Unexpected Risk from a Beneficial Device
At least 40
reports have been submitted to PA-PSRS in which patients fell while wearing sequential compression devices (SCDs). SCDs are considered to be a safe, noninvasive, and effective method of preventing deep vein thrombosis in post-surgical patients1 and in patients who are immobile for extended periods.2
SCD units comprise an electric air compression pump and tubing that transfers the air from the pump to three-chambered pneumatic sleeves, which are placed over a patient’s leg. These chambers inflate
in a cycle, applying pressure in a sequential fashion, starting from the ankle/foot to the calf or thigh.2 This results in a wavelike, milking motion that stimulates muscle activity3 in the immobile patient, thus promoting venous blood flow and preventing thrombosis.1
While multiple studies demonstrate the benefits of SCDs,4 reports submitted to PA-PSRS indicate that SCDs may increase the risk of harm when patients fall. Reports of falls in patients with SCDs were more than three times as likely to be reported as Serious Events compared to reports of falls in which SCDs were not mentioned.
The proportion of Serious Events reported in patients who fell while wearing SCDs was 15% (compared to 4.7% in all reports of falls*). Further, 23% of those occurrences categorized as Incidents had minor injuries requiring such interventions as application of a dressing, ice, cleaning of a wound, limb elevation, or application of a topical medication. Other characteristics of patients who fell wearing SCDs are described below.
Fifty percent (50%) of these falls occurred between midnight and 8 a.m., when staffing levels are reduced, and when patients are sleepy, in the dark, and more prone to disorientation.
While 62% of the patients were in their 70’s and 80’s, a patient as young as 22 years old fell while wearing SCDs. An additional 30% of these patients were in their 50’s and 60’s, suggesting that this type of problem may occur throughout all adult age ranges--not solely among the advanced elderly.
Figure 1 displays the following data according to age cohort: 1) the proportion of reports submitted to PA-PSRS concerning patient falls with SCDs applied, and 2) the proportion of hospitalized patients.** The display reveals that patients 75 to 84 years of age may be at greater risk for falling with SCDs applied than other age cohorts.
Fifty-eight percent (58%) of the reports were associated with patient toileting: ambulating to the bathroom, using bedside commode, fall in the bathroom, and using a urinal to void. In most reports, the narrative description indicated that the patient was independently mobile. Many reports reflected that the patient got tangled up/tripped on the SCD tubing.
Risk Reduction Strategies
The patterns in these reports provide clues to risk reduction strategies that may promote a safer environment when patients require SCDs. The following tips may be applicable to patients wearing intermittent pressure devices, as well:
Regularly assessing patients for the need for SCDs. If a patient is mobile, SCDs may no longer be required. Timely discontinuation of SCDs when medically appropriate may help to prevent falls.
Providing patient and family education (verbal, videotape, and written) concerning the reason for SCDs, how long they are to be applied, and calling for assistance so that the sleeves can be removed prior to leaving bed. Such education could be provided pre-operatively and when SCDs are applied.
Automatically instituting fall prevention protocols on all patients wearing SCDs regardless of age, including a toileting schedule, rapid response to call bells, and regular re-orientation.
Assisting with patients’ toileting needs–particularly on night shift.
Considering the feasibility of SCD units that have an audible disconnect/low pressure alarm or using bed/chair exit alarms so that healthcare providers can hear and quickly respond to patients wearing SCDs that are attempting to ambulate.
One manufacturer has developed a miniature SCD that not only operates via line
current but can also be powered by battery for up to four hours. The battery pack is worn during ambulation.2 Such devices may reduce patient falls caused by getting tangled or tripping on tubes connected to an SCD unit hooked on the bed.
Determining the proper size of the compression sleeves for each patient by using a measuring tape.1 This will help prevent the compression sleeves from slipping out of place because of poor fit.
These measures may enhance the benefits of sequential compression device use while, at the same time, reducing the risk of patient harm.
