Supply Chain

Managing supplies is a crucial part of moving medical products from the manufacturer to patient’s bedside. Efficient supply chains can reduce healthcare costs and make medical devices more affordable for patients and health systems. This news page includes content on supply shortages, inventory management, and procurement practices.

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Assembly issue spurs FDA recall on manual resuscitators

A problem with the B/V filters on SunMed adult resuscitators can cause the devices to malfunction. Due to the high safety risk this poses to patients, the FDA has assigned this recall its most serious designation.

FDA recalls real-time glucose monitors after 56 injuries

Receivers on active glucose monitors manufactured by Dexcom are reportedly failing to send alerts when a patient’s blood sugar levels are dangerously high or low. There have been no deaths linked to the malfunction. 

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FDA issues recall on defective cranial drills after 10 injuries

The devices are manufactured by Integra LifeSciences. Due to a manufacturing error where inadequate welding has caused bits to get stuck in patients’ skulls, this recall has been designated as the most serious type.

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Trump teases 200% tariff on all pharmaceutical imports

After issuing a 50% tariff on copper imports this week, President Donald Trump said a massive levy on drugs could be announced “very soon.” The details are currently unknown. 

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Sanitation issue forces FDA recall of ventilator suction systems

Ballard Closed Suction Systems will need to be returned to the manufacturer for a refund due to the high risk of a potentially fatal infection stemming from their use.

FDA issues Class I recall on infant heated wire circuits prone to disconnect

The faulty adapters must not be used. The devices, manufactured under the brand name AirLife, must be identified and quarantined because of the high risk of severe injury or death associated with the malfunction.

Philips and Medtronic extend 30 year patient monitoring partnership

The two companies will continue combining components to make patient monitoring systems, under the new terms of the expanded deal that includes a "pledge program" to improve quality.

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FDA announces recall of Baxter infusion pumps with mismatched software

Spectrum V8 and V6 infusion pumps may have accidentally had their software switched, which could result in underinfusion or a fluid overload. While no injuries have been reported, for safety the affected pumps need to be removed from where they are used and sold. 

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Around the web

Cardiovascular Business
Heartflow, a leader in AI-powered imaging evaluations, files for IPO

Heartflow, known for its AI-based CCTA evaluations, appears to be going public. The news follows years of momentum for the California-based company, including improved Medicare reimbursements for cardiac CT and a new Category I CPT code for its Plaque Analysis software.

Cardiovascular Business
ASNC lobbies Congress to curb prior authorization, oppose AUC mandates and embrace payment reform

Suman Tandon, MD, an American Society of Nuclear Cardiology board member, explains the group's call on Congress to update a number of healthcare policies. 

Cardiovascular Business
CMS proposal includes cardiologist pay bump—cuts to high-value services still a concern

The 2026 MPFS proposed rule includes higher conversion factors across the board. However, some cardiology groups remain concerned about a series of reimbursement reductions for high-value cardiology services.