Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbility

M

Martin IT

#21
Re: Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbili

Everyone used a lot of examples, but only JaxQC was the only one who remembered the main problem regarding this all: you need to talk to the users.
Finally Marcello! At the end you understand what I mean when I speak about 'experience' and when I said that the best way to made an effective Risk Analysis is talking with
more than a people ( 'the Post-Sales Manager, the product specialist, the Clinical Manager ' )

Happy Christmas
 
Elsmar Forum Sponsor
B

bob_north

#22
Re: Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbili

Michael,

Marcelo is right on with all answers. Kim Trautman does say that about use error in her book. Additional points regarding use error and the FDA position can be found in the Ron Kaye and Jay Crowley guidance published in 2000, Medical Device Use Safety: Incorporating Human Factors in Risk Management. The other standards are useful, but Kaye and Crowley is their desk reference against your submission.

For the FDA's submission process, the final validation study is crucial, especially in 510(k) work. They are rejecting submissions based on shoddy or non-existent human factors studies that thoroughly wring out use error risk. You need about 15 participants doing directed tasks with the device, and looking for any usability errors that could lead to adverse consequences.

Your initial use error risk analysis should have tracked down these errors early and often. We use a deep task analysis for this, then a lot of formative usability tests to clean out the design of error with users.

The now offered AAMI course covers all this in detail. Take a look at their events calendar for the next offering. And, the FDA reviewer in charge of use error review presents at this workshop.

Regards, Bob
 
F

Factoring Humans

#23
Re: Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbili

Everyone used a lot of examples, but only JaxQC was the only one who remembered the main problem regarding this all: you need to talk to the users. You can ask anyone on the manufacturer staff, but they will mean nothing if you do ask the real users. A lot of problems arise when the staff of the manufacturer cannot translate the user requirements, including usability requirements, into product features that have high usability.
What methods are medical device manufacturers currently utilizing to talk to real users during the design process, before physical prototypes are manufactured for final validation studies?

Interviewing users? Conducting surveys? Presenting storyboard mock-ups of the device?
 
B

bob_north

#24
Re: Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbili

Yes, all of those you mention are frequently used under the names of Contextual Inquiry, Formative Usability Testing, Cognitive Walkthroughs, Ethnographic Research (another name for contextual inquiry stressing good observation in the field with questioning as follow up).

All of these lead to one thing when you're ready-a validation test of the user interface with 15 or so representative users performing the routine and risky non routine tasks without moderator intervention. Follow up with questioning about near misses or reported task difficulties. It's all about failures, not success. If you show up at FDA with anything short of this, you will likely receive a "request for additional information." You don't want one of these.

AAMI HE 74, Human Factors Process in Med. Dev. Design is an excellent source of testing formats, as is the newly released AAMI HE75, Human Factors in Medical Device Design, section on T&E. See the AAMI site for details.

"If you don't usability test your products, your users will.."

Bob North
 
Thread starter Similar threads Forum Replies Date
M Clinical Benefit of device that only aids in a process for managing or treating disease EU Medical Device Regulations 2
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5
qualprod Managing a "special" customer into the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
A Managing overseas travel risks to food handlers Food Safety - ISO 22000, HACCP (21 CFR 120) 3
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
L Managing design projects: New Medical Device Project or Change Design and Development of Products and Processes 1
M Medical Device News DHS – Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients Medical Device and FDA Regulations and Standards News 0
F Device Standards - Managing Changes to existing standards that apply to our devices Other Medical Device Related Standards 1
J Design Verification - Managing Changes Design and Development of Products and Processes 4
Jane's You may or may not have the same person managing Operations and QA ISO 13485:2016 - Medical Device Quality Management Systems 18
Q Managing Internal/External RNC and Complaints in same Format ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L Managing Finance Processes - Identification of Sub Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Microbiology Testing - Managing a Microbiology Process Hospitals, Clinics & other Health Care Providers 2
R Managing Level 3 Production Documents - Document Control System Help Document Control Systems, Procedures, Forms and Templates 6
G Managing Ongoing Compliance to Standards when they are Changed Misc. Quality Assurance and Business Systems Related Topics 3
R Managing Employee Training Files - 21 CFR Part 820.25 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Need ideas on managing Shelf Life Studies within an organization ISO 13485:2016 - Medical Device Quality Management Systems 1
I Any recommendations on software for managing the APQP, PPAP, PFMEA, Control Plan etc? Quality Assurance and Compliance Software Tools and Solutions 2
R Managing Tooling Condition at Suppliers Supplier Quality Assurance and other Supplier Issues 6
B Subsidiary - No Managing Director - Is ISO 9001 Certification Possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Looking for Practical Advice in Managing Measurement Uncertainties Measurement Uncertainty (MU) 3
L Managing ITP with an ERP system Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Q Form for Managing Coating Process Parameter Changes during Production Document Control Systems, Procedures, Forms and Templates 2
S Managing a Significant Number of Outstanding Non-Conformities Nonconformance and Corrective Action 6
A Software Tools for managing a QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Managing Inspection Records with a Database and Destroying Paper Records Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
D Process for Managing Documents which are Overdue for Review Document Control Systems, Procedures, Forms and Templates 17
S Q1 Manufacturing Site Assessment - Managing Post-Job 1 Changes Procedure Manufacturing and Related Processes 1
B Are there any Standards related to Managing an Airport Various Other Specifications, Standards, and related Requirements 3
Q Managing Internal and Client Complaints ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Industry Best Practices for managing outside Engineering Consultants Design and Development of Products and Processes 3
Q Process or Departments - Document Content and Managing the Process Approach ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Filtering ECR/ECO by quality management? Managing Engineering Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Managing the Unexpected - Book Recommendation Book, Video, Blog and Web Site Reviews and Recommendations 1
T Internal Conflict of Interest in Managing Suppliers Supplier Quality Assurance and other Supplier Issues 2
L Managing Certificates of Analysis or Conformance for Products Quality Assurance and Compliance Software Tools and Solutions 4
T Managing Audit Reports and Schedules General Auditing Discussions 3
M Managing Changes to an SFDA Registered Device China Medical Device Regulations 6
F Who manages QI projects? Quality or PMO? Managing Six Sigma and Lean Projects Six Sigma 2
Hami812 Attribute Data Gage R&R - Managing Data Sets - Minitab Using Minitab Software 2
E Nonconformity on managing documents for Electric Arc Furnace Manufacturing and Related Processes 4
D Managing an Employee Suggestion Program Quality Manager and Management Related Issues 4
K Managing Prerequisite Programme Activities Food Safety - ISO 22000, HACCP (21 CFR 120) 2
M Non Normal Data Managing - Clements Method to get Process Characteristics Statistical Analysis Tools, Techniques and SPC 8
J Managing New and Revised Electronic Documents (Procedures) - Share Point Document Control Systems, Procedures, Forms and Templates 8
N Managing Subcontracting Process - Material Traceability from Warehouse to Processing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
G Should ISO/QMS policy be signed by the Managing Director or anyone from Top Mgt? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Managing Quality Risks in Construction Quality Manager and Management Related Issues 14

Similar threads

Top Bottom