Retained Foreign Objects Part I: Definition and Considerations
By Kelsey O'Brien
Retained foreign objects are generally considered “never events” in medicine; the presence of a retained foreign object is a serious and preventable incident that should never occur in a healthcare setting.
When Is An Object Considered Retained?
A foreign object is generally considered “retained” if it is left behind at the end of surgery. The American College of Surgeons has endorsed the National Quality Forum’s definition of “end of surgery” as the moment “…after all incisions or procedural access routes have been closed in their entirety, device(s) such as probes or instruments have been removed, and, if relevant, final surgical counts confirming accuracy of counts and resolving any discrepancies have concluded and the patient has been taken from the operating/procedure room,” where applicable. In other words, a foreign object is not considered retained if it is identified intraoperatively and removed prior to surgical closure.
When Is An Object Considered Foreign?
In determining whether an object is “foreign” under CPLR 214(a), Courts consider the nature of the materials implanted, as well as their intended function. See, Rockefeller v. Moront, 81 NY2d 560, 564, 618 NE2d 119, 601 NYS2d 86 (1993); Walton v. Strong Mem. Hosp., 25 NY3d 554, 573, 14 NYS3d 757, 35 NE3d 827 (2015). Generally, materials considered foreign objects are those which serve no intended continuing treatment purpose post-operatively. This can include—but is not limited to—surgical paraphernalia like clamps, scalpels, scissors, and sponges. These objects serve a temporary medical function intraoperatively, but are intended to be removed upon the procedure’s end.
Other “foreign” objects are less straightforward.
In Walton, supra, an atrial catheter for cardiac monitoring was intentionally left in the body for several days postoperatively. However, when the catheter was removed, a fragment was inadvertently left behind. The Walton Court held that the retained catheter fragment was not a fixation device, but instead should be considered a foreign object.
Differentiating Fixation Devices from Retained Foreign Objects
Generally, a foreign object is not a “fixation device,” chemical compound, or prosthetic aid (such as a prosthetic joint implant). For example, a plastic nasal stent applied for postoperative healing purposes was held to be a fixation device that did not constitute a “foreign object.” (LaBarbera v NY Eye & Ear Infirmary, 91 NY2d 207 [1998]). An IUD has been held to be a fixation device. (Rodriguez v Manhattan Med. Group, P.C., 155 AD2d 114 [1st Dept 1990]). Another fixation device was held to be a suture which was deliberately placed intraoperatively, but on an incorrect organ. Rockefeller, supra. Fixation devices are intentionally placed for a continuing (even if temporary) treatment purpose, but it does not follow that everything that is intentionally placed for a continuing treatment purpose is a fixation device.
The Impact and Prevention of Retained Foreign Objects
Retained foreign objects can clearly have an adverse and substantial impact upon patients, including physical and emotional harm. Patients can experience complications such as generalized pain, infection, or the need for further surgical intervention. The response to—and medical management of— retained foreign objects also has a profound financial effect on the health care providers, institutions, and their malpractice insurers.
Reasonable precautions should be taken perioperatively to reduce the risk of retained foreign objects. Traditional methods for preventing retained foreign bodies have centered on visual inspection of the surgical site and manual counts; this comes with the obvious risk of human error, potentially due to miscommunication, time pressure, or other environmental distractions. Post-operative imaging such as plain radiographs (x-rays) may also be useful if there is a suspicion of a retained foreign object.
Technological Advances Improve Outcomes
Within the last several years, the medical device industry has made significant advances in identifying potentially retained foreign objects prior to surgical closure. For example, Medtronic's Situate Detection System uses low-frequency radio waves to detect sensors embedded in sponges. Another method, Stryker's SurgiCount Safety-Sponge System, uses a technology that tracks every medical sponge by way of a unique identifying barcode or tag.
In our current advent of Artificial Intelligence, one can only imagine that new and improved methods of risk reduction strategies will emerge in improving patient outcomes and reducing potential medical and legal liability exposure.
If you have questions about retained foreign object cases or other facets of medical malpractice law, please contact Kelsey O’Brien.
