Implanted devices are used to keep the heart beating regularly, to shock a heart that is beating chaotically, to stimulate parts of the brain or to deliver drugs. Millions are in use worldwide.

The implants are increasingly equipped with wireless technology, allowing for remote device checks and freeing patients from repeated doctor visits.

But this convenience may come with unanticipated risks, warns a team of researchers in the US.

The researchers, from three American universities, have demonstrated how to use a radio to hack a combination heart defibrillator and pacemaker, suggesting it could be possible to remotely control someone’s heart.

The team reports that it is possible to extract private medical information and reprogram the devices without a patient realising it.

They were able to reprogram the devices to shut down and to deliver jolts of electricity that would potentially be fatal had they been inside a person.

However, the researchers stressed that there had never been a reported case of a patient with an implantable cardiac defibrillator or pacemaker being targeted by hackers.

Their efforts cost $30,000 and the study was designed to identify and prevent future problems.

The research was led by two computer scientists - Tadayoshi Kohno of the University of Washington and Kevin Fu of the University of Massachusetts Amherst - with cardiologist Dr William Maisel of the Beth Israel Deaconess Medical Centre and Harvard Medical School.

The report, to published at www.secure-medicine.org, will be presented and published at the Institute of Electrical and Electronic Engineers Symposium on Security and Privacy in Oakland, California in May, though it omits key details to prevent abuse.

Dr Maisel said one aim of the research was “to encourage the medical device industry to think more carefully”.

“Fortunately, there are some safeguards already in place, but device manufacturers can do better,” he said.

“We hope our research is a wake-up call,” added Dr Kohno, an assistant professor of computer science and engineering at the University of Washington, who fears that this kind of hacking could soon be attempted.

“In the 1970s, the Bionic Woman was a dream, but modern technology is making it a reality. People will have sophisticated computers with wireless capabilities in their bodies. Our goal is to make sure those devices are secure, private, safe and effective.”

The team has set out three defence mechanisms that require no battery power, making them potentially easy to incorporate in the devices without extensive redesigning: a device that audibly alerts patients of security breaches, one that authenticates requests for access from outside devices and a vibrating device that patients can sense.

The researchers’ hacking experiments used an implantable cardiac defibrillator, a sophisticated device that automatically regulates the heart beat by sending small corrective electrical signals to the heart or by delivering a large shock to restore a potentially fatal heart rhythm back to normal.

The model they tested contained computers and radios that allow health care practitioners to diagnose patients, read and write private medical information, and adjust the device’s therapy settings wirelessly.

In computer laboratory bench tests, the research team used an inexpensive software radio to intercept and capture signals sent from the implantable device. They were able to obtain detailed information about a hypothetical patient, including name, diagnosis, date of birth and medical ID number.

Researchers could determine the make and model of the device and access real-time electrocardiogram results, as well as data on the hypothetical patient’s heart rate and cardiac activity.

The team then mounted attacks. They were able to turn off the therapy settings stored in the implantable device, rendering it incapable of responding to dangerous cardiac events. Additional commands were delivered, resulting in the delivery of a shock that could induce ventricular fibrillation, a potentially lethal arrhythmia.

Bruce Lindsay, an electrophysiologist at the Cleveland Clinic and president of the Heart Rhythm Society, said defibrillator transmissions were “not designed to withstand terrorist attacks”.

“But I don’t think the findings have any great clinical significance,” he added. “To hack the system, you have to get the programmer right up against the patient’s chest. It’s not as if somebody could do this from down the street.”

Key defibrillator makers are Medtronic Inc, Boston Scientific Corp and St Jude Medical Inc. It was Medtronic’s Maximo defibrillator that Maisel’s team studied.

Medtronic spokesman Rob Clark said the risk of any “deliberate, malicious or unauthorised manipulation of a device is extremely low.”

Future versions capable of transmitting signals as far as 30 feet from a patient will incorporate stronger security, he said.

Boston Scientific said its defibrillators “incorporate encryption and security technologies designed to mitigate these risks,” including measures to prevent unauthorized reprogramming.

St Jude said: “As the study points out, the likelihood of unauthorised or illegal manipulation of an implantable device is extremely remote, and St Jude Medical is not aware of such an event with our devices.”

The Food and Drug Administration said it was working on standards to raise the security of medical devices that receive instructions over radio waves but had not finalised them.

“The chance of an ICD being reprogrammed by a computer hacker is extremely remote,” said a spokeswoman, using the abbreviation for implanted defibrillator.

