DEPARTMENT OF
LIFELONG LEARNING
Student Name:
Natasha D Silva
Student Number:
C00290843
Subject Name:
Medical Device Technology: Design, Development and Testing
Lecturer Name:
John Byrne
Assignment No:
CA02
Total word count:
1,600
DECLARATION
 I declare that all material in this submission e.g. thesis/essay/project/assignment is
entirely my/our own work except where duly acknowledged.
 I have cited the sources of all quotations, paraphrases, summaries of information, tables,
diagrams or other material; including software and other electronic media in which
intellectual property rights may reside.
 I have provided a complete bibliography of all works and sources used in the preparation of
this submission.
 I understand that failure to comply with the Institute’s regulations governing plagiarism
constitutes a serious offence.
Student Name: (Printed)
Natasha D Silva
Student Number(s):
C00290843
Programme Title & Year:
Medical Device Regulatory Affairs
Module :
Medical Device Technology: Design, Development and Testing
Signature(s):
Natasha D Silva
Date:
04/04/2023
Note:
a) An individual declaration is required by each student for joint projects.
b) Where projects are submitted electronically, students are required to type their name
under signature.
c) The Institute regulations on plagiarism are set out in Section 10 of Examination and Assessment
Regulations published each year in the Student Handbook.
Risk Scenario and its Mitigation
Introduction
The goal of risk management in the healthcare industry is to identify, monitor, evaluate, reduce,
and avoid risks to patients. It entails a complicated network of clinical and administrative systems,
processes, procedures, and reporting structures. Every year, about 98,000 individuals (about the
seating capacity of the Los Angeles Memorial Coliseum) die from medical mistakes while
hospitalized (Institute of Medicine, 2000). Medical care today is fraught with risk.
Although the healthcare system is made up of numerous individual participants, collaboration is
the key to achieving its final objectives of patient care and safety. When medical mistakes occur,
even if they are caused by an individual's actions, the organization must take the proper next steps
to recognize, learn from, and enhance the prevention of such events. This places more emphasis
on systemic policy changes than on individual actions (McGowan, et al. 2022).
Patient harm has long been attributed to medication-related mistakes, which can include incorrect
dosage, incorrect administration, and giving patients drugs to which, they have a known
intolerance. As an additional measure to prevent medication-related errors, many hospitals have
increased the accessibility and visibility of pharmacists. This includes 24-hour pharmacist phone
consultations, pharmacist review and sign-off on all medication orders, and physical presence of a
clinical pharmacist in higher risk medical settings, such as intensive care and emergency medicine
(McGowan, et al. 2022).
Instead of placing blame on individuals for human errors, healthcare professionals and patients
need to be protected by a multi-faceted system and culture of protection.
Incident
A patient safety incident is a situation or occurrence that might have caused unneeded harm to a
patient or did. The word "unnecessary" is used in this definition to acknowledge the fact that
mistakes, infractions, patient abuse, and purposefully unsafe acts happen in the healthcare industry
and are unnecessary incidents. A mistake is when a planned action is not carried out as meant or
when the wrong plan is used (Runciman et al., 2009).
A mistake is when a planned action is not carried out as meant or when the wrong plan is used.
Errors can appear when the incorrect thing is done (commission) or when the right thing is not
done (omission), depending on whether they occur during the planning or execution phase
(Runciman et al., 2009).
Wilson's disease, a genetic condition in which a person cannot correctly metabolize and excrete
copper, was identified in a 12-year-old female patient. Initially, there was a nine-month delay
during which the child was diagnosed with a liver disease. The need for therapy from a pediatric
hepatologist caused an additional delay. However, the pediatric hepatologist recommended a 30day supply of the chelating agent Penicillamine, a drug that binds with copper and aids the body
in excreting it, as well as Zinc Acetate and Vitamin B6 when the patient was finally diagnosed.
Three refills were recorded for each prescription (Healthcare Providers Service Organization, n.d.).
The pharmacist was a contract employee hired by a national network of pharmacies. Only a few
days had passed since she started working for the drugstore when the patient's electronic
medication was transmitted to the store. She filled in the wrong order, which was for a 30-day
quantity of penicillin 250 mg) BID (twice a day) instead of penicillamine BID. The pharmacist
was not working at the drugstore when the patient picked up their Penicillamine prescription
because she had only been employed temporarily.
The pharmacy continued to complete the order for penicillin instead of penicillamine over the
subsequent nine months, compounding the pharmacist's mistake. The patient's hepatologist raised
the patient's dose from BID to TID (three times a day) at one time during the nine-month course
of treatment because the patient's serum liver enzymes and copper levels in her urine were not
getting better.
The patient was taken to a nearby emergency room (ED) by her mother during month eight of
taking the wrong medicine due to a two-day history of a rash with little relief from taking an over
the counter (OTC) antihistamine. The child's hepatologist was contacted by the ED doctor, who
concluded that Wilson's disease or an allergic response to Penicillamine were not probable causes
of the child's rash. The patient should start taking a steroid dose pack, increase the antihistamine
dosage, and follow up with the pediatric hepatologist in two days, both parties concurred. Despite
the ED labeling her prescription as Penicillin 250 mg TID rather than Penicillamine, the
medication error was still not discovered at the follow-up visit.
