HARRISBURG: Patients undergoing hip replacement surgery can in rare cases experience Bone Cement Implantation Syndrome (BCIS). In five out of six reports of BCIS received by the Patient Safety Authority the patient died from cardiac arrest associated with implantation of the new hip prosthesis.
While trends show a decrease in the use of cement for hip replacements from 66% in 1995 to 39% in 2001, the Authority believes the issue warrants attention since approximately 11,000 hip replacements are expected to be performed in Pennsylvania this year alone. The numbers are also expected to increase with the aging “Baby Boomer” population.
Elderly patients with underlying heart disease who must receive surgery for a hip fracture using bone cement are most at risk of developing BCIS. Some other risk factors for BCIS include: patients who suffer from severe osteoporosis and patients who have fixed heart rates with pacemakers.
“The cases we’ve seen through the reporting system [PA-PSRS] involve patients who were having hip replacement surgery done using bone cement,” said Dr. John Clarke, Clinical Director of PA-PSRS. “While bone cement is associated with BCIS, it is important for orthopedic surgeons to know the syndrome is actually caused by the seal and pressure that develops when the hip prosthesis is inserted after the cement has been placed, not by the cement itself. Other materials could also cause the same seal and pressure which leads to the syndrome.”
Although cardiac arrest and death are the most catastrophic outcomes associated with BCIS, some warning signs that occur within minutes of using the bone cement include: low blood pressure, fluid in the lungs, increased airway resistance, irregular heartbeat, hypothermia and increased bleeding.
Dr. Clarke added that the impact of this complication of using bone cement may not have been noticed had it not been for the aggregation of the cases over the past two years through the PA-PSRS reporting system.
“Although the complication is rare, it accounted for a significant fraction of the intra-operative deaths that were reported to PA-PSRS,” Dr. Clarke said. “If we did not have a system to aggregate these events, each one most likely would have been dismissed as a single event in that facility and the overall significance of this syndrome would not have been appreciated. But five deaths from only six reports statewide prompted an investigation. When we identified the cause, we found that experts had, over time, found effective solutions that we are able to bring to the attention of all the orthopedic surgeons in the state through an Advisory.”
The Advisory article, entitled “Bone Cement Implantation Syndrome,” includes several risk reduction strategies. These include evaluating and monitoring the patient’s condition before and during surgery for factors indicating high risk; thoroughly cleaning the shaft of the thigh bone before inserting the prosthesis; and using techniques for inserting the cement that minimize the pressure.
For a list of the preventive measures, BCIS warning signs and treatment go to http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2006/Dec3(4)/Pages/01b.aspx. For a copy of the pocketguide available with these guidelines go to http://patientsafetyauthority.org/EducationalTools/PatientSafetyTools/bcis/Pages/pocket_guide.aspx.
In addition, the 2006 December Advisory contains an article on hospital bed rail entrapment and measures facilities can take to prevent injury or death from entrapment. The Authority has received over 100 reports of patients being trapped in bed rails. Nationwide, from 1985 through 2005, the U.S. Food and Drug Administration (FDA) received 691 reports of hospital bed entrapment including 413 deaths, 120 nonfatal injuries and 158 occurrences in which staff intervention prevented the injuries. Facilities have also been provided with a toolkit to help them implement changes within their facilities to reduce the risk of patients being trapped in their bed rails.
The tool kit includes: 1) a single-topic reprint of the “I’m Stuck, and I Can’t Get Out! Hospital Bed Entrapment” article; 2) a poster for bed entrapment awareness; and 3) a brief, self-running slideshow with audio narration on risk reduction strategies related to bed entrapment, which can be downloaded and shown to front-line caregivers. For a detailed look at the toolkit go to http://patientsafetyauthority.org/EducationalTools/PatientSafetyTools/bed_safety/Pages/home.aspx.
Other articles in the December 2006 Advisory provide analysis of the following events based on actual reports submitted to PA-PSRS by healthcare facilities in Pennsylvania:
- Perforations of the Colon during Colonoscopy: A colonoscopy is a fairly routine procedure performed approximately 320,000 times each year in Pennsylvania. However, at least 125 patients experienced a colonic perforation associated with the procedure which resulted in further surgery and complications. Risk mitigation strategies are provided.
- Traditional Methods for Confirming Feeding Tube Placement are Outdated: Patients needing a feeding tube for various health conditions are often put at risk because of outdated methods of confirming proper placement of the feeding tube. Clinicians should consider new methods for confirming proper placement to reduce risk of misplacement and improve patient safety.
- The Dangers Associated with Heparin Therapy: This high-alert drug has recently caused hospitals nationwide to take a closer look at how they store the medication since three premature infants died in an Indiana hospital (not in Pennsylvania) as a result of an overdose. Errors associated with heparin that have been reported to the Authority are multifaceted. They include: errors due to look-alike packaging; wrong-dose errors and the incorrect use of heparin with other drugs. Risk mitigation strategies are provided.
For a copy of the December 2006 Patient Safety Advisory, go to http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2006/Dec3(4)/Pages/home.aspx.
BACKGROUND
The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act as amended, to help reduce and eliminate medical errors by identifying problems and recommending solutions that promote patient safety. Under the Act, all Pennsylvania-licensed hospitals, birthing centers, ambulatory surgical facilities and certain abortion facilities are required to report what the Act defines as “serious events” and “incidents” to the Authority. More than 460 healthcare facilities are subject to Act 13 reporting requirements.
Facilities submit reports of serious events and incidents through the Pennsylvania Patient Safety Reporting System (PA-PSRS), a confidential web-based system that was developed for the Authority under a contract with ECRI, a Pennsylvania-based independent, non-profit health services research agency, in partnership with EDS, a leading international, information technology firm, and the Institute for Safe Medication Practices (ISMP), also a Pennsylvania-based, non-profit health research organization.
More than 430,000 reports have been submitted through PA-PSRS since the program was initiated in June 2004. Ninety-six percent of these reports are Incidents or “near-misses.” Based on those reports, the Authority issues quarterly and supplementary Patient Safety Advisories to advise hospitals and other healthcare facilities about steps they can take to reduce and prevent patient harm.
The Authority has been named a recipient of the 2006 John M. Eisenberg Award for advancing patient safety and quality. Presented jointly by the Joint Commission on Accreditation of Healthcare Organizations and the National Quality Forum, the award acknowledges the Authority’s impact on patient safety because of efforts to make the PA-PSRS system into a nationally recognized resource for education and learning about patient safety.
For more information on the Patient Safety Authority, PA-PSRS or previous Patient Safety Advisories, visit the Authority’s website at www.patientsafetyauthority.org.
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