* Based on an analysis of all reports of falls received through August 18, 2005. Relative risk ratio was 3.18 (95% CI: 1.526.66).
www.phc4.org** Based on publicly available data from the Pennsylvania Health Care Cost Containment Council (). Estimates were based on statewide inpatient hospital data from the fourth quarter of 2003 through the fourth quarter of 2004.
Daly S, ed.
Nursing procedures. Springhouse (PA): Springhouse Corporation; 1996:184-187.
ECRI. Circulatory assist units, intermittent; sequential; stockings; compressing; pneumatic.
Healthcare Product Comparison System 2004 Jul:1-44.
Markel DC, Morris GD. Effect of external sequential compression devices on femoral venous blood flow.J South Orthop Assoc 2002 Nov 15;11(1):2-8.
Kleinbart J, Williams MV, Rask K. Prevention of venous thromboembolism. Chapter 31. In:
Making health care safer: a critical analysis of patient safety practices. Agency for Healthcare Research and Quality Pub No. 01-E058; 2001:333-348.
SCD Misconnection Could be Fatal
While this issue has not yet been identified in PA-PSRS reports, a potentially fatal hazard associated with sequential compression devices (SCDs) has been reported elsewhere.1,2 SCD hoses can be mistakenly attached to needleless Luer ports of intravenous (IV) administration sets. Since SCD units pump air under pressure, a misconnection to a patient’s IV system could result in fatal air embolism.
Such misconnections have occurred when the SCD unit had male Luer-type connectors on the end of the hoses. The male SCD Luer fittings may be compatible with the needleless Luer ports on certain IV administration sets or extension lines.
Some SCD units have a protective mechanism that shuts the unit off when back pressure is not detected. However, this shut-off protection may not be activated because back pressure can be created when air infuses into a patient.
Several strategies may help to reduce the risk of misconnection:
- Heightening staff awareness of the possibility of such misconnections. This means reaching all staff that may connect, reconnect, or disconnect any tubing for patient use throughout the facility (transport, students, technicians, nurses, physicians).
- Assessing whether the facility’s SCD equipment has male Luer connectors.
- If feasible, purchasing SCD units that have male fittings that are mechanically incompatible with your facility’s female IV ports.
- If purchasing new SCD equipment is not feasible, considering permanent attachment of non-Luer connectors to SCD hoses and purchasing compression sleeves with a compatible non-Luer female connector (recognizing that this option may void certain legal protections and warranties).
- Establishing a tracing protocol that involves having every person trace tubing back to the source (such as the SCD unit) before connection or disconnection occurs.
- Developing a written policy that identifies the categories of healthcare workers who are authorized and not authorized to make tubing connections, disconnections, and reconnections.
- Providing education concerning the reason for the prohibition both to those authorized and those not authorized to perform such tasks.
- Facilitating practice/role playing exercises to assist unauthorized staff in learning how to decline request to connect or disconnect medical tubing.
- As a supplement to the above risk reduction strategies, labeling SCD tubing indicating that it supplies air.
Misconnections of oxygen tubing and noninvasive blood pressure (NIBP) monitoring tubing to needleless IV ports have resulted in fatal air emboli.3,4 The potential for misconnection errors exists with intermittent compression devices, as well.
- ECRI. Hazard report: fatal air embolism caused by the misconnection of medical device hoses to needleless luer ports in IV administration sets.
Health Devices 2004 Jun;33(6):223-5.
- Institute for Safe Medication Practices. Safety briefs: misconnection of IV tubing.
ISMP Medication Safety Alert! 2003 Sep 4;8(18):1.
- Institute for Safe Medication Practices. Blood pressure monitor may connect to IV ports.
ISMP Medication Safety Alert! 2003 Jun 12;8(12):1-2.
- Institute for Safe Medication Practices. Problems persist with live-threatening tubing misconnections.
ISMP Medication Safety Alert! 2004 Jun 17;9(12):1-2.