How to define/identify emerging risks?

FoGia

Involved In Discussions
#1
Hello,

I'm having a hard time getting a grip on how to define and identify "emerging risks". "Emerging risks" and "emerging issues" appear once and twice, respectively. It seems to me that there is a difference between previously unidentified risks (that may stem from oversight during the risk analysis) and risks increasing in severity/occurrence after gaining more clinical experience data.
Unfortunately I don't see a definition for what can be considered an "emerging risk". Does someone know more?
 
Elsmar Forum Sponsor

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#2
Can you help me understand the written requirement? In the USA we use the MAUDE database during annual risk review to determine strategy.
 

FoGia

Involved In Discussions
#3
The MDR mentions emerging issues/risks relative to:
- the PMCF activities "detecting emerging risks on the basis of factual evidence " (annex XIV)
- the review of notified body assessment of technical documentation and clinical evaluation documentation, "identification of concerns and emerging issues concerning the safety and performance of devices " (art 45)
- the expert panel, "to contribute to identification of concerns and emerging issues on the safety and performance of medical devices;"(art. 106)

An emerging risks could be stemming from any source of data, not only adverse event databases but also complaints, literature, studies etc.
 

Tidge

Trusted Information Resource
#4
My $0.02 (subject to exchange rates):

"Emerging Risks" is a category for risks that an otherwise compliant medical device manufacturer might not have considered, or for risks where that same otherwise compliant manufacturer may have "underestimated" the risks based on consensus, state-of-the-art understanding of the design of the medical device and its use. Some examples come to mind:
  • Cooler/Heaters used during cardiovascular procedures (somewhat recently) became implicated in potential spread of bacillus. The larger community of health delivery organizations and medical device manufacturers were ignorant of this possibility. This is an example of a threat that existed all along, but was practically invisible to the consensus community.
  • Cybersecurity issues relating to Integrity (of performance). Common design features (for quick software checks/updates) allow for risks that devices will be damaged by bad actors.
The above examples are now "old news", but at one point they were "emerging risks". Going (much) further back, you can look at how (in the USA) the FDA has some specifically identified devices in some of their processed (e.g. "Blood Handling" software systems... because of the AIDS crisis), these sorts of ad hoc additions were specifically added because of some sort of "emerging risk".

"Emerging Risk" is not supposed to be a CYA for avoiding due diligence. For example, if there is a consensus standard for electrical safety, a manufacturer cannot expect to fail 60601-1 test criteria, go to market, and then claim that "electrical safety" was an 'emerging risk' they didn't know had to be addressed.
 

Steve Prevette

Deming Disciple
Leader
Super Moderator
#5
To me, emerging risks are something unforeseen. Sometimes you can find it in your performance data, sometimes in customer response data, worker opinions, and just keeping your eyes open. Statistical trending of the data does help you identify changing conditions, the unforeseen.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#6
I think I understand. When COVID-19 broke out we thought about how our device is used and how having an airborne pathogen like COVID could change the risks with using our device or other devices.
 

Junn1992

Quite Involved in Discussions
#7
A recent example I can think of is this:

"Long term use of the mobile app might result in strain to the eyes". - Risk assessment related to usability of the app.

Emerging risk:
"The app plays a video that has flashing light similar to strobe lights. This may result in photosensitive epilepsy" - Occurred in similar device during clinical trial, uncovered during literature review.
 

FoGia

Involved In Discussions
#8
From the feedback here it looks like different scenarios could be interpreted differently however since there is no regulatory definition it remains a subjective manner in some cases to distinguish previously unknown risks as merely the result of oversight (this can typically happen for risks with a low occurrence) and with no potential to alter the conclusion of the benefit/risk profile and the risks that are indeed developping because of hard to foresee causes.
Interestingly Annex XIV part B on PMCF makes a distinction between previously unknown side-effects and emergent risks (why not say emerging?) so there seems to be a distinction, however not clearly explained.
The FDA has a guidance with a more precise view on what are "emerging signals".
 
