Risk Management within Medical Devices

MScSED - Module: MCT626

Researcher: Niamh St John LynchAdvisor: Dr Owen MolloyDate: 04 May 2016

 

Experience

Qualifications / Experience

Quality Manager J&J, Boston Scientific, Beckman

Coulter / Danaher, Merit Medical, Bioniche / Mylan, Phardiag / Menarini Group

20 Years in IT, Pharmaceutical and Medical Devices

BSc Cognitive Science (Hons)MSc NeuropharmacologyCertified to ISO 14971:2016

Certified to ISO 13485:2016Certified to GMP/GDP/RP

Niamh Lynch (nee St John)

Contents

BackgroundDefinitionsIntroductionProblem OverviewResearch QuestionLiterature ReviewResearch MethodologyConclusion

Requirements Relevance?

Background

Risk management is central to all Medical Device manufacturers and with the changes to ISO 14971:2012 and more recently ISO 13485:2016

All Medical Device companies need to review their approach

ISO 14971 Risk Management

Risk PlanRisk Analysis

Risk Evaluation

Risk ControlEffectiveness

MonitoringRisk

AcceptabilityRisk Report Risk Benefit

Analysis

ISO 14971:2012

Risk PlanRisk Analysis

Risk Evaluation

Risk Control Effectiveness monitoring of

controlsRisk Report

ISO 14971:2007/20

09

Risk AnalysisRisk

EvaluationRisk Control

ISO 14971:2001

Risk Assessment

Only

ISO 14971-1:1998

21 CFR Part 820 required for

device modification

includes Design Control and Validation including

labelling and packaging

QSR 1996

Medical Device

AmendmentClass III medical

devices to go through PMA

FDA GMP 1976

Definition of Risk

“the combination of the probability of occurrence of harm and the severity of that harm” Q9 (2006)

Definition of Risk Management

“the systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk”, Q9 (2006).

Why Perform Risk Management?

Reduce Risk to Patients

Reduce Risk to Business reduce cost

Risk management attempts to identify, measure, mitigate or control risks, which as we defined above, are the opportunity for loss or injury in order to protect the public from harm arising from new medical devices or changes to existing medical devices

What is a Medical Device? Medical Device - “Any instrument, apparatus, implement, machine,

appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for human beings for one or more of the specific purpose(s) of the following:

Diagnosis, prevention, monitoring, treatment or alleviation of disease; Diagnosis, monitoring, treatment, alleviation of or compensation for

an injury; Investigation, replacement, modification, or support of the anatomy

or of a physiological process; Supporting or sustaining life Control of conception Disinfection of medical devices Providing information for medical purposes by means of in vitro

examination of specimens derived from the human body; and which does not achieve its primary intended action or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means”

Problem Overview

Patient Harm, Injury and Death continue to occur

Product Recalls and Failures continue Risk Management System Requirements

require ‘robust’ risk techniques Risk Management Systems continue to be

difficult to maintain Risk Management Systems are for the most

part, not integrated within it’s QMS FMEA is main tool used in Medical Devices –

not robust enough to identify all risk

Literature Review

Lit Review Demonstrates:

FMEA is the tool of choice for manufacturing, manufacturing services and suppliers to the industry.

Ref. Dumbrique, R. (2010). Implementation of Risk Management in the Medical Device Industry. Master’s Theses Paper 3855. San Jose State University. SJSU Scholar Works

Research Question Two key questions :

Do Medical Device companies continue to rely heavily on Failure Modes and Effects Analysis (FMEA) as the primary tool for risk assessment

(ref. Lopez, et al (2010), Kamm (2005) and Lu Gan (2012)?

Does the FMEA adequately support Risk Management throughout the full lifecycle of the Product Development Process to meet relevant Medical Device standards, ISO 13485:2016 and ISO 14971:2012?

Failure Modes Effects Analysis

FMEA LimitationsSome of the limitations of the FMEA listed by McDowall (2005 and Gan, 2011) include:Components can be tedious and difficult to analyze

when part of complex systemsCompound failure effects cannot be analyzedCost and time consuming, unless carefully controlled Successful completion requires expertise, experience

and good team skills Incorporating all possible factors influencing the

system, such as human errors can result in lengthy analysis, difficult to manage.

Data redundancies can be a problem and is time consuming

How Can Technology Help?

A software risk management tool is proposed to overcome these significant problems within the industry.

The aim for the software tool suggested is to streamline the process, create efficiencies within the Quality Management System (QMS), reduce real risk to the business and ensure compliance to the relevant regulatory standards and authorities.

Research Methodology

A combination of methodologies are required to conduct this research:

Content AnalysisLiterature Review Data Surveys for current statusExperimental Research & Development relevant

architectural design

Useful Websites

ASQ: http://www.asq.org FDA: http://www.fda.gov ; http://www.21cfrpart11.com ICH: http://www.ich.org IEE: http://www.iee.org ISPE: http://www.ispe.org/gamp/ BSI: http://www.bsi-global.com NIST: http://csrc.nist.gov/publications/nistpubs/index.html WHO: http://www.WHO.org EU: http://ec.europa.eu GHTF: http://ghtf.org now http://www.imdrf.org

Q&A

Go Raith Maith Agat

Thank You