The process of sterilisation is an extremely important part of the healthcare industry, which has experienced an increase in the number of methods used to sterilise medical equipment, implantable devices and consumables. Traditionally, items are sterilised when heat, irradiation, high pressure, filtration or chemicals are applied to medical or surgical equipment. But as the medical device supply chain becomes more efficient, new methods of sterilisation are coming to the fore.

In terms of products and services, the sterilisation technology industry has been segmented into consumables, services and finally devices, which occupied the largest share in the global market in 2016, due to the growing number of hospitalacquired infections (HAIs), rising number of hospitals, and increasing pharmaceutical, biotechnology and medical device sectors. The vendors in this area offer two major types of sterilisation services: contract sterilisation and sterilisation validation, with the former having a bigger share of the market.

Pharmaceutical and biotechnology companies make up the largest percentage of end users in the sterilisation technology market, and are expected to generate a revenue of $3.2 million by 2023. An uptick in the number of these businesses, combined with the increasing production of pharmaceutical and biotechnology products, is boosting the growth of this segment. Hospitals, medical device companies, ambulatory surgical centres and clinics, as well as academic and research organisations are other key end users in the industry.

In the Asia-Pacific region, the market for sterilisation technology has experienced a significant upturn due to the ageing population, rising healthcare expenditure, expanding pharmaceutical industry, high pollution levels and growing interest in medical tourism. South Asia’s healthcare expenditure was 3.9% of its total GDP in 2000 and went up to 4.4% in 2014, according to the World Bank. Asia-Pacific’s flourishing healthcare infrastructure is, therefore, generating huge revenue opportunities for the region’s medical device manufacturers to adopt for sterilisation products and services.

Determining the right sterilisation method for a particular medical device can be a daunting task; if the incorrect method is selected, the consequences for the device, patient and time to market could be catastrophic.

Choosing vendors

When selecting a vendor for contract sterilisation, medical device companies must take a wide range of factors into consideration. As most vendor validation periods can last as long as two to four months, it can be financially detrimental to complete a validation, only to find that the new relationship isn’t quite right after the first month of processing.

A few aspects of quality control stand out, in particular, when selecting a sterilisation vendor. The segregation of processed and unprocessed products must be carried out diligently, as it is impossible to know if a product has been sterilised just by looking alone. Vendors should also be able to confirm that their process or product flow keeps processed and unprocessed products apart. The second – and seemingly obvious – factor is the cleanliness of a facility, including its pest control practices, which should not be overlooked. Conscientious site maintenance is imperative for maintaining the quality of a sterilisation outfit.

It’s also extremely important to remember that contract sterilisation facilities do not ensure the sterility of a product. Instead, they check if the validated cycle was run to the client’s specification and no non-conformances were found.

Packaging problems

The rise of HAIs and an ageing population, together with the demand for sterilised products and less invasive surgical procedures, have all influenced the sterile medical market’s growth. However, this has also been hindered by stringent packaging regulations.

Critical-to-quality requirements that are not linked to a product’s intended use can result in irrelevant criteria being assessed in order to gauge the efficacy of a device’s packaging. This creates considerable delays to market, wasting the manufacturer’s time, money and resources.

During the design phase, product innovation proves beneficial for more than guaranteeing packaging specifications are accurate and suited to particular scenarios. It also helps create a product that can fulfil its purpose, while minimising risk factors when used in critical healthcare environments.

In a Packaging Digest interview, Dr Laura Bix, professor and associate director at the Michigan State University School of Packaging, US, said research from her graduate students showed that packaging design can affect the risk of contamination.

“Material curl, namely material that curls in, can impact the rate of contact,” she explained. “Packaging designers can help or hinder the opening process,” as an opening process with less movement and a fluid motion can reduce contact.

Focusing on the manufacturing process during the design phase ensures that the path to the market will become more efficient. Prediction tools allow designers to understand how a certain part will behave in manufacturing, so they can amend it accordingly to maximise production runs.

