Why International Medical Device regulators and the TGA have<br>Nurse Call Systems in their sights?

The purchase, installation and use of non-clinically regulated Nurse Call Life Safety Systems across healthcare facilities is of growing concern for patient safety, clinical risk and any Clinical Risk Committee, actively perusing corporate governance.

Recent international changes to the definition and regulation of Medical Devices have determined Nurse Call Systems to be considered Medical Devices. Under this international regulation and national legislation all Nurse Call Systems are for the first time to be clinically regulated, audited and certified. This regulatory practice improves patient safety, reduces clinical risks, and is good news for any State based or Private Hospital Corporate Risk and Clinical Risk Committee actively perusing corporate governance. It’s also welcome news within the industry, as system designers and manufactures have invested in professionalization of their systems, processes and practices to meet these international onerous standards.

The Therapeutic Goods Administration (TGA) of Australia (change for each web site FDA on .com TGA on .au) and various international bodies through membership of the International Medical Device Regulators Forum (IMDRF) regulated Nurse Call Systems as Medical Devices through their new definition of what constitutes a medical device. Additionally, consensus was recently reached by the IMDRF (members include; Australia-TGA, US-FDA, European Commission Directorate General Health and Consumers, Canada-Canada Health and Japan-Pharmaceuticals and Medical Devices Agency – to name a few) harmonising the definition and requirements for software “to be considered a Medical Device”. This new definition included Nurse Call Systems.

The medical devices industry, network IT device mobility industry and the nurse call / life safety systems industries are currently experiencing significant technology convergence. This technology convergence is accelerating to meet demand for; workflow productivity, QA, reporting, efficiency and patient safety. However the legacy Nurse Call Systems, and some current technology nurse call systems provide nothing more than a basic life safety system. These system technologies are analogous to “Florence Nightingale’s 1860 system of telling a patient to ring the bell if you need me”. That’s one hundred and fifty years (150) with no real improvement in patient safety delivered by life safety systems. Currently available basic electrical light and buzzer systems (circa 1980’s) are clearly not medical devices.

The new harmonised definition of medical device, as implemented by the IMDRF and member counties is as follows;

Medical devices are defined as:

(a) any instrument, apparatus, implement, machine, appliance, implant, software, material or other similar or related article, including any in vitro diagnostic device, intended by the person under whose name it is or is to be supplied, to be used, alone or in combination, for human beings for the specific purpose of one or more of the following:

(i) diagnosis, prevention, monitoring, treatment or alleviation of disease;

(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;

(iii) investigation, replacement, modification, or support of the anatomy or of a physiological process;

(iv) supporting or sustaining life;

(v) control of conception;

(vi) disinfection of medical devices;

(vii) providing information for medical purposes by means of in vitro examination of specimens derived from the human body.

(b) the medical device software regulation is summarised as;

(i)     ISO 13485 – Quality Systems Medical Devices and section 21 CFR 820

(ii)    UL1069 – Nurse Call and Signalling Equipment Edition 7

(iii) DIN 0834 – Call systems in hospitals, nursing homes and similar institutions

(iv)   FDA MDDS – Medical Device Data Systems Class I

(v)    EN 6060-1 – Safety Requirement medical electrical equipment

Various countries have already implemented international legislation regulating Nurse Call Systems. The US Food and Drug Administration (FDA) in 2011 regulated Nurse Call Systems as part of their Medical Device Data Systems (MDDS) legislation, initially as a Class I device and more recently as a Class II device. 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 the IMDRF agreements have seen national regulation legislating that software within medical devices must conform to a medical device grade superset of ISO 9000 quality control procedures referred to as QSR820. These standards are onerous for non-medical grade systems (such as electronic light and buzzer systems) but wholly known and practiced within the medical devices industry. In Australia the Act (legislation) is available on the TGA website.

The United States, through the FDA, is several years ahead of the regulation and audit process with its MDDS legislation implemented in 2011. The FDA has implemented a robust audit process for manufactures of Nurse Call Systems and has already issued many warning letters to manufactures of ‘adulterated’ nurse call systems. This includes letters instructing manufacturers to stop manufacturing until audited issues have been resolved. These audit adverse findings and warning letters are published on the FDA website and are publically available.

