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Post-marketing Safety Measures

PMDA Medical Safety Information

Among the medical incident reports and adverse drug reaction/malfunction reports that have been collected to date, information on similar events that have been repeatedly reported and cases leading to issuance of notifications on revisions of PRECAUTIONS is described in the "PMDA Medical Safety Information" in an easy-to-understand manner and is widely disseminated. Important reminders to encourage healthcare professionals to safely use drugs and medical devices are included. The articles have been prepared with reference to the opinions of healthcare professionals such as physicians, pharmacists, nurses, and clinical engineers and specialists such as those in the field of ergonomics, as well as industry organizations of marketing authorization holders of drugs and medical devices.

 
Posted in No. Title
February 2024 68
Precautions for Blood Purification in Patients Receiving ACE Inhibitors [1,538 KB]
January 2024 67 Precautions for Route of Administration of Total Parenteral Nutrition [524 KB]
October 2023 66 Precautions in Handling of Tracheostomy Tubes (No. 2) [933 KB]
March 2023 65 Precautions for Handling of Sustained-Release preparations [427 KB]
March 2023 64 Precautions for Cleaning and Disinfection of Gastrointestinal Endoscopes [521 KB]
March 2022 Extra
3
Reminder Series No. 3
(Precautions for Magnetic Resonance Imaging (MRI) Scans) [1,521 KB]

