Have you wondered what happens when a medical equipment fails in hospitals? If a ventilator stops suddenly or a surgical stapler malfunctions?
Worst case scenario: the patient dies.
A year-long joint investigation of the global medical devices industry, carried out in 2018 by NBC, the International Consortium of Investigative Journalists and more than 50 media partners, found that across all types of medical devices, more than 1.7 million injuries and nearly 83,000 deaths were reported to the United States Food and Drug Administration (FDA) over the last decade.
"In the US, preventable medical errors cause about 100,000 to 300,0000 deaths a year and is the third leading cause of death after cardiopulmonary disease and cancer.
"Of the preventable medical errors, among the top five are malfunction of medical equipment, infection and medication error.
"Not all of them lead to death, but some do,” reveals Dr Marcus Schabacker, president and CEO of ECRI Institute, a non-profit, independent organisation committed to the safety, efficacy and cost-effectiveness of healthcare.
In the last 50 years, the billion-dollar medical device industry has revolutionised treatment for some of the deadliest scourges of modern medicine, introducing devices to treat or diagnose heart disease, cancer and diabetes.
But who keeps tabs on these devices?
The tragic death of a young child in a Philadelphia emergency room, caused by a malfunctioning defibrillator led physician Joel J. Nobel to focus his energy on improving resuscitation technology, which eventually resulted in the setting up of ECRI Institute.
Since its establishment in 1968, the organisation has helped saved countless lives through scientific research and dedicated search for meaningful improvements in medical devices and patient care.
Today, ECRI Institute has more than 5,000 members worldwide, ranging from hospitals to government agencies and manufacturers.
"In the past two years, our engineering team conducted 170 evaluations on devices in 50 medical categories, including anaesthesia and respiratory care, imaging, infection reduction, infusion therapies and patient monitoring.
"As a result, manufacturers voluntarily made significant improvements to 55 medical devices – improvements directly attributed to ECRI’s research and influence in the healthcare community.
“We believe our approach is the quickest, most effective way to make medical devices safer.
"And we’re the only independent organisation in the world doing this,” says Dr Schabacker, who is an anaesthesiologist and intensive care specialist by training.
He was speaking at the recent opening of The ECRI Institute International Research Centre, the organisation’s first medical device evaluation laboratory outside the US.
Located in Bandar Sunway, Selangor, it will evaluate medical devices used across all care settings in Europe and Asia to help medical professionals make informed decisions that improve patient safety.
ECRI Institute, which has its headquarters in Pennsylvania, US, established its Asia-Pacific office in Kuala Lumpur 20 years ago to support healthcare technology decision-making and patient safety throughout the region.
“There was an incident here about 20-odd years ago when a piece of equipment failed and the patient died.
"Someone from the Health Ministry sought our experts from the US to perform investigations and that led to the setting up of ECRI here.
"We are also a third party forensic investigator for medical devices; we look at what went wrong and share our findings,” says Eric Woo, ECRI Institute Asia Pacific’s regional director.
Testing for safety
Dr Schabacker says, “Basic healthcare problems are similar all over the world. The Asia Pacific region is one of the fastest growing healthcare markets.
"We are getting better at treating diseases and people are living longer.
"Also, the demand for qualified personnel is higher than supply, so the less educated and less trained people, i.e. friends or family members, need to take over the care and treatment of the patient.
"Care is moving out of the traditional location of the hospital into ambulatory surgical centres, cancer centres, etc.
"Standards that have been developed over decades in the hospitals are not being applied in these care settings and are not being adhered to by less trained people.
"ECRI wants to ensure that the equipment that is going to be used is safe and effective. The Health Ministry has been helpful in allowing us to bring in products not registered n Malaysia for testing. So, we’re going to be able to test additional products that we couldn’t test before, especially from Asia Pacific members.”
Devices sold internationally will be evaluated in Malaysia under the same protocols ECRI Institute uses in the US.
The devices to be tested are dependent on key trends in healthcare, and if a member identifies a problem with a product.
"For example, this month, we may want to test ventilators. We look at what’s available in the market and see who are the key manufacturers, reach out to them and tell them we’re testing the product.
"Most of them comply and send us their product, or we will buy or lease the device for testing,” explains Dr Schabacker.
Once the tests are completed, a summary and rating is sent to each of the participating manufacturers.
"As you can imagine, there is a variety of reactions, particularly if it is not a good rating. We give them a chance to comment and fix the problem.
"Once fixed, we retest the device and modify our report, which is published. All our findings are based on facts.
"We try to get into a three-year rhythm for testing electrical medical devices,” he says.
The testing time depends on what device it is, and in an ideal scenario, it takes between six to eight weeks.
Says Woo, "We hope the devices are sent to our lab for testing, but sometimes, it’s not feasible to send the bigger ones such as CT scanners, so we may be invited to their factory to perform the test.
"Or the manufacturer will give us a reference site (like a hospital) to go to.
“Manufacturer may not send their devices on time, so we have to wait; we can’t push them to send faster, so there is a delay in getting the device.”
Among the first devices to be evaluated locally are large-volume infusion pumps, surgical lights, point-of-care blood gas analysers, portable ultrasound machines, continuous positive airway pressure (CPAP) units and digital radiography systems.
Dr Schabacker says, "Infusion pumps are a big area of concern because they are utilised most frequently.
"Usually, very potent drugs are given through these pumps, so a small deviation from dosage can have a big effect.
"These pumps are getting more complicated, and with the shortage of qualified personnel using them, there is a high risk of user-device interaction problems.”
New safety concerns
According to ECRI Institute’s 2019 Top 10 Patient Safety Concerns for Healthcare Organizations, diagnostic errors and improper management of test results in electronic health records (EHRs) are among the most serious patient safety challenges facing healthcare leaders in 2019.
Many healthcare providers rely on EHRs to help with clinical decision support, and tracking test results though technology is just one tool in the diagnostic process.
The institute’s list of concerns addresses systemic issues facing health systems, such as behavioural health concerns, clinician burnout and skills development.
Mobile health technology – number four on the list – opens up a world of opportunities by transporting healthcare to the home, but also presents potential risks.
The report also highlights ongoing clinical issues with infections from peripheral intravenous (IV) lines, sepsis and anti-microbial stewardship. In the outpatient setting, at least 30% of antibiotic use is unnecessary.
The list of patient safety concerns does not necessarily represent the issues that occur most frequently or are most severe.
It identifies new risks, how existing concerns may be changing because of new technology or care delivery models, and persistent issues that need renewed attention or that might have additional solutions.
Two of Dr Schabacker’s biggest concerns involve sterility issues with endoscopes and cybersecurity.
"Endoscopes are not made for single use, and we have indicated for years that there is a problem because of how they are designed, how they’re used and how they’re treated.
"There is a higher risk of contamination from one patient to another.
"With cybersecurity, there is the risk of being able to hack into medical devices and maliciously manipulate them so that they cause a risk. This is especially critical for clinical pacemakers and internal defibrillators.”
Woo feels that the problems with medical devices are partly due to the providers.
"They are too visionary and running too fast with a lot of the technologies, which are not tested enough,” he opines.
"We’re not talking about concerns using software as a medical device.
"The issue is that a very safe, low risk device has now been embedded with software technology because of integration.
"It then creates new risks and this is yet to be thought through by many providers as the benefits seem wonderful and supersedes everything else.”