The US Food and Drug Administration (FDA) has released a new white paper emphasizing the importance of integrating cybersecurity into the connected technologies that support medical product manufacturing.

Modern manufacturing environments increasingly rely on operational technologies—such as programmable logic controllers and distributed control systems—that are often connected to networks but not originally designed with cybersecurity in mind. As a result, the FDA indicates that it can be difficult to determine what, when, and where network communications are occurring, potentially increasing the risk of cyber incidents.

In the white paper, Securing Technology and Equipment (Operational Technology) Used for Medical Product Manufacturing, the FDA notes that commercially available manufacturing equipment may not natively comply with national or international cybersecurity standards. To address this, the agency urges manufacturers to adopt state-of-the-art cybersecurity practices through careful system design and configuration.

The paper is intended to raise awareness and provide a summary of best practices to help reduce vulnerabilities across the US medical product manufacturing sector and its supply chain.

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The US Food and Drug Administration (FDA) has issued import alerts for select Olympus Medical Systems devices manufactured in Japan due to due to unresolved concerns related to quality system regulation violations.

The affected devices include specific models of ureterorenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors. These products, produced by Olympus Medical Systems Corporation and its subsidiaries, will now be refused entry into the US under Import Alert 89-04, which cites noncompliance at Olympus’ Aizu manufacturing facility.

The FDA says in the alert that it has taken actions related to quality system requirements and compliance concerns with Olympus and that it is continuing to engage with the company to accelerate corrective actions related to the ongoing violations and minimize risk to patients. 

“FDA takes seriously its role in assuring patients that medical devices are safe and effective,” reads the alert from the agency. 

What Health Care Providers Should Know

According to the FDA, health care providers should:

• Be aware of the import alerts and consult the FDA’s table of affected models and Unique Device Identifiers.
• Note that the alerts do not apply to related products such as replacement parts, connectors, or single-use consumables.
• Continue using devices already in use, provided they are functioning properly and not showing signs of damage.
• Follow all labeling and reprocessing instructions for cleaning and sterilization.
• Remove from service any devices that are damaged or fail a leak test.
• Establish maintenance and inspection schedules per manufacturer guidance.
• Discuss risks and benefits with patients prior to procedures involving the affected devices.
• Promptly report any adverse events to the FDA to aid in ongoing safety monitoring.

The FDA emphasizes its ongoing engagement with the company to ensure corrective actions are implemented and patient safety risks are mitigated. The FDA says it will update providers and the public as more information becomes available.

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ECRI has published a collection of resources that can help healthcare leaders safely integrate artificial intelligence (AI) solutions into care delivery.

Healthcare organizations are increasingly looking to AI to streamline workflows and cut costs, but AI can pose significant risks to patient safety if not properly assessed and managed. 

AI-enabled tools offer wide-ranging benefits, and predictive AI is already being tested and used in care delivery with its scope set to expand into even more applications. These systems depend on high-quality data, robust clinical validation, and a clear understanding of their intended use. Inadequate training data, poor integration,and lack of transparency can lead to inappropriate outputs and degraded care.

ECRI’s new AI Resource Hub provides free, publicly accessible tools designed to help organizations thoughtfully procure, implement, and oversee AI technologies while addressing these critical safety and performance concerns.

The hub includes position papers, webinars, expert-authored articles, and regulatory insights. Among the key materials is ECRI’s seven-point position paper, which offers recommendations for assessing functionality, mitigating bias, and ensuring clinical validation. The paper also answers critical questions around regulatory clearance and post-deployment monitoring.

Additional resources cover ECRI’s recent submission to the White House Office of Science and Technology Policy, ethical frameworks for AI use, and guidance for managing machine learning updates in AI-enabled medical devices.

The resource hub also features materials previously available only to ECRI members, reflecting what the organization calls an “unmet need” for industry-wide support in responsible AI integration.

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Medtronic has issued a voluntary recall notice for specific Newport HT70 and HT70 Plus ventilators, as well as certain related Newport service parts, advising customers to discontinue clinical use of the affected devices.

According to the company, an investigation into customer complaints identified two separate capacitors on the ventilator’s controller printed circuit board assembly (PCBA) that could fail. If either component fails, it may result in the ventilator shutting down during use or in the shutdown alarm not sounding effectively.

No instances of both capacitors failing on the same PCBA board have occurred, nor are they anticipated to occur, according to a company release.

If a ventilator fails and does not provide adequate ventilation, the patient may not be able to breathe on their own, leading to low oxygen levels, high carbon dioxide levels, and potentially severe consequences like brain injury or death. There have been 63 medical device reports associated with this issue, including two serious injuries and one death. 

HT70 and HT70 Plus ventilators are intended for use by home users, as well as for infant and pediatric patients who may be at higher risks of injury or death due to unanticipated ventilator failures.

Customers should remove the affected devices from use and replace with an alternate means of ventilation. Medtronic is not correcting these issues on affected ventilators or service parts and will no longer service affected ventilators identified in this notification. 

