SBS - The best value in QMS software

Defining the lifetime of an Implantable Medical Device

E

ehoqa

#1
I've looked through threads regarding record retention times, but I'm still not entirely sure how to go about defining the lifetime of our implantable product. I understand that the record retention times depends on the regulatory requirements of MDD and CMDR as well since we're planning to sell there. Hope someone can provide some guidance in defining the lifetime of our implantable product.

The product is very simple -- it's not active and doesn't break down inside the body. All it is is a weight that helps weigh down a specific part of the body, so really the functionality of it will last forever. We provide it sterile (and also a non-sterile version), and the shelf-life is 3 years for the packaging, but the device itself is still usable/functional if re-sterilized.

We currently say that the lifetime of the device is the lifetime of the patient. I feel that's too vague, since the users are generally older but children can use the implant as well. Do we need to decide on X number of years for the device? Or can we just say the records will be kept for an indefinite amount of time?
 
Elsmar Forum Sponsor
M

MIREGMGR

#3
I've looked through threads regarding record retention times, but I'm still not entirely sure how to go about defining the lifetime of our implantable product. (...) so really the functionality of it will last forever. (...) We currently say that the lifetime of the device is the lifetime of the patient. I feel that's too vague, since the users are generally older but children can use the implant as well.
This is not likely a records retention question at root. Instead it's about marketability. If you define your implantable to have a shorter service lifetime than the patient's possible life, you are stating that the device may not be safe and effective beyond that lifetime, and the patient may require replacement surgery at that product lifetime end.

Your doctor-end-users, and possibly their patients, and possibly whoever is a third party payer for the procedures involved as well, may have a lot to say about how your device is marketed.

If I were a doctor and had a choice between an implantable that the maker says will be safe and effective for the lifetime of my patient, or an alternate implantable that has a shorter safe and effective lifetime of X years, I'd tend toward choosing the former.
 
E

ehoqa

#4
Thanks for your reply. I originally posted my question on an old records retention discussion but it was moved to a start this new discussion.

The purpose of my question was to define our records retention periods based on regulatory requirements. For example, QSR 820.180(b) says that records need to be kept for the "time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer."

If the expected life of our device is the lifetime of the patient (which varies!), how do I document our record retention periods? Can we just say certain types of records will be kept indefinitely? Or do we need to state the number of years (this is what I'm afraid of because "lifetime of the patient" isn't a certain number of years)?
 
M

MIREGMGR

#5
If you state that the relevant records will never be discarded by your business, I don't think an NB will gig you for inconsistency with your marketing.

100 years from now, a successor to you could tune up the policy if need be.
 

somashekar

Staff member
Super Moderator
#6
Also note that the records of such devices reaches the user and eventually reaches the patient who carries it for his lifetime. This is from the point of his follow-up and care necessary at any future date, at any place. Apart from stating an open retention time, your vital records are also shared appropriately and can be elaborated in your procedure.
The intent is more towards retreiveability of a specific record for any purpose rather than just the manufacturer keeping in possession.
 
