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This study will
use a descriptive type of research design, specifically; a comparative
–descriptive research design. This
design is appropriate because the hospital will be described in terms of
some basic variables such the number of years it has been in the industry; its
size, categories of services offered, number of medical practitioners, and
medical devices utilized. The hospital will also be described in terms of its
experiences on medical device-related deaths and injuries and how these were

It is also
comparative because the extent of compliance of the hospital will be compared
to the standards of medical device reporting set by the FDA.

Both quantitative
and qualitative data will be gathered.
The quantitative part will be on quantifiable variables, such as average
number of patients, hospital size statistics/figures, number of reports
submitted by type of medical device and categories of related adverse
incidents. Qualitative data will be gathered on the experiences of the
hospitals, its medical practitioners, families of patients, and other
stakeholders of the hospital on adverse events.


Respondents will
be different groups of stakeholders: patients, medical practitioners, support
personnel, households of patients, and others who have been directly or indirectly
involved in the medical device- related adverse incidents.

A combination of
purposive and stratified sampling techniques will be utilized. Respondents will
be identified based on the purpose of the study. To ensure that the groups of
stakeholders are represented, a stratified sampling technique will also be
used. This would mean that the population would be divided into groups or
strata and specific number of respondents will come from each.This is to ensure that each group is


The instruments
that will be utilized are survey questionnaire, interview guide, and
observation checklist. The survey questionnaire will have items on basic
descriptive (basic information about the hospital, its facilities, and
equipment, the patients, and others) whereas the interview guide and
observation checklist will provide qualitative data that will supplement the
data gathered from the questionnaire.

The instruments
will be tested in terms of validity and reliability. The validity will test the
questionnaire and other instruments to see if they provide answers to the
research questions. The test of reliability is in terms of the instrument can
provide stable results even when conducted twice to the same set of
respondents. It will also be a test of consistency of the scores that will be
derived from the responses.


To analyze the
quantitative data that will be gathered, measures of central tendency (mean,
median, mode), measures of variability (standard deviation, variance), t-test
of difference between means (for two groups), and ANOVA (for three groups) will
be used.


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