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A Surgical Junkyard

Retained surgical items (RSIs) can be classified into four general categories: 1) soft goods (e.g., sponges, towels); 2) sharps (e.g., needles, blades); 3) instruments; and 4) miscellaneous small items and device fragments. The first three categories have been long recognized, but more recently the fourth category of miscellaneous items and “surgical junk” — parts and fragments of instruments and devices — has gained increased attention.

If we go back to the November 2010 California Department of Public Health report (1) of the eight hospital-safety failures that involved RSIs, half of the cases involved miscellaneous items and device fragments. There was a retained guidewire, a portion of a retractor, a piece of a drill bit and a small metal device. In other reports (2, 3), needles are a source of frequent miscounts, and in 65 percent of cases the needles were never found. Undoubtedly, a small needle is frequently left in a patient because a clinician decides that it would be too difficult or risky to remove, and a small needle (<13-15mm) left in a large cavity is unlikely to cause harm (4).

In 2008, the Food and Drug Administration (FDA) published a notification of serious adverse events arising from fragments of medical devices and instruments left behind after surgical procedures (5). FDA characterized these as unretrieved device fragments (UDFs) and discussed problems of tissue reaction, infection, perforation, blood vessel embolism and death. Sources of UDFs are from instrument failure that develops from extensive use over time (burrs, loose parts), as well as instrument faults that are present (poor welds, rough surfaces) in newly purchased surgical instruments (6). Portions of devices or instruments can be inadvertently left in patients when the surgical team doesn’t recognize at the time of operation that a piece of an instrument or device has separated and a part remains in the patient. A broken piece of an instrument can be intentionally left in a patient when a clinical decision is made that it would be impossible to retrieve the fragment, such as can happen with a broken drill bit embedded in bone.

Since RSIs and UDFs are a system problem, many stakeholders can be involved in the solution. Each stakeholder has to become a “content expert” in his/her role. For example, the surgeon performs a methodical wound exam in every case and the circulating nurse directs the activities to account for all items. In the prevention of UDFs there is an important, but undeveloped, role for the surgical scrub technologist. The surgical scrub handles all the equipment that moves in and out of the patient during the operation, and is in a unique position to examine the equipment before it is passed to the surgeon and when it is handed back after use. The scrub technologists can become the “content experts” on the condition of the equipment, and develop the knowledge to become familiar with the existing parts of instruments so they can recognize when they receive something back from the field that it is not intact — then the scrub technologist can speak up and begin working with the team to retrieve the missing item. Currently in many hospitals, scrub technologists are not certified and have in-service classes with the nursing staff. Here is an opportunity for them to begin to structure their own educational activities in the development of a domain of expertise. Lastly, the care of the instruments and devices in the supply-processing areas, as well as the design and manufacture of these surgical tools, is important to investigate when presented with a UDF problem or case.

Guidewires are lost during vascular catheterizations performed in any area and are frequently related to problems in the method of catheter insertion. The events can be prevented by safe technique. The new 2010 AORN Recommended Practices (7) have guidelines for operating rooms and procedure areas in the management of small miscellaneous items and device fragments to prevent their inadvertent retention, and these guidelines should be consulted. Hospitals and surgical technologists can look into programs of certification. The Association of Surgical Technologists will be meeting in San Francisco in early June 2011(8) and will provide an opportunity to look into the increasing professionalism of this group of “content experts” so we can work together to make sure there is “NoThing Left Behind.”

References

1. CDPH Issues Administrative Penalties to 12 Hospitals — 11/12/2010.

2. Gibbs VC, Coakley RD, Reines HD. Preventable errors in the operating room: retained foreign bodies after surgery — part 1. Curr Probl Surg. 2007; 44:281.

3. Greenberg CC, Regenbogen SE, Lipsitz SR et al. The frequency and significance of discrepancies in the surgical count. Ann Surg. 2008 248:337

4. Gibbs V.C. — NoThing Left Behind®: A National Surgical Patient Safety Project to Prevent Retained Surgical Items — 10/1/2004.

5. FDA Public Health Notification: Unretrieved Device Fragments. 2008.

6. Daly PM, Brophy T, Steatham J, Srodon PD, Birch MJ. Unretrieved Device Fragments — the clinical risk of  using poor quality surgical instruments. Medical Device Decontamination. 2010: 14:18.

7. AORN, Perioperative Standards and Recommended Practices, July 2010.

8. Association of Surgical Technologists.

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