In August 2024, the U.S. Food and Drug Administration (FDA) announced that ICU Medical issued an update recall to the use instructions for its Plum 360, Plum A+ and Plum A+3 infusion systems because of a manufacturing defect that can substantially diminish the life of the batteries. ICU Medical’s latest notice expands the affected products from a March 2023 notice to include all replacement batteries manufactured by CSB.

One potential positive from the COVID-19 pandemic was heightened awareness and use of personal protective equipment (PPE). However, protecting people from virus transmission does not automatically equate to protecting surfaces from hazardous drugs, researchers reported in the August 2024 issue of the Clinical Journal of Oncology Nursing. Although surface contamination varied by agent and setting, overall, they found no significant change from pre- to post-pandemic.

On August 6, 2024, the U.S. Food and Drug Administration (FDA) announced that Smiths Medical is issuing a correction recall for its CADD-Solis Ambulatory Infusion Pump because of multiple issues related to outdated software. The FDA said that the recall involves correcting certain devices, not removing them from where they are used or sold. 

On August 6, 2024, the U.S. Food and Drug Administration (FDA) reported that Baxter International Inc. is voluntarily recalling one lot of heparin sodium in 0.9% sodium chloride injection to the consumer level because of the potential for elevated endotoxin levels. 

On July 10, 2024, the U.S. Food and Drug Administration (FDA) updated the Medical Device Shortages List to include blood culture media bottles (product code MDB). It also sent a letter to healthcare providers indicating that it is aware that the United States is experiencing interruptions in the supply of BD BACTEC blood culture media bottles because of recent supplier issues. The FDA said that the supply disruption is expected to affect patient diagnosis, follow-up patient management, and antimicrobial stewardship efforts. BD previously issued a letter in June 2024 to customers identifying the affected product. 

On July 22, 2024, the U.S. Food and Drug Administration (FDA) reported that Hikma Pharmaceuticals USA, Inc., is extending its voluntary recall of one lot of acetaminophen injection, 1,000 mg/100 ml (10 mg/ml), to the consumer and user level. The product is being recalled because a bag labeled dexmedetomidine HCL injection (400 mcg/100 ml) may be inside an overwrap labeled as acetaminophen injection (1,000 mg/100 ml [10 mg/ml]).

Implementing a standard guideline for nursing management of patients receiving new U.S. Food and Drug Administration–approved chemotherapy, immunotherapy, and biotherapy decreased 1:1 patient–nursing hours by nearly 65% and saved more than $100,000 per year at one health system in south Florida, a team of nursing leaders reported in a poster presentation at the 49th annual ONS Congress^® in April 2024.

On June 5, 2024, the U.S. Food and Drug Administration (FDA) announced that HomeoCare Laboratories Inc. is voluntarily recalling two batches of StellaLife oral care products to the consumer level because of the presence of microbial contamination.

On May 29, 2024, the U.S. Food and Drug Administration (FDA) announced that Sagent Pharmaceuticals issued voluntary nationwide recall of two lots of docetaxel injection, USP (80 mg per 8 ml multidose vials and 160 mg per 16 ml multidose vials), because of the potential presence of particulate matter from the stopper in the drug product.

On March 27, 2024, the U.S. Food and Drug Administration (FDA) announced that Amneal Pharmaceuticals, LLC, is voluntarily recalling four lots of vancomycin hydrochloride for oral solution, USP, 250 mg/5 ml, packaged in 80 ml, 150 ml, or 300 ml pack sizes, to the consumer level.

This ONS resource was produced for educational purposes only. Refer to the full elranatamab-bcmm (Elrexfio™) package insert for all details.

On March 21, 2024, the U.S. Food and Drug Administration (FDA) approved safety labeling changes regarding dihydropyrimidine dehydrogenase deficiency for fluorouracil injection products. The update was a collaboration between FDA’s Office of Generic Drugs and the Oncology Center of Excellence.

