The low-temperature option

Dean Burand, regulatory affairs manager at IHSS, discusses the impact of low-temperature decontamination and the options for cost reduction within the healthcare market

The sterilisation and disinfection of medical instruments is becoming increasingly challenging, with the growth in ever-more-sophisticated devices. This causes problems with traditional methods of cleaning. In this article, Dean Burand, regulatory affairs manager at IHSS, explores the reputational risks with specific reference to decontamination and discusses the options for effective decontamination, including traditional high-temperature processes, low-temperature technology, and the options for in-house or outsourced services

Mention budgets and cost cutting and most healthcare professionals will inwardly groan.

It probably seems to many people in the sector – especially those with long memories – that financial pressures have been with us since time immemorial.

Unfortunately, and without wishing to add to the general despondency around this subject, the situation is unlikely to improve in the foreseeable future.

This was highlighted in the recent publication from HFMA, NHS Financial Temperature Check, which stated that: “At the end of 2015/16 NHS trusts reported a net deficit of £2.45 billion.

There is a growing risk if sterilisation has to be compromised or if the use of advanced medical devices has to be curtailed because they cannot be reliably reprocessed due to cost constraints or lack of skilled staff

“The scale of the deficit across the English NHS is unprecedented and would have been larger were it not for some non-recurrent measures.

”This potentially stores up problems for the future.”

The situation is exacerbated by the short-term economic and political turmoil following the Brexit referendum, and the growing long-term pressures on services from a growing and aging population.

Even advances in technology, although bringing benefits for clinicians and patients alike, can present fresh challenges if investment in new equipment, staff training, or facilities is required, but cannot be adequately funded.

A classic example of this dilemma can be seen with the introduction of a new generation of sophisticated medical devices, where design and functionality have been revolutionised by the use of embedded microprocessor technology and advanced materials of construction.

In particular, the latest generation of devices, ranging from endoscopes and Transoesophageal Echocardiography (TOE) probes, to robotic surgical instruments such as the da Vinci system, are transforming the way in which healthcare professionals work and the standards and outcomes of patient care.

These devices, however, require specialised handling as they are generally constructed from lightweight composite or flexible materials and often incorporate sensitive electronic components, typically microprocessors and EEPROMS (Electrically Erasable Programmable Read-Only Memory), together with miniature batteries and connections for accessories or external systems.

These specialised electronics and materials of construction can be difficult to reprocess in existing high-temperature stream sterilisation systems, where temperatures up to 137°C and pressures of between 1.0 and 3.5 atmospheres are normally used to render the device sterile.

Typically, composites and flexible materials will delaminate or distort when subjected to high temperatures, pressures and moisture, while the operating life of batteries and integrity of electronic circuits can be adversely affected; it has even been known for the data stored in memory devices to be irretrievably erased.

If the growth in the use of the latest advanced medical devices is to continue successfully then it is essential that a range of appropriate sterilisation services become freely available, at a time when healthcare budgets look set to be cut even further

There is, therefore, a growing risk if sterilisation has to be compromised or if the use of advanced medical devices has to be curtailed because they cannot be reliably reprocessed due to cost constraints or lack of skilled staff.

Until recently, this issue has been exacerbated by the limited options available.

The frequently-used alternative to high-temperature steam sterilisation is manual cleaning with warm water and detergent, followed by disinfection using chlorine dioxide or chlorhexidine wipes.

In some instances, disinfection at low temperatures using chemicals or a washer-disinfector may also be used.

The problem with manual decontamination is that it is difficult to carry out safely and consistently, while chemicals have to be handled by staff and securely stored. The entire process must therefore be rigorously policed and documented to minimise the risk of human error – all of which requires specialised training, takes time, and adds to the overall cost.

A further option is the use of Ethylene Oxide (ETO). This gas chemically reacts with amino acids, proteins and DNA to prevent microbial reproduction.

Although it can offer an effective method of sterilisation, the ETO process suffers from a number of problems. In particular, it uses a highly-flammable, petroleum-based gas that is a recognised carcinogen, while the capital cost for installing an ETO system and secure infrastructure is often prohibitive.

Additionally, the process stages required for sterilisation are extremely slow, often requiring up to seven days before devices can be returned to use; consequently, clinical teams using ETO often have to invest in higher levels of inventory, adding to costs, or compromise on levels of patient care.

Cost benefit

The benefits offered by the new generation of advanced medical devices are unparalleled, making the technology indispensable. However, this presents a dilemma.

The price of new technology is high – a Da Vinci system, for example, is in excess of £1m, plus annual maintenance fees. This cost must then be added to the overhead of operating onsite low-temperature decontamination systems and associated facilities, plus investment in staff training, validation procedures. and the loss of valuable floor-space that could otherwise be used for clinical duties – all of which can equate annually to several hundred thousand pounds.

A new, and perhaps more viable, option for many hospitals is to partner with a specialised outsourced provider, which has the dedicated facilities and levels of investment capable of delivering a fast and cost-effective low-temperature sterilisation service. IHSS, for example, uses the latest hydrogen peroxide (H 2 O 2) technology, which has been developed specifically for sterilising advanced medical devices, such as ureteroscopes, choledochoscopes, intubation endoscopes and the Endoeye Flex 3D videoscope.

Outsourced services will be vital to give healthcare professionals an affordable alternative to in-house manual or ETO techniques, that deliver operational value without compromising the patient experience

The process uses a vaporised mixture of H 2 O 2 and water moisture, injected at elevated temperature into a sterilisation chamber. The vapour penetrates cavities and lumens, with the H 2 O 2 condensing onto instrument surfaces to deactivate microorganisms by attacking the cell walls and inner part of each cell. The entire process can be completed in under 60 minutes, and enables batches of devices to be reprocessed quickly, cost-effectively and safely.

There are many advantages to outsourcing: moving cost from the capex to opex budgets, without the need for new investment; cost reduction; transference of risk; faster and more-efficient reprocessing; operational flexibility to cope with fluctuations in demand; better utilisation of hospital staff and available space; and improved patient care.

If the growth in the use of the latest advanced medical devices is to continue successfully then it is essential that a range of appropriate sterilisation services become freely available, at a time when healthcare budgets look set to be cut even further.

Outsourced services will be vital to give healthcare professionals an affordable alternative to in-house manual or ETO techniques, that deliver operational value without compromising the patient experience.

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