Medical Devices

New device brings a larger screen, integration with more clinical systems, a panic button and do not disturb features.

The message of the 60 exhibitors and 12 sessions: That health information technology is not just for providers or payers but now directly impacts the individual patient.

MedicalDirector CEO Matthew Bardsley shares digital predictions for medical professionals going into 2019.

A global investigation has found that unsafe medical devices have caused 1.7 million injuries globally and almost 83,000 deaths in the last 12 years. According to The Implant Files, a year-long investigation of the manufacturers of devices by the International Consortium of Investigative Journalists (ICIJ), unsafe medical devices have been allowed into global markets as a result of poor regulatory systems, a lack of transparency and insufficiently strict rules on testing.   Some of these medical devices that have caused “adverse incidents” include pacemakers, contraceptives, artificial hips and breast implants grafted into patients’ bodies.  The investigation found some devices did not complete patient trials. The report stated that some pacemakers, for example, were implanted even though their manufacturers knew of problems; other devices were approved without proper regulatory procedures.  In the report, ICIJ referenced a case in the US, where 27-year-old Charlissa Dawn Boyce’s family filed a lawsuit after an an implantable defibrillator, which was later recalled by St. Jude Medical for battery problems, didn’t shock her heart back into beating and resulted in her death. It found that nearly 350,000 of the defibrillators were used on patients globally before the recall occurred in 2016. Another example of a faulty medical device is in India, where 44-year-old Vijay Vojhala suffers from difficulty walking, vision problems and irregular heart rhythms, which he claimed was a result of his Johnson & Johnson replacement hip. More than half a million patients globally got these replacement hips before they were taken off the market. Webinar: Optimizing Medical Device Safety: A Closed Loop Processy Findings "underline the need for drastic regulatory changes" Oxford University Clinical Epidemiologist Carl Heneghan told the Australian Financial Review it was unacceptable to keep maintaining this system. The findings have raised questions over how much scrutiny devices actually undergo in the global industry before being used on patients and if regulators pick up and act on findings fast. According to The Guardian, the Royal College of Surgeons President Professor Derek Alderson said the number of incidents involving flawed devices is enough to “underline the need for drastic regulatory changes”, in addition to the introduction of mandatory national registries for implantable devices. “In contrast to drugs, many surgical innovations are introduced without clinical trial data or centrally held evidence,” he said. “This is a risk to patient safety and public confidence.” According to the Australian Financial Review, US trade group for medical device manufacturers AdvaMed recommended that medical devices should be assessed differently to pharmaceuticals as implants are harder to randomise during clinical trials than drugs.  "To suggest that human trial mandates would end future harm misleads both the patient and the public into falsely thinking that all adverse events can be erased through such trials," AdvaMed Head of Technology and Regulatory Affairs Janet Trunzo said.   Trunzo also spoke against industry businesses that claimed to have problems reaching patients after recalls. "High-risk medical devices, especially life-sustaining implants, have specific tracking procedures in place to ensure companies can quickly notify patients and providers of any significant issues," Trunzo added. Responding to questions from the ICIJ, the US Food and Drug Administration (FDA) mentioned that patient remains a cornerstone of its regulatory commitment and that it is working towards the creation of a program that scans clinical information and other data to identify problems quickly. It also recently introduced a new goal to be "consistently first among the world's regulatory agencies to identify and act upon safety signals related to medical devices". The ICIJ identified The Implant Files as the “first-ever global examination of the medical device industry and its overseers.” To run the investigation, ICIJ journalists, along with 250 reporters and data specialists across 58 media organisations in 36 countries teamed up to assess device incident reports, analyse health records, and run patient interviews.  Originally published on Healthcare IT News Australia.

Pivot Labs, a collaboration with tech services company Persistent Systems, will also seek innovative ways to boost clinical outcomes and manage costs.

While the two federal agencies have worked together on vulnerability disclosures in the past, a new memorandum of agreement will improve coordination.

The Food and Drug Administration issued a cybersecurity alert on two Medtronic devices that could allow a hacker to hijack the software update process to change the device’s function. Medtronic disabled the online software update to eliminate the flaw. IMPACT Following a review of potential security vulnerabilities around the internet connection, the FDA found 34,000 CareLink cardiac implantable electronic devices are at risk. If exploited, a hacker could change the programmer’s functionality or the device itself during the implantation or follow-up visits. The flaw is found in the internet connection between the CareLink 2090 and Encore 29901 Programmers, used for downloading software from Medtronic’s Software Distribution Network. The programmers are used by providers to adjust the cardiac device settings and collect locally stored data. While software updates typically include new software for the programmer functionality and updates to the implanted device firmware through a virtual private network, the programmers don’t verify they’re still connect to the VPN before downloading the updates. As a result, attempting to update the program through the internet connection will result in an error message. Medtronic updated its network, which was approved by the FDA on Oct. 5. The fix will intentionally block the currently existing programmer from accessing the Medtronic SDN. The vendor is continuing to implement security updates to further address the flaw. The FDA recommends providers continue to use the programmers, as network connectivity isn’t required for normal CIEF programming. Further, providers should not attempt to update the programmer through the SDN, which is no longer available. Future updates are currently only available through Medtronic with a USB update. THE TREND Medical device vulnerabilities are well-known, and vulnerability reporting by vendors have increased 400 percent per quarter since the FDA released its cybersecurity guidance in 2016. However, the increase in FDA alerts is meant to further improve cybersecurity, rather than to shame the vendor. Medtronic has reported several vulnerabilities in recent years, as has Philips, Abbott and a host of others. .jumbotron{ background-image: url("http://www.healthcareitnews.com/sites/default/files/u2231/cybersecurity-jumbotron-712.jpg"); background-size: cover; color: white; } .jumbotron h2{ color: white; } Focus on Cybersecurity In October, we take a deep dive into security strategy and pressing threats. Twitter: @JF_Davis_ Email the writer: jessica.davis@himssmedia.com

