USA FDA requests postmarket studies on positive displacement needleless connector risks

[Wishart, Michael]

The US FDA has sent an open letter to US ICP’s about the possible risk
of bacteraemia in patients with positive displacement needleless
connectors. They have also requested further postmarket studies by some
specific manufacturers to ascertain the level of risk as compared to
other needleless technologies.

‘Because there is presently insufficient information to determine if
positive displacement connectors increase the risk of BSI compared with
other needleless connectors, FDA is requiring the companies to conduct
postmarket surveillance studies to provide an assessment of the risk
associated with positive displacement needleless connectors.’

They have not currently advised any changes in practices or use of
positive displacement needleless connectors, but that current SHEA/IDSA
recommendations should be followed.

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm220459.htm

Definitely worth keeping an eye on!

Cheers
Michael

Michael Wishart | GPH – Infection Control Coordinator

GPH – Quality & Safety Unit (Infection Control) | Greenslopes Private
Hospital
Newdegate Street, Greenslopes QLD 4120
t: 07 3394 7919 | f: 07 3394 7985
e: WishartM@ramsayhealth.com.au | w: http://www.ramsayhealth.com.au

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