Prof Tipu Aziz of Oxford University, who does brain implants, comments: “This is a very interesting report,” but adds: “It is unlikely at present that this will be a risk to my patients. It is also even more unlikely to be of interest to hackers in general and very few terrorists.”

A British spokesman for the manufacturer Medtronic adds: “There has not been a single reported incident of such an event in more than 30 years of device telemetry use, which includes millions of implanted patients worldwide.”

The Medicines and Healthcare products Regulatory Agency, the UK government agency which is responsible for ensuring that medical are acceptably safe says it will investigate: “Despite an extensive database of adverse incidents, the Agency has never received any reports of hacking associated with implantable medical devices such as pacemakers or ICDs (implantable Cardioverter defibrillators).

“Nevertheless, as part of our adverse incident investigation process this we will look into this further, in consultation with the relevant device manufacturers.”

Each year, about 920,000 people in the U.S. have a new or recurrent heart attack, also called myocardial infarction (MI). ST-segment elevation myocardial infarction (STEMI) is a common and especially severe type of heart attack. While there are no exact statistics for STEMI, the number has been estimated between 200,000 and 400,000.

Rapid treatment to reopen the blocked artery is vital because more heart muscle dies the longer it’s deprived of blood flow.

Current criteria for evaluating quality of care includes elapsed “door-to-balloon” or “door-to-drug” time — the time span from the moment a patient enters a hospital emergency room until blocked arteries are re-opened either by angioplasty or a clot-busting drug.

However, “the clock starts ticking from the moment a person develops symptoms of a heart attack,” said Henry H. Ting, M.D., lead author of the statement and a cardiologist at the Mayo Clinic in Rochester, Minn. “The pertinent measure of system performance is from the time of first medical contact with paramedics or other emergency medical personnel to reperfusion therapy (reestablishing blood flow to the heart muscle).”

Ting and colleagues evaluated progress since STEMI guidelines were first issued by the American Heart Association and the American College of Cardiology in 2004. They were updated last year. The guidelines recommend that all emergency medical services acquire and use pre-hospital electrocardiograms to evaluate patients with suspected acute coronary syndromes.

“If pre-hospital ECGs were more widely used and integrated with systems of care, the time from first medical contact to balloon reperfusion could be reduced to less than 60 minutes,” Ting said. The recommended goal is 90 minutes or less.

Delays from the time a person has heart attack symptoms to when they receive artery-opening treatment can be divided into four time intervals: (1) symptom onset-to-EMS arrival; (2) EMS arrival-to-hospital arrival; (3) hospital arrival-to-ECG; and (4) ECG-to-reperfusion. Pre-hospital ECG programs, if effectively implemented and coordinated with comprehensive systems of care, have the potential to decrease the latter three time intervals – and eliminate the third one.

The statement presents examples of using pre-hospital ECGs, including systems of care with door-to-balloon times approaching 30 minutes or less. In these systems, pre-hospital ECGs are used to activate the cardiac catheterization laboratory while the patient is en route to the hospital, and the patient is transported directly to the cath lab (bypassing the emergency room evaluation).

Despite the recent recommendations, fewer than 10 percent of EMS systems have adopted the use of pre-hospital ECGs, and the rate has not substantially changed since the mid-1990s.

“Furthermore, even when a pre-hospital ECG is acquired, the information is often not translated into effective action to decrease delays in treatment,” Ting said. “It is a lost opportunity to improve the quality of care for STEMI patients if the information from a prehospital ECG is not used to change downstream processes of care.”

The reluctance of patients with acute coronary syndromes to call 9-1-1 is a major obstacle to realizing the full public health benefits of pre-hospital ECGs and organizing systems of care. Studies show that more than half of STEMI patients take themselves to the hospital rather than use EMS. In addition, recent studies have shown that the longest delay for STEMI patients – two hours on average – is from the time of symptom onset to hospital arrival, said Ting.

Other barriers include:

• ensuring EMS and emergency rooms have the capacity to meet demand for services;
• developing standards for education and quality assurance for EMS providers;
• improving collaboration among EMS, emergency medicine physicians and cardiologists;
• co-ordinating hospital networks to provide the ideal patient care;
• overcoming insurance reimbursement issues for prehospital care;
• studying unintended consequences from implementing pre-hospital ECG programs.

