U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. General Hospital Devices and Supplies
  5. Infusion Pumps
  6. Infusion Pump Risk Reduction Strategies for Facility Administrators and Managers
  1. Infusion Pumps

Infusion Pump Risk Reduction Strategies for Facility Administrators and Managers

(Includes, but is not limited to: Chief Executives, and Directors of Quality, Risk, Patient Safety, Information Technology, Clinical/Biomedical Engineering, Nursing, Medicine, Pharmacy, Materials Management.)

Introduction

Performance problems have occurred across all types of external infusion pump (see What Is an Infusion Pump?) in a variety of clinical settings. The problems are not specific to one infusion pump manufacturer. These problems can lead to over- or under-infusion and/or delays in therapy.

The causes of these performance failures include, but are not limited to:

  • Software defects
  • Inadequate user interface design ("human factors" issues)
  • Damaged mechanical parts (e.g., doors and latches)
  • Battery failures

For more information on specific problems, see Examples of Reported Infusion Pump Problems.

Healthcare facilities that use infusion pumps should have policies and procedures in place to promote patient safety. Additional practices such as using "smart pump" technology may also be in place to help reduce risks.

Facility administrators and managers may consider the following strategies to help reduce risks to patients. While these strategies are not applicable to all types of infusion pumps in all clinical settings and patient populations, facility administrators and managers may find them useful.

Reduce Risks

Plan Ahead

  • Conduct a facility-wide risk assessment of infusion pump problems (e.g., utilize your incident/occurrence reports, event-logs, and "smart pump" data, if available).
    • Analyze where, when, how, and why the problems occur, and with which medications.
    • Implement risk reduction strategies as appropriate for your facility.
    • Establish back-up plans in case of an infusion pump failure that allow clinicians to obtain a working infusion pump and infusion tubing quickly when caring for high-acuity patients.
  • Have an effective system in place to receive, communicate, and implement hazard alerts and recalls of infusion pumps. Notify clinicians of recalls and provide information and/or training regarding the issue.
  • Develop a multidisciplinary team to standardize high-risk drug concentrations and make the concentrations readily available in the drug library. Additionally, this team may want to evaluate the effectiveness of dose ranges including hard and soft limits of drug libraries, if applicable.

Address Known Problems

  • Address recalls and hazard alerts promptly for infusion pumps in your inventory.
  • Work with the manufacturer to comply with the recall strategy if your facility has products that are affected.
  • Communicate to all departments involved instructions for responding to a recall.
  • Monitor infusion pumps for recurring problems.

Train and Educate

  • Provide training and educational activities for all employees designed to promote the safe use of infusion pumps, including drug library usage.
  • Provide easy access to infusion pump instructions and troubleshooting guides. Potential methods include:
    • Placing instructions and troubleshooting guides on your intranet where clinicians may quickly access them.
    • Training "super-users" for your infusion pumps in each area of the hospital/facility and provide training for every shift. This provides additional resources for emergency consultation when an infusion pump fails.
    • Providing staff with contact information for "super-users."

Develop Policies and Procedures

  • Adopt policies for additional approaches to reduce risk that apply to your facility and patient populations. These may include:
    • Labeling the infusion pump channels and infusion tubing with the medication name and port of entry.
    • Double-checking settings on infusion pumps with an independent second healthcare practitioner when using high-risk medications (e.g., Insulin, Heparin, Vasopressors, Diprivan, Total Parenteral Nutrition (TPN), Morphine, etc.).
  • Provide information that instructs staff when to tag and remove an infusion pump from service and the details that should be included.
  • Create a multidisciplinary team approach to evaluate your internal incident/occurrence reports.
  • Create an ongoing infrastructure to oversee quality improvement with medical devices.

Monitor Progress

  • Evaluate adherence to established protocols and procedures for drug library usage (i.e., adherence to high and low limits for dose ranges if used by your hospital, adherence to standard concentrations).
  • Monitor the effectiveness of your protocols and procedures related to infusion pumps.

Research Infusion Pumps Before Purchase or Rental

  • Use resources such as FDA's MAUDE and recall databases to research reported problems or infusion pump performance. Ask manufacturers questions about how they have addressed these problems.
  • Create a multidisciplinary team (e.g. staff with human factors training, nurses, physicians, biomedical engineers, information technologists, and pharmacists) to formulate and implement a plan to evaluate infusion pumps prior to purchasing or renting.
  • Establish a plan for training staff on and phasing in new infusion pumps.

Report Problems

  • Ensure reporting is easy for staff.
  • Encourage an environment where staff are rewarded for reporting mistakes and near misses.
  • Provide a mechanism where all involved in infusion pump safety work together to share information and create strategies to reduce risk.
  • Follow your hospital/facility protocol for reporting events where the infusion pump may have caused or contributed to a death or serious injury. You are also encouraged to report any other infusion pump safety concerns through your hospital/facility protocol.
  • Deaths that are associated with the use of an infusion pump, as with all medical devices, must be reported by facilities to the FDA, and deaths and serious injuries must be reported to the manufacturer. Serious injuries must be reported to the FDA if the manufacturer is not known.
  • You are encouraged to file a voluntary report with the FDA for any pump problem that you may encounter.
  • HIPAA restrictions do not apply to reports submitted to FDA.
 
Back to Top