Connecting to medical devices in hospital and at home
Integrating the Healthcare Enterprise (IHE) is holding a pre-conference half-day workshop this Sunday in Melbourne as an education event to inform HIC 2016 attendees about developments in interconnecting patient care devices (PCD) to electronic medical records (EMRs), both in the hospital and the home.
In the hospital setting, we will look at taking the integration of vital signs devices beyond the ICU, as well as the connection of therapeutic devices such as infusion pumps and integrated electronic medications management (EMM) systems. In the home care setting, we will look at telehealth devices, hospital in the home and the long-term monitoring and support of the elderly and people with chronic illnesses.
IHE is a worldwide organisation of some 900 members, concerned with developing standards-based profiles and use cases for organisations to solve clinical problems of interoperability so that standard profiles can be implemented in complex medical care, hospital and home care environments.
As well as IHE PCD profiles, the IHE Australia pre-conference workshop will also look at the role of middleware and integration vendors, telehealth and mobile telepresence devices, the security of medical device integration and core standards for communications and data such as ISO 80001.
The workshop is a preparatory event prior to the 2017 PCD Connectathon and Showcase that IHE Australia is planning to run in conjunction with HISA at HIC 2017 in Brisbane next year.
In accordance with the operating rules of IHE International, vendors will aim to successfully demonstrate completion of the PCD use case tasks at the 2017 connectathon. They will then be able to publish an IHE integration statement (PDF) attesting to their capability.
Successful vendors will then be able to participate in the IHE Australia Showcase event at HIC 2017 in Brisbane. At the PCD showcase, vendors can demonstrate their results from the IHE 2017 connectathon and display proven capabilities in the area of connecting patient care devices to a wider audience of potential buyers.
Patient care devices (PCD)
The IHE PCD domain was formed in 2005 to address the integration of medical devices into the healthcare enterprise, from the point-of-care to the EHR. Interoperability specifications like the IHE PCD technical framework support the automation of clinical tasks, resulting in significant improvements in patient safety and quality of care.
US-based Todd Cooper, one of the early IHE developers, will be a presenter at the pre-conference workshop in Melbourne. Todd is currently co-convenor of the ISO technical committee 215-JWG 7, covering the application of risk management to IT networks incorporating medical devices.
In 2006/2007, IHE developed the first PCD profile which was successfully tested in a connectathon and demonstrated at HIMSS '07. The demonstration showed exchanging information from vital signs, physiological monitors, ventilators, infusion pumps, and anaesthesia workstations with enterprise applications such as clinical information systems.
A modern ICU, operating room or emergency department contains numerous items of sophisticated equipment, linking hardware and software, from a multiplicity of vendors. There is an obvious need for the implementation of interoperability standard profiles to make it all work together in a wireless communications environment.
Medications are now being administered automatically by smart infusion pumps to the majority (80 to 90 per cent) of all hospital patients. In order to achieve HIMSS Level 7 recognition, all clinically relevant data must exist electronically in the EMR within 24 hours of creation (not after patient discharge).
This HIMSS requirement means that all paper documents must be scanned at the point of care and entered into the EMR. Again, all relevant data from patient care devices needs to be fed back to the EMR, highlighting the need for a bi-directional communication process.
Achieving interoperability in a modern hospital is a complex process. The 96-bed St Stephen’s Hospital in Hervey Bay, a fully integrated digital hospital, cost $87.5 million to build. This cost includes features such as collecting data from anaesthetic machines and blood pressure machines and the use of bi-directional infusion pump data which are automatically recorded in the patient’s electron medical record.
Safety of PCD
Safety of patient care devices is a major issue driving the need for implementation of IHE PCD profiles to achieve interoperability. In the US, there have been numerous adverse incidents with infusion pumps automatically administering drugs to patients, resulting in some 87 product recalls.
