Changes in materials for medical devices, other than IVD medical devices
Example
Category (Significant, non-significant)
Change in radiation source (e.g. radioisotopes) or type of medicinal substances in the medical devices that incorporate medicinal substances in an ancillary role, such as:
- Change in the drug of a drug eluting stent.
Significant
Change in type, source, processing and/or supplier of biological materials (including cells, tissues and/or derivatives of animal, human, microbial or recombinant origin) without a change in the intended purpose of the biological material, such as:
- Change in source of hyaluronic acid from Streptococcus zooepidemicus to Streptococcus equi.
Significant
Change in material or material formulation (of non-biological origin) including changes to device coating or surface modification technique in a medical device that is intended to make direct/indirect contact with body tissues and fluids or is absorbed by the body, such as:
- Peripherally Inserted Central Catheter (PICC).
- Introduction of a colorant change into the insertion hub of a PICC that is part of the fluid path for fluid administration or withdrawal from a patient. Cardiovascular Catheter.
- A change of material to a cardiovascular catheter that comes in contact with body tissue (e.g. change to/from polyether block amide (PEBA), Polyamide or polyether ether ketone (PEEK).
Significant
Change to concentration or drug specification of medicinal substances in medical devices that incorporate medicinal substances in an ancillary role, such as:
- Change in the concentration of the drug in a drug eluting stent.
- Change in the concentration of antibiotics or a change to a different antibiotic in a catheter. coated with antibiotic.
- Catheters that coated with antibiotics.
Significant
Change in supplier or vendor of the material, but the material meets the manufacturer’s previously reviewed specification
Non - Significant
Peripherally Inserted Central Catheter (PICC).
Introduction of a colorant change into the flush port of a PICC. The flush port is an access port for flush syringes for IV line clearance or volume block and is not intended to be used for fluid administration or withdrawal from a patient.
Non - Significant
Talisium is a Registered Trademark of Talisium Pty Ltd
Sahjogita Kathuria
Sahjogita Kathuria is Director Regulatory Affairs and Quality Assurance in Terumo India Pvt. Ltd.
She joined Terumo in 2017 and has a total of 17 years experience in RA/QA. At Terumo her responsibility is to ensure organizational effectiveness by providing leadership for the RA/QA function.
In her previous experience, she worked with CR BARD, Sanofi Pasture, BAXTER and RANBAXY and has experience in medical devices, biologicals, vaccines and new drugs.
Sahjogita is a certified lead auditor for Medical Device Quality Management System ISO – 13485:2016 and a certified internal auditor ISO – 9001:2008.
She is actively engaged in various medical device industry forums and is part of the core group for APACMed capacity building group.
Recently, she played a very important part in creating an exclusive forum for Japanese healthcare companies in India named Japan Medical Device Association in India (JMDAI).
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Accessibility Help
Conformance Statement for e-LfH
Our complete Accessibility Conformance Statement can be found on our website.
Accessible Style
We make efforts to support users of different forms of assistive technology (AT) by providing assistive text, subtitles and captions in our e-learning sessions, where appropriate. We also provide a high contrast version of our e-learning sessions for users with vision disabilities. This style can be enabled and disabled by selecting this icon Use high contrast stylesheet in the footer of the session.
Selecting the high contrast style switches off many colour options, making most of the content black and white. Alternative versions of some content is also provided, for instance where it would otherwise be difficult for users with visual impairments or for those users not using a mouse device.
e-Learning for Healthcare's aim is to make this e-learning session as usable and accessible as possible. Please contact us if you require further help, if you have any feedback, or if you would like to report any difficulties.
Changing the text size and zoom level
Many web browsers, and other user agents, have built-in functionality that allows you to zoom in and out of the e-learning session. This allows you to make text and images in the session larger or smaller.
- Internet Explorer (PC) - Select the CTRL key and "+" (plus) to zoom in. Select the CTRL key and "-" (minus) to zoom out. Select CTRL + 0 to return to the default size.
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Access Keys
Access keys let you navigate around the e-learning session without using a mouse or other pointing device.
Table of Access Keys Used
Access keys are intended to provide an alternative form of navigation by using keyboard shortcuts. Please note that only numeric keys have been used in this e-learning session, in an effort to provide the alternative navigtation while not conflicting with any other software that may use access keys or any access keys already defined by the user themselves.
Some assistive technology tools such as the IBM HomePage Reader and WindowEyes already make use of the alt+[access key] combinations. As such, users of these tools may not be able to use some of these access keys.
- 0 - open this Access Keys Help page (this page). This web page opens in a new window.
- 1 - go to the first page of this e-learning session.
- 2 - skip to main content of current page.
- 3 - open the menu.
- 4 - go to the previous page in current session.
- 5 - go to the next page in current session.
- 6 - go to the help and support on the e-Learning for Healthcare website. This web page opens in a new window.
How to use Access Keys in your Browser
- Internet Explorer 8 and above (PC)- Hold down the ALT key and the access key. In some cases you may find that you need to hold down the ALT key with the access key and then release both keys and press ENTER.
- Chrome (PC) - Hold down the ALT key and the access key. In some cases you may find that you need to hold down SHIFT+ALT and the access key.
- Chrome (Mac) - Hold down the CTRL+Option (opt) key and the access key.
- Firefox (PC) - Hold down the SHIFT+ALT keys and the access key
- Safari (Mac) - Hold down the CTRL key and the access key
Author Umesh Dashora
Royal College of Physicians
Member of Federation of Royal Colleges that has supported and contributed material towards the ACUMEN project. Principal copyright holders for ACUMEN project.
Royal College of Physicians of Edinburgh
Member of Federation of Royal Colleges that has supported and contributed material towards the ACUMEN project.
Royal College of Physicians and Surgeons of Glasgow
Member of Federation of Royal Colleges that has supported and contributed material towards the ACUMEN project.