Widespread implementation of pre-hospital ECGs is being addressed by the American Heart Association’s Mission: Lifeline, a national initiative launched in 2007 to improve regional systems of care for patients with STEMI. Mission: Lifeline’s initial phase includes emergency medical services system assessment and improvement.

Co-authors are Harlan M. Krumholz, M.D.; Elizabeth H. Bradley, Ph.D.; David C. Cone, M.D.; Jeptha P. Curtis, M.D.; Barbara J. Drew, R.N., Ph.D.; John M. Field, M.D.; William J. French, M.D.; W. Brian Gibler, M.D.; David C. Goff, M.D., Ph.D.; Alice K. Jacobs, M.D.; Brahmajee K. Nallamothu, M.D.; Robert E. O’Connor, M.D.; and Jeremiah D. Schuur, M.D. Author disclosures are available on the manuscript.

Over this period of time many changes have taken place, both with Sonic and SCHILLER. For example, the first ECG machine model to be installed was AT-6 and it used an old DOS based version of SEMA software. Now, after three generations of ECG machine and several software upgrades Sonic now has the most advanced ECG data management system in Australia.

Sonic’s pathology companies right across Australia use the combination of SCHILLER software and machines. They include, Melbourne Pathology, VIC. Douglass Hanly Moir Pathology, NSW, Capital Pathology ACT, Southern IML Pathology, NSW, Barratt and Smith Pathology, NSW and Clinpath, S.A.

To use the American Heart Association heart attack risk assessment, go to the AHA’s risk assessment website http://www.americanheart.org/riskassessment or to the new Google Health website http://www.google.com/health. There, you enter your blood pressure and cholesterol levels, weight, age and other risk factors. You can then export data into your personal health record (PHR) on Google Health.

While taking the heart attack risk assessment, you can also find out if you have metabolic syndrome, a group of risk factors that greatly increases the chances of developing cardiovascular disease, including stroke and diabetes.

Those who haven’t taken the risk assessment, but have a PHR on Google Health, can also import data about their risk factors directly into the risk assessment tool and evaluate their risk without re-entering the data.

Personal health information entered into the American Heart Association’s Heart Attack Risk Assessment tool is collected, maintained and disclosed in accordance with the American Heart Association Privacy Policy, which is available here.

Joining forces with Google is one more way for the American Heart Association to reach out and help Americans live longer, healthier lives, free of heart disease and stroke.

The ARGUS PRO Transport II is an intensive care monitor which meets the specific needs of clinics and rescue services. The unit provides full performance for bedside and transport, without restrictions regarding the measured parameters. Suitable for Intensive Care Units, Operating theatres, Recovery rooms, Emergency wards, Ground-, and especially Air Rescue Services.

Features:

• Small size and low weight
• Full functionality of the highest capacity Intensive Care Monitoring Systems
• Intuitive user interface via touch screen
• Direct access to all important settings of the shown parameters
• Unlimited number of display configurations can be saved so the display can be adapted to the needs of any monitoring situation
• As a part of the ARGUS PRO System, the ARGUS PRO Transport II can display the data of any other ARGUS PRO monitor within the clinic network

Options:

• Resting ECG and FAX
• Graphical ST analysis
• Systolic blood pressure variation
• Cardiac Output

NRMA Careflight has taken delivery of five of SCHILLER’s mobile ARGUS PRO Lifecare units. Three will be used by Careflight International medical retrieval teams operating across the world from bases in Sydney, Darwin and Perth. Two others are being used on board the helicopters participating in Careflight’s HIRT trial.

SCHILLER Australia managing director Harry Packer said the Argus PRO Life Care unit combines an intensive care patient monitor, defibrillator and transcutaneous pacemaker. It weighs just 2.1kg making it highly portable.

“This unique, lightweight yet powerful device opens up many new horizons in emergency care as well as inter-hospital or in-house patient transfers ,” Mr Packer said.

The unit has already been put to the test by Careflight International on a rescue mission last month involving a man who sustained severe head trauma in Bali.

Careflight’s chief medical officer Dr Alan Garner said there is nothing on the market that compares with it for size, weight and capability.

Dr Garner said savings in weight and size are critical in medical emergencies, particularly for pre-hospital trauma.

“The Schiller Argus Pro Lifecare unit replaces a defibrillator, Capnograph and Propack monitor, saving us valuable space and around 6.5kg,” Dr Garner said.

“Added features such as the alarm functions, 12 lead ECG, Masimo Pulse Oximetry and hot swappable batteries means no other unit gets anywhere near it,” he said.