A few weeks later, the mother brought the patient to a separate ED because her rash was getting
worse, she had a fever, and she was experiencing new joint discomfort. The kid was decided to be
admitted for potential Drug Reaction with Eosinophilia Systemic Symptoms (DRESS) condition
during the ED appointment. A hospital pharmacist eventually found the prescription mistake after
the patient was admitted (Healthcare Providers Service Organization, n.d.).
Root Cause Analysis
A technique or methodology known as root cause analysis (RCA) is used to examine an incident
to help identify health system failures that might not be immediately obvious at initial review
(Singh, et al. 2021).
An RCA's goal is to pinpoint system flaws that caused or enabled the incident to occur and to make
suggestions for steps that should be taken to stop or lessen the likelihood of a repeat of the same
incident. Since this medication error falls under the previously mentioned description of a patient
safety incident, an RCA was performed. The RCA team was appointed (Singh, et al. 2021).
A root cause analysis takes place to investigate:
-what happened during the treatment which caused harm to a patient
-why did the incident take place
-how can the incident be avoided in the future
Figure 1: Ishikawa Fish Bone Analysis
Data was taken from medical records, pharmacy records and interviews were held with the
concerned parties such as the patient's mother, the initial pharmacist, the pediatric hepatologist and
the doctor from the first emergency department visit.
A fishbone diagram was used to identify the potential causes of the medical error.
-Human factors: The initial pharmacist must have been inexperienced, distracted or fatigued. This
could also be the case for the personnel in the pharmacy who continued to dispense the drug, the
pediatric hepatologist and the ED doctor.
- Communication breakdowns: There could have been a miscommunication between the various
personnel involved such as the initial pharmacist and the pharmacists who continue to dispense
the drug or in between the pediatric hepatologist and the first ED doctor.
- Systemic issues: the medication ordering or dispensing process may be confusing or prone to
errors. Especially in this case both the drugs sound alike. The pharmacy or the hospital at which
the pediatric hepatologist worked did not have effective medication safety protocols in place.
Resolutions:
- When entering a drug purchase into the pharmacy computer, abide by pharmacy procedures and
use only authorized Sig codes or mnemonics (Healthcare Providers Service Organization, n.d.).
- Never presume that names with similar sounds are interchangeable. One of the main contributors
to pharmacy mistakes is names with similar sounds. Sound-alike drugs should be distinguished
from one another and plainly labeled, including with the use of obvious warning labels.
- For added safety, make sure that all medications are examined before being filled, ideally by a
different pharmacist. Each prescription must be compared to the original order when it is filled by
a single pharmacist, who must also ensure that the right medication, dosage, and quantity are given
to patients, and that the label, patient directions, and any applicable warnings are accurate
(Healthcare Providers Service Organization, n.d.).
- Do thorough study on the uses, side effects, and risks of any new medications before dispensing
them.
- Make sure that each pharmacy computer is set up to provide up-to-date, thorough drug research
that is updated immediately or otherwise delivered on a regular basis for each pharmacy employee.
- Once the drug has been thoroughly studied and understood, it is important to explain the patient's
clinical history, diagnosis, and drug usage to make sure the medication given is suitable for the
desired clinical effect.
- Any computerized warning override should be treated as an incident, and you should routinely
review all overrides to look for system errors, formulary gaps, insufficient or incorrect Sig codes,
practitioner ordering issues, and competency problems with pharmacists and pharmacy
technicians.
- Regarding any queries about the recommended medication, such as contraindications and
interactions, speak with the prescribing practitioner and, if necessary, seek advice from the
supervising pharmacist or pharmacy director (Healthcare Providers Service Organization, n.d.).
Conclusion
Root cause analysis can be used to find factors within the process that may make it more difficult
to provide high-quality patient treatment when identifying medical errors becomes challenging or
complex due to numerous underlying factors (Singh, et al. 2021).
Given that most medical errors are preventable, conducting a thorough root cause analysis can
increase patient safety and help healthcare companies set an example for others. Understanding
the "Why" behind the cause of a medical error and identifying potential future strategies to mitigate
it and improve patient outcomes require the collaboration of all healthcare team members and
clinicians involved in patient care (Singh, et al. 2021).
References
Healthcare Providers Service Organization (n.d.). Case Study: Wrong Drug Repeatedly
Dispensed over nine-month Period Leads to Hospital Admission. [online] www.hpso.com.
Available at: https://www.hpso.com/Resources/Legal-and-Ethical-Issues/Wrong-drugrepeatedly-dispensed-over-nine-month-pe [Accessed 4 Apr. 2023].
Institute of Medicine (2000). To Err Is Human. [online] Washington, D.C.: National Academies
Press. doi:https://doi.org/10.17226/9728.
McGowan, J., Wojahn, A. and Nicolini, J.R. (2022). Risk Management Event Evaluation and
Responsibilities. [online] PubMed. Available at:
https://www.ncbi.nlm.nih.gov/books/NBK559326/ [Accessed 3 Apr. 2023].
Runciman, W., Hibbert, P., Thomson, R., Van Der Schaaf, T., Sherman, H. and Lewalle, P.
(2009). Towards an International Classification for Patient Safety: key concepts and terms.
International Journal for Quality in Health Care, 21(1), pp.18–26.
doi:https://doi.org/10.1093/intqhc/mzn057.
Singh, G., Patel, R.H. and Boster, J. (2021). Root Cause Analysis and Medical Error Prevention.
[online] PubMed. Available at: https://www.ncbi.nlm.nih.gov/books/NBK570638/ [Accessed 4
Apr. 2023].