Thread starter Similar threads Forum Replies Date
B How FDA define a new variant/generation or a new device US Medical Device Regulations 11
A Define timeline for Major and Miner Audit finding General Auditing Discussions 4
T How do you define your Hazards? <a Risk Management discussion> ISO 14971 - Medical Device Risk Management 16
M Define voltage and frequency to perform tests 61010-1 and 61326-1 for CE certification CE Marking (Conformité Européene) / CB Scheme 4
I Sampling processes - Who must define the AQL level? AQL - Acceptable Quality Level 9
V Who should define and own the Design and Development Plan and how to maintain the updates and revisions. ISO 13485:2016 - Medical Device Quality Management Systems 2
S API Spec Q1 - How to define Management Representative competency for QMS Oil and Gas Industry Standards and Regulations 12
M How To Define ISMS (information Security Management System) Scope IEC 27001 - Information Security Management Systems (ISMS) 18
K How to define Expected life service life of medical device Other Medical Device Related Standards 4
S How to Define Importers under EU MDR / Brexit EU Medical Device Regulations 3
M Should Potential Customer Complaint Outcome Define Registrar NC Rating? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K ISO 9001:2015 clause 9.2.2 a. - Define the audit criteria and scope Internal Auditing 2
Q QI Macro Histogram - Can someone define *sorted data*? Capability, Accuracy and Stability - Processes, Machines, etc. 7
H How to define Root Cause when some points are out of control chart Statistical Analysis Tools, Techniques and SPC 6
I How do you define Risk (Medical Device)? ISO 14971 - Medical Device Risk Management 30
M SOP or template for a study to Define Storage Conditions of Orthopaedic Implants EU Medical Device Regulations 3
D Definition Client - How does the government define their clients? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
alonFAI How to define a Risk Based Approach for Supplier Management per ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
G How to define the scope of QMS as per ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
R How to define QMS certification scope statement? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
R Review of "Key Data" for contract labs, but SOP doesn't define "key data". Problem? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
G Procedure to define Signing Authority for Procurement Limits ISO 13485:2016 - Medical Device Quality Management Systems 2
P Can a company define new quality standards for special industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
L Are there any requirements to define barcode requirements ? Misc. Quality Assurance and Business Systems Related Topics 2
X How to define Calibration Acceptance Criteria General Measurement Device and Calibration Topics 3
H ISO 17025 - How to define a "Test Equipment" ? ISO 17025 related Discussions 2
J Where do you define Internal Auditor qualifications? Internal Auditing 9
V Is there an approach to define the "must 'or' should" in supplier audits? US Food and Drug Administration (FDA) 2
T Internal Audit - How to define the Importance of Departments and Processes Internal Auditing 8
T Help me understand how to define Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 40
L How to define R & D Receiving (Incoming) Inspection Plan Design and Development of Products and Processes 18
B How to define and implement Configuration Management Document Control Systems, Procedures, Forms and Templates 5
C How to Define and Document Controls of Outsourced Processes Food Safety - ISO 22000, HACCP (21 CFR 120) 5
S Please help me define training requirements for a Career in Regulatory Affairs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
K How to define the Acceptances Criteria for all equipment? Manufacturing and Related Processes 7
L Definition Program - How do you define Program with regard to ISO 9001? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
A Supplier Evaluation SOP - How do I Define Major and Minor Suppliers? Supplier Quality Assurance and other Supplier Issues 14
Q Where to define Authorities and Responsibilities in Documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J Define Energy Used/Delivered - Applicable to Electrical or Mechanical Power or both? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R 820.50 (A) (2)Define the Type and Extent of Control to be exercised over Vendor Misc. Quality Assurance and Business Systems Related Topics 5
A Where to define Process Tailoring Form used in CMMI in the ISO 9001 Quality Manual? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Criteria to define QMS processes in ISO/TS 16949:2009 IATF 16949 - Automotive Quality Systems Standard 23
S How to define New Equipment? Device is Returned, Refurbished or Repaired Misc. Quality Assurance and Business Systems Related Topics 3
C Controlling Documents: Beyond the standard, how do we truly define what to control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C How to define Process Special Characteristics (SC) FMEA and Control Plans 4
kedarg6500 What is the meaning of "define/defined" in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
Crusader Local Control Document procedure....define it or not? Document Control Systems, Procedures, Forms and Templates 24
M Excel Templates for Plan & Define Phase in NPI Process for Tire Manufacturer Excel .xls Spreadsheet Templates and Tools 1
R Define Data from Taguchi to Response Surface Methodology in Minitab Using Minitab Software 2
K How to define PVC Pellet Quality Manufacturing and Related Processes 8

Similar threads

Top Bottom