Society of Interventional Radiology position statement: prevention of unintentionally retained foreign bodies during interventional radiology procedures.


Guideline Developer(s)

Society of Interventional Radiology

Date Released

2011 Nov

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of evidence supporting the recommendations is not specifically stated.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Prevention of unintentionally retained foreign bodies during interventional radiology procedures

Potential Harms

Not stated

Rating Scheme for the Strength of the Recommendations

Not applicable

Qualifying Statements

Qualifying Statements
  • A primary goal of the Society of Interventional Radiology (SIR) is ensuring high-quality outcomes and patient safety in vascular and interventional radiology. The clinical practice guidelines of the SIR attempt to define practice principles that generally should assist in producing high quality medical care. These guidelines are voluntary and are not rules. A physician may deviate from these guidelines, as necessitated by the individual patient and available resources. These practice guidelines should not be deemed inclusive of all proper methods of care or exclusive of other methods of care that are reasonably directed towards the same result. Other sources of information may be used in conjunction with these principles to produce a process leading to high quality medical care. The ultimate judgment regarding the conduct of any specific procedure or course of management must be made by the physician, who should consider all circumstances relevant to the individual clinical situation. Adherence to the SIR Quality Improvement Program will not assure a successful outcome in every situation. It is prudent to document the rationale for any deviation from the suggested practice guidelines in the department policies and procedure manual or in the patient's medical record.
  • These recommendations apply only to interventional radiology procedures that are performed by interventional radiologists in the interventional radiology suite. Procedures performed in the interventional radiology suite by multidisciplinary teams are likely to involve more extensive wounds than those typical of interventional radiology procedures. Procedures performed in areas of the hospital outside of the interventional radiology suite should be performed in accordance with the standard operating procedures of that area.
  • The opinions expressed herein are those of the authors and do not necessarily reflect those of the Food and Drug Administration or the Department of Health and Human Services.

Methodology

Methods Used to Collect/Select the Evidence

Searches of Electronic Databases

Description of Methods Used to Collect/Select the Evidence

An in-depth literature search was performed using the Medline and PubMed databases. The time frame of the literature search was from 1982 to 2011. No inclusion/exclusion criteria were applied. Search terms used were sponges, retained instruments, comprehensive accreditation, improving safety in OR, foreign objects, preoperative standards, patient safety in OR.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence

Not stated

Rating Scheme for the Strength of the Evidence

Not applicable

Methods Used to Analyze the Evidence

Review

Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations

Expert Consensus

Description of Methods Used to Formulate the Recommendations

Not stated

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation

Not stated

Description of Method of Guideline Validation

Not applicable

Identifying Information and Availability

Bibliographic Source(s)

Statler JD, Miller DL, Dixon RG, Kuo MD, Cohen AM, Duncan JR, Gordon RL, Gross K, Saad WE, Silberzweig JE, Stecker MS, Suri R, Thornton RH, Bartal G, Society of Interventional Radiology Safety and Health Committee. Society of Interventional Radiology position statement: prevention of unintentionally retained foreign bodies during interventional radiology procedures. J Vasc Interv Radiol. 2011 Nov;22(11):1561-2. [10 references] PubMed

Adaptation

Not applicable: The guideline was not adapted from another source.

