If you cast your mind back to 2020, you might remember seeing a lot more medical device bags than you ever had before – or likely will again.
The pandemic years were truly an experimental time, but the fundamentals of medical device bags were there for all to see; strict and clear labelling, tough but easy to open, non-shedding materials, and totally sealed from the elements until the point of use.
It really cemented medical packaging into public consciousness. And while it might have seemed overkill, it’s actually just the standard.
That’s because, in the tightly regulated world of healthcare, every single medical device has to be treated with precision and safety. Packaging is vital to this – and medical device bags are incredibly important for the safe use of life-saving medical equipment.
We’ve been working in the medical packaging sector for decades, and we understand the five essential features that define high-performance medical device packaging. From sterility to clarity, these are the non-negotiable features for medical device bags that healthcare professionals (and patients) can trust.
Durability and sterility
The biggest responsibility of medical device bags is to maintain the sterility and integrity of its contents, from the moment it’s sealed on the production line. And polythene is an ideal material for this, which is why medical device bags usually employ it in some way. It has incredible barrier properties, is chemically inert, and is inhospitable to microbes (especially when treated).
Polythene is highly flexible, biocompatible, and non-shedding (meaning no particles fly off when it’s opened), making it a mainstay of surgical, clinical, and laboratory environments.
But medical device packaging also has to withstand a ton of physical stress during transit. Impacts, compression, and abrasion are par for the course in logistics – but a breach in the packaging material, no matter how small, compromises the entire sterile barrier. The device becomes unusable, because any breach is an unacceptable risk to patient safety.
Again, polythene excels in durability, without having to be wastefully overengineered.
Multilayer laminated polythene is a useful tool for many medical applications, creating a composite of films, foils, and paper-backed packaging systems.
Stability
Medical device bags aren’t just a shield – theyre a protective environment for the goods inside. Biological contaminants are one thing, but environmental factors can degrade devices, too. The most significant threats are moisture, oxygen, ultraviolet radiation, and temperature changes.
Many medical devices can be susceptible to corrosion or oxidation when exposed to humidity or air – and some medications within devices are temperature-sensitive, too.
Medical device bags have to block out moisture and vapour that could cause corrosion or degradation. They have to be stable in a wide range of temperatures, and not deform or become brittle if in cold chain logistics. While polythene doesn’t provide insulation in the traditional sense, sudden temperature changes won’t cause condensation to form inside – which would be catastrophic for a sterile device. And with the right additives, polythene can remain flexible and predictable in temperatures from -40ºC to 90ºC!
Read more – Properties of Polythene
Medical packaging also needs to be UV resistant. This is for sterilisation purposes mainly, but there can be significant exposure to UV during some treatments and therapies. It’s also a factor during extensive use out in the field, or storage in less than ideal conditions (pressed against a window in a supply cupboard, for example).
Clarity and transparency
A medical device bag must offer excellent transparency, crystal-clear labelling, and offer zero ambiguity as to the product inside. This is literally a matter of life and death!
In a clinical emergency, seconds count. Staff need to identify the contents of a package quickly and accurately. Poor clarity, poor labelling, confusing designs – these get in the way of nurses and doctors trying to save someone.
The ability to visually confirm the device, its size, its configuration, and any specific features through the packaging is crucial for speed, and reducing errors.
Polythene has exceptional clarity at the right blend and gauge, and maintains its clarity over time. Polythene resists hazing, discolouration, and clouding, and it can also be printed with exceptional accuracy – which we’ll come to next.
Precision printing and colour-coded labelling
Polythene is printable with high precision. Even the smallest package can be labelled clearly; with legible, durable text and imagery that resists rubbing or fading.
Product name, lot number, expiry date, sterilisation method, and unique device identification credentials can be applied – plus any legislative information that needs to be present.
Colour-coding can also be built-in, and that’s important for certain devices – hospital colour codes are strict, and waste streams have to be separated to avoid contamination. If medical devices have been used for certain procedures or have been exposed to therapies like chemo or radiotherapy, then they’ll need to enter a colour-coded waste stream.
But blue packaging is important, too. Hospitals use blue because, with the exception of the sky, the sea, blueberries, and a handful of flowers – nature doesn’t give us much blue. Any blue packaging sticks out like a sore thumb against most natural things, including human bodies – so using blue limits the risk of accidentally introducing contaminants during surgery or treatment.
Tamper resistant, but easy-to-open
These two might seem to be in opposition – but they have to work in perfect harmony.
Medical device bags must be secure and tamper-evident, but easy to open.
Imagine a doctor losing a patient because they couldn’t open a piece of medical packaging fast enough. Because it kept slipping in their hands, or got stuck to their gloves, or the opening notch failed – or any other number of failures that could happen.
It doesn’t bear thinking about… But the result would be loss of life, total distrust in the packaging and product, and a long investigation into the root causes of the failure.
This is where medical packaging design has to be considered the most; because while it’s got to be an impenetrable fortress to the elements and to microbes, it must be easily and predictably accessible at the point of need.
A tamper-evident seal is another critical security feature that provides immediate, visible proof that the sterile barrier has been maintained. If the package has been compromised at any point in the supply chain, the evidence should be clear and unmistakable.
This often takes the form of a printed seal that, if broken, can’t be perfectly restored, or a tear-off strip that is visibly detached.
But it cannot come at the cost of usability.
The package must be designed for aseptic presentation, meaning it can be opened easily by a scrubbed healthcare professional without contaminating the sterile contents.
This involves features that allow the package to be opened with a smooth, controlled action – so the device can be removed easily, without dropping it or having it jump out of the bag.
The goal is to allow the sterile device to be transferred directly to the sterile field without the outside of the package coming into contact with the device or the field. This careful balance is the difference between your regular consumer grade packaging, and the kind used in a clinical environment.
At NPF Packaging, we take medical device bag design seriously – and work with our partners closely to create packaging solutions that meet the high levels of performance they need.
Get custom made medical device bags
Order bespoke medical device bags – from NPF Packaging, the polythene experts. Get high definition printing on coloured polythene, with custom blends available for the most demanding medical products.
Get a quote now, or call us on 01773 820415 to get started.