Keeping software up to date without disrupting care delivery requires a plan for regular patching – and responding to emergency alerts when necessary.

The healthcare sector is well-aware that medical devices are vulnerable, but it’s hard to obtain the extra resources to fix the issue.

President Trump on Wednesday threatened to add new import taxes on an additional $257 billion of Chinese goods to the $200 billion established on Monday. This was in response to China on Tuesday announcing plans to impose new tariffs on $60 billion in U.S. exports. Even though it’s only a threat at this point, rather than brush it off, hospital IT executives would be smart to monitor the developments because further tariffs could bring higher prices on everyday technologies, such as computer hardware and software, not to mention consumables, pacemakers, MRI Machines and other medical equipment manufactured in China. Hospital supply chain directors, in fact, “are appropriately paranoid but cautiously optimistic,” said Peter Allen, executive vice president of sourcing operations at Vizient, which is a member of the Healthcare Supply Chain Association. Allen and others from the management consulting company have met with the top 20 hospital supply chain managers in the country. Because supply contracts through a Group Purchasing Organization are often three years long and many got renewed last year, hospitals are currently much more concerned over whether the government is going to cut 340B or Medicare reimbursement to unsustainable levels, Allen said. But Allen said, “We work everyday on pricing. It’s still a work in progress. The next question is, what’s the supplier going to do? They might just move the production to Vietnam.” The trade war began in July, when the U.S. implemented tariffs of 25 percent on $34 billion worth of Chinese imports and Beijing retaliated with its own tariffs on $16 billion worth of U.S. goods, according to CNBC. If fully implemented, the new tariffs would cover virtually all imports of Chinese goods, according to The Wall Street Journal. Two hospital supply chain directors interviewed said they won’t fully know the impact of the tariffs until they start doing their new, yearly budgets. Jerry Dea, executive director of Supply Chain Management at Cedars-Sinai in Los Angeles, will begin the budget process in February for a July 1 start to the fiscal year. The hospital has its group purchasing organization through Vizient. The consumable supply contract will keep prices stable for now, he said. “Our contract is recent and the price is locked,” Dea said. But when current contracts with suppliers expire, whether in a year or three years, the tariffs could increase prices on everything from medical devices to parts for printers and copiers, computers, furniture, machinery for paper products - which in turn could affect the cost of paper towels or toilet paper - batteries, microscopes and scientific equipment. Consumables include such high-use devices as pacemakers. Cedars Sinai purchases from 600 to 700 a year, according to Dea. Dea said he would be asking for budgetary quotes from vendors about any tariffs on the products when he starts his budget. “At that time we will go through categories of supplies to see where we’re expecting an increase,” Dea said. “Where I’m more concerned is some of the capital equipment.” For instance, MRI machines are bought on as as-needed basis. “That’s where I’m more concerned about the tariffs,” Dea said. “I still think this is one of those situations where you don’t know what you’re going to be hit with, until it comes up.” There’s also the unknown of which goods will be added to the federal exemptions list. For instance, Apple products have been given an exemption. Dea said he originally thought orthopedic implants would be a concern, and then the ortho implants were given an exemption. Cedars-Sinai uses products from Cisco, Dell and HP, companies which have all requested exemptions to the tariffs. “We buy from all those companies,” Dea said. “Our primary provider for PCs is Dell, we use a lot of Cisco Systems. Even from a technology standpoint we could be hit by these tariffs.” Reddy Gottipolu, chief supply chain officer for the Memorial Hermann Health System, said the tariffs could affect a lot of imaging items and the commodity items. Another piece that’s difficult to estimate is the impact due to the assembly that goes into a final product. Components could be made in China, but assembled in the U.S., or the other way around. They’ll know when the suppliers come back asking for price increases, he said. Gottipolu admits the tariffs have the potential to adversely impact all hospitals’ profitability and cash flow. “We just started discussing it, we haven’t seen the impact yet,” Gottipolu said. “I’m a little concerned but at the same time not too alarmed.” Allen believes that competition will help to keep prices low on supplies from China, even with the tariffs. For instance, one wheelchair manufacturer they use makes wheelchairs in China. But if their competitors do not, they can’t increase prices and stay competitive, he said. “I still think it’s a wait and see of what’s impacted and how it’s going to impact each individual system,” Dea said. Twitter: @SusanJMorse Email the writer: susan.morse@himssmedia.com