Hospital Harm: Retained Foreign Body
A retained foreign body is a patient safety incident in which a surgical object is accidentally left in a body cavity or operation wound following a procedure (Canadian Patient Safety Institute (CPSI), 2016a).
- Topics
- Patient safety
- Hospital harm
- Audience
Point of care provider
Quality or safety improvement lead
Policy advisor or analyst
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Goal
Reduce the incidence of retained foreign body.
Overview
Healthcare Excellence Canada has developed this Hospital Harm Improvement Resource – a compilation of resources to support patient safety and improvement efforts.
Retained foreign body during surgery
Patients with retained foreign bodies may sustain both physical harm (perforation of the bowel, sepsis and even death) and emotional consequences (depression, post-traumatic stress disorder, anxiety) following the incident. These complications can occur early in the postoperative period, or even months or years later (Gawande et al., 2003; Healthcare Insurance Reciprocal of Canada (HIROC), 2016; The Joint Commission, 2013).
The Organisation for Economic Co-operation and Development (OECD) reports for the year 2017 that the average rate for a foreign body left inside the patient's body during a procedure, per 100,000 medical and surgical discharges is 3.8, versus the Canadian rate of 9.8, which represents a 14 per cent increase over the last five years (Canadian Institute for Health Information (CIHI, 2019a and CIHI, 2019b).
A 10-year review of medico-legal cases in Canada between 2004 and 2013 found that retained foreign bodies or wrong surgery were identified in 12 to 18 per cent of surgical incidents (Canadian Medical Protective Association (CMPA & HIROC, 2016).
Retained foreign bodies can include:
Soft devices, such as sponges and towels
Small miscellaneous items, including unretrieved device components or fragments (such as broken parts of instruments), stapler components, parts of laparoscopic trocars, guidewires, catheters, and pieces of drains
Needles and other sharps
Instruments, most commonly malleable retractors
(The Joint Commission, 2013)
The most common root causes of retained foreign objects reported to The Joint Commission are:
The absence of policies and procedures
Failure to comply with existing policies and procedures
Problems with hierarchy and intimidation
Failure in communication with physicians
Failure of staff to communicate relevant patient information
Inadequate or incomplete education of staff
(The Joint Commission, 2013)
Traditional methods of preventing retained foreign bodies included "cavity sweeps" and manual counting protocols – both of which are prone to human error. Current practices for counting sponges have a 10 to 15 per cent error rate. In addition, 80 per cent of retained sponges occur with what staff believe is a correct count (The Joint Commission, 2013)
Catheter shearing leading to retained foreign body
Most catheter procedures occur without complications however the insertion and removal of catheters can lead to retained foreign bodies when part of the catheter breaks off. Shearing typically occurs during insertion or removal of the catheter from patients. Catheter fragments remaining in patients can result in serious complications due to the location or migration of the fragment or inflammation at the fragment site. Reasons for catheter shearing include the following:
Applying excessive force while removing the catheter
Withdrawing the catheter back through the insertion needle
Withdrawing the catheter over a deformed or damaged needle bevel
A flaw in the catheter from defects during the manufacturing process
Damaging the catheter during or after placement in the patient
(Pennsylvania Patient Safety Authority, 2009; Weinstein & Hagle, 2014)
Importance to Patients and Families
Communication failures are common in the operating room and can lead to increased complications such as retained foreign bodies. Use of a surgical safety checklist may prevent communication failures and reduce complications. While the physical act of "checking the box" may not necessarily prevent all adverse events, the checklist is a scaffold on which attitudes towards teamwork and communication can be encouraged and improved. Compliance with the checklist includes communication with the patient and is critical for the effects on patient safety to be realized (Pugel et al., 2015).
Sylvie Dubé couldn't figure out why she was overcome with pain in her shoulder after she woke up following an operation…"It felt like I had been stabbed," Dubé told Radio-Canada, recalling the surgery on March 14….As weeks went on, the pain worsened….Feeling discouraged, the couple showed up at the emergency room more than two months after the surgery..
That's when Dubé underwent an X-ray. Puzzled radiologists told her there was a large medical instrument lodged inside her stomach (Gentile, 2017).
Clinical and System Reviews, Incident Analyses
Given the broad range of potential causes of a retained foreign body, clinical and system reviews should be conducted to identify potential causes and determine appropriate recommendations.
Occurrences of harm are often complex with many contributing factors. Organizations need to:
Measure and monitor the types and frequency of these occurrences.
Use appropriate analytical methods to understand the contributing factors.
Identify and implement solutions or interventions that are designed to prevent recurrence and reduce risk of harm.
Have mechanisms in place to mitigate consequences of harm when it occurs.
To develop a more in-depth understanding of the care delivered to patients, chart audits, incident analyses and prospective analyses can be helpful in identifying quality improvement opportunities. Links to key resources for conducting chart audits and analysis methods are included in the Hospital Harm Improvement Resources Introduction.