Regulation and audit within other IMDRF member countries including; Australian, UK and EU, within the National Health Systems, Private healthcare and manufacturers facilities has been historically largely unaudited, and to a lesser extent unregulated. As a consequence of the lagging audit processes and procedures many acute care facilities in these counties still consider the purchase and implementation of a Nurse Call System to be a “non-clinical acquisition”. Even more concerning for patient safety is the practice of nurse call systems being purchased as part of a building industry contract as an ‘electrical switch’, under the same contract as bricks and mortar and taps in the bath room and ceiling tiles; not even purchased as an Information Communication Technology (ICT) system. This demonstrates a flagrant disregard for legislation and regulation.

Perhaps the days of purchasing complex medical device systems through the building contract sub-contracted to an electrician should come to an end?

Recently, a number of large high profile Australian State Government Hospital project failures and delays (highlighted in this article) can be attributed to acquisitions based on builders and electricians not understanding the clinical importance of various medical devices their significant interfaces and the regulation around medical devices conforming to Australian and International Standards. Rather they evaluate selection of these clinically regulated devices based upon total building contract price along with other building materials – such as bricks and mortar. Several similar project problems and delays are occurring in hospital sites globally at great cost to an already cash strapped government public health care systems. This is especially gulling for taxpayers as the percentage of GDP allocated to Health Care budgets in all OECD increases (see link here) as delays and queues for non emergency procedures continues to grow over the long term.

The practice of acquiring complex medical systems via a contracted electrician with little knowledge (or no knowledge and understanding) of medical devices and the rapidly changing national and international regulation is a significant risk. Not only is it a risk to patient safety and consequent adverse events, it is ICT complexity construction project risk and finally a business risks 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 and the associated complex integration into physiological monitoring devices.

As a point of clarity here and as a sanity check in this discussion let’s consider ‘what is at risk’?

Can you imagine trusting a building construction electrician with the responsibility for implementation and delivery of a nurse call system in a new hospital project, which at completion will be required to;

  1. Accept an alarm from a physiological monitoring device, such as a hart rate monitoring medical device attached to a patient in an acute condition in a private room.
  2. Automatically send this patient safety alarm to a rostered nurse’s (or agency nurse filling in because of the nursing shortage) BYOD smart device,
  3. Send this message via a system that identifies the right person with the right skills on the appropriate shift to interpret the alarm and respond or escalate accordingly.
  4. If that alarm is not answered in a specific clinical pathway, then it’s automatically escalated to alternate nurse or department skilled to handle this escalated acute life threating alarm.

In the simple daily scenario above we cover several detailed issues such as;

But the bottom line is; hospitals being designed now for construction in 2017/18 will shortly be contracted to a builder and the subcontract for nurse call will be handed to an electrician, the responsibility of commissioning a medical device and all the interfaces required for a hospital to be commissioned in 2020 will be handled by an electrician! This system will be expected to meet the technological and physiological medical device demands of nurse call and associated medical device interfaces for usable life of some 15 years – that’s to 2035!

In the 1990’s we realised that ICT (Information, Communication and Technology) systems should not be part of a construction project and should be delivered at a later stage outside the building contract or at least by a technology partner evaluated as a technology and or medical device and not part of the bricks and mortar contract. This five hundred pound gorilla still in the room in the second decade of 21st century is really the responsibility of the acquisitions teams within health organisations. The hospital-project-purchasing group is divided into two areas, clinical acquisitions (medical devices) and non-clinical acquisitions (bricks and mortar). A non-clinical acquisition of a nurse call system may impact adversely on business objectives, the future well-being of patients and thus corporate clinical governance standards. The regulation is clear; nurse call systems need to be moved to the clinical acquisition group.

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 and evidence of audits by the FDA,
  • Achievement of EN 60601-1 as per EU Medical Devices Directive and evidence of bi-annual audits by independent European standards authorities;
  • Accreditation to QSR820 (that is a superset of ISO9000 medical section, which has an accordingly higher requirement / superset of standards for medical devices and evidence of audits by the US FDA;
  • Listing and accreditation of UL1069 and evidence of audits by independent US standards authority;
  • Implementation of highest EU nurse call systems requirement DIN 0834 and evidence of bi-annual audits by independent European authorities.
  • CarePlus™ is the world’s most certified nurse call system, meeting Australian and international medical device standards and audited by International independent medical device and nurse call regulators.