Department Project No. Document No. Doc Rev. · Preliminary Hazard Analysis (PHA) – Train Travel...

Training Handbook Department TRG Project No. 190101 Document No. HBK001 Doc Rev. 01

© 2019 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited. of 20 pages

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Introduction to ISO 14971 - Risk Management for Medical Devices

Training Handbook

Presented By Maria Mylonas

Department TRG Project No. 190101 Document No. HBK001 Doc Rev. 01


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How to use this handbook

The handbook is organized to focus on particular skills and revisions. These lessons allow you to learn and practice the skills used throughout the course. The following icons are used in this handbook.

Activity Revision exercise or written task

Important Important points to remember for the assessment

Quick Link or Tip A shortcut, tip, or favourite link

Discussion Group discussion activity

This intellectual property remains the property of PharmOut Pty Ltd. It is intended for training purposes and its format and contents are copy written by ©PharmOut 2019. For further information go to www.pharmout.net



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Table of Contents

How to use this handbook ................................................................................................. 2 1. Medical Device Risks ................................................................................................. 4 2. Determining risk controls – PIP breast implants ...................................................... 5 3. Preliminary Hazard Analysis (PHA) – Train Travel .................................................... 6 4. FMEA: Bungee Jumping ............................................................................................ 8 5. Apply RM Tools ....................................................................................................... 13 6. Workshop: Medical device app................................................................................ 14 7. Transfer of Learning Plan ........................................................................................ 20



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1. Medical Device Risks

What are some of the medical device related risks in your area of work?Think about:

• Risk to patients?• Risk to medical practitioners”• Risk to environment?• Anything else?



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2. Determining risk controls – PIP breast implants

In 2013, the PIP breast implant scandal hit the news. Did the manufacturer determine their design controls properly? As the company executives were jailed for fraud, unfortunately risk control was probably not part of the product life-cycle. Read the following news excerpts and complete the table fields. The man who sparked a global health scare by selling breast implants containing industrial silicone was jailed for four years yesterday by a court in Marseille. Jean-Claude Mas, founder of Poly Implant Prothèse (PIP), was convicted of aggravated fraud. Four other defendants, former PIP executives or managers, were also found guilty and given jail sentences. The firm caused an international health scare when it was found that the faulty implants had been made with substandard and non-authorised material not fit for humans. At one time PIP was the third biggest global supplier of breast implants, used in an estimated 300,000 women in 65 countries. Some of the women were given the faulty implants during breast reconstruction operations after undergoing mastectomies as part of their cancer treatment. At their month-long trial in May the accused had admitted fraudulently using unapproved gel in the implants, at an annual profit of €1m, but Mas had denied it was harmful, while three of his co-accused said they were unaware of the possible dangers. (http://www.theguardian.com/world/2013/dec/10/french-breast-implant-pip-jean-claude-mas-jailed; 07/03/2016)

Complete the following table by proposing possible protective measures for equivalent implants manufactured by a responsible company.

Hazard Inherent safe design Protective measure



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3. Preliminary Hazard Analysis (PHA) – Train Travel

For this activity we will examine the hazards associated with getting on a train. Let’s just focus on hazards associated with the use of the train doors.

1. In relation to the train doors, what are the hazards associated with getting on

a train? Use the table on the following page to record your answers:

a. In the first column, list the hazard (potential source of harm) b. In the second column, list the harm (the potential damage caused by the

hazard) c. In the third column list the control strategy



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Hazard Harm Control Strategy / Mitigation

Train starts with door open. Passenger falls out of moving train.

Train must not be capable of moving with any door open.



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4. FMEA: Bungee Jumping

Perform a risk assessment on Bungee Jumping. Your instructor will divide you into groups. In groups discuss:

• what ‘Bungee Jumping’ is • what the prerequisites for bungee jumping are • what equipment is required • what can go wrong

Now, work in pairs and complete the FMEA Table on the following pages When completing the FMEA table, categorise process step failure modes using the following method:

Risk Level Risk Level = Severity x Occurrence x Detectability e.g. H = high M = medium L = low



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Process Step (A)

Potential Failure Mode (B)

Potential Failure Effects

(C)

Sev (S)

Potential Causes (E)

Occ

(O)

Current Controls (G)

Det

(D)

Risk level

What is the stage or step(s)?

In what ways can the process step or input fail?

What is the impact on the key output variable once it fails?

What causes the key input to go wrong?

What are the existing controls and procedures that prevent the cause or the failure mode?

E.g Cord Cord is too long Serious injury or death H Incorrect calculation by operator

L Second check of calculation by another operator

M M



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Process Step (A)



(C)

Sev (S)


Occ

(O)


Det

(D)

Risk level





What are the existing controls and procedures that prevent the cause or the failure mode?



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5. Apply RM Tools

In the table below, write down which risk tools can be used for each item selecting from the list of risk tools.

Risk tools from Annex G: a. Preliminary Hazard Analysis (PHA) b. Fault Tree Analysis (FTA) c. Failure Mode Effects Analysis (FMEA) d. Failure Mode, Effects and Criticality Analysis (FMECA) e. Hazard Operability Analysis (HAZOP) f. Hazard Analysis and Critical Control Points (HACCP)

Tip: There may be more than one 1 appropriate tool, select all that can be used and identify the ‘best tool to use’.

Item Quality System Best tool to use

Out of specification test result OOS investigations

New equipment for the QC lab Change Control

New spreadsheet for calculating process capability

Change Control

Replacement part on packaging line

Maintenance



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6. Workshop: Medical device app

Read the following scenarios on the development of a medical device app and answer the questions in the fields provided. Scenario: The Design and Development team at ‘Great Medico Apps’ are developing a Smartphone app that receives data from a CPAP (Continuous Positive Airway Pressure) Class II device. The app is intended to be used by patients at home, with a CPAP machine, to routinely monitor their blood pressure, oxygen and carbon dioxide blood saturation, and heart rate. The patient logs on to the app and enters general information at the time of each test. The app transmits this data to a central database which is then viewed and acted upon by a healthcare professional.

Q1. What benefits could this bring to users, the public, patients, physicians or healthcare providers?



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Q2. Complete a preliminary hazard analysis (PHA) for the medical app in the table below.

Hazard Harm Control



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Scenario: The Design & Development team meet to discuss the product requirements of the app and record the following notes:

Q3. Using the hazards identified in Q2 and the product requirements above, estimate the risks associated with the medical app by completing the FMEA table on the next page. Assume that any high or medium risk will require risk mitigation. Suggest suitable risk reduction measures and determine if the residual risk is acceptable.

When completing the FMEA table, categorise failure modes using the following method:

Risk Level = Severity x Occurrence x Detectability Residual risk is determined by reassessing the severity, occurrence and detectability.



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Process Step (A)



(C)

Sev (S)


Occ (O

)


Det (D

)

Risk level

Risk Reduction Residual risk

acceptable?





What existing controls /procedures prevent the cause or failure mode?

What changes prevent/reduce reoccurrence?



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7. Transfer of Learning Plan

Action Comments

What did you learn today?

What specifically will you implement from today?

What do you need to follow up on and learn more about?

What actions do you need to take to find out more about the topics you wrote above?

DOCUMENT END

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