The role of hospital medical devices in patient deaths is the focus of new protocols from the US Centres for Disease Control (CDC) and Britain's National Health Service (NHS).
The CDC's non-mandatory guidelines come upon the heels of two deaths when nearly 180 patients were exposed to bacteria from contaminated endoscopes. The CDC has been investigating duodenoscope-transmitted infections since 2013.
The NHS has issued a patient safety alert on non-invasive ventilators (NIVs) after four deaths. Unlike life support ventilators, NIVs can lack the features to warn staff of delivery problems, such as disconnection and loss of oxygen supply.
Patient safety was an issue to when health leaders from more than 80 countries gathered in Qatar last week to learn about the latest research, ideas and health innovations which have the potential to revolutionise the future of global healthcare at the World Innovation Summit for Health (WISH), a global initiative of the Qatar Foundation for Education, Science and Community Development.
The summit saw world leaders, policy makers and healthcare experts come together to discuss solutions to some of the most urgent global health challenges, including addressing the epidemic of type 2 diabetes, tackling dementia, enhancing patient safety, improving universal health coverage and addressing the decline in children’s mental health.
In light of reports more than 180 patients at the University of California, Los Angeles' Ronald Reagan Hospital have been exposed to a potentially deadly bacteria from contaminated medical scopes, one of the focuses of the WISH meeting – errors in patient safety – has increased relevance. These errors in patient safety that rank third only to heart disease and cancer claiming hundreds of thousands of lives each year are clearly a serious global public health issue yet are often over-looked in national policy and global agendas.
Failure to address the growing concern contributes to waste in the healthcare system and sky-rocketing costs, world leading experts said. It is estimated that as much as one-third of all US healthcare spending was consumed by waste in 2011. A report from WISH's global experts identified key issues such as a lack of regulation, understanding and integration as well as offering a range of innovative solutions that will provide recommendations to global policy makers.
Patient safety has historically been recognised as a significant area for improvement in healthcare systems around the world but despite decades of evolving practice and trillions of dollars in investment there are still too many incidents of harm and even deaths. Intensive care units, operating rooms, emergency rooms and clinics are packed with an ever-increasing number of devices that do not talk to each other. Now, more than ever, the report led by Dr Peter Pronovost, senior vice president for patient safety and quality, and director of the Armstrong Institute for Patient Safety and Quality at Johns Hopkins Medicine in the US, says, patient safety could benefit from a more holistic approach both in developed and less-developed regions; initiatives in the UK have reduced MRSA by 90% whilst the current Ebola outbreak required the new thinking around challenge of waste disposal and protection of workers in under-resourced regions.
Pronovost said: "For too long in healthcare, the mind-set has been that patient harms are inevitable, that silos are natural, and that heroism rather than thoughtful design keeps patients safe. Through the work undertaken behind today’s WISH report it is clear that what is missing is a systematic, sector-wide approach, underpinned by sound principles in safety science. In their current state, healthcare systems too often harm rather than help."
"In our WISH report we advocate for a holistic system solution to eliminate preventable harm in healthcare. Patient safety is – or should be – one of the fundamental building blocks of every healthcare system."
Meanwhile, nearly 180 patients at UCLA's Ronald Reagan Medical Centre may have been exposed to potentially deadly bacteria from contaminated medical scopes, and two deaths have already been linked to the outbreak.
The Los Angeles Times reports that the two people who died are among seven patients that UCLA found were infected by the drug-resistant superbug known as carbapenem-resistant Enterobacteriaceae (CRE). The outbreak is the latest in a string of similar incidents across the country that has top health officials scrambling for a solution.
UCLA said it discovered the outbreak late last month while running tests on a patient. This week, it began to notify 179 other patients who were treated from October to January and offer them medical tests. By some estimates, if the infection spreads to a person's bloodstream, the bacteria can kill 40% to 50% of patients.
At issue is a specialised endoscope inserted down the throats of about 500,000 patients annually to treat cancers, gallstones and other ailments of the digestive system. These duodenoscopes are considered minimally invasive, and doctors credit them for saving lives through early detection and treatment. But medical experts say some scopes can be difficult to disinfect through conventional cleaning because of their design, so bacteria are transmitted from patient to patient.
UCLA said it immediately notified public health authorities after discovering the bacteria in one patient and tracing the problem to two of these endoscopes. The university said it had been cleaning the scopes “according to standards stipulated by the manufacturer,” and it changed how it disinfects the instruments after the infections occurred.