The FDA has noted the lack of infusion pump standards and has commenced an infusion pump improvement initiative to address safety issues associated with infusion pumps. Smart infusion pump drug libraries need to be constantly updated with minimum and maximum dosages and upper and lower administration rate limits and also need to make use of decision support rules to trigger infusion pump alarms.
PCD alarm management
Alarm management is a problem area with patient care devices as nurses can suffer from alert fatigue and may ignore or over-ride alarms from smart infusion pumps in the majority of cases. For example, an alarm following the detection of a bubble in a saline infusion line may not affect patient safety, but a similar alarm during an insulin infusion for a diabetic patient may have the potential for serious consequences.
Developments in decision support are designed to assist operators to better manage alarm reporting and improve patient safety and reduce adverse events.The three use cases shown at the IHE PCD ’09 Showcase outlined the complexity of the hospital environment, the number of vendors involved, and the constant interaction of the alarm reporter and the alarm manager actors.
Reasons to attend
There are a number of reasons to attend the IHE Australia workshop for a range of vendors and users of patient care devices, depending on the PCD profile they are interested in.
For CIOs, a well known PCD profile is device enterprise communication (DEC). This profile supports publication of information acquired from point-of-care medical devices to applications such as clinical information systems and electronic health record systems, using a consistent messaging format and device semantic content.
From a clinical point of view, the most useful PCD profile is the point-of-care infusion verification (PIV) profile. This profile supports communication of a five-rights validated medication delivery/infusion order from a bedside computer assisted medication administration (BCMA) system to an infusion pump or pump management system, thus "closing the loop."
Optionally, the DEC profile may be used to selectively monitor the status of the devices that have been programmed.
Of great interest to hospital managers and biomedical engineers is the medical equipment management (MEM) profile. This profile investigates the question of how health IT might support the activities of clinical engineering/biomedical engineering staff, improving quality and workflow efficiency. Key topics include unique device identification, real-time location tracking, hardware/software configuration and patch management, and battery management.
An immediate benefit to hospital IT managers is the ability to use IHE PCD profiles as part of their purchasing process to ensure compliance by mapping clinical requirements to purchasing requirements.
Organisations can use IHE PCD profiles to request conformance to IHE’s standardised information transfer profiles in their purchasing documents such as request for proposal (RFP) documents. These RFP requirements ask suppliers to spell out conformance to IHE PCD profiles, actors, transactions, and nomenclature as recorded in integration statements..
By including these IHE conformance requirements in an RFP, an organisation can assess how well a new device or information system under consideration will support a standards-based approach to information transfer.
This RFP document can be a living document and be updated with additional device types and additional clinical requirements as required.
Participation in the 2017 events
The IHE PCD planning and technical committees are responsible for developing IHE integration profiles and planning deployment activities, such as testing events and educational programs. The PCD committees are composed of users and developers of medical devices/systems and information systems.
As with previous IHE Australia connectathons, PCD vendors and EMR vendors will be invited to join an IHE Australia connectathon planning committee. The PCD committee will be composed of clinical users and developers of medical devices/systems and information systems, as well as representatives from standards bodies such as HL7 and FHIR.
Professional bodies such as the Australasian College of Physical Scientists and Engineers in Medicine (ACPSEM) and Society for Medical Biomedical Engineers (SMBE) will also be invited to join.
The aim of the planning committee will be to develop use case scenarios that will be useful and will assist organisations to resolve existing interoperability issues with PCDs. After discussions, vendors will be requested to respond to an expression of interest and to commit to funding and participation in the 2017 connectathon and showcase.
The IHE Australia pre-conference workshop at HIC 2016 is being held at the Crown Plaza Hotel in Melbourne on Sunday, July 24, from 12.30pm to 5.30pm. For more information and to register, see the HIC website.
Bernie Crowe is the events manager for IHE Australia. His role is to coordinate activities and ensure communication between clinical users and vendors of systems and equipment so that the use cases demonstrated at Connectathons are clinically relevant and user driven to resolve real world problems.