On March 5, 2024, the U.S. Food and Drug Administration (FDA) announced that Smiths Medical ASD Inc. is recalling its Medfusion model 3500 syringe pump because of issues associated with earlier software versions, including high-priority alarms during motor issues, wrong infusion restarts, screen locks, bolus interruptions, incorrect dose displays, low doses, motor errors, wrong settings recall, corrupt configurations, auto locks, and toolbox issues with loading dose time values. If a device has undetected issues, it may fail and delay, interrupt, or not deliver the therapy per the programmed setting.

On February 27, 2024, the U.S. Food and Drug Administration (FDA) issued a safety communication to patients and healthcare providers about the potential risk for serious complications with BioZorb Marker and BioZorb LP Marker devices by Hologic, Inc., which are implanted in soft tissue, including breast tissue, to mark a site for medical procedures (e.g., radiation therapy for breast cancer treatment).

On February 14, 2024, the U.S. Food and Drug Administration (FDA) reported Smiths Medical ASD Inc.’s recall of its Medfusion model 4000 syringe pump because of issues associated with earlier software versions that may affect the alarm system, the pump, the control screen, and other parts of the pump. If undetected issues are present in the device, the device has the potential to fail and delay, interrupt, or fail to deliver the therapy per the programmed setting.

Unavailability of necessary drugs, supplies, and equipment—including an increasing number of lifesaving drugs with no viable alternatives—because of shortages are “making it nearly impossible to provide safe, high-quality patient care in a fiscally responsible manner,” healthcare professionals across a variety of disciplines reported on a 2023 ECRI and Institute for Safe Medication Practices survey.

On January 19, 2024, the U.S. Food and Drug Administration (FDA) announced that it is adding a boxed warning to the denosumab (Prolia^®) prescribing information about the significant risk of developing severe hypocalcemia in patients with advanced chronic kidney disease. The warning and new labeling contain information to help reduce that risk, including appropriately selecting patients for denosumab treatment, increased monitoring of blood calcium levels, and other strategies.

On December 20, 2023, the U.S. Food and Drug Administration (FDA) reported that Busse Hospital Disposables, Inc., had recalled its tracheostomy care tray, dressing change tray, and tracheostomy care set. Busse’s recall is in direct response to Nurse Assist LLC’s, November 6, 2023, recall of its 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, over sterility concerns, which is the only saline used in the Busse trays and kits. The recall doesn't apply to the other kit components. FDA identified it as a class I recall, where use of the devices may cause serious injuries or death.

On December 15, 2023, the U.S. Food and Drug Administration (FDA) published a public update about its work to strengthen safety requirements and consumer communication about risks surrounding breast implants. Through the following actions, FDA said it intended to support patient-provider discussions and shared decision-making for breast implants.

On November 27, 2023, the U.S. Food and Drug Administration (FDA) reported that Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune^® Oral Solution (cyclosporine oral solution, USP), 100 mg/ml, in the United States because of crystal formation observed in some bottles that could result in incorrect dosing. The issue was identified during an investigation of crystallization in a different lot of cyclosporine oral solution, USP, 100 mg/m. No other Sandimmune formulations are affected.

On November 28, 2023, the U.S. Food and Drug Administration (FDA) issued a safety communication to patients and healthcare professionals regarding BCMA- or CD19-directed autologous CAR T-cell immunotherapies. The agency said it received reports of T-cell malignancies, including CAR-positive lymphoma, in patients who received treatment with those products. The reports came from clinical trials and postmarketing adverse event data sources.

On November 21, 2023, the U.S. Food and Drug Administration (FDA) advised that Bayer issued a voluntary recall for one lot of larotrectinib (Vitrakvi^®) oral solution 20 mg/ml in 100 ml glass bottles to the user level because of Penicillium brevicompactum microbial contamination observed during routine stability testing.

On November 20, 2023, the U.S. Food and Drug Administration (FDA) alerted healthcare providers and facilities not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia (PCA) pumps while the agency further evaluates a reported issue. FDA classified it as a class I recall, the most serious type of recall, where use of the product or device may result in serious injury or death.

On November 17, 2023, the U.S. Food and Drug Administration (FDA) announced that B. Braun Medical, Inc., is recalling its Infusomat Space Volumetric Infusion Pump System because of faulty occlusion alarms, causing the pump to stop delivering medications, including high-risk medications such as vasopressors. Interrupting the infusion of high-risk medications may lead to hemodynamic instability, which may be life-threatening or lead to death in some cases. FDA is aware of 51 reports, one injury, and one death related to the recall. The agency has identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.

