EN ISO 14971 - Transitioning to 2009 version
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Transcript of EN ISO 14971 - Transitioning to 2009 version
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Complying with ISO 14971: Transition from 2007 to 2009
presented by
John Beasley Owner & Sr. Consultant
MedTech Review
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Topics
• Understanding need for Risk Management • Implementing ISO Standards • Outline of ISO 14971 • Key Changes under EN ISO 14971:2009 • Final Comments
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Understanding need for Risk Management
Advances in TECHNOLOGY bring increases in RISK to both pa?ents and users
Classic example: Radia?on Treatment for cancer
BENEFIT to pa?ent outweighs RISK to which the pa?ent and the user is exposed
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Understanding need for Risk Management
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Understanding need for Risk Management 25 MeV Radiotherapy Machine X-‐rays & Electrons
200 rad (e) or 25000 rad(x)
Error on selec?on, SoUware bug, Beam not reset
Pa?ent received 25000 MeV , “malfunc?on 54 displayed “
Technician fired 2 more ?mes
4 Months later pa?ent died
“Captain Kirk forgot to put his phaser on stun”
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Implementing ISO Standards
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Implementing ISO Standards
• For the EU (and CE Marking) manufacturers have until 31 Mar 2010 to comply before cessation of the 2000 version
• Some Notified Bodies are offering registration certificates to ISO 14971
• EN ISO 14971:2009 identical to ISO 14971:2007 but includes annexes that show how it meets the essential requirements of AIMD, MDD and IVDD
had
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Outline of ISO 14971
• Risk Management Objectives • Risk Management Process
– Risk Analysis – Risk Evaluation – Risk Control – Overall Residual Risk – Risk Management Report – Production & Post Production
• Annexes
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Risk Management Objectives • Management Policies • Documented Procedures • Tasks
– Analysis – Evaluation – Risk control
Enable medical device manufacturers to iden6fy all foreseeable hazards and hazardous situa6ons relevant to a par6cular device and demonstrate with documented evidence that related risk has been reduced to an acceptable level.
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Risk Management Process
• Interactive with design, engineering, production, purchasing, sales, quality assurance and regulatory affairs
• Perpetual process, beginning with design & development and continuing through to the use of devices, where user feedback reveals actual performance
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Interactive
• ISO 13485:2003 Medical devices. Quality management systems. Requirements for regulatory purposes
– Paragraph 7.1: Planning of Product Realization – “The organization shall establish documented
requirements for Risk Management throughout product realization. Records arising from Risk Management shall be maintained”
– (See ISO 14971 for guidance related to Risk Management)
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Interactive
• ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process – Describes
• general principles • general categorization • Evaluation • identification of gaps • identification of additional data sets • the assessment of the biological safety
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Interactive
• BS EN 62366:2008 Medical devices. Application of usability engineering to medical devices – Specifies process to
• Analyze • Specify • Design • Verify • Validate
It can be used to iden6fy, but does not assess or
mi6gate, risks associated with abnormal use.
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Perpetual
• Clause 1 – Scope • Clause 2 – Terms & Definitions • Clause 3 – General Requirements for Risk Management • Clause 4 – Risk Analysis • Clause 5 – Risk Evaluation • Clause 6 – Risk Control • Clause 7 – Evaluation of overall residual risks
acceptability • Clause 8 – Risk Management Report • Clause 9 – Production & Post Production Information
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Perpetual • Annex A – Rationale for requirements • Annex B – Overview of the risk management process for medical devices • Annex C – Questions that can be used to identify medical device
characteristics that could impact on safety • Annex D – Risk Concepts applied to medical devices • Annex E – Examples of hazards, foreseeable sequences of events and
hazardous situations • Annex F – Risk Management Plan • Annex G – Information of Risk Management Techniques • Annex H – Guidance on risk management for in-vitro diagnostic
medical devices • Annex I – Guidance on risk analysis process for biological hazards • Annex J – Information for safety and information about residual risk • Annex ZA/ZB/ZC – Relationship between the standard and the
Essential Requirements of the MDD / AIMDD / IVD
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Management Responsibilities
• Top Management must show its commitment by: – Providing adequate resources – Assigning qualified personnel – Defining & documenting the policy for
determining risk acceptability – Conduct internal audits on risk management
activities
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Risk Management Team
• Qualification of Personnel: Personnel must have knowledge and experience – How the device works and its intended use – Knowledge of the technologies involved – How the device is manufactured and
constructed – Familiar in risk management techniques
Records of qualifica?ons must be kept as part of the Risk Management File!
