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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