Philips Monitors With Lithium Batteries At Risk
Following reports that some Philips SureSigns monitors were overheating or igniting, the UK’s Medicines and Healthcare products Regulatory Agency issued a warning that lithium ion batteries manufactured by Philips that have exceeded their specified replacement interval can overheat and ignite.
Current labeling and instructions for use don’t provide full instruction on when to replace the batteries, so Philips is issuing updated instructions for use and a software upgrade to provide system warnings to management on the battery replacement cycle.
Halyard Health’s Ventilator Suction Cups May Interrupt Ventilation
Flex connectors in Halyard Health’s closed suction kits are at risk for interrupting ventilation, the UK’s MHRA warned.
The company issued an urgent field safety notice that it received reports that certain flex connectors supplied with its Halyard closed suction kits with flex connector may become loose or disconnect before or during use. If disconnection occurs during use, it would result in an open respiratory circuit and interrupt patient ventilation.
The company advised that flex connectors be replaced if there is an inadequate connection.
Scottish MPs Call for Ban on Vaginal Mesh Implants
Scotland is taking a different approach than NHS England to address concerns over vaginal mesh implants, with some members of the Scottish parliament calling for the implants to be banned for pelvic organ prolapse and stress urinary incontinence.
Scotland’s Secretary for Health and Sport Jeane Freeman requested that health boards immediately halt the use of transvaginal mesh in cases of pelvic organ prolapse and stress urinary incontinence “pending the implementation of a new restricted use protocol that will ensure that procedures are carried out only under the most exceptional circumstances and subject to a robust process of approval and fully informed consent.”
Scotland called on health boards to suspend the use of vaginal mesh implants in 2014. However, unless the country leaves the United Kingdom, it does not have the regulatory authority to ban the use of the mesh, as that is regulated by the UK’s Medicine and Healthcare products Regulatory Agency.