Unregulated medical devices used extensively across Australian hospitals

30th July 2014

The installation and use of non-clinically regulated Nurse Call Life Safety Systems across Australian healthcare facilities is of growing concern.

Recent international changes to the definition and regulation of medical devices have determined Nurse Call Systems to be considered medical devices. Under Australian and international legislation, this requires all Nurse Call Systems to be clinically regulated, audited and certified. This regulatory practice improves patient safety, reduces clinical risks, and is good news for any State and private hospital based Corporate Risk and Clinical Risk Committee actively pursuing corporate governance.

The Therapeutic Goods Administration (TGA) of Australia and various international bodies through the International Medical Device Regulators Forum (IMDRF) regulate Nurse Call Systems as medical devices. A consensus was recently reached by the IMDRF (members include; Australia – TGA, US – Food and Drug Administration (FDA), European Union – European Commission Directorate General Health and Consumers, Canada – Canada Health, and Japan – Pharmaceuticals and Medical Devices Agency) harmonising the definition and requirements for software “to be considered a medical device”. This new definition included Nurse Call Systems.

International legislation regulating Nurse Call Systems has already been implemented by various countries. The US FDA has regulated Nurse Call Systems as part of their Medical Device Data Systems (MDDS) legislation, with 510K pre-market approval required for Nurse Call Systems. In the EU suppliers of Nurse Call Systems are required to meet the Medical Device Directive (MDD) for patient safety requirement EN 60601-1. Further IMDRF agreements have seen international regulation requiring that software within medical devices conform to a medical grade superset of ISO 9000 quality control, referred to as QSR820. These standards are onerous for non-medical grade systems but wholly known within the medical devices industry.

Nurse Call Systems within Australian private and public healthcare facilities have been historically largely unregulated, with many acute care facilities considering the purchase and implementation of a Nurse Call System to be a non-clinical acquisition. Often included as part of a building industry contract as an electrical switch, not even as an Information Communications Technology system (ICT). Recent high profile State Government Hospital project failures and delays at large acute care facilities in Australia (highlighted in this article), can be attributed to acquisitions based on builders and electricians not understanding the technical importance of various medical device interfaces and regulation around medical devices conforming to Australian and international standards. Rather evaluation of clinically regulated devices is based upon total building contract price along with other building materials. Several similar project problems and delays are occurring in hospital sites in various Australian locations at great cost to an already cash strapped State based health care system.

The practice of acquiring complex medical systems via a contracted electrician with little knowledge of medical devices or the rapidly changing national and international regulations is a significant risk. Not only is it a risk to patient safety and consequent adverse events, it is an ICT complexity construction project risk, and finally a business risk for private and Government hospitals. Importantly, it’s also a risk to the companies involved in the building industry for which their insurers are unprepared and likely not covered in this specialist area of medical devices integration. Internationally certified and approved Nurse Call Systems (as a medical device) are available in Australia, but come at a premium in comparison to non-certified and unaudited electronic or electrical systems.

NiQ Health views these international regulations and standards of highest priority with their CarePlus™ Nurse Call Life Safety System. CarePlus™ offers a solution that meets the highest level of patient safety; with approval from the FDA’s MDDS 510K, achievement of EN 60601-1, and accreditation of QSR820. CarePlus™ is the world’s most certified nurse call system, meeting Australian and international regulations for medical devices.