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U.S. Department of Health and Human Services

Medical Devices

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Patient-Controlled Analgesia (PCA) Pumps with Keypad Locking Mechanisms

Problem Description

Many manufacturers have designed PCA pumps with locking keypads and/or other features aimed at preventing a patient or family member from changing drug delivery information. It is important for clinical staff to be aware of the specific locking mechanisms available on their pumps and to ask questions about these features to ensure appropriate drug security and safety. For example, some pumps remind the clinician to lock the pump after programming; others will only issue a prompt if an automatic keypad mechanism has been activated.

Reported Incident

Recently, MedSun received a report from a hospital whose staff were not trained on the use of the automatic keypad locking mechanism available on their PCA pumps. Because the mechanism was not activated, there was no reminder to lock the keypad leaving the potential for the pump’s keypad to remain unlocked and opening up the possibility for potential patient harm.

Recommendation

User facilities should have a clear and consistent policy addressing whether the facility’s pumps have locking mechanisms. If the pumps have locking mechanisms, the policy should indicate the specific operation of the locking mechanism, who is responsible for activating the mechanism and how activation of the mechanism will be checked by the various departments handling the pump including nursing, clinical engineering, patient and transport.