Monday, January 7, 2019

Top FDA-related stories of 2018

FDA approves opioid 10 times stronger than fentanyl

Dsuvia, a new prescription opioid was approved by the US FDA in November despite criticism of  its approval amidst the opioid epidemic.

Dsuvia is a sublingual formulation of the opioid sufentanil that is delivered through a disposable, pre-filled, single-dose applicator. It is restricted to use in certified medically-supervised health care settings ‒ such as hospitals, surgical centers and emergency departments ‒ for administration by a health care professional. 

It is 10 times more potent than fentanyl and is 1,000 times more potent than morphine

FDA proposes antibiotic subscription plan for hospitals

On Sept. 14, the FDA Commissioner Scott Gottlieb, MD announced the FDA’s 2019 Strategic Approach for Combating antimicrobial resistance, which includes a proposal for a subscription-based model for hospital, which could see hospitals paying a flat rate for access to a certain number of doses of an important new antimicrobial. These subscription fees could be priced at a level to create a sufficient return on the investment to develop drugs with a certain profile. The plan also addresses four key areas:

·      Facilitating product development to ensure a robust pipeline of safe and effective treatments that can combat resistant organisms..
·      Promoting antimicrobial stewardship; careful stewardship across human and animal health can help preserve the effectiveness of available treatments and may help slow the development of antimicrobial resistance.
·      Supporting the development of tools for surveillance of antimicrobial use and for determining when pathogens develop resistance. 
·      Advancing scientific initiatives to help all stakeholders answer critical questions related to antimicrobial resistance. This includes research that can support the development of alternative treatment approaches. These can include bacteriophages, fecal microbiota transplants and live biotherapeutic products.

FDA clears Apple Watch for ECG screening

Apple Watch Series 4 includes an ECG sensor to alert users if their heart rhythm is irregular, which has been cleared by the FDA as a Class II device under the generic name electrocardiograph software for over-the-counter use. This was announced by Apple COO Jeff Williams during the company's Sept. 12 event in Cupertino, California.

The App displays a single channel ECG similar to a Lead I ECG and determines the presence of atrial fibrillation or sinus rhythm. The ECG data displayed by the ECG app is intended for informational use only.

Six guidelines from FDA to prevent surgical fires

In a safety communication issued on May 29, the US FDA issued six recommendations for healthcare providers to reduce surgical fires and related patient injury, including recommendations for safely using medical devices during surgery.

1.   A fire risk assessment at the beginning of each surgical procedure
2.   Encourage communication among surgical team members
3.   Safe use and administration of oxidizers
4.   Safe use of any devices that may serve as an ignition source.
5.   Safe use of surgical suite items that may serve as a fuel source
6.   Plan and practice how to manage a surgical fire

(Source: Becker’s Hospital Review, US FDA)

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

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