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Each accounted for 8% of the total 1,411 reported sentinel events, ranking second and third respectively. Both errors saw increases from 2022, with wrong surgeries up by 26% and unintended retention by 11%. These errors, often termed “never events,” indicate the need for improved procedural and organizational practices within surgical teams. Wrong Surgeries:Wrong surgeries, including procedures performed on the wrong site or patient, or unintended procedures, were reported 112 times.

The article discusses the issue of medical device recalls by the FDA, highlighting a significant concern: many of these recalls do not result in the actual removal of the devices from use. Instead, the FDA and manufacturers often allow the devices to remain in use, sometimes with revised instructions or additional training for doctors.

The firm manufactures the Excelsius GPS surgical robot, a Class II medical device. The inspection, conducted from February to March 2024, revealed that the company’s practices did not meet the required quality standards, leading to the devices being classified as adulterated under U.S. law. Key violations include failure to implement corrective and preventive actions, inadequate complaint investigations, and delays in mandatory medical device reporting (MDR).

McLaren Health Care, a 13-hospital system in Michigan, has been hit by a cyberattack for the second time in less than a year. The attack disrupted IT and phone systems, leading to the cancellation of some non-emergency services, although emergency care and most surgeries continue as usual. Patients are advised to bring their medical records to appointments in case electronic systems are still affected.

The article discusses the U.S. Food and Drug Administration’s (FDA) concerns about the quality of Chinese-made plastic syringes and broader issues with Chinese-manufactured medical products. Suzanne Schwartz, a director at the FDA’s Center for Devices and Radiological Health (CDRH), highlighted that the problems with these products are systemic and have been ongoing for years, not just recently.

This growth is driven by increasing awareness of dental health, rising cases of dental caries, advancements in dental technology, and a surge in demand for cosmetic and laser dentistry. The popularity of smile makeovers, invisible braces, and root canal procedures are also contributing to the market’s expansion. Technological innovations like dental caps, dentures, and implants are enhancing the patient experience, particularly in cosmetic dentistry.

On July 11, 2024, the U.S. Food and Drug Administration (FDA) issued a warning letter to Brassica Pharma Pvt. Ltd. following an inspection that uncovered significant violations of Current Good Manufacturing Practice (CGMP) regulations at their facility in Thane, India. The inspection, conducted from January 15-19, 2024, revealed numerous compliance issues that led to the adulteration of their drug products under the Federal Food, Drug, and Cosmetic Act.

Summary of “Charted: Expected Healthcare Cost Increases for 2025” A recent report by PricewaterhouseCoopers’ (PwC) Health Research Institute forecasts an 8% rise in healthcare costs for 2025, the highest since 2012. This growth is attributed to various factors, including inflation and increased demand for high-cost drugs and behavioral health services.

Microsoft’s Forced Updates: A Critique of the Global IT Outage In his article, Can Kisi critique the recent global IT outage caused by a flawed update from cybersecurity firm CrowdStrike, which affected Microsoft Windows devices. The incident exposed significant vulnerabilities in the digital infrastructure, impacting critical sectors like airlines, healthcare, and finance.

The FDA has issued a Class I recall, its most serious classification, for Baxter’s Life2000 Ventilator system due to a faulty battery charging dongle. This defect may cause the ventilators to shut down unexpectedly, posing a risk of ventilator failure for patients reliant on them for breathing, especially those who are unconscious. While no deaths have been reported, there has been one injury linked to this issue.