Intrathecal Pump Management by Registered Nurses
To: Interested Parties
From: Barbara Zittel, RN, Ph.D, Executive Secretary, State Board for Nursing
Subject: Intrathecal Pump Management by Registered Nurses
Date: June 2011
The Board for Nursing has received a number of inquiries regarding whether it is within the scope of practice of Registered Professional Nurses (RNs) to refill implanted intrathecal infusion pumps utilized for pain management.
As background information, the use of implantable infusion pumps is increasingly being used in the treatment of chronic pain management. Intrathecal drug therapy permits long-term delivery of parenteral drugs, most commonly opioids, for chronic pain relief, and baclofen for the control of spasticity related to multiple sclerosis, cerebral palsy, and spinal cord injuries. Because small volumes can be delivered over a long period of time, individuals do not need to be confined in health care facilities between medication refills. Additionally, smaller doses of medications are typically needed than with other routes of administration.
Unfortunately, medication errors are common in intrathecal pump drug delivery. The Federal Drug Administration (FDA) has received reports of massive opiate overdoses which have occurred when the incorrect port was selected during the filling or refilling of pumps. Such errors, which result in concentrated morphine being injected into the intrathecal space, have resulted in seizures, pulmonary edema, respiratory depression, coma and death.
The State Board for Nursing has opined that there is nothing in Education Law that would legally prevent an RN from performing this function based on a patient specific order from an authorized provider. However, a facility has the right to determine whether or not to permit its nursing staff to provide this function. That determination should be based on an analysis of the degree to which RNs can be deemed to be competent in the procedure and the degree to which a comprehensive system of support can be provided to the RN to assure patient safety. In addition, the following conditions must be met:
- The RN must be deemed competent in the procedure, which in addition to the technical aspects of filling/refilling pumps, also requires the RN to accurately assess pain, conduct a physical examination and assess subtle changes in condition. Such competency is attained initially through successful completion of didactic coursework and a series of demonstrations in the procedure under supervision.
- The RN must demonstrate annual updates of appropriate education, skill training and clinical competence. Competency assessment must be documented in the personnel file of each RN.
- The RN must be designated by the facility/practice to carry out the procedure. Because there is considerable evidence across a wide range of procedures and functions that demonstrate improved outcomes in situations with high case volumes, the number of RNs trained in this procedure should be limited to assure a caseload sufficient to attain expertise. During annual competency updates, only the names of RNs with high case volumes should continue to be designated by the facility/practice to carry out this procedure.
- Written policies and procedures must be developed that clearly define the RN’s role.
- Errors should be anticipated. It is recommended that a failure mode and effects analysis (FMEA) be implemented to identify errors and actions to reduce patient harm. Additionally, standardization of orders, use of pumps with a reservoir port only, separation of kits, and verification of kits based on manufacturers’ written recommendations, should be considered as ways to further reduce errors.
- A physician or nurse practitioner must be immediately available for emergencies, including diagnosing and responding to overdoses including removing cerebrospinal fluid by lumbar puncture or through the catheter access port, if indicated.
We hope this clarification is helpful. If you have questions or need additional information, please contact the New York State Board for Nursing by phone 518-474-3817 ext. 1-120, or by e-mail firstname.lastname@example.org.