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Risk Management Plan
• Contents of a Risk Management Plan: – Scope of planned risk activities – Identify & describe the medical device – Define responsibilities & authorities – Requirement for review of risk management
activities – Verification Activities – Define Risk Acceptance Criteria
Manufacturers shall establish and document a risk management plan for a par5cular device
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Risk Management Plan
• So how detailed does it need to be? – “commensurate with the level of risk
associated with the medical device” • Annex F for guidance • Forms part of the risk management file
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Risk Analysis
• Will people use the device correctly? • Where in the production process might
variations impact the conformity of the device to its intended product specifications?
• Risks are weighted to consider its probability of occurrence and the seriousness of its potential effects.
Iden6fying foreseeable hazardous situa6ons
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Risk Analysis Records
• Must include: – description and ID for device analyzed – who conducted the analysis – scope and date
• Forms a part of the Risk Management File
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Risk Analysis Methods Events Causes Hazardous
Situa?ons
Accident / Incident / Harm
Primary Cause A
Event 1
Event 2
Primary Cause B Event 3
PHA -‐ Preliminary Hazard Analysis FTA – Fault Tree Analysis
FMEA -‐ Failure Mode and Effects Analysis Ishikawa -‐ Cause and Effect (Fish Bone Diagram)
HACCP -‐ Hazard And Cri?cal Control Point HAZOP -‐ Hazard And Operability Study
Accident / Incident / Harm
Man Machine
Material Method
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Risk Evaluation
• Estimated risks are compared to the risk acceptability criteria (Risk Management Plan)
• Comparison determines appropriate level of risk reduction if necessary
• For each hazard determine whether the estimated risk is so low, reduction is not required
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Risk Control
• Reducing risk through available control measures.
• Must be consistent with the state-of-the art – a measure that naturally shifts as science progresses
Inherent Safety by Design
(GHTF-‐SG3/N15R8)
Protec?ve Measures in the device or its
manufacture
Provide Informa?on for safety, such as warnings in IFU etc.
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Overall Residual Risk
• Risk / Benefit Analysis – If you have any outstanding unacceptable
risks you need to establish if the benefits of the device / therapy outweigh the risks • Reviews • Clinical Evaluation
• Essential Requirements: – 1, 2, 4, 6, 7, 8.6, 9.2, 9.3, 11.2, 11.3, 11.4,
11.5, 12.1,12.5, 12.6, 12.7, 12.8, 13.5
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Risk Management Report
• “Prior to release for commercial distribution the manufacturer shall carry out a review of the risk management process”: – the RMP has been implemented – the overall residual risk is acceptable – appropriate methods are in place to gather
production & post production data • Results of the review must be recorded in the
RM Report • Person with appropriate authority shall
conduct the review
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Production & Post Production
• Must ensure that appropriate methods are in place to gather: – Production Data – Inspection Data – Design Changes – Post Production Data
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Production & Post Production
• Production Experience – Non-conformance (rejects, re-work etc) – Scale up issues
• Design Changes – Drawings, Materials, Methods, Packaging,
Sterilization, optimization studies • Post Market Surveillance
– Active surveillance – Complaints
• CAPA
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Maintaining Risk Management File
• Continue to monitor throughout entire lifecycle – Risks continue to remain acceptable – See if any new hazards or risks are identified -
especially CAPA – Verify or review assumptions & scoring values – Effect of State of the Art advances – Competitor products experience
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Key Changes of EN ISO 14971:2009
• Phase of the Life Cycle – 7.1 and 7.3.2 address the need to examine
different stages of the product, including manufacture, product release, in-use errors and disposal
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Example – HDR Brachytherapy • HDR Ir 192 inserted into catheters • Wire broke in one of catheters • Catheter disposed of in 4 days • 6 Days in storage • Detected at medical waste incinerator
More than 90 people accidently irradiated
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Key Changes of EN ISO 14971:2009
• Type of Hazard – This version of the standard distinguishes
between hazard (potential source of harm) and hazardous situation (circumstances in which people, property, or the environment are exposed to one or more hazards).
– The risks must be estimated for both.
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Key Changes of EN ISO 14971:2009
• Confirmation of Standard Applicability – This standard is now applicable to all medical
devices, including In Vitro Diagnostic Devices (IVDs), for which a specific annex (H) was added about the identification of hazards. • No direct risk - indirect risks
– The extent to which the diagnosis relies on the analytical result (i.e., contribution to the medical decision)
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Final Comments
• FMEA, whether Design (DFMEA), Process (PFMEA) or Use (UFMEA) is a risk management technique mentioned by the standard but it does not alone address all the requirements of EN ISO 14971
• Documentation is often missing to demonstrate compliance to EN ISO 14971
• Start by performing a Gap Analysis
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Thank You
John Beasley Owner & Sr. Consultant MedTech Review, LLC
www.medtechreview.com Email: [email protected]
SKYPE: medtechreview