Sponges Left Behind

by William W. Steward, MD

The most commonly reported surgical error is retained surgical sponges?  The February 2011 edition of The Joint Commission Journal for Quality and Patient Safety includes the publication of a comprehensive, independent research study on what is estimated to be the most commonly reported surgical error is retained surgical sponges.

According to occurrence rates substantiated in the study, a surgical sponge is left behind in a patient once every approximately 8,000 operations.(1) Additionally, consistent with previous studies,(2,3) the vast majority of retained sponges were found to occur despite a “correct” count being reported before completion of the operation. Given how these items are used in surgery, the number of individual sponges used and their physical properties, combined with the inherently demanding, chaotic and pressured environment of the operating room, surgical teams should be applauded for getting their counts correct the vast majority of the time.

However even this seemingly low occurrence rate translates into a significant number of actual events. With an estimated 32 million procedures performed annually in the United States, an occurrence rate of one in 8,000 implies approximately 4,000 retained sponge annually, just under 11 events every single day. Data made publicly available through state mandated reporting of adverse events in hospitals sheds additional perspective on the prevalence of this error, as the information consistently demonstrates that retained surgical sponges are the most commonly reported surgical adverse event.(4)

For the patient, retained sponges are typically associated with significant morbidity, including intestinal obstruction, intra-abdominal abscess, peritonitis, discharging sinus, visceral perforation, re-operations to remove the object and even death.(5,6) Though not physically impacted, the human cost of these events extends beyond the patient, as the entire surgical staff involved can typically expect a range of legal and professional ramifications.

Though estimates vary of the actual total costs involved with retained sponge incidents, the economic consequences are undeniably significant. Direct costs can include legal fees, settlement payments, non-reimbursable additional healthcare services (additional surgery to remove the item, the treatment of any infections, additional hospital stays), loss of reputation (including both healthcare institutions and all involved surgical staff), government fines, higher insurance premiums, compromised operating room efficiency and loss of time (establishing and maintaining root cause committees, implementing corrective measures, staff meetings, depositions). Taking a closer look at just the estimated legal and additional healthcare service costs alone helps put the total costs of these events into perspective. According to the U.S. Health and Human Services, the average medical malpractice payment since 1990 has been $234,318.(7) Non-reimbursable additional surgery and related care expenses from retained sponges are estimated by the Center for Medicare & Medicaid Services to average $63,000 per incident.(8) These two variables alone imply approximately $300,000 in costs per retained sponge. Assuming the 4,000 annual events estimated above, the legal and medical costs from retained sponges are costing hospitals in the United States over $1.2 billion every year.

The study mentioned above recently published in The Joint Commission Journal on Quality and Patient Safety, entitled, Using a Data-Matrix-Coded Sponge Counting System Across a Surgical Practice: Impact After 18 Months, is the most comprehensive study ever published on the subject of retained surgical sponges. In addition to trials over a multi-year period, over 1.8 million sponges were used in over 87,000 procedures. Completely independent in nature and performed by researchers at one of the most renown healthcare institutions in the world, the study suggest that retained surgical sponges, and the costs associated with them, are entirely preventable with a proven and cost-effective solution. The institution implementing the solution, called the SurgiCount Safety-Sponge® System, eliminated the occurrence of retained surgical sponges over the course of the entire 18 months of use.

The peer-reviewed study details two randomized, controlled trials conducted at a high-volume surgical practice, the subsequent implementation of the Safety-Sponge System across all 128 operating rooms at the affiliated institution, and a comprehensive evaluation of the solution after 18 months of use. The trial evaluated the Safety-Sponge System’s effectiveness on reducing retained surgical sponges, efficiency, impact on operative time, ergonomics and staff satisfaction. Key results of the study include:

Prior to implementation, a retained surgical sponge occurred at the institution approximately every 64 days.

