Releasing explanted medical devices

AORN Journal, June, 2008 by Sharon Giarrizzo-Wilson

QUESTION: A number of our orthopedic surgeons are making arrangements to have exp[anted appliances returned to their patients. Is this an acceptable practice? What information should be included in our policