any other
options for interface control. Some innovations can
eliminate inequities, such as using 3D printing to
include lower-tech electronics in low-income nations.
Still, this potential will not be appreciated as long as the
research is incentivised today. Healthcare research is
focused mainly on commercially viable goods that can
disregard changes that may be achieved by societal or
structural change.
VI. LIMITATIONS OF THE STUDY
The willingness to generalise the findings is a critical
drawback. First, the report excluded smaller
underserved rural hospitals, which may have revealed a
different medical data collection of ethics concerns,
even though equality in resource availability was
identified as one of the top five problems.
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Second, despite the study's efforts to include non-
clinicians, male clinicians' dominance in the survey
may have tainted the findings and conclusions. It may
also clarify why no ethical concerns about paramedical
personnel and their interactions with doctors were
raised.
VII. CONCLUSION
The central ethical issues as alleged by the participants
were: (1) Patients' Rights, (2) Equity of resource
distribution, (3) Confidentiality of patients, (4) Patient
Safety, (5) Conflict of Interests, (6) Ethics of
privatisation, (7) Informed Consent, (8) Dealing with
the opposite sex, (9) Beginning and end of life, and (10)
Healthcare Team Ethics.This collection, however, was
not exhaustive. This study's findings were meant to be
compared to those of another task. Since the differences
in culture and healthcare systems, discrepancies were
predicted.
REFERENCES
1. Gibbs JN, et al. 2014. 510(k) statistical patterns. Medical Device and Diagnostic Industry, 2 Dec,
https://www.mddionline.com/510k-statistical-
patterns.
2. Roger WA, Hutchison K. 2017. Hips, knees, and hernia mesh: When does gender matter in surgery?
International Journal of Feminist Approaches to
Bioethics 10(1):148-174.
3. Hutchison K, Sparrow R. 2017. Ethics and the cardiac pacemaker: More than just end-of-life
issues. Europace, online first
doi:10.1093/europace/eux019.
4. IMDRF Software as a Medical Device (SaMD) Working Group. 2014. "Software as a Medical
Device": Possible Framework for Risk
Categorisation and Corresponding Considerations.
International Medical Device Regulators Forum,
http://www.imdrf.org/docs/imdrf/final/technical/im
drf-tech-140918-samd-framework-risk-
categorization-141013.pdf.
https://www.mddionline.com/510k-statistical-patternshttps://www.mddionline.com/510k-statistical-patterns