The US Food and Drug Administration (FDA) designated this recall a Class I recall, the most serious type. Medtronic notes in a release that it will continue working with the FDA and other regulatory bodies on this recall. 

In February 2024, Medtronic announced its decision to exit the ventilator business, including the Newport product line. The company says it will continue to fulfill existing contracts and work with regulators as it winds down operations.

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Zyno Medical is recalling certain Z-800 series infusion pumps due to a software issue, according to a medical device recall notice from the US Food and Drug Administration, which notes that this recall involves removing the devices from where they are used or sold.

Zyno Medical stated that certain Z-800, Z-800F, Z-800W and Z-800WF infusion pumps were released to customers with incorrect software versions that had not undergone required verification and validation testing. As a result, these pumps can experience unexpected performance problems, including issues with essential functions and risk measures such as air in line detection, alarm volume, and reverse flow prevention.

The worst case scenarios of incorrect air in line detection and incorrect audio alarms associated with other failures could result in serious harms such as under- or over-delivery of drugs, air in line that infuses a venous air embolism of up to 1mL, undetected flow reversal of drugs or parenteral fluids, and lowering of the Keep Vein Open (KVO) rate from 5 mL/hr to 1 mL/hr, which can lead to very low KVO flow rates and possibly cause a blood clot to form at the distal end of the catheter, ultimately leading to peripheral IV catheter (PIV) failure.

At this time, Zyno Medical has not reported any serious injuries or deaths. The FDA has identified this as a Class I recall, the most serious type. 

What to Do

On May 7, 2025, Zyno Medical sent affected customers an email recommending the following actions:

• Discontinue use of affected devices and follow instructions for the return of the device.
• Check inventory for affected products, verify serial numbers, and confirm product location.
• Report any transferred product and pass this notice to the appropriate personnel who need to be informed if the identified devices have been transferred to another location.
• A representative from Zyno Medical’s partner company, Intuvie LLC, will be in contact with you to coordinate instructions on exchanging devices to remediate this action.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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Advocate Health and The Joint Commission have announced a new collaboration focused on improving patient safety and care quality across the health system’s 69 hospitals. The initiative will use systemwide accreditation and performance benchmarking to identify opportunities for continuous improvement and operational efficiency.

As part of the agreement, Advocate Health—one of the largest nonprofit integrated health systems in the US—will pursue hospital accreditation across its entire network. The approach is intended to support consistent quality standards across facilities and provide a framework for measuring outcomes within the system and against comparable peer groups.

According to The Joint Commission, the benchmarking tools available through its accreditation process allow for both system-level and facility-specific performance views, helping healthcare teams assess strengths and target areas in need of improvement.

“When hospitals and clinics deliver higher quality care, people get to spend more time where it matters most—with their families, loved ones, and in the work they find meaningful,” says Advocate Health chief medical officer Betty Chu, MD, in a release. “By aligning our organization around a unified set of evidence-based standards, we’re empowering our entire team to drive improvements for all.”

Jonathan B. Perlin, MD, PhD, president and CEO of The Joint Commission, adds in a release: “A systemwide approach to accreditation is best for health systems to deliver safe and quality care, which in turn benefits patients, the workforce, and communities. We look forward to working with Advocate Health to build resilient health care, enable continuous improvement, and share data, insights, and experiences to advance health outcomes.”

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Medtronic and its subsidiary, Covidien, are recalling the Shiley adult flexible tracheostomy tube with TaperGuard cuff reusable inner cannula as the tube may become dislodged or move out of place if the securement flange becomes disconnected, according to a medical device recall notification from the US Food and Drug Administration. 

This could prevent patient breathing and/or block the airway, which may lead to a serious or life-threatening emergency.

On Feb 26, 2025, Medtronic sent all affected customers an Urgent Medical Device Recall notice regarding the affected tracheostomy tube, recommending the following actions:

• Quarantine all unused product from the affected lot of Shiley adult flexible tracheostomy tube with TaperGuard cuff reusable inner cannula.
• Return all unused product from the affected lot in your inventory to Medtronic as described on the Customer Confirmation Form.

The use of a device that has disconnected the flange from the device cannula may result in respiratory failure, airway tissue injury, choking, respiratory tract infection, tightening of the airways, treatment delay, and/or death.

Medtronic has not reported any serious injuries or deaths associated with this issue.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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Baxter has issued a letter to affected customers recommending Novum IQ large volume pumps to be corrected prior to use due to a potential for underinfusion, according to a medical device recall notice from the US Food and Drug Administration (FDA).

The correction is recommended if the device has been powered off with the administration set loaded, or after the “standby mode” feature has been activated. Keeping the administration set loaded in the pump for an extended amount of time may result in underinfusion due to the compression of the set. The risk increases when infusing at higher flow rates after a longer duration in standby mode or powered off.

