Archived – Health Risks Associated with Use of INFUSION PUMPS – Notice to Hospitals

Starting date:

April 16, 2004

Posting date:

April 16, 2004

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Hospitals

Identification number:

RA-17000750

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Notice about Health Canada advisories

NOTICE TO HOSPITALS – Health Canada Endorsed Important Safety Information on INFUSION PUMPS

April 16, 2004

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Nursing, Surgery, Emergency Medecine, Pharmacy, Pediatrics, Anesthesia, Geriatrics, Internal Medicine, Dentistry, Intensive Care and other involved professional staff of nursing homes and nursing associations. Post this NOTICE in your institution.

Subject: Health risks associated with use of INFUSION PUMPS

Health Canada is aware of numerous injuries and some deaths associated with the use of infusion pumps, including general purpose pumps, enteral pumps, insulin and patient-controlled analgesia (PCA) pumps. The purpose of this notice is to provide information about the nature of these incidents and recommendations for reducing their frequency.

Between 1987 and March 2003, Health Canada received reports of 425 separate incidents involving infusion pumps. A few of these incidents did not occur in Canada. Of the 425 incidents, 23 resulted in death, 135 resulted in injury, and 127 could potentially have led to death or injury. Of these, 20 deaths and all 135 injuries were caused or suspected to have been caused by the pump. These include incidents that were caused by user error, but not those that may have been caused by deliberate misuse. Further statistics are given in the charts below.

Recently, concern over such adverse incidents has led several organizations to publish articles on the topic. In May 2001, ECRI published a review of PCA pumps^{1Footnote 1} with evaluation criteria that can probably apply to other types of pumps and should be considered before purchasing and using a pump.

In July 2003, the Institute for Safe Medication Practices Canada (ISMP Canada), issued a Safety Bulletin^{Footnote 2} which highlighted the lack of free-flow protection mechanisms, which can result in serious consequences if the user fails to use the manual roller clamp on the infusion line. Two other bulletins from ISMP^{Footnote 3} provide information about safety issues relating to patient-controlled analgesia (PCA) pumps.

A national hospital survey^{Footnote 4}, conducted in 2003 by ISMP Canada and co-ordinated through the Canadian Healthcare Association, attempted to identify problems users have experienced with pumps in Canada. This survey indicated that a number of facilities still use pumps without adequate free flow protection. Other problems being cited include incorrect flow rate, dosage errors and air sensor problems. The detailed results of the survey will soon be published on the ISMP web site.

Health Canada's review of incident data has also revealed reports of misloading of the IV tubing in the pump. In some cases, the pump's misloading sensors may fail to identify this situation, leading to over or under infusions without alarm.

In March, 2003, the US Joint Commission on Accreditation of Healthcare Organizations (JCAHO) indicated, as part of its National Patient Safety Goals, that it would assess accredited facilities to ensure that free-flow protection is present on all general-use and PCA intravenous infusion pumps^{Footnote 5}.

In light of the reported incidents and above articles, Health Canada makes the following recommendations:

1. Training. Institutions should establish policies on the use of infusion pumps, and keep them up to date. Users should be properly trained in the use of the pump, including proper IV set loading and placement procedures, and made aware of the pump usage protocols. Nursing staff should be given additional training if they are rotated to another ward or hospital that uses a different model of infusion pump.
2. Free-flow protection. Users should use pumps and administration sets equipped with free-flow protection^{Footnote 6}. For those pumps that do not offer free-flow protection, establish a capital replacement plan to replace them with newer pumps. Leasing or renting newer pumps may be worth considering.
3. Ergonomics. Users should purchase pumps with good ergonomic design, as these can have a direct bearing on ease of use and therefore safety. See articles referenced above for further information. When selecting a pump, determine if the manufacturer's product meets various voluntary human factors standards such as ANSI/AAMI HE74-2001, "Human Factors Design Process for Medical Devices". See http://www.fda.gov/cdrh/humanfactors/resource-manufac.html#3 for a list of human factors standards.
4. Programming safeguards. Users should consider purchasing pumps with safety features such as software that provides safeguards against dosing and infusion rate errors. These "smart" pumps can incorporate hospital-defined protocols with built-in maximum allowable dose and infusion rates for specific patient types, or alarms to indicate when an infusion parameter is outside a pre-determined range. Users should carefully assess the potential for error if the operator does not change the pump's pre-programmed drug and concentration settings to those used in their facility. Purchase of pumps with default drug concentrations of zero may be an option to consider. For high risk medications, dosage programming and subsequent changes should be verified by a second caregiver.
5. Patient-controlled analgesia. Care givers should evaluate patients on PCA pumps and determine whether the patient needs to manage his/her own pain and is capable of doing so. Patients should be properly educated on the pump's use.
6. Prevention of tampe ring. Choose a pump with a lock-out feature to prevent tampering by either the patient or visitors, especially in the case of pumps used at home.
7. Licensed devices. Infusion pumps are designated Class II or Class III devices under the Medical Devices Regulations, and require a licence issued by Health Canada before they may be imported or sold. This licence must be renewed annually. Health care facilities should ensure that all pumps they purchase have a valid medical device licence issued by Health Canada. Health Canada has established a public-access data base of all currently licensed devices, which contains detailed information on products and manufacturers and is updated daily. See www.mdall.ca.
    

  CANADIAN INFUSION PUMP INCIDENT DATA  

Health Canada asks that you share these recommendations with your staff or membership and encourage their implementation in the interest of patient safety.

For additional information on the technical content of the Notice, please contact the Manager, Device Surveillance Division, Medical Devices Bureau at 613-954-0287. If you have any concerns, problems or complaints pertaining to INFUSION PUMPS, you may report them to:

Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 3002C
Ottawa, Ontario K1A 0K9
Tel.: The Medical Devices Hotline 1-800-267-9675

For other inquiries: please refer to contact information.

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.

 

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