On November 15, 2023, the U.S. Food and Drug Administration (FDA) reported that Fresenius Medical Care is recalling three types of its Sanxin single-use syringes because of leakages. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.

On November 6, 2023, the U.S. Food and Drug Administration (FDA) announced that Teleflex, and its subsidiary Arrow International, are recalling 1,905 pressure injectable central venous catheter kits due to mislabeling regarding the presence of chlorhexidine in these products. FDA has identified it as a class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

On November 6, 2023, the U.S. Food and Drug Administration (FDA) announced Nurse Assist, LLC’s, recall and warned consumers, healthcare providers, and healthcare facilities not to use recalled saline (0.9% sodium chloride) and sterile water medical products manufactured by Nurse Assist, LLC, and sold under various brands, because they may not be sterile.

One in four U.S. nurses reported being assaulted during the past year—two every hour—and it is happening in oncology settings, too, authors wrote in the Clinical Journal of Oncology Nursing.

On October 25, 2023, the U.S. Food and Drug Administration (FDA) announced that Exela Pharma Sciences, LLC (Exela), is voluntarily recalling the following products to the consumer level because it observed silicone particulate matter during routine inspection of retained samples.

Healthcare workers are five times as likely to experience workplace violence as other workers, according to government data. In a National Nurses United survey in 2022, 40% of hospital nurses said they’d seen an increase in violent incidents. Karen Coughlin, chair of the Massachusetts Nurses Association’s workplace violence and abuse prevention task force, joins John Yang to discuss.

On October 2, 2023, the U.S. Food and Drug Administration reported Hospira, Inc.’s, voluntary recall of several lots of 4.2% sodium bicarbonate injection, USP, 5 mEq/10 ml vial; 1% lidocaine HCl injection, USP, 50 mg/5 ml vial; and 2% lidocaine HCl injection, USP, 100 mg/5 ml vial to the user level because of the potential for presence of glass particulate matter.

On September 29, 2023, the U.S. Food and Drug Administration (FDA) issued an updated safety communication to consumers, healthcare providers, and facilities about certain surgical N95 respirators and masks manufactured by Owens and Minor (O&M) Halyard. FDA updated its recommendations for the products based on new data and information from O&M Halyard.  

On September 20, 2023, the U.S. Food and Drug Administration (FDA) announced that Medline Industries had recalled a single lot of Hudson RCI AddiPak^® unit dose vial, 0.9% full normal saline solution, because it may be nonsterile. FDA identified it as a class I recall, the most serious type of recall, where usage may cause serious injuries or death.

On September 11, 2023, the U.S. Food and Drug Administration announced Novartis’s voluntary nationwide recall at the consumer level of one lot of its Sandimmune^® Oral Solution (cyclosporine oral solution, USP), 100 mg/ml, in the United States because of observations of crystals in some bottles that could result in incorrect dosing. No other cyclosporine oral solution formulations are affected.

When Ethan was 15 years old, he was diagnosed with osteogenic sarcoma. He underwent chemotherapy and was deemed cancer free for nearly 10 years. Maria, an advanced oncology certified nurse, worked closely with Ethan’s healthcare team throughout his treatment. She got to know Ethan, his sense of humor, and his dreams of becoming a child psychologist.

When summer ends in the northern hemisphere and the autumnal equinox ushers in fall on September 23, 2023, the earth begins to tilt away from the sun, making the nights grow longer and days shorter until the winter solstice. Those of us working 12-hour shifts especially notice the decrease in daylight, coming to and leaving our workplaces in darkness. 

U.S. Representatives Diana DeGette (D-CO) and Debbie Wasserman Schultz (D-FL), along with more than 50 members of the U.S. Congress, wrote a letter in June 2023 calling on the U.S. Food and Drug Administration (FDA) to abide by a court-ordered deadline to review outstanding Premarket Tobacco Product Applications for e-cigarette products that remain on the market without approval. The call comes after FDA failed to meet the initial deadline of September 9, 2021, to complete its review of all pending e-cigarette applications.

