The challenge

According to the press, Australian hospitals face an estimated $1 billion overhaul of their sterilization departments to improve the processing of medical equipment under new Australian Standards – AS/NZ Sterilization Standards 4187:2014 (see ‘Hospitals to improve sterilization processes in push to beat postoperative infections’, The Courier Mail, 22 October 2016). New sterilization standards for Australia and New Zealand became operational in December 2016 and set out tougher regulations into the reprocessing of reusable medical devices in health service organisations. The changes aim to make the standards be more consistent with European standards. Hospitals are required to comply by December 2021 and the time to implement capital works to comply is drawing near.

The new sterilization standards were prepared by the Joint Standards Australia/Standards New Zealand Committee HE-023, Processing of Medical and Surgical Instruments. They supersede AS/NZS 4187:2003 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities.

Australian hospitals are required to be licensed in the relevant State and Territory and must comply with safety and quality requirements. For example, in Victoria, private health facilities are required to comply with the Health Services Act 1988 (Vic) and the Health Services (Health Service Establishment) Regulations 2013 (Vic). In NSW, hospitals are required to be registered under the Private Health Facilities Act 2007 (NSW) and the Private Health Facilities Regulation 2017 (NSW).

In order to attract private health insurance, hospitals are required to be accredited against the National Safety and Quality Healthcare (NSQHS) Standards: Private Health Insurance (Accreditation) Rules 2011 (Cth).

Health departments (regulators) determine which services must undertake accreditation to the NSQHS Standards. All States and Territories have agreed that hospitals and day procedure services will be accredited to the NSQHS Standards from January 2013.

NSQHS does not specifically refer to AS/NZS 4187:2014; however, that is implied by the term ‘relevant national standards’.

The Australian Standard AS/NZS 4187 is the national standard most commonly used to meet the requirements in Action 3.14.1 (of the 2nd Edition, which is applicable from 1 January 2019).

To comply with the requirements of Action 3.14.1, where health service organisations apply AS/NZS 4187:2014, health service organisations will need to:

  • complete a gap analysis to determine the current level of compliance with AS/NZS 4187:2014 and document the findings;
  • document a detailed implementation plan specifying timeframes to enable full implementation of AS/NZS 4187:2014 over a five-year period, from December 2016; and
  • implement the plan and demonstrate progress toward implementation

Hospitals are required to comply by December 2021. Accreditation is awarded on a three or four-year cycle, depending on the accrediting agency, so some facilities are coming up for re-accreditation.

We understand that a number of hospitals currently do not meet the new standards and that it will be very expensive to upgrade current facilities to be compliant. We also understand that a number of hospitals are experiencing difficulties complying with the new water quality standard.

It is absolutely mission-critical for hospitals to have properly sterilized equipment and that the equipment is available at all times.

Hospitals would want to avoid issues with the sterilization and non-availability of hospital equipment like those faced at Fiona Stanley Hospital in 2015 when delays were experienced in returning sterilized medical equipment to the hospital (see ‘Serco stripped of control for sterilising Fiona Stanley Hospital’s medical equipment’, ABC News, 24 February 2015).

Hospital operators should be assessing their compliance with the new standards and implement planning for compliance if they are not already compliant.