MS RPh FASHP
Director of Pharmacy
Department of Pharmacy
Mercy & Unity Hospitals
The use of intelligent infusion devices with decision-support software (ie, “smart pumps”) can assist in adverse drug event prevention. This article describes key implementation steps and the pharmacist’s leadership role in the implementation and ongoing optimisation of the devices for safe infusion therapy. Key steps include conducting a failure modes and effects analysis (FMEA), defining how the available functionality will be utilised at the institution, customising procedural information and conducting thorough training.
Identification of a comprehensive multidisciplinary site team for product selection and implementation is critical. The team should include representatives from pharmacy, materials purchasing/supply, biomedical engineering, nursing (from each patient care area), risk management, quality, infection control, education, administration, radiology and anaesthesia. Other user departments should be represented (eg, ambulance personnel, IV team).
The site team and vendor develop the work outline, including the timeline and rollout schedule. The team decides the degree of standardisation within or between sites implementing the software. Each major area of work (eg, clinical care areas, drug library, equipment, conversion, practice/policies, education, barcoding) should have a lead person. Contacting the vendor and sites that have implemented the devices is useful to accelerate the work. A comprehensive communication plan is critical during planning and implementation.
After selection of the intelligent infusion device vendor, conducting an FMEA of the incoming technology and IV infusion process can identify key implementation procedures. Implementation of new infusion devices increases the risk of adverse events. An FMEA identifies potential failures, potential causes and recommended actions to optimise use of the incoming technology. The actions should close some of the gaps that existed with the outgoing technology, rather than automate bad practices. Analysing the features of the incoming infusion devices and highlighting important differences from the current technology assists in development of training. One example is the importance of terminology definition (eg, what is the difference between “concurrent” and “piggyback”?). Training scenarios can target the key steps where risks are identified in the FMEA to improve the safety of the transition.
Drug formularies and rules
The smart infusion devices are programmed with drug formularies and rules that will trigger a warning when a caregiver attempts to administer an IV infusion outside of the institution’s defined allowable limits. A “soft limit” will prompt a warning to the user to reprogramme or override the warning. A “hard limit” will stop the user. The site can set up a number of different clinical care areas in the infusion devices (eg, paediatrics, ICU, non-ICU, epidurals), each of which have their specific drug library and rule set (eg, library drug entry options, soft limits, hard limits). Refer to Table 1 for a hypothetical example of five medications listed on an ICU drug library rule set.
Pharmacy plays a key role in the development of formularies and rules. Close collaboration with nursing and careful drug library development are critical for successful implementation. Settings should prompt warnings for safety but allow clinical care. Excessively tight limits or hard stops can lead to nurse frustration, ignoring the alerts or not using the library.
Other device configurations include maximum/minimum patient weight. Some infusion device software allows for setting up other clinical alerts (eg, warning about rapid vancomycin infusion). The infusion device software functions similarly to an airline “black box”, tracking all setting changes. This information is used for quality assurance and performance improvement. More sophisticated devices link with hospital information systems (eg, laboratory, pharmacy, physician order entry, barcoding) and require more complicated rules and implementation processes.
The decision to purchase a wireless system or utilise machine-readable coding can add significant information systems involvement. A wireless system often involves acquisition and installation of a server, as well as network configuration and integration. Developing or installing interfaces for machine-readable coding and labelling of supplies and medications with machine-readable coding are significant projects.
Infusion device and supply logistical planning includes acquisition, storage and distribution strategies. Acquiring samples of new supplies (eg, tubing, adapters) in advance allows the creation of a product conversion list, the development of new stocking labels, the revision of computer naming and the identification of training needs. Determination of device and supply needs includes allocation, reserves and a provision to procure additional devices quickly if needs arise. It is important to not underestimate product storage (ie, existing and incoming), infusion device assembly and logistics of the product exchange during conversion.
If using a wireless system, autoprogramming is instantaneous. If not wireless, the initial drug library and CCA (cluster configuration archives) and any upgrades are individually loaded on each infusion device. Therefore, piloting of the drug library is important. A plan for future upgrade downloads is needed.
Training is key to successful implementation. The critical analysis of the potential functionality of the incoming infusion devices helps the team define how the institution will utilise the functionality (eg, use of the loading dose, delayed start, multistep and standby functionality), identify important differences from the current technology and identify associated policy and procedure changes. All policies relating to IV infusions should be reviewed prior to training.
Training should address the specific needs of all staff utilising the infusion devices (eg, patient care, ancillary, transportation). Utilise clinical scenarios for hands-on learning and skills checklists to assess competence. Postimplementation training on special functionality reinforces proper use.
Infusion device utilisation data are readily available from wireless technology. If not wireless, manual downloads are required. The team should regularly review the data from the infusion devices for proper use and identify areas for performance improvement, optimising the safety features of the devices.
An FMEA analysis can assist in devising an intelligent infusion device implementation plan to optimise patient safety. Significant planning and multidisciplinary collaboration are required for smooth and efficient implementation. Pharmacists play a vital leadership role, particularly in drug library and rule development and ongoing monitoring. As infusion device technology improves, pharmacists have additional data to improve the safety and management of IV drug therapy.
Improving Medication Safety in Health Systems through Innovations in Automation Technology
Focus on infusion pumps
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