It’s now nearly a decade since AS/NZS 4187:2014 set stringent requirements for every hospital’s Central Sterile Supply Department (CSSD), which is responsible for reprocessing reusable medical devices such as scalpels, forceps or scopes. 

Far tougher than expected, the new Standard caused considerable confusion and concern when it was launched. Hospital executives were concerned about the expense and disruption that the capital works would require and asked for more time. A working group (HE023) was established to advise on a way forward and the standard and deadlines were revised a little in 2019

Then came a global pandemic. Hospitals were on the frontline of a healthcare emergency, diverting all available resources to treat COVID-positive patients with a workforce constantly diminished by the virus.

The Australian Commission on Safety and Quality in Healthcare’s most recent guidance allows hospitals until 31 December 2024 to achieve full compliance. But, given the scale of the task, late 2024 is not all that far away. How can hospitals achieve compliance on time? 

Understand the water quality requirements

Aquacure Water Treatment is a family-owned, Brisbane-based business that has been installing new water treatment plants at many hospitals to enable compliance with the new Standard. 

Managing director, Christopher Hall, says that before 2013, most CSSDs were just using tap water to clean instruments. “That was better in some places than others. Some CSSDs were doing a bit more to soften their water but it’s a very big change from that practice to the new Standard which requires demineralised water to be used for cleaning, final rinse and steam generation.”

The relevant sections of the Standard are: 

  • Section – cleaning
  • Table 7.2 – final rinse
  • Table 7.4 – steam generators. 

Using demineralised water throughout the whole CSSD requires: 

  • A new water treatment plant
  • New pipework
  • A new pipework methodology.

“You can’t just connect the new machines to the old copper piping,” says Hall. “Demineralised water needs new piping, usually stainless steel. The whole piping system needs redoing to achieve microbial control in the final rinse, which the Standard requires.”

Understand the other requirements 

The Standard goes further than water quality, requiring CSSDs to: 

  • Be able to trace devices to patients 
  • Store sterile stock in compliant shelving
  • Ensure cleaning and disinfecting equipment is compliant
  • Redesign their floor plan to separate clean and dirty activities.

“You’ve not only got to rip out your pipework and install a whole new water treatment system,” says Hall. “You’ve also got to approach the whole CSSD workflow differently to segregate activities and you’ve got to install new equipment too. In practice, you’re looking at a minor to major construction job, which will involve shutting down the CSSD at some point.”

Recognise the reality

There are many obstacles to meeting the new Standard by the end of 2024, including costs, the impact on surgery and the tight timeframe. 

“Before COVID, a lot of the resistance was based on cost,” says Hall. “And cost pressures have worsened since then. We’re seeing unprecedented price hikes in materials like stainless steel, energy and freight costs and we’re also in a tight labour market with supply delays.” Aquacure is less affected by supply chain issues than most companies because it builds its water treatment plants in Brisbane.

Shutting down the CSSD has ramifications for the provision of surgery. Most hospitals are trying to work through a backlog of elective surgeries after a number of pandemic-related suspensions of activity. Few are in a position to suspend surgery again to remodel the CSSD. 

While some hospitals have chosen to time construction works for the Christmas/New Year period when activity levels are lower, this won’t be possible for everyone. 

That means other solutions are needed, such as offsite processing at a neighbouring facility or installing a mobile or modular CSSD, which Hall describes as “an essential part of the solution for many hospitals.”

Then there are the timelines. Achieving compliance requires: 

  • Conducting a gap analysis
  • Developing an implementation plan
  • Gaining quotes from a large number of providers that may include architects, hydraulic engineers, air filtration experts, builders and water specialists
  • Commissioning the work and locking in the tradespeople – if you can in such a tight market. Construction in a live hospital is a specialist job and many experienced companies are already busy.

“If you haven’t started yet, you need to get moving,” says Hall. “And if you have started, you probably need to quicken your pace.”

Ultimately, Hall believes this work does deliver tangible results for hospitals. “Customers tell us that, with better water, they’re getting better reprocessing results and their expensive surgical instruments are lasting longer.”

Use a mobile or modular CSSD

For many hospitals, commissioning a mobile or modular CSSD offers a way to either: 

  • Create a window of opportunity for construction works on the main CSSD to be completed by 31 December 2014, or
  • Meet the standard on time while creating breathing space to commission construction works for the main CSSD. 

Mobile or modular CSSDs already comply with AS/NZS 4187:2014 (2019), removing the prospect of regulatory risk and giving hospital executives peace of mind. Modular facilities can be designed bespoke to each hospital’s particular needs. 

If you’d like to learn more about how a mobile or modular CSSD could help your hospital meet the looming deadline for compliance with the sterilisation standard, please contact Q-bital Healthcare Solutions.