• During the study, 87,404 procedures were performed over 18 months using 1,862,373 Safety-Sponges. None were retained.
• Use of the Safety-Sponge System caused no workflow disruption or increase in case duration.
• Staff satisfaction with the Safety-Sponge System was acceptable with a high degree of trust in the system.
• The Safety-Sponge System was found to be highly reliable and cost-effective.

Though this study alone presents a significant amount of evidence as to the clinical effectiveness of the Safety-Sponge System, the aggregate usage data of the solution is overwhelming. To date, an estimated 36 million Safety-Sponges have been used in over 1.6 million procedures with no retained sponges in any case where the solution was utilized. Additionally, current users include a growing number of teaching, community and government hospitals, including five of the 14 U.S. News and World Report 2010-2011 Honor Roll Hospitals. This represents more Honor Roll Hospitals than all other sponge technologies combined.

The SurgiCount Safety-Sponge System is a complete sponge counting and documentation system shown to help prevent the occurrence of retained sponges by assuring a more accurate accounting of those items before and after surgery. By labeling each sponge with a unique identifier, the system helps to prevent users from incorrectly counting the individual sponges and unintentionally leaving one inside the patient. In addition to a world class customer base already successfully using the product, the solution is the most cost effective sponge technology available.(9) Further, unlike radio frequency based solutions that have been shown in numerous studies to introduce the possibility of electromagnetic interference,(10,11) the SurgiCount Safety-Sponge technology introduces no such risk.

With a cost-effective solution proven to help hospitals eliminate the most commonly reported surgical adverse event, hospitals should highly consider implementing the SurgiCount Safety-Sponge System to better protect their surgeons and operating room staff, reduce preventable costs and provide the highest standard of care to their patients.

References

1. Robert R. Cima, M.D., et al: Using a Data-Matrix-Coded Sponge Counting System Across a Surgical Practice: Impact After 18 Months, The Joint Commission Journal on Quality and Patient Safety, February 2011, pg. 51-58.
2. Robert R. Cima, M.D., et al: Incidence and Characteristics of Potential and Actual Retained Foreign Object Events in Surgical Patients, Journal for the American College of Surgeons, Vol. 207, No. 1, July 2008.
3. Caprice Greenberg, MD, MPH, Atul Gawande, MD, MPH, Beyond Counting: Current Evidence on the Problem of Retained Foreign Bodies in Surgery?, Annals of Surgery, Volume 247, Number 1, January 2008.
4. Minnesota Department of Health, Adverse Events in Minnesota; First, Second, Third, Fourth, Fifth, Sixth and Seventh Annual Public Report.
5. Gonzalez-Ojeda A., et al; Retained foreign bodies following intra-abdominal surgery. <I>atogastroenterology 46:808-812, Mar.-Apr. 1999.
6. Ahmad G., et al; Retained sponge after abdominal surgery, J Coll Physicians Surg Pak. 2003 Nov; 13(11):640-3.
7. U.S. Health and Human Services, 2006 Annual Report of the National Practitioner Data Bank.
8. Center for Medicare & Medicaid Services, Proposed Changes to the Hospital IPPS and FY2009 rates.
9. Atul A. Gawande, MD, MPH, FACS, et al; Novel strategies to prevent retained surgical sponges: A decision-analytic model predicting relative cost-effectiveness, Journal of the American College of Surgeons, 2008.06.183.
10. 10.  Seth J. Seidman, Food and Drug Administration, et al; Electromagnetic compatibility of pacemakers and implantable cardiac defibrillators exposed to RFID readers, Int. J. Radio Frequency Identification Technology and Applications<$>, Vol. 1, No. 3, 2007.
11. 11.  Binita S. Ashar; Ann Ferrier, Radiofrequency Identification Technology in Health Care: Benefits and Potential Risks, JAMA, November 21, 2007, Volume 298, No. 19.

William W. Stewart, M.D., is a board certified urologist who has been in practice for more than 30 years. He has researched patient safety issues for the past 20 years and is the co-founder of SurgiCount Medical and co-inventor of the Safety-Sponge® System.