Adding instructional symbols to a device’s packaging is another way of ensuring a product is opened and used in a specific way that does not reduce the efficacy of a device. To help healthcare professionals check if a sterile barrier has more than one layer, the Sterile Barrier Association has proposed a new symbol, which has a solid line to indicate the presence of a validated barrier; a dotted line will also show if there is an additional protective layer, like a dust cover. Symbols may assist with aseptic presentation, but they also present many challenges, including fitting them on packages and checking that people recognise what they signify.

The impact of sterilisation on devices

Finding the optimal sterilisation method requires taking the specific properties of a medical device into account. Certain polymers, for example, may react differently to the sterilisation process. To prevent colour changes or the loss of mechanical properties in processes like steam sterilisation, materials have to be resistant – especially to high temperatures.

In hospitals, housings for diagnostic and monitoring equipment typically have to withstand highly aggressive and concentrated cleaning agents. This can created stress cracks in the plastic, which may lead to fluids infiltrating a medical device and damaging expensive electronics. This is why it is crucial for the right material to be used.

Despite the wealth of literature about sterilisation methods and equipment, there is very little about the impact of sterilisation on electronics. Advances in semiconductor technologies also mean that integrated circuits are found in a wide array of medical equipment.

UV-C lamps could also have dire implications in clinical settings, such as operating rooms. Scientists have developed a lamp that kills the influenza virus, but isn’t harmful to human skin or eyes.

“No matter how well you sterilise a room beforehand, the medical staff can still bring in dangerous bacteria like MRSA,” said David Brenner, director of the Center for Radiological Research at Columbia University Irving Medical Center. “If you have a lamp over the surgical site that can sterilise the air, you can prevent the bacteria from floating down and contaminating the wound.”

A new autoclave

The purpose of sterilisation is to render all microorganisms inactive on or in a product, without making it ineffective. An autoclave, for example, is simple and relatively inexpensive to install in-house, but many products simply cannot take the heat involved in steam sterilisation.

Prestige Medical, a specialist in developing and manufacturing sterilisation equipment, has now added a range of autoclaves to its extensive portfolio. The company’s new Advance Pro autoclave employs the FlexiRack system, which has a unique aluminium rack that can support 12 individual rails and can be arranged into 20 different configurations. FlexiRack also introduces a groundbreaking heat transfer system that has been designed to take full advantage of the high-performance thermal conductivity properties of aluminium.

In a press release, John Potter, Prestige’s managing director, explained the importance of developing technology that can comply with evolving industry standards. He said, “With infection control regulations becoming increasingly more stringent, a new breed of equipment is required that is capable of meeting these challenges. And with Advance Pro as part of our new generation of integrated decontamination solutions, we are able to take infection control to even greater levels.”

Single-use devices

One ingenious way of avoiding the pitfalls of contract sterilisation is employing single-use devices. These are the ‘bread and butter’ of Xenco Medical, a company that aims to put an end to reusing metal instruments that drain hospitals of precious time and resources. Instead, it offers surgical instruments and implants that are packaged together in sterile, single-use systems.

Founder and CEO Jason Haider has stated that the business works to improve what he calls an “antiquated medical device supply chain”, with packaging being at the heart of this goal.

Speaking to Pharmaceutical & Medical Packaging News, he said, “As the inefficiencies of reused metal devices have necessitated repeated sterilisation and the cumbersome transport of heavy metal trays after each surgery, both hospitals and outpatient surgery centres have had to compromise on the cost-effectiveness of their care.” Haider estimated that sterilising and transporting reusable devices after an operation requires a minimum of three and a half hours to complete.

With sterilisation costing nearly $1,000 per surgery, losing time to the unavailability of instruments and implant sets is costly, especially for small facilities like outpatient surgery centres. Haider calculated that, with Xenco Medical’s solution, disposing of single-use surgical instruments could range “from $0.09–0.71, and the savings from sterilisation alone averages from $850–950 a case”.

Xenco Medical’s devices are the first composite-polymer systems of their kind. “Because of these material properties, the instruments have the same appearance, handling and performance as metal instruments, without the associated inefficiencies, deterioration and risk of patient-to-patient pathogen transfer,” Haider added.

If companies like Xenco can prove to be environmentally and financially sustainable, while maintaining a forwardthinking business model that can secondguess a technologically developing industry, then the future looks bright for the medical sterilisation market.