Thread starter Similar threads Forum Replies Date
M Defining the lifetime of orthopedic implants joints Other Medical Device and Orthopedic Related Topics 2
5 Major Nonconformance for not "clearly" defining the "device lifetime" ISO 13485:2016 - Medical Device Quality Management Systems 2
T Defining Product Lifetime - Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 5
T Defining the lifetime of medical devices - long lasting parts such as bone screws. ISO 13485:2016 - Medical Device Quality Management Systems 3
K Defining risk control measures IEC 62304 - Medical Device Software Life Cycle Processes 13
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J Defining staff competence - Small mechanical workshop Occupational Health & Safety Management Standards 20
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
T Defining sampling plan for different AQL AQL - Acceptable Quality Level 3
M Defining frequency of measurement tools callibration Calibration and Metrology Software and Hardware 3
M Defining and Documenting Record Retention CE Marking (Conformité Européene) / CB Scheme 5
G Defining performance metrics for DFMA implementation Design and Development of Products and Processes 2
S Defining a Quality System from scratch - Preferred system and documentation names Document Control Systems, Procedures, Forms and Templates 4
A Defining Expected Service Life in Risk Management File Reliability Analysis - Predictions, Testing and Standards 5
C Defining Approvals Required for Design Control Documents ISO 13485:2016 - Medical Device Quality Management Systems 6
K Defining Acceptance Quality Level, I need clarity on AQL 1.5, 2.5, 4.0 AQL - Acceptable Quality Level 5
C AS9100 rev D 8.5.1 c 2 - Defining the Machine in-process frequency per ANSI/ASQ Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
V Defining Safety Precautions for Category 4,5 Molecules Occupational Health & Safety Management Standards 2
E European Regulations defining the terms Repair and Refurbish EU Medical Device Regulations 5
T Defining Major vs. Minor Changes to Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
GStough Adequately Defining Which Suppliers to Audit and Frequency Supplier Quality Assurance and other Supplier Issues 8
E Quality Techucuan (Technician) in Electronics - Defining Postion Requirements Career and Occupation Discussions 4
moritz Defining a good Scope for Critical SOPs ISO 13485:2016 - Medical Device Quality Management Systems 7
T Standards for defining audible alarms/warnings for OR instruments IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Defining Critical Vs. Non-Critical Suppliers/Service Providers (API Q1, 9th. Ed.) Oil and Gas Industry Standards and Regulations 2
B IEC 60601-2-24 - Defining Storage Volume IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Defining Sub-Disciplines for Chemical Testing Laboratory Employee Proficiency Testing General Measurement Device and Calibration Topics 1
T Defining Nonconformances in a Service Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Defining Reliability and Confidence Levels Reliability Analysis - Predictions, Testing and Standards 8
J Defining Martial Arts and Gymnastics Statistical Techniques Statistical Analysis Tools, Techniques and SPC 4
V Defining the criteria for equipment to be qualified or requalified Qualification and Validation (including 21 CFR Part 11) 2
R Need help on defining scope for Design Verification File for Class III IVD 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J Defining CCP (Critical Control Points) in a Rice Mill Plant Food Safety - ISO 22000, HACCP (21 CFR 120) 9
S Process Map and defining KPIs Misc. Quality Assurance and Business Systems Related Topics 5
B Defining Expected Oxygen Leakage for Safety Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
G Defining Post Mold Cure Ramp-Down Temperature Manufacturing and Related Processes 2
K Audit Nonconformity on Defining 'Outsourced' Infrastructure Maintenance Quality Manager and Management Related Issues 21
G Points to consider while defining the Quality Policy AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
G Defining Quality Objectives for Product Realization and Design and Development AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Developing Documentation and Defining Processes as Subcontractor IATF 16949 - Automotive Quality Systems Standard 6
C Defining ISO 9001:2008 Scope for a Sterilization Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Defining Skilled vs. Semi-Skilled vs. Unskilled Labor Manufacturing and Related Processes 1
I Defining the scope for ISO 9001 Registration - Software, Hardware and Customer Care ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Product Specification vs. Information Defining Product - The differences? 7.3.3.1 IATF 16949 - Automotive Quality Systems Standard 6
R Defining Interaction of Processes in a Software Company Software Quality Assurance 3
N Where to begin defining and monitoring Quality Metrics in a Machine Shop Manufacturing and Related Processes 9
A Testing Process Audit - Defining a Process Compliance Mechanism Software Quality Assurance 2
R Defining the type of Applied Part - Metal Probe (Applied Part) employs Water Cooling IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Defining Security Interfaces for Scope for ISMS - Need help IEC 27001 - Information Security Management Systems (ISMS) 10
A Defining the differences between Prototype vs. Production Guidelines? Contract Review Process 5

Similar threads

Top Bottom