The UK’s Medicines and Healthcare products Regulatory Agency released urgent field safety notices for a range of medical devices, including Zimmer Biomet’s patello-femoral joint milling handpiece, Avance and Amingo anaesthetic machines and monitors, and Fujifilm’s flexible duodenoscope.
Zimmer Biomet issued an urgent field safety recall for all distributed Gender Solutions PFJ Milling Handpieces, following complaints of inoperability. The complaints were related to a lack of preventative maintenance.
The affected units were distributed between September 2007 and August 2016.
The company said an inoperable handpieces may result in surgical delay and or increased risk of infection. There are no specific patient monitoring instructions related to this field action, and company representative can check the functionality of specific handpieces. Malfunctioning handpieces should be returned to Zimmer Biomet.
Avance and Amingo Safety Issues
Datex-Ohmeda issued an urgent field safety notice that certain Avance CS2, Avance, and Amingo anesthesia devices can show a system malfunction if the lower storage drawer containing the optional large tray insert accessory is closed with too much force.
The notice says that if the devices show a system malfunction, they will:
The company said an unresolved system malfunction could result in loss of patient ventilation and hypoxia. However, there have been no injuries reported as a result of this issue.
All Avance CS2, Avance, and Amingo anesthesia devices with the optional large tray insert accessory installed are susceptible to the problem. Datex-Ohmeda said the devices may continue to be used after the large tray insert is removed, and it provided instructions for doing so.
The company asked clinical users receiving the notice to destroy all large tray inserts in their possession.
The large tray insert can also be used with the Aespire family of devices, but they are not susceptible to this issue. The small tray insert does not pose a problem.
Fujifilm Duodenoscope Operations Manuals
Fujifilm issued an urgent field safety corrective action noting that revised operations manuals have been issued for its ED-530XT and ED-530XT8 Duodenoscope.
The revised manuals reflect newly validated manual cleaning and high-level disinfection procedures in light of reports of multi-drug resistant bacteria on endoscopes used for endoscopic retrograde cholangiopancreatogram procedures. The company has been working with the FDA to validate the new reprocessing procedures.
The revisions modify the cleaning and disinfection processes and require the use of a new disposable distal end cleaning brush for cleaning the duodenoscope’s distal tip, forceps elevator, and elevator recess, in addition to the use of the existing Fujifilm valve cylinder cleaning brush.
Fujifilm is providing all users of the devices with revised operations manuals and samples of new disposable distal end cleaning brush.