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Safety Information

Revised: 29 August 2013

Infusion Device Safety Software

MEDICAL DEVICE SAFETY ALERT

To:
Chief Executive Officers
District Health Boards and Private Surgical Hospital

Attention:
Materials Management
Risk Managers
Biomedical Engineering

23 March 2009

Infusion Device Safety Software

Medsafe has received several reports of actual and potential adverse events relating to infusion devices resulting from users being able to by-pass the safety software. Medsafe recommends healthcare organisations ensure that staff are granted access only to the level of functionality appropriate to their patient care role.

Manufacturers of infusion devices frequently incorporate features such as restricted access to functions via access codes and medication safety software as ways of reducing the possibility of delivering inappropriate doses of medication to patients.

Inappropriate doses of medication may have serious consequences for the patient.

When a healthcare organisation is considering what access to provide staff required to operate an infusion device Medsafe recommends that the organisation conducts a risk analysis which includes consideration of the following factors;

Medsafe notes that should a healthcare organisation make a decision that allows staff to bypass the infusion device's safeguards or is contrary to the manufacturer’s recommendations for the use of that device, then it must accept the responsibility for the risks associated with that decision.

Medsafe is the New Zealand Medicines and Medical Devices Safety Authority and is a business unit of the Ministry of Health.

For queries regarding medical device safety please contact us at devices@moh.govt.nz

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