Source(s) of Funding

Society of Interventional Radiology

Guideline Committee

Society of Interventional Radiology Safety and Health Committee

Composition of Group That Authored the Guideline

Committee Members: John D. Statler, MD, Virginia Interventional and Vascular Associates, Fredericksburg, Virginia, Department of Radiology, Uniformed Services University of the Health Sciences, Silver Spring, Maryland; Donald L. Miller, MD, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland; Robert G. Dixon, MD, Department of Radiology, University of North Carolina, Chapel Hill, North Carolina; Michael D. Kuo, MD, Department of Radiology, University of California, Los Angeles, Medical School, Los Angeles, California; Alan M. Cohen, MD, Department of Vascular and Interventional Radiology, University of Texas Health Science Center, Houston, Texas; James R. Duncan, MD, PhD, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, Missouri; Roy L. Gordon, MD, Department of Radiology, University of California, San Francisco, San Francisco, California; Kathleen Gross, MSN, RN-BC, CRN, Department of Interventional Radiology, Greater Baltimore Medical Center, Baltimore, Maryland; Wael E.A. Saad, MD, Department of Radiology, University of Virginia Health System, Charlottesville, Virginia; James E. Silberzweig, MD, Department of Radiology, Beth Israel Medical Center, New York, New York; Michael S. Stecker, MD, Division of Angiography and Interventional Radiology, Brigham and Women's Hospital, Boston, Massachusetts; Rajeev Suri, MD, Department of Radiology, University of Texas Health Sciences Center San Antonio, San Antonio, Texas; Raymond H. Thornton, MD, Department of Radiology, Interventional Radiology Service, Memorial Sloan-Kettering Cancer Center, New York, New York; Gabriel Bartal, MD, Department of Diagnostic and Interventional Radiology, Meir Medical Center, Kfar Saba, Israel

Financial Disclosures/Conflicts of Interest

R.G.D. is an educational consultant for Bard Access Systems. None of the other authors have identified a conflict of interest.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available from the Society of Interventional Radiology Web site.

Print copies: Available from the Society of Interventional Radiology, 10201 Lee Highway, Suite 500, Fairfax, VA 22030

Availability of Companion Documents

None available

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on January 23, 2015.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Scope

Disease/Condition(s)

Foreign bodies unintentionally retained during interventional radiology procedures

Guideline Category

Prevention

Clinical Specialty

Preventive Medicine
Radiology

Intended Users

Advanced Practice Nurses
Hospitals
Nurses
Physician Assistants
Physicians

Guideline Objective(s)

To provide recommendations for the prevention of unintentionally retained foreign bodies during interventional radiology procedures

Target Population

Patients undergoing interventional radiology procedures performed by interventional radiologists in the interventional radiology suite

Interventions and Practices Considered
  1. Avoiding use of sponges smaller than a standard 10-cm x 10-cm (4 x 4) for packing of wounds or incisions
  2. Performing thorough visual and tactile inspections after sponge removal and again before the incision is closed
  3. Use of sponges with radiopaque markers for packing
  4. Performing fluoroscopy at conclusion of procedures
Major Outcomes Considered

Incidence and likelihood of retained foreign bodies during interventional radiology procedures

Recommendations

Major Recommendations

The following recommendations apply only to interventional radiology procedures performed by interventional radiologists in the interventional radiology suite. Procedures performed in the interventional radiology suite by multidisciplinary teams are likely to involve more extensive wounds than those typical of interventional radiology procedures. Procedures performed in areas of the hospital outside of the interventional radiology suite should be performed in accordance with the standard operating procedures of that area.

  1. Sponges smaller than a standard 10-cm x 10-cm sponge (i.e., a 4 x 4) should not be used for packing of wounds or incisions. The 4 x 4 sponges should not be cut into smaller pieces for packing of wounds or incisions.
  2. Whenever sponges have been used in an incision or cavity, thorough visual and tactile inspections should be performed after sponge removal and again before the incision is closed.
  3. If the incision or cavity does not permit a thorough visual and tactile inspection because of its size or shape, only sponges with radiopaque markers should be used for packing, and either fluoroscopy should be performed at the conclusion of the procedure to exclude a retained sponge or a sponge count should be performed at the conclusion of the procedure.
  4. If there is any concern of possible retention of a needle or instrument, fluoroscopy should be performed at the conclusion of the procedure unless the additional radiation for fluoroscopy is of greater concern.
Clinical Algorithm(s)

None provided

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need

Staying Healthy

IOM Domain

Effectiveness
Safety

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