Ventilator Recall by Philips – Recall Announcement / Alert from CDSCO
Medical Device Alert on Ventilator of Philips – Announcement from CDSCO
Following message is shared by National Coordination Center (NCC) –Materio vigilance program of India(MvPI), Indian Pharmacopoeia Commission(IPC), Ghaziabad, Autonomous body of Ministry of Health and Family Welfare, Govt of India:
Dear Healthcare Professionals,
As CDSCO has issued Medical Device Alert on Philips Ventilator, kindly go through the link shared below to know more about the alert :
Kindly update NCC MVPI team whether the said ventilator make is available/used in your hospital premises.
If yes, kindly send the feedback to the following email ids, by submitting duly filled “Field Safety Correction Action Form” shared below :
Please email your feedback along with duly filled field safety form to :
Kindly request your hospital team to take immediate necessary action as mentioned in alert notice.
About CDSCO – https://cdsco.gov.in/opencms/opencms/en/Home/
About IPC – https://www.ipc.gov.in/
About MVPI Program Launched by IPC :
Ministry of health and family welfare, Government of India has approved the commencement of Materiovigilance Programme of India (MvPI) at Indian pharmacopoeia commission on July 6, 2015 to monitor the safety of medical devices in the country. Indian Pharmacopeia Commission is functioning as National coordination center for MvPI and various steps and strategies have been made by NCC including launching of reporting tools to report MDAE, enrollment of new Medical Device Adverse Events Monitoring Centers and many others are in pipeline.
Training and workshops are organized in different regions of the country to improve the adverse event reporting practice and the attitude of healthcare professionals. NCC in collaboration with Central Drug Standard Control Organization, National Health System Resource Centre and Sree Chitra Tirunal Institute for Medical Sciences and Technology provides training and technical support to the stakeholders and this guidance document will be an important tool for conducting Materiovigilance activities. We are hopeful that this document will support to ensure
the safety and efficacy of medical devices in the country by illuminating various components of MvPI.
For more information about MVPI, download the document below :
Role of Hospitals and other Healthcare Organisations in reporting Adverse Events to IPC :
Hospitals and other Healthcare organisations have to report adverse events caused by drugs or devices to IPC under PVPI or MVPI program.
Since many of the Hospitals and Healthcare organisations are Certified , Accredited for many Quality and Patient Safety Programs in the country , Certification or Accreditation Programs calls for mandatory reporting of Adverse Events caused by Drugs or Devices to Patients, Employees etc.
Since the Ventilator is Recalled by the manufacturer on “Health and Safety Grounds”, Healthcare organisations which have been using the cited make of the Ventilator have to share the feedback to MVPI Cell of IPC in the format shared above. These are the Globally defined Regulatory Protocols and all healthcare organisations have to follow the same.