Note) Also refer to Checklist before entering the MRI room [1,267 KB] prepared by JIRA.
March 2022 63 Precautions for the Pre-operational Check Prior to the Use of Ventilators [545 KB]
March 2022 62 PCPS/ECMO Cannula Accidental Removal [648 KB]
March 2022 61 Failure to Break Separation of Two-chamber Bag Preparations (Bag-type Kit Preparations) [396 KB]
August 2020 60 Precaution when Handling Thoracic Catheters [592 KB]
August 2020 59 Outbreak of Fire from Medical Devices Due to a Short Circuit [236 KB]
April 2020 Extra
2
Reminder Series No. 2
(Precautions in Handling Tracheal Tubes) [1,275 KB]
April 2020 Extra
1
Reminder Series No. 1
(Precautions in Ventilator Use, etc.) [1,542 KB]
May 2022
(Revised)
July 2019
58 Introduction of Connectors to Prevent Misconnection (for Enteral Applications) [895 KB]
February 2019 57 Precautions when Using Subcutaneous Ports and Catheters [984 KB]
February 2019 56 Precautions when Using Compression Stockings [423 KB]
August 2018 55 Introduction of Connectors to Prevent Misconnection (Neuraxial Anesthesia) [1,129 KB]
June 2018 54 Precautions When Using an Indwelling Bladder Catheter [519 KB]
March 2018 53 Introduction of Connectors that Prevent Misconnection [474 KB]
December 2017 52 Precautions When Using an Open Ventricular Drainage Circuit [762 KB]
September 2017 51 Mix-up of Drugs Due to Similarity of Nonproprietary Names [603 KB]
March 2017 50 Precautions when setting syringe pumps [545 KB]
November 2016 49 Precautions against Misuse (Overdose) of Antirheumatic Methotrexate Preparations (Part 2) [559 KB]
January 2016 48 Precautions in handling of Three-way Stopcocks [716 KB]
September 2015 47 Handling of Lines for Drug Solution Administration [1,339 KB]
December 2015
(Revised)
May 2015
46 Precautions When Handling the Blood Purification Device [786 KB]
August 2014 45 Precautions in Handling of Indwelling Venous Needles [473 KB]
May 2014 44 Medication Errors in Prescription Orders [703 KB]
March 2014 43 Risks in Handling of Gastrostomy Tubes [838 KB]
February 2014 42 Precautions in Handling of Nasogastric Tubes [783 KB]
January 2014 41 Precautions in Handling of Epidural Catheters [603 KB]
October 2013 40 Precautions in Handling of Vaccines [1168 KB]
September 2013 39 Precautions in Handling of Tracheal Mask [595 KB]
May 2013 38 Improper Assembly of Resuscitator Bags [743 KB]
September 2016
(Revised)
April 2013
37 Precautions in Handling of Insulin Injectors [774 KB]
March 2013 36 Accidental Removal of Tubes and Lines [775 KB]
October 2012 35 Precautions in Handling of Tracheostomy Tubes [958 KB]
October 2012 34 Precautions in Handling of Glycerin Enemas [521 KB]
March 2017
(Revised)
September 2012
33 Accidental Burns during Surgery using a Light Source, an Electric or Laser Scalpel [745 KB]
June 2012 32 Precautions in Handling of Closed Suction Catheters [2.6 MB]
July 2020
(Revised)
May 2012
31 Precautions in Handling of Radiopharmaceuticals for Injection [1,134 KB]
April 2012 30 Precautions in Handling of Endotracheal Tubes [1,538 KB]
April 2020
(Revised)
December 2011
29 Precautions in Bedside ECG Monitoring [1,591 KB]
November 2011 28 Precautions in Handling of Blood Glucose Meter [923 KB]
October 2011 27 Precautions in Handling of Drug Products Attached with Reconstitution Solution [2.9 MB]
September 2011 26 Precautions for Magnetic Resonance Imaging (MRI) Scans (Part 2) [1,290 KB]
Note) Also refer to Checklist before entering the MRI room [1,267 KB] prepared by JIRA.
September 2011 25 Precautions for Magnetic Resonance Imaging (MRI) Scans (Part 1) [976 KB]
June 2011 24 Precautions in Using Needle-free Valves [656 KB]
November 2020
(Revised)
April 2011
23 Precautions in Handling of Insulin Vial Preparations
(Ensuring the Use of Insulin Syringes) [1,163 KB]
February 2011 22 Precautions in Handling Blood Tubing Sets used for Blood Purification [1,209 KB]
January 2011 21 Precautions in flow rate programming of infusion pumps [603 KB]
November 2010 20 Precautions in Artificial Respiration (No.3) [1,443 KB]
September 2010 19 Administration error of concentrated potassium (K) solutions for injection [748 KB]
June 2010 18 Precautions in Handling of Lancing Devices for Capillary Blood Sampling [845 KB]
May 2010 17 Precautions in Handling of Prefilled Syringes [2.9 MB]
April 2010 16 Precautions in Handling of Electric Scalpels (Part 3) [308 KB]
April 2015
(Revised)
March 2010
15 Precautions in Handling of Electric Scalpels (Part 2) [437 KB]
February 2010 14 Precautions in Handling of Electric Scalpels (Part 1) [2,016 KB]
October 2009 13 Medical Gas Mix-Ups [2.5 MB]
September 2009 12 Misconnection of tourniquet cuff [3.2 MB]
August 2009 11 Precautions in Artificial Respiration (No.2) [3.0 MB]
May 2009 10 Good Management & Maintenance of Automated External Defibrillators (AEDs) [399 KB]
February 2009 9 Recall of Jackson-Rees Circuits [1,686 KB]
February 2009 8 Compatibility between a "Type A" Needle (JIS T 3226-2) and an Insulin Pen (JIS T 3226-1) [675 KB]
January 2009 7 Precautions in Artificial Respiration (No.1) [643 KB]
October 2008 6 Precautions against misuse (overdose) of antirheumatic methotrexate preparations [341 KB]
June 2008 5 Handling of lancing devices for obtaining blood samples [1,460 KB]
June 2008 4 Precautions against smoking and use of fire in Long-term Oxygen Therapy (LTOT) [818 KB]
January 2008 3 Precautions against improper connection of speech valves etc. to tracheostomy tubes [3.6 MB]
November 2007 2 Recall of Resuscitators [1,675 KB]
November 2007 1 Points to note in case of obstruction of feeding tube [624 KB]