Connecticut Governor Orders Long-Term Care Facility Staff To Be Vaccinated Against COVID-19

Angie Szumlinski Announcements

Governor Ned Lamont today announced that in an effort to protect some of the most vulnerable residents of Connecticut from the impact of COVID-19, he has directed an executive order be issued to require employees of all long-term care facilities in the state to be vaccinated against the virus. Executive Order No. 13B, which was filed today and takes effect …

FDA Recalls and Safety Announcements

Angie Szumlinski Announcements

Boston Scientific Recalls INGENIO Family of Pacemakers and CRT-Ps Due to Risk of Transition to Safety Mode SterRx, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL Due to Microbial Contamination Stop Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody Tests: FDA Safety Communication

AHCA, NCAL Respond to Introduction of Elder Justice Act Reauthorization

Angie Szumlinski Announcements

In a statement following the bill’s introduction, AHCA/NCAL President and Chief Executive Office Mark Parkinson said, “We appreciate Congressman Neal, Sen. Casey, Sen. Wyden, and Congresswoman Bonamici’s work around the reauthorization and modernization of the Elder Justice Act, and that it incorporates proposals from our Care For Our Seniors Act. We are glad to see policymakers provide a desperately needed focus on …

False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System No Longer an Issue

Angie Szumlinski Announcements

On March 10, 2021, based on new data provided by Becton, Dickinson and Company (BD), the FDA reissued the EUA for the BD SARS-CoV-2 Reagents for the BD Max System test, and the test no longer has an increased risk of false positive results.   For updated labeling, including results of a post-authorization study, see the Instructions for Use. Accordingly, all …

Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks

Angie Szumlinski Announcements, News

The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially …

CDC Media Statement regarding Mask-Wearing Recommendation

Angie Szumlinski Announcements

On July 27th, CDC updated its guidance for fully vaccinated people, recommending that everyone wear a mask in indoor public settings in areas of substantial and high transmission, regardless of vaccination status. This decision was made with the data and science available to CDC at the time, including a valuable public health partnership resulting in rapid receipt and review of unpublished data. …

CMS removes civil monetary penalties for prior noncompliance solely on a per-instance basis

Angie Szumlinski Announcements

CMS is hereby removing the July 7, 2017 Memo (S&C 17-37-NH) from its guidancerepository. CMS is hereby removing the July 7, 2017 Memo (S&C 17-37-NH) from its guidance repository. In that memo, CMS instructed CMS Locations (formerly “Regional Offices”) to impose civil monetary penalties for prior noncompliance solely on a per-instance basis. Upon further consideration, CMS has determined that the …