He said he had received very good feedback from Austrian counterparts who had been using the unit extensively.

Mr Packer said that the Westpac Rescue Helicopter Service and Hawkes Bay Rescue Service in New Zealand and Careflight Queensland had also expressed interest in the system.

NRMA CareFlight, a registered charity, is conducting the world’s first randomised clinical trial (HIRT) to evaluate the benefits of rapid response physician care to head injury patients. CareFlight International, the commercial branch of the organisation, provides medical retrieval services anywhere in the world.

SCHILLER Australia supplies a wide range medical equipment including electrocardiographs, long-term ECG and blood pressure recorders, spirometers, medical IT solutions, patient monitors and external defibrillators. It has offices in Newcastle, NSW and Melbourne, Victoria.

One of the most powerful intensive care patient monitors goes mobile - with defibrillator and transcutaneous pacemaker!

Whatever the requirement - emergency care, inter-hospital or in-house patient transfer. The ARGUS Pro LifeCare assists you without compromise. All this power in a unique, compact 2.1 kg package.

The ARGUS Pro LifeCare covers:

• Full diagnostic ECG (I, II, III, aVR, aVL, aVF, V1-V6)
• NIBP
• SpO2 with plethysmogram
• etCO2 with capnogram
• 2 temperatures
• 2 invasive blood pressures
• Defibrillator with AED and MANUAL mode
• Extremely gentle defibrillation energy using Multipulse Biowave® (biphasic pulsed defibrillation impulse, patented)
• Transcutaneous pacemaker

The bright, clear 4.8″ screen can display 3 waveforms with 7 parameter measurements providing a complete patient overview. All acquired data, including voice recording, is stored by the ARGUS Pro LifeCare for later external review or case analysis. The combination of SCHILLER Multipulse Biowave® AED/manual defibrillator, pacemaker and monitoring functions is unique and opens many new horizons in emergency care and hospital applications.

ARGUS PRO LifeCare can additionally be used in combination with the ARGUS Pro Transport monitor to provide the full range of patient monitoring.

Optional:

• Shock frame with rescue bag and handle
• etCO2 mainstream sensor
• External thermal 3-channel printer
• ARGUS PRO LifeCare charging unit
• Full range patient monitoring with ARGUS PRO Transport

Defibrillation:

• Using paddles, pads or internal spoons
• Maximum efficiency thanks to Multipulse Biowave technology

Optional semi-automatic defibrillation mode (AED):

• Automatic adaptation of the energy level when paediatric electrodes are connected

Optional external pacemaker:

• 3 pacing modes: Fix, Demand, Overdrive (frequency x 3)

The adhesive pads for defibrillation and pacing are the same, and are also compatible with the SCHILLER FRED easy and DEFIGARD 6002.

Monitoring options:

• ECG: simultaneous display of up to 12 leads
• SpO2 measurement using Masimo™ sensor: automatic measurement and plethysmogram as soon as the cable is connected
• NIBP: adult and paediatric; the last 4 measurements are displayed on the screen

Printer options:

• Possibility to print up to 12 ECG leads, SpO2 curve, tabular trends, and the defibrillator test result
• 3 channels; paper width: 80 mm

Power supply:

• Mains, battery (autonomy can be doubled by the addition of a second battery) or an external power supply unit

Developed for pre-hospital emergencies, the DG4000 is also perfect for intra-hospital use.

A single button gives access to all major functions:

• Energy selection in manual mode
• Pacemaker
• AED

The DG4000 features Multipulse Biowave® technology with energy settings ranging from 2 to 200 joules.

It comes in two types, with paddles or pads, both with a bright and clear display, a 3-lead ECG cable and mains or battery supply.

Features:

• Manual or semi-automatic defibrillation
• ECG
• USB interface for data transfer from the internal memory and software updates

In addition, the following options are available:

• SpO2
• Pacemaker
• Printer
• GSM data transmission
• AED mode (for units with pads)

The compact size of DG4000 makes it the ideal device for any emergency!

“Time is life!”

Features:

• Direct keys for the important functions
• Manual mode as a standard
• ECG measurement software
• Various user-programmable report formats on internal or external printer
• Interface to PC
• Voice Prompt
• Extremely gentle defibrillation energy using Multipulse Biowave® (biphasic pulsed defibrillation impulse, patented)

Options:

• Memory
• Automatic ECG measurement and computer-aided ECG interpretation for pediatric and adult ECG’s
• Thrombolysis recommendation software
• SEMA data management PC software