4 Common Misconceptions About Medical Device Labeling
When mentioning to medical devices labelling, the term labelling contains all necessary information provided along with the device. Which includes;
- Symbols, labels, instructions, warnings and control labels applied to the medical device by coding colour, moulding, machining or printing.
- The information is shown on the medical device User Interface
- Documents were given with the device like installation instructions, user manuals, as well as maintenance instructions
- Details printed on the device packaging
Medical device labeling is adapted in all jurisdictions. And below are threesome common jurisdictions as well as the relevant requirements:
- Canada: Canadian Medical Device Regulations clause 21
- EU: Medical Device Directive Annex 1, clause 13
- USA: FDA CFR 21 Part 801
According to statistics that in spite of showing 5% of the world population. Us produces more waste than any other country worldwide. That waste sometimes even extends into medical practices as well as the devices used to improve the health of our patients. Not every device or product labelled “Single use: is actually only usable once. So many can be used and repossessed again.
Whom there are items in medical practice that are made to use only once, there is really a huge benefit to reprocessing certain medical devices labelled as use once devices.
Medical Device Label Description
Let’s know about 4 common misconceptions about medical device labeling.
#1 MEDICAL DEVICE LABELING IS JUST THE LABEL ON THE DEVICE
Before going further, it is very important to get on a big misconception cleared up. Most of the people think that medical device labeling is just the label on the device. When we mention about the label(s) it means we are talking about the device labels that are on the box or pouch. they do not consider about IFU ( information for use).
As per FDA labelling…
“All “label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents”.
Well, the device labelling is extremely important, it not that something to be done at the end of the project. So, you can do it in between as it’s not the matter of duplicating hat the other has done.
#2 YOU CAN ESSENTIALLY DUPLICATE THE PREDICATE DEVICE LABELING
Something that we’re on the whole, is that our device ought to nearly coordinate the predicate device when we’re presenting a 510(k).
The vast majority accept this implies they can take the predicate device marking, swap in their device name and call it great.
Sadly, it is quite difficult.
When you’re planning your device marking, you can surely begin with the predicate device name. It will give you a decent beginning stage for what admonitions and alerts you may need to incorporate.
In any case, you can’t stop there.
Your marking is a piece of your outline yields and should be dealt with accordingly.
You additionally need to ensure you’re connecting your mark to your hazard administration. In the event that you’ve distinguished unsafe circumstances or damages that aren’t said on the predicate name, you have to ensure you consider including them on yours.
Sometimes, the predicate device was made a very long time before your device and new data about perilous circumstances and damages might be accessible.
Concerning whatever remains of the naming, particularly the IFU, don’t accept that you can simply swap out the data on the most proficient method to utilize the predicate device with how to utilize yours.
You have to ensure you’re doing your due constancy on how simple the IFU is to peruse and get it.
#3 THE QUALITY IS NO GOOD AS MENTIONED
Like new devices, reprocessing is managed by the FDA, with prerequisites that reprocessed devices be spotless, sterile, and as protected and viable as when they were spic and span. Indeed, reprocessors are held to considerably stricter models than the first gear maker (OEM). They should submit 510(k)s and get FDA freedom on all devices. They are likewise examined by the FDA much more regularly than the first maker.
Each gadget is altogether reviewed for reprocessing bid. Most SUDs can be reprocessed a few times over, contingent upon development, material synthesis, and taking care of. Gadget reprocessing cycles are followed by means of a small scale carving process.
At a point, when a gadget has satisfied its reprocessing lifetime, it will be expelled from the cycle lastly discarded. Regardless of whether despite everything it falls inside the adequate life expectancy, if a gadget can’t be appropriately cleaned, sanitized or guaranteed to be practically equal to another gadget, it won’t be reprocessed. For instance, class III implantable devices, for example, pacemakers and substitution heart valves—are not reprocessed.
As a result of these thorough capabilities, the nature of a reprocessed gadget is similarly as great or stunningly better than a shiny new gadget. Truth be told, a Midwest medical procedure focus played out a visually impaired investigation blending reprocessed and new careful instruments for their techniques, and the specialists couldn’t differentiate.
#4 THE ADDRESS MENTIONED ON THE LABELING IS ACTUALLY WHERE THE MEDICAL DEVICE IS MADE
This is one is the last misconception of many people that the address mentioned on the device labelling is the place where the device is actually manufactured.
Nowadays, more and more devices are being manufactured by contact manufacturer and in different locations. With all the places involved in, which location goes on the device labelling is totally based on the place where you’re going to sell your device.
According to 21 CFR part 801.1, the FDA needs that the label “ should mention conspicuously the place and name of the business of the product manufacturer, distributor or packer. And if the device is not made by the person whose place and the name is mentioned on the label, the place and name should be mentioned as it reveals the connection of a person with a product such Manufactured by___ that means mentioning company address on the label is necessary.
But what about the rest of the world?
It is possible to have multiple addresses on your device label if you’ve purchased a device being sold in the EU or any other country.
The MDD needs the address and name of the product manufacturer and the address and name of the authorized representative.
Medical device labeling requirements
Manufacturers of electronic devices covered under a set standard shall give the following details on a label or tag permanently written on the product. Mentioned below information should be viewable when the price is totally completed.
The full name and address of the manufacturer of the product
The product should contain the name and address of the product manufacturer or company. Abbreviations like Inc., Co., or the initial of the middle and first name of the person may be used.
The month or year and place of manufacture
The manufacturer place should be exposed in a code and that code has been earlier supplied to the Director. The year or month of manufacture cannot be abbreviated. The four-digit number and the month must appear as below:
“MAN 8 FACTURED: (Insert Month and Year of Manufacture)”
Medical Label Symbols
Importance of Medical Device Labeling
Due to the dangers of misbranding as well as the associated recalls if such medical devices, it is very important for manufacturers to have the right labelling. As the drug and food administration has some rules and regulations about what cannot and can be included, it is very essential for manufacturers to understand what and how to include it. Likewise, they must also know what cannot be included.
General details about labelling
The specifications for what should not or should be included in labelling is governed by FDR 21 code 801 You know that the labelling of the medical device comes attached along with the device or inside the device.
The medical device labeling should include a general description, display panel, information on troubleshooting, as well as some additional information. The place and name o company or business should also be written.
Now, all the 4 misconceptions about medical device labeling must be clear to you. As now you know that device labelling is more than just label anything on the medical device so you simply do not copy the device labelling and that addresses on the device labelling completely depend on where the device has been brought to sell.