These large volume pumps are intended to provide intravenous infusion of drugs, IV nutrition, blood, and blood products. Underinfusion can lead to patient dehydration, inadequate drug therapy, and nutrition. Underinfusion in pediatric patients may create an increased risk of morbidity and mortality.

Baxter has reported one serious injury and no deaths associated with this issue.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Photo caption: Novum IQ large volume pumps

Photo credit: Baxter

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BiVACOR, a clinical-stage medical device company developing a titanium Total Artificial Heart, announced that its device has received Breakthrough Device Designation from the US Food and Drug Administration (FDA).

The designation supports the BiVACOR Total Artificial Heart as a bridge to transplant for adults with severe biventricular or univentricular heart failure where current treatments, including LVADs, are not viable. The FDA’s Breakthrough Device program is reserved for technologies that may significantly improve outcomes for patients with life-threatening or irreversibly debilitating conditions. It offers priority regulatory interaction and accelerated pathways to approval.

“This is more than a regulatory milestone. It’s a validation of a concept we’ve spent decades proving that a fully implantable, total artificial heart isn’t just possible, it’s necessary,” says Daniel Timms, PhD, founder and chief technology officer of BiVACOR, in a release. “Patients with biventricular failure have been overlooked for too long. The early results from our clinical trial show that we can give them a second chance, without the compromises of older technologies. The Breakthrough Device Designation puts us on a faster track to deliver exactly that.”

Trial Expansion Follows Early Success

The designation follows the first phase of BiVACOR’s FDA Early Feasibility Study, where five patients in the US received the Total Artificial Heart between July and November 2024. Based on positive safety and performance data, the FDA approved the expansion of the trial to include 15 additional patients starting later this year.

BiVACOR’s device represents a new category in artificial heart technology. Compact enough to fit most men and women, the Total Artificial Heart uses magnetic levitation, similar to maglev trains, to suspend a single dual-sided rotor. This rotor simultaneously powers the right and left circulatory systems, mimicking the natural heartbeat without valves or mechanical wear points. Its simplified design allows for pulsatile flow, large blood gaps to reduce trauma, and long-term durability.

“We’ve seen every kind of artificial heart technology over the last four decades, but this is the first system I’ve encountered that combines engineering elegance, efficiency, and safety with true clinical viability,” says William Cohn, MD, BiVACOR chief medical officer and heart surgeon at the Texas Heart Institute, in a release. “The early results are remarkable with no strokes, no device-related complications, and a safety profile unlike anything in this space. With Breakthrough status in hand, we’re entering the next phase with the wind at our backs and real momentum to bring this to more patients.”

Heart failure affects more than 6 million Americans, and thousands of patients each year progress to irreversible biventricular failure. However, the number of available donor hearts remains stagnant, with fewer than 4,500 transplants performed annually in the US. BiVACOR is targeting this gap with a durable artificial replacement engineered for eventual long-term support.

The BiVACOR Total Artificial Heart is currently investigational and not approved for commercial use.

Photo caption: Total Artificial Heart

Photo credit: BiVACOR

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The US Food and Drug Administration (FDA) has classified three recent safety notices from Smiths Medical regarding its CADD-Solis Ambulatory Infusion Pumps and CADD-Solis VIP pumps as Class I recalls—the agency’s most serious designation.

The corrections involve updates to device instructions rather than product removals, but the FDA warns that failure to follow the new guidance could lead to serious injury or death depending on the clinical context and medication being infused. Smiths Medical has not reported any injuries or fatalities associated with the issues.

The updates address the following concerns:

• Infusion Pump False Occlusion Alarm: Under certain conditions, a CADD-Solis pump may trigger a false Upstream Occlusion (USO) Alarm. The erroneous USO alarm may occur when there is a delay of more than one hour between the first prime or infusion of a new CADD Administration Set and the next prime or infusion of the same CADD Administration Set. The USO Alarm is a high-priority alarm that will interrupt an ongoing infusion or delay initiation of an infusion. The pump cannot resume or start an infusion until the alarm is cleared.
• Infusion Pump Thermal Damage Issue: Damage to the rechargeable battery pack circuit board, Wireless Communication Circuit Board, or battery separators is associated with the potential for thermal damage in affected infusion pumps. Damage to or inoperable batteries may lead to a delay in therapy or interruption of therapy. The user would be alerted with the normal “Low Battery” or “Depleted Battery” alarms. The presence of excessive heat from damaged or shorted components is also possible, which may result in a thermal injury.
• Infusion Pump Intermittent Connection Issue: CADD-Solis pumps may lose communication with the CADD wireless communication module if wireless network setting changes on the hospital network are not compatible with the CADD wireless communication module. This may result in a “Wireless Module Intermittent Connection” high priority alarm, which will stop an ongoing infusion. When this alarm triggers, the pump must be power cycled to clear the alarm.

Smiths Medical has issued updated use instructions to affected customers and continues to monitor the situation. The FDA urges healthcare professionals to follow the revised guidance to ensure patient safety.

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