Medical Errors

Two patients die due to dosing errors with Medtronic infusion pump.
The Minneapolis Star Tribune reports Medtronic “said two people have died following dosing errors with its problem-plagued SynchroMed II infusion pump, an implanted device…that slowly injects pain medications into a patient’s spinal canal.” The Tribune mentions that the Food and Drug Administration “filed a consent decree against Medtronic in 2015 for repeated failures to correct manufacturing problems.” The problem of “overinfusion was first disclosed in March 2014. “
Robotic surgical tools are more difficult to clean, study suggests.
HealthDay reports “it’s virtually impossible to remove all contamination from robotic surgical instruments,” according to a new study published in Infection Control & Hospital Epidemiology. Researchers found that cleaning surgical instruments according to manufacturers’ instructions was 99.1% effective for standard instruments, but only 97.6% effective for robotic instruments.
FDA issues guidance adding boxed warning for contraceptive device.
Congressional Quarterly reports that the Food and Drug Administration “released final guidance that will require” Bayer to “add a boxed warning to its label” for its Essure permanent contraceptive device “outlining the potential for significant medical problems.” The guidance “also proposed the use of a patient decision checklist to further inform any potential recipient of the device…of the possible short- and long-term effects.”