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PMDA Medical Safety Information

Among the medical incident reports and adverse drug reaction/malfunction reports that have been collected to date, information on related events that have been repeatedly reported and cases leading to notifications for revisions of package inserts is described on the "PMDA Medical Safety Information" in an easy-to-understand manner and is widely disseminated. Important reminders to encourage safe use of drugs and medical devices to healthcare professionals are included, which have been considered based on the opinions of healthcare professionals such as physicians, pharmacists, nurses, and clinical engineers, specialists such as those in the field of ergonomics, as well as industry organizations such as marketing approval holders of pharmaceuticals or medical devices.

The information below is English translation of the "PMDA Medical Safety Information". In the event of inconsistency, the text in Japanese shall prevail.

Posted on No. Title
March 2022 Extra
Reminder Series No. 3
(Precautions for Magnetic Resonance Imaging (MRI) Scans)
March 2022 63 Precautions for the Pre-operational Check Prior to the Use of Ventilators
March 2022 62 PCPS/ECMO Cannula Accidental Removal
March 2022 61 Failure to Break Separation of Two-chamber Bag Preparations (Bag-type Kit Preparations)
August 2020 60 Precaution when Handling Thoracic Catheters
August 2020 59 Outbreak of Fire from Medical Devices Due to a Short Circuit
April 2020 Extra
Reminder Series No. 2
(Precautions in Handling Tracheal Tubes)
April 2020 Extra
Reminder Series No. 1
(Precautions in Ventilator Use, etc.)
May 2022
July 2019
58 Introduction of Connectors to Prevent Misconnection (for Enteral Applications)
February 2019 57 Precautions when Using Subcutaneous Ports and Catheters
February 2019 56 Precautions when Using Compression Stockings
August 2018 55 Introduction of Connectors to Prevent Misconnection (Neuraxial Anesthesia)
June 2018 54 Precautions When Using an Indwelling Bladder Catheter
March 2018 53 Introduction of Connectors that Prevent Misconnection
December 2017 52 Precautions When Using an Open Ventricular Drainage Circuit
September 2017 51 Mix-up of Drugs Due to Similarity of Nonproprietary Names
March 2017 50 Precautions when setting syringe pumps
November 2016 49 Precautions against Misuse (Overdose) of Antirheumatic Methotrexate Preparations (Part 2)
January 2016 48 Precautions in handling of Three-way Stopcocks
September 2015 47 Handling of Lines for Drug Solution Administration
December 2015
May 2015
46 Precautions When Handling the Blood Purification Device
August 2014 45 Precautions in Handling of Indwelling Venous Needles
May 2014 44 Medication Errors in Prescription Orders
March 2014 43 Risks in Handling of Gastrostomy Tubes
February 2014 42 Precautions in Handling of Nasogastric Tubes
January 2014 41 Precautions in the Handling of Epidural Catheters
October 2013 40 Precautions in the Handling of Vaccines
September 2013 39 Precautions in Handling of Tracheal Mask
May 2013 38 Improper Assembly of Resuscitator Bags
September 2016
April 2013
37 Precautions in Handling of Insulin Injectors
March 2013 36 Accidental Removal of Tubes and Lines
October 2012 35 Precautions in Handling of Tracheostomy Tubes
October 2012 34 Precautions in Handling of Glycerin Enemas
March 2017
September 2012
33 Accidental Burns during Surgery using a Light Source, an Electric or Laser Scalpel
June 2012 32 Precautions in Handling of Closed Suction Catheters
July 2020
May 2012
31 Precautions in Handling of Radiopharmaceuticals for Injection
April 2012 30 Precautions in Handling of Endotracheal Tubes
April 2020
December 2011
29 Precautions in ECG Monitoring
November 2011 28 Precautions in Handling of Blood Glucose Meter
October 2011 27 Precautions in Handling of Drug Products Attached with Reconstitution Solution
September 2011 26 Precautions for Magnetic Resonance Imaging (MRI) Scans (Part 2)
September 2011 25 Precautions for Magnetic Resonance Imaging (MRI) Scans (Part 1)
June 2011 24 Precautions in Using Needle-free Valves
November 2020
April 2011
23 Precautions in Handling of Insulin Vial Preparations
(Ensuring the Use of Insulin Syringes)
February 2011 22 Precautions in Handling Blood Tubing Sets used for Blood Purification
January 2011 21 Precautions in flow rate programming of infusion pumps
November 2010 20 Precautions in Artificial Respiration (No.3)
September 2010 19 Inadvertent administration of potassium (K) solutions for injection
June 2010 18 Precautions in Handling of Lancing Devices for Capillary Blood Sampling
May 2010 17 Precautions in Handling of Prefilled Syringes
April 2010 16 Precautions in Handling of Electric Scalpels (Part 3)
April 2015
March 2010
15 Precautions in Handling of Electric Scalpels (Part 2)
February 2010 14 Precautions in Handling of Electric Scalpels (Part 1)
October 2009 13 Medical Gas Mix-Ups
September 2009 12 Misconnection of tourniquet cuff
August 2009 11 Precautions in Artificial Respiration No.2
May 2009 10 Good Management & Maintenance of Automated External Defibrillators (AEDs)
February 2009 9 Recall of Jackson-Rees Circuits
February 2009 8 Compatibility between a "Type A" Needle (JIS T 3226-2) and a Insulin Pen (JIS T 3226-1) No.8
January 2009 7 Precautions in Artificial Respiration (No.1) No.7
October 2008 6 Precautions against misuse (overdose) of antirheumatic methotrexate preparations No.6
June 2008 5 Handling of lancing devices for obtaining blood samples No.5
June 2008 4 Precautions against smoking and use of fire in Long-term Oxygen Therapy (LTOT) No.4
January 2008 3 Precautions against improper connection of speech valves etc. to tracheostomy tubes No.3
November 2007 2 Recall of Resuscitators No.2
November 2007 1 Points to note in case of obstruction of feeding tube No.1


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PMDA Medical Safety Information