If your review reveals that your cases of retained foreign body are linked to specific processes or procedures, you may find these resources helpful:
Agency for Healthcare Research and Quality (AHRQ). https://www.ahrq.gov/
American College of Surgeons - Revised statement on the prevention of unintentionally retained surgical items after surgery (2016). http://bulletin.facs.org/2016/10/revised-statement-on-the-prevention-of-unintentionally-retained-surgical-items-after-surgery/#.WxVdN0xFyUl
Association of periOperative Registered Nurses (AORN). https://www.aorn.org/
Canadian Patient Safety Institute. Surgical Safety Checklist (2009)
Nothing Left Behind. www.nothingleftbehind.org
Pennsylvania Patient Safety Advisory. http://patientsafety.pa.gov/
Retained Surgical Items: Events and Guidelines Revisited (2017) http://patientsafety.pa.gov/ADVISORIES/Pages/201703_RSI.aspx
Epidural or Subarachnoid Catheter Shear (2009) http://patientsafety.pa.gov/ADVISORIES/Pages/200909_84.aspx
Plumer's Principles and Practice of InfusionTherapy. Text Book (Weinstein, S.M.; Hagle, M.E. 9th Edition. 2014).
The Joint Commission. Preventing unintended retained foreign objects. Sentinel Event Alert. Issue 51, 2013. Available at: https://www.jointcommission.org/assets/1/6/SEA_51_Retained foreign bodies_10_17_13_FINAL.pdf
World Health Organization - Safe Surgery. https://www.who.int/patientsafety/safesurgery/en/
Measures
Vital to quality improvement is measurement, and this applies specifically to implementation of interventions. The chosen measures will help to determine whether an impact is being made (primary outcome), whether the intervention is actually being carried out (process measures), and whether any unintended consequences ensue (balancing measures).
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Whenever possible, use measures you are already collecting for other programs.
Evaluate your choice of measures in terms of the usefulness of the final results and the resources required to obtain them; try to maximize the former while minimizing the latter.
Try to include both process and outcome measures in your measurement scheme.
You may use different measures or modify measures to make them more appropriate and/or useful to your particular setting. However, be aware that modifying measures may limit the comparability of your results to others.
Posting your measure results within your hospital is a great way to keep your teams motivated and aware of progress. Try to include measures that your team will find meaningful and exciting (IHI, 2012).
Discharge Abstract Database
Discharge Abstract Database (DAD) Codes included in this clinical category: D24: Retained Foreign Body
Concept: Foreign object or substance unintentionally left in the body during a medical or surgical procedure
T81.5 / T81.6: Identified as diagnosis type (2)
Success Stories
Hopital Charles LeMoyne, Quebec, 2009
The surgical instruments management program at Hôpital Chalres LeMoyne is effective and provides the highest level of safety. There is a well–established, efficient tracking system. All instruments are identified with a unique number. When trays are prepared, instruments are logged using a scanner system. Trays are then identified with a barcode. During surgery, all instruments and devices are logged in a computer databank referenced to the patient's name. This system makes it possible to identify every instrument used in a specific operation (Hôpital Charles LeMoyne, 2009).
References
Canadian Institute for Health Information (CIHI). Canada continues to lag behind other OECD countries on measures of patient safety. Ottawa, ON: CIHI. 2019a.
Canadian Institute for Health Information (CIHI). OECD Interactive Tool: International Comparisons. Published 2019b. http://www.cihi.ca/en/oecd-interactive-tool-international-comparisons-patient-safety
Canadian Medical Protective Association (CMPA), Healthcare Insurance Reciprocal of Canada (HIROC). Detailed Analysis. Surgical Safety in Canada: A 10-Year Review of CMPA and HIROC Medico-Legal Data. 2016.
Canadian Patient Safety Institute (CPSI). Retained Foreign Object. Published 2016.
Canadian Patient Safety Institute (CPSI). Surgical error inspires doctor to champion the safety of all patients. Published 2016.
Gawande AA, Studdert DM, Orav EJ, Brennan TA, Zinner MJ. Risk Factors for Retained Instruments and Sponges after Surgery. N Engl J Med. 2003;348(3):229-235. doi:10.1056/NEJMsa021721.
Gentile D. "It felt like I had been stabbed," says patient left with 33-cm metal plate inside after surgery. CBC News. Published June 28, 2017. https://www.cbc.ca/news/canada/montreal/montreal-hospital-instrument-left-inside-patient-sylvie-dube-1.4181278
Hôpital Charles LeMoyne. Leading Practices: Surgical Instruments Management Program. Ottawa, ON: Health Standards Organization; 2009. https://healthstandards.org/leading-practice/surgical-instruments-management-program/
Institute for Healthcare Improvement (IHI). How-to Guide: Prevent Harm from High-Alert Medications. Cambridge, MA: Institute for Healthcare Improvement (IHI); 2012.
Leung W. Canada worse than other wealthy countries in patient safety – including objects left in body after surgery, data show. The Globe and Mail. Published November 7, 2019. https://www.theglobeandmail.com/life/health-and-fitness/article-canada-worse-than-other-wealthy-countries-in-patient-safety/
Pennsylvania Patient Safety Authority. Epidural or Subarachnoid Catheter Shear. Pa Patient Saf Auth. 2009;6(3):84-86.
Pugel AE, Simianu VV, Flum DR, Patchen Dellinger E. Use of the surgical safety checklist to improve communication and reduce complications. J Infect Public Health. 2015;8(3):219-225. doi:10.1016/j.jiph.2015.01.001
The Joint Commission. Preventing unintended retained foreign objects. Sentin Event Alert. 2013;(51).
Weinstein SM, Hagle ME. Plumer's Principles and Practice of Infusion Therapy. Ninth. Philadelphia, PA: Lippincott Williams & Wilkins; 2014.
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