Infusion Pumps

Smart Pumps

Intravenous medications represent an important source of risk of harm to the patient. As the IHI states: “When intravenous medications are involved in ADEs, the harmful effects to the patient may occur more rapidly and be more severe than errors with oral medications, due the direct administration into the bloodstream.” However, the degree of risk reduction with smart pumps is highly dependent upon integration into the hospital’s information systems, and the degree of improvement may be limited if the hospital does not yet have all of its patient information in integrated electronic systems.

The following resources assist in successful smart pump implementation.

Smart Infusion Pump Technology: Don’t Bypass the Safety Catches, Pennsylvania Patient Safety Advisory 2007 Dec;4(4):139–43. (free full access).

Smart Medication Delivery Systems: Infusion Pumps, Healthcare Human Factors Group, April, 2009. (free full access).

Ontario Health Technology Advisory Committee (OHTAC) Recommendation: Implementation and Use of Smart Medication Delivery Systems, July 2009. (free full access).

Proceedings from the ISMP Summit on the Use of Smart Infusion Pumps: Guidelines for Safe Implementation and Use, September 2009. (free full access).

The following reference describes the opportunities for improved safety that are not addressed by a particular smart pump implementation.

Nuckols TK, Bower AG, Paddock SM, et al. Programmable infusion pumps in ICUs: an analysis of corresponding adverse drug events. Journal of general internal medicine. 2008;23 Suppl 1:41-5. (free full access).

FDA Infusion Pump Improvement Initiative

The FDA CDRH (Center for Devices and Radiologic Health) is embarking on an initiative to reduce adverse events from external infusion pumps. The FDA is planning to significantly revamp the way in which it evaluates applications for new pumps. In particular, it is expecting that manufacturers will address human factors risks. Hazards that in the past were solely addressed by expecting the user to follow specific procedures now may have to be addressed by design instead.

CDRH White Paper on the infusion pump initiative.

Infusion Pump Improvement Initiative home page.

• Infusion Pump Risk Reduction Strategies for Clinicians
• Infusion Pump Risk Reduction Strategies for Pharmacists
• Infusion Pump Risk Reduction Strategies for Clinical and Biomedical Engineers and Health Information Technology Professionals
• Infusion Pump Risk Reduction Strategies for Facility Administrators and Managers
• Infusion Pump Risk Reduction Strategies for Home Health Nurses
• Infusion Pump Risk Reduction Strategies for Patients Using Infusion Pumps at Home

Use Hazard Examples (from the FDA draft guidance for industry and FDA staff)

Hazard	Corresponding Risk(s) to Health	Potential Cause(s)
User does not understand how to initiate pump operation	Delay of therapy	User interface design is confusing. User confused by pump operation, instructions for use insufficient or lacking, training insufficient or lacking. Note: Can apply to lay users particularly.
The pump is programmed incorrectly	Overdose Underdose Delay of therapy Incorrect therapy	User believes “piggy back” is accounted for in set up but it is not.
		The instructions for use are confusing for the user.
		The user specifies incorrect configuration parameters (blood glucose reading, drug concentration, etc.)
		The user accidentally touches the pump console, presses the wrong key or key “bounces” when hit, changing or mistakenly programming pump settings.
Infusion stopped prematurely	Underdose Delay of therapy	The user forgets to resume the pump after suspending it.
		User is unaware of battery capacity.
The user fails to detect or understand pump notifications	Overdose Underdose Delay of therapy Incorrect therapy	Background noise or nuisance alarms cause user to fail to detect or to ignore them.
		The user muffles the pump’s speaker or other audio devices, either intentionally or unintentionally
Wrong medication or concentration is delivered	Incorrect therapy Delay of therapy	User selects and sets up pump with incorrect medication or incorrect concentration.
		Medication is correct but user selects incorrect concentration or delivery rate for that medication.
Physical set up, such as routing of tubing or selection of appropriate tubing set is incorrect	Overdose Underdose Delay of therapy	User believes infusion is occurring but it is not.
		User is required to perform excessive programming task sequences or perform them repeatedly.
		User is confused about pump set-up, troubleshooting, or operation tasks.
		Physical set-up of pump components is difficult.
User “works around” or “bypasses” software limits on drug/dose parameters	Overdose Underdose	Software configuration, possibly user-defined configuration, is not applicable to current treatment and user is compelled to “work around” or “bypass it”.
		“Work around” or “bypass” requirements are required so often the user does not attend to displayed limits.
User ignores or misinterprets software-generated “warnings”	Overdose Underdose Incorrect therapy	Warnings are displayed so often that user ignores them.
		Warning statements are not sufficiently informative, meaningful or appropriate for the condition
User misinterprets or misunderstands pump status or operational mode	Overdose Underdose Incorrect therapy Delay of treatment	Pump operates differently than expected.
		Pump operational mode indications are absent or not communicated effectively.
		Display characters not distinguishable.
The pump is disconnected	Underdose Delay of therapy Exsanguantion	The user’s motions cause the pump to be disconnected from the user.
Excessive bolus administration due to too many bolus requests from the user	Overdose	The user forgets previously received boluses, and requests for unnecessary boluses without consulting with bolus history records.
(Drug) Leakage	Underdose Trauma Allergic response	The user does not follow instructions to disconnect the pump.
The drug reservoir is detached during normal pump use	Underdose Delay of therapy	The user’s motions cause the reservoir to be disconnected.