CDC HAN re Meningococcal Disease

CDC has issued a Health Alert Network Advisory on a rapid increase in meningococcal disease, mainly attributable to Neisseria meningitidis serogroup Y. The increase disproportionately occurs in people ages 30–60 years (65%), Black or African American people (63%), and people with HIV (15%). It frequently has a clinical presentation other than meningitis: 64% presented with bacteremia, and at least 4% presented with septic arthritis. The 18% 2024 case-fatality rate is 64% higher than the historical rate. CDC recommends:

• Heightened suspicion for meningococcal disease, particularly among disproportionately affected populations,
• Awareness that patients may present without symptoms typical of meningitis, and
• Ensuring that all people recommended for meningococcal vaccination, including people with HIV, are up to date for meningococcal vaccines.

Find full details in the HAN at https://emergency.cdc.gov/han/2024/han00505.asp.

FDA Warning – Rings/Watches Not Accurate Glucose Monitors

The FDA has warned that “Smart” Rings and Watches that do not pierce the skin do not accurately measure blood sugar (glucose), even if they claim to do so. For people with diabetes, inaccurate blood glucose measurements can lead to errors in diabetes management, including taking the wrong dosage of medications that can quickly lead to mental confusion, coma, or death, within hours of the error.

For details, recommendations, and further instructions, see https://www.fda.gov/medical-devices/safety-communications/do-not-use-smartwatches-or-smart-rings-measure-blood-glucose-levels-fda-safety-communication. Some smart watches are capable of reading remote signals from other implanted or skin-piercing devices that do accurately report blood sugar. The Warning does not apply to these.

Recalls – Benzocaine Spray, Vancomycin+ IV Bags

The FDA has announced the recall of one lot, 1A16420, of Insight Pharma Americaine 20% Benzocaine Topical Anesthetic Spray because of contamination with Benzene. For more information and instructions, see https://content.govdelivery.com/accounts/USFDA/bulletins/381778b.

The FDA has also announced the recall of 33 lots of Leiters Health IV bags of vancomycin, phenylephrine, and fentanyl due to the potential for superpotency because they may contain twice the labeled amount of drug. These could be life-threatening if infused. For more information and instructions, see https://content.govdelivery.com/accounts/USFDA/bulletins/383d406.

Recall: Fresenius 2008 HD Machines

The FDA has announced a Class I Recall of certain Fresenius Medical Care 2008 Series Hemodialysis Machines because of contamination from a toxic chemical. Find the list of specific models, recall instructions, and all other details, at https://www.fda.gov/medical-devices/medical-device-recalls/fresenius-medical-care-recalls-some-hemodialysis-machines-potential-exposure-toxic-compounds. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

CDC HAN Alert re RSV Respiratory Virus

CDC has published a Health Alert Network Advisory (HAN) on a surge of RSV or Respiratory Syncytial Virus in the Southeastern US. Find the HAN bulletin at https://emergency.cdc.gov/han/2023/han00498.asp. RSV is different from Flu and COVID (and the “common cold”). “Syncytial,” pronounced something like “SIN-see-teal,” means that a whole mass of single-nucleus cells have merged into one big multinucleated cell. Like Flu and COVID, RSV can be serious or even fatal for vulnerable populations.

As people begin to make holiday travel plans, it is important to be aware of specific illnesses they may encounter. Some patients have family from the Southeastern US that may be coming here, or they may be planning to travel themselves, in which case they should talk to their healthcare provider about their individual risks. Although the spread of RSV has not increased here yet, the health advisory contains helpful information about new adult RSV vaccines that are available, and guidance for healthcare providers on how to care for at-risk individuals over the age of 60.

See also https://nwrnbulletins.wordpress.com/2023/09/06/9-19-cdc-call-re-flu-covid-rsv-vaccines/.

Recall: Medtronic Mahurkar HD Catheters

The FDA has announced the Class I recall of Mahurkar QPlus Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters for Potential Catheter Hub Defect. “Use of these devices may cause serious injuries or death.” For details see https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-mahurkar-acute-dual-lumen-high-flow-hemodialysis-catheters-potential-catheter-hub/.

Recall: Teleflex Arrow CVC Access Kits

The FDA has announced a Class I recall of Teleflex Arrow MAC Two- and Three-Lumen CVC Access Kits. For details and instructions, see https://www.fda.gov/medical-devices/medical-device-recalls/teleflex-and-arrow-international-llc-recall-arrow-mac-two-lumen-central-venous-access-and-pressure.

FDA Warning on Prolia/denosumab re Risk of Severe Hypocalcemia

Prolia (denosumab) by Amgen: Drug Safety Communication – FDA Investigating Risk of Severe Hypocalcemia in Patients on Dialysis. Preliminary results from an internal FDA study investigating hypocalcemia in dialysis patients treated with the osteoporosis medicine Prolia (denosumab) show a substantial risk with serious outcomes, including hospitalization and death. Because of the frequency and seriousness of these risks, the FDA is alerting health care professionals and patients about them and is continuing to evaluate this potential safety issue with Prolia use in patients with advanced kidney disease, particularly those on dialysis. The FDA will communicate the final conclusions and recommendations when the review is completed and there is more information to share. Prolia works by blocking a protein called RANK (receptor activator of nuclear factor kappa beta) and helps prevent bone cells called osteoclasts from breaking down bone in the body. A health care professional administers Prolia by injection once every six months. Find the full FDA Notice at https://www.fda.gov/safety/medical-product-safety-information/prolia-denosumab-amgen-drug-safety-communication-fda-investigating-risk-severe-hypocalcemia-patients.

Class I Recall: Insulet DASH Insulin Manager

The FDA has announced a Class I Recall, indicating risk of severe injury or death, of all copies of the Omnipod DASH Insulin Management System Personal Diabetes Manager (PDM), for risk of battery swelling, leakage, extreme overheating, explosion, and fire danger. For full details and instructions, see https://www.fda.gov/medical-devices/medical-device-recalls/insulet-recalls-omnipod-dash-insulin-management-systems-personal-diabetes-manager-pdm-risk-battery.

Class 1 Recall: Covidien HD Catheters

The FDA has announced the Class 1 recall of specific lots of Covidien (Medtronic) Palindrome and Mahurkar HD Catheters because of hub defects which can cause leakage and other problems leading to inadequate dialysis or more serious safety issues. Class 1 recalls imply risk of serious injury or death. For details see https://www.fda.gov/medical-devices/medical-device-recalls/covidien-llc-medtronic-recalls-palindrome-and-mahurkar-hemodialysis-catheters-due-catheter-hub.