Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Arthroscopic shaver safety review

This article was originally published in The Gray Sheet

Executive Summary

FDA is encouraging surgical facilities to evaluate the adequacy of their cleaning procedures for arthroscopic shavers after becoming aware of instances where pieces of tissue remain within shavers after cleaning in accordance with manufacturer instructions. Retained tissue can compromise the sterilization process for the devices, which are used for tissue resection and bone debridement. The agency advises hospitals to be sure that all personnel responsible for cleaning the products comply with the manufacturer's instructions, carefully inspect the devices following cleaning, and report any problems with retained tissue in arthroscopic shavers through FDA's MedWatch safety and adverse event reporting system. In the July MedSun newsletter, the agency notes that the hospital that brought the problem to its attention is effectively inspecting its shavers after cleaning by looking at the channels of the shaver hand piece with a 3 mm scope

You may also be interested in...



Regenerative Medicine Comes Of Age – In The Age Of COVID-19

Regulatory review resource-intensive cell and gene therapy licensing applications are rolling toward US FDA along expedited pathways, while complete response letters and missed goal dates start to stack up under pandemic inspection constraints.

With Warp Speed Decisions Already Made, Transitioning To Biden Admin Should Be No Trouble, Slaoui Says

As vaccines near availability, Moncef Slaoui says his full-time role at OWS may be ending. He has not met with the Biden Transition team, but notes that other Warp Speed officials have.

Agios’ Phase III Data Move It Closer To First Therapy For Rare Anemia

Strong top-line efficacy in pyruvate kinase deficiency patients who don’t receive regular transfusions looks approvable, analysts say, but Agios will await data in regularly transfused patients.

Topics

UsernamePublicRestriction

Register

OM004559

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel