From COVID-19 EUAs to ‘insidious’ remote care risks: ECRI’s top 10 MedTech hazards

Managing the challenges arising from the emergency approval of numerous new medical devices during the COVID-19 pandemic is the biggest medical technology security concern hospitals will face next year, the ECRI monitoring group said in a new report health technology risk.

Products approved under the FDA emergency approval process to meet the unprecedented demand for ventilators, diagnostic tests, and other medical aids during the public health crisis may not be as safe or effective as devices that support the normal process of approval said the patient safety organization in its latest ranking of the top health technology hazards.

The pandemic has also highlighted other concerns about device security, ECRI said. These include risks arising from remote control of medical devices at the bedside, consumer use of products in care decisions, use of ultraviolet light for disinfection, rapid adoption of telemedicine, and imported masks from N95 style that may not protect healthcare workers.

ECRI compiles an annual list of the Top 10 Medical Device Safety Risks based on incident investigations, reporting databases, and independent device testing. Other issues with this year’s list include errors in drug display selection, cybersecurity risks with third-party components, artificial intelligence applications that can misrepresent patient populations, and poor quality assurance for 3D printing devices.

1. EUA device management.

The FDA approved hundreds of new devices at the start of the pandemic, including the SARS-CoV-2 testing program. Because the EUA system uses benchmarks to determine safety and performance, hospitals must monitor performance issues as well as changes in the state on a daily basis, warned ECRI in the report.

The team cited the example of the FDA in repealing the EEA for anti-pollution classes that were found to rise above the maximum air pollution limit. “We are concerned that the hospital does not have a comprehensive system in place to address this complex problem,” said ECRI CEO Marcus Schabacker in a statement.

2. Option to select drug defects.

The drug system, safety, and management system that displays a list of similar drugs when a user types a few characters in the search box can select a drug bug that could result in serious injury or death. ECRI research found that 92% of drug names contain the first three letters of at least one other drug. The organization reduces the number of input characters to five out of three game positions.

3. The speed of telehealth.

The disease has spurred a surge in telehealth activities and is expected to continue and accelerate through 2021. Sudden changes in the delivery of health services present challenges resulting from inadequate staff training and the lack of mitigation of systems that could increase the likelihood of medical errors or cybersecurity violations preventing some patients from receiving care, according to ECRI. One possible answer is technological research and analysis of the prevalence of cybersecurity, as well as confirmation of patient selection systems.

4. N95 import masks.

The ECRI study found that more than 60% of inhalation air samples from the Institutes of Occupational Safety and Health Services did not accept both air and detectable air. A related problem is a KN95 sleeve imported from China. Using ineffective air purifiers can make employees and patients more susceptible to infectious diseases.

5. Depending on the user level of the product.

Healthcare providers are considering using consumer devices to reduce sleep visits and COVID-19 announcements, or when traditional medical devices are not available. But the amounts of these products can be inaccurate or misleading, ECRI said. The organization recommends avoiding the use of customer care tools, especially when diagnosing critically ill patients.6. UV devices for disinfection.

Ultraviolet light technologies can be used to disinfect surfaces and rooms, but they may not deliver a high enough dose to inactivate microorganisms, ECRI said. The devices are not normally regulated by the FDA. Improper use can result in unsafe UV light values   for the operator or others.

7. Vulnerabilities in software components.

The report also identified third-party operating systems and other software embedded in medical devices, in particular components that are no longer supported by the vendor, as significant cybersecurity risks. Device manufacturers such as BD, Medtronic, and GE Healthcare have been exposed to cyber threats over the past year, seeking recommendations from the Cybersecurity and Infrastructure Security Agency.

Hospitals may not be able to identify the devices that affected the software, going against efforts to address vulnerabilities in device components, ECRI said. The group recommends that healthcare institutions evaluate the ability of vendors to inventory software on their devices, as well as those considered for purchase.

8. Bias in AI data.

Unreliable artificial intelligence technologies can mislead some patient populations, leading to misdiagnosis and improper care decisions, ECRI has warned. Avoiding errors in the data used to train an algorithm is a key challenge, especially in diagnostic imaging. ECRI recommends that hospitals conduct a risk-benefit assessment for medical technologies that incorporate AI.

9. Risks associated with the operation of the remote device.

According to ECRI, remote control medical devices designed for bedside use create “insurmountable risks” for patients with less frequent visual assessments, reduced device performance due to longer tubing sets, or reduced blood pressure. The ability to hear or see Functions, increased risk of infection, and greater potential are associated with manipulation. The operation of the remote device should only be considered in very unusual circumstances, the group said.

10. Quality of 3D printed devices.

Patient-specific 3D printing devices manufactured by layers of raw materials may not fuse as intended if the object is created without proper review of clinical design, quality control of the manufacturing process, and final validation of the product. Improperly designed 3D printing devices could lead to surgical complications, infection, or patient injury, ECRI has warned.