In a record number of outreaches, the U.S. Food and Drug Administration issued warning letters in June 2023 to 189 retailers for selling unauthorized tobacco products. Two notable brands included in the warning, Elf Bar and Esco Bars, sell disposable e-cigarettes that come in flavors that appeal to youth, such as bubblegum and cotton candy.

As overall monthly unit sales of e-cigarettes increased by 46.6% from January 2020–December 2022, according to June 2023 data from the Centers for Disease Control and Prevention, tobacco cessation advocates continue to fight an uphill battle. Purchases grew from 15.5 million units to 22.7 million units in the study period.

On August 1, 2023, the U.S. Food and Drug Administration (FDA) reported Baxter Healthcare Corporation’s June 15, 2023, recall of SIGMA Spectrum infusion pumps with master drug library (version 8) and Spectrum IQ infusion systems with dose IQ safety software (version 9) because of false alarms for upstream occlusion after pump software upgrades to version v8.01.01 and v9.02.01, respectively. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.

A growing literature base supports the use of medical cannabis in cancer care and symptom management, and as of April 2023, 42 states, including 3 territories and the District of Columbia, allow for medical use. As more patients use or seek to use medical cannabis during their cancer trajectory, oncology nurses are looking to the latest research behind medical cannabis, how cannabis can impact their patients’ treatment plans and symptom management, and legislation in the state in which they practice.

Nearly 80% of nurses have witnessed or been victims of racism or discrimination from patients—and nearly 60% from colleagues—according to a May 2023 Robert Wood Johnson Foundation report published in partnership with the National Opinion Research Center at the University of Chicago.

On June 14, 2023, the U.S. Food and Drug Administration reported that the Harvard Drug Group, LLC, conducting business as Major Pharmaceuticals and Rugby Laboratories, issued a voluntary recall of a single lot of dronabinol capsules, USP, 2.5 mg, and ziprasidone hydrochloride capsules, 20 mg, after receiving a report that some unit dose cartons labeled as ziprasidone hydrochloride capsules, 20 mg, contained blister packages labeled as and containing dronabinol capsules, USP, 2.5 mg.

A battalion of trained nurse reinforcements is waiting just outside the U.S. borders, eager to help alleviate the nursing shortage, but the system that lets international nurses enter and work in the United States is heavily congested. And according to the U.S. State Department’s June 2023 Visa Bulletin, the backlog is only worsening.

On May 22, 2023, the U.S. Food and Drug Administration (FDA) reported ICU Medical’s recall of replacement batteries for its Plum 360™, Plum A+™, and Plum A+3 infusion systems because of a manufacturing defect that can substantially diminish how long the batteries can run the system. FDA identified it as a class I recall, the most serious type of recall, where use may cause serious injuries or death.

In an attempt to strongly regulate the e-cigarettes and vapes industry, the U.S. Food and Drug Administration filed civil money penalty complaints against four tobacco product manufacturers for manufacturing and selling e-liquid products without authorization. The action marks the first time FDA has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic Act’s premarket review requirements for new tobacco products. 

On April 27, 2023, the U.S. Food and Drug Administration reported that Teva Pharmaceuticals USA, Inc., issued a voluntary recall of certain lots of fentanyl buccal tablets, a schedule II substance, to the consumer level because safety updates were omitted in the lots’ product insert/medication guide. Teva Pharmaceuticals USA, Inc., manufactured and labeled the product lots exclusively for Mayne Pharma, Inc.

With the anticipated end of the public health emergency looming after three years of being consumed by the COVID-19 pandemic, Xavier Becerra, secretary of the U.S. Health and Human Services, wrote a letter to state governors praising their efforts in the pandemic, offering a supportive hand, and highlighting the Biden-Harris administration’s accomplishments in combating COVID-19.

Coming to you from Congress, we're speaking with some of the key speakers presenting at the the 48th annual conference. Here, Tamryn Gray, PhD, RN, MPH, Chris Snyder, and Lauren Ghazal, PhD, FNP-BC, talk about their sessions and ways you can learn more about important topics like caregivers, safety and violence in health care, and nursing sustainability.