State and federal officials are looking into the situation at UCLA as they wrestle with how to respond to the problem industry-wide.
The US government is close to finalising instructions to prevent medical devices responsible for transmitting "superbugs" from spreading the potentially fatal pathogens between patients, the scientist leading the effort is quoted by Reuters Health as saying. The new protocol for the reusable devices is being developed by the US Centres for Disease Control and Prevention (CDC), whose disease detectives have investigated duodenoscope-transmitted infections since 2013.
The report says the CDC's guidance would not be mandatory – only the US Food and Drug Administration (FDA) has authority to require a manufacturer to include more stringent safety instructions for medical devices. The FDA can also order products be redesigned.
The FDA has not taken either step, despite knowing since at least 2009 that duodenoscopes have spread pathogens among patients. But this week it warned the medical community that the devices can transmit superbugs.
Though CDC protocols are not mandatory, they carry considerable weight because hospitals that ignore them could be vulnerable to lawsuits. FDA spokesperson Leslie Wooldridge said the agency is "actively engaged with the manufacturers of duodenoscopes" and with the CDC "to develop solutions to minimise patient risk associated with" the devices.
The CDC is close to unveiling a detailed procedure aimed at preventing more cases, said infectious disease expert Dr Alexander Kallen of the CDC. Called a "surveillance culture," the procedure involves swabbing the device after it has supposedly been disinfected and then allowing any microbes to grow into detectable colonies, much as doctors take throat swabs to determine if a patient has a strep infection.
The protocol has undergone pilot testing at Virginia Mason Hospital and Medical Centre in Seattle with good results, Kallen said. The Seattle hospital reported a duodenoscope-related superbug outbreak last month. "We feel right now that we have a protocol people could use," Kallen said. "Our goal is to have this available very soon if people think this is the right way to go."
The manufacturers have been criticised for failing to redesign the scopes six years after their potential to transmit infections came to the attention of physicians and regulators. Olympus and Fujifilm did not immediately respond to requests for comment. Pentax spokesperson Mariano Franco said the company is working with the FDA and others “to determine potential approaches that would contribute to the mitigation of pathogen transmission with duodenoscopes,” but had not yet identified one “that would address these concerns.”
In similar vein, the UK's National Health Service (NHS) has warned that hospital staff must be familiar with the specific equipment being used to provide patients with non-invasive ventilation, in the wake of several fatalities.
According to a Nursing Times report, it has issued a patient safety alert over the risk of severe harm and death from unintentional interruption of non-invasive ventilation (NIV). The alert has been issued to raise awareness of the problem, after national monitoring highlighted it as a risk, said NHS England.
In one incident a mask for NIV was attached to a patient’s face but the ventilation machine had not been switched on. The patient became severely hypoxic and died. Three additional fatal incidents involved the oxygen supply being found to be disconnected. In these cases, the length of time the oxygen tubing was detached was unknown, as no regular checking of oxygen tubing was completed and no patient observations were recorded.
The safety alert noted that some non-invasive ventilators may not have alarms to warn staff of delivery problems, and if they have, they may have been disabled by staff for various reasons. As devices may differ in their modes of operation, it is "important that staff are familiar with the specific functions" of the equipment being used and that patients receiving NIV are monitored, it warned.
[link url="http://www.multivu.com/players/English/7449051-world-innovation-summit-health-2015/"]WISH press release[/link]
[link url="http://www.wish-qatar.org/media-center/press-release-details?item=137&backArt=71"]WISH press release[/link]
[link url="http://dpnfts5nbrdps.cloudfront.net/app/media/1430"]WISH patient safety report[/link]
[link url="http://www.latimes.com/business/la-fi-hospital-infections-20150218-story.html#page=1"]Full Los Angeles times report[/link]
[link url="http://www.reuters.com/article/2015/02/21/us-usa-superbug-cdc-idUSKBN0LP01520150221"]Full Reuters Health report[/link]
[link url="http://www.nursingtimes.net/nursing-practice/specialisms/patient-safety/patient-safety-alert-issued-over-use-of-non-invasive-ventilation/5082471.article"]Full Nursing Times report[/link]
[link url="http://www.england.nhs.uk/wp-content/uploads/2015/02/psa-niv.pdf"]NHS safety alert[/link]