SBS - The best value in QMS software

Deciding if a medical device shall be supplied sterile or not

R

RA Lille

#1
#1
Has anyone got a good rationale, a decision tree or a list of questions that could be used to help DnD engineers to decide if a medical device shall be supplied sterile or not ?
I'm aware of the Spaulding classification, but it's more applied for retreating/reuse of MD.
Here the point is, as a manufacturer how could we decide that a MD shall be sterilized or not ?

lots of factors play an essential role : impact of the method of sterilization (discoloration, temperature,...) impact of the manufacturing flow (environment or not), compatbility of materials…

For example, a gastroscope should be disinfected before being used on a patient. But shall a single used device used in the digestive tract be sterile ? it will be in contact with food and so on… so, physicians say, give it non sterile… the point is, is there any constructive justification of this ? how could I incorporate such rationale in a technical file ? in a sterilization procedure (let's say "choose of sterilization" procedure) that would be defended in a microbiological audit ?

I'm sure I'm clear,
any idea/info is welcome,
thanks !
 
Quickly Organize an Intelligent TDP from DISCUS
Elsmar Forum Sponsor
J0anne

J0anne

Joanne
#2
#2
I wouldn't ask a physician and I wouldn't want a non-sterile gastroscope anywhere near me, would you?

This will be determined in your risk assessment.

You can market it non-sterile, but you'll still have to validate the sterilisation/cleaning method so that you can tell the user how to sterilise/clean it safely before use and to ensure the sterilisation/cleaning method doesn't impact the device's safety and efficacy.

When you say it's single use, is it going to be used once and discarded?

Or will it be reused?

Reuse and resterilisation/cleaning also has to be validated to determine how many times it can be reused safety and effectively.
 
R

RA Lille

#3
#3
dear J0anne,

thanks for your answer.
You know, most of gastroscopes used in endoscopy are not sterile, they're disinfected… not sterilized… anyway, it's not the point.

I was initially wondering whether there is any simple decision tree or questions (as part of a risk assessment) that could be used to discuss and debate with RnD engineers. Something to help them to decide if the device should be sterile or not, if it should be sterilized prior use or simply disinfected… .

single use is single use, i.e. used then discarded.
reuse means reprocessing.

Even if the debate about reuse/reprocessing (means cleaning + disinfection or cleaning+disinfection + sterilization) is really interesting, the point of my wondering came earlier : how could an engineer decide or choose if the device he is designing shall be single used, sterile or not, reusable or not. I'm microbiologist and QA/RA, I'm not the engineer… i'm looking for Tools to help risk assessment during RnD process.
 
somashekar

somashekar

Staff member
Super Moderator
#4
#4
Just throwing in my hat .... If the device is going to come in contact with blood (Vascular system), then the risk of infection leads you to think sterilization. Otherwise as you mentioned about gastroscopes, they are cleaned and disinfected following a laid out method. (Clinically clean)
You must also look at the pyrogen levels apart from sterilization in your risk assessment.
 
R

RA Lille

#5
#5
Dear Somashekar,
i agree with you, when you're QA or microbiologist or both, you could easily think about infection risks.
Indeed, pyrogen levels should also looked at.
I'm looking for something more systematic, as a list of questions or a list of imputs that mechanical engineers could use to check if they'd thought at all risks to define the status of the device they're designing, and also the choice of the method of sterilization (if needed) they could use…

a bit as
which tissues will your device be in contact with ? blood, mucuous tissue, bone, skin….
is your device entering into the body ?

Is your device resistant to high temperature (>120°C) Yes/ No. if Yes, is it resistant to pressure ?
Could your device be discolored ?
is your device containing lots of tubes, inner parts…
does your device contain ambient air ?

I'm looking to draw up a kind of systematic review of risks and sterilization issues to help engineers to manage the risks at the beginning, from the conception.
 
J0anne

J0anne

Joanne
#6
#6
I understand. My personal preference would be for it to be supplied for use as sterile.

As for tools, the best tool you have is your risk management procedure.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D Deciding whether or not pre-market clinical investigation is required for low risk device EU Medical Device Regulations 5
J Deciding between Professional Use or Lay Person IVD Test - Human fecal stool specimens Other Medical Device and Orthopedic Related Topics 1
A Trimming the Inspection Report - Deciding which are the CTF dimensions Manufacturing and Related Processes 3
P Deciding whether or not a new 510k is needed Other US Medical Device Regulations 2
J Deciding what Raw Materials we should require CofCs for ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
shimonv Deciding When to Submit a 510(k) for a Change to an Existing Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
B Deciding when to submit a Special 510(k) US Food and Drug Administration (FDA) 10
A Deciding on when to go for Cp & Cpk or Pp & Ppk Study? Statistical Analysis Tools, Techniques and SPC 3
R Deciding what Processes need Control and Monitoring - 820.70 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
V Is permission from Registrar needed for deciding on in-house calibration? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Deciding if Calibration is needed for Production Instruments General Measurement Device and Calibration Topics 8
A Process FMEA - Help in deciding "detection ranking" of a failure mode FMEA and Control Plans 5
Q Deciding HOw to Measure Alloy Hardness after Casting Various Other Specifications, Standards, and related Requirements 2
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
H EU CE marking for Medical Device Class I EU Medical Device Regulations 0
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Brian Benzarti Medical Devices CLP Regulation Quality Assurance and Compliance Software Tools and Solutions 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
dgrainger Informational Medicines and Medical Devices Act 2021 UK Medical Device Regulations 0
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
S Medical Device MRI Compatibility EU Medical Device Regulations 3
M NICE Medical Technology Evaluation Programme - Recommendations Service Industry Specific Topics 0
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
J Warnings/Cautions in Medical Device IFU Medical Device and FDA Regulations and Standards News 4
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1
A Sampling plan for in-process QC (medical devices) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
M V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device) Design and Development of Products and Processes 2
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 1
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
B Specialized Medical Apparel Manufacturing and Related Processes 1
B Free Sales Certificate for Non Medical Devices Other Medical Device Related Standards 2
M Medical device substance based-leachables Other Medical Device Related Standards 2
K Usability for custom made medical devices IEC 62366 - Medical Device Usability Engineering 5
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
dgrainger Informational MHRA - Regulating medical devices in the UK - Post Brexit - 2021-02 UK Medical Device Regulations 0
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
L Medical Device Registration in Macau Other US Medical Device Regulations 1
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 4
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
S Medical watch Class II (AP Type CF) with USB connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
T B2C Medical Device Shipping across the US Other Medical Device Related Standards 0
M Medical Device Registration In Malaysia Other Medical Device Regulations World-Wide 2
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1

Similar threads

Top Bottom