Revised: 29 August 2013
Safety Information
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;
- The manufacturer's recommendations for staff access to the various functions or functional levels of the infusion device
- The level of training, expertise and clinical knowledge that may be required to use the various functions/functional levels
- The potential consequences for patients of permitting staff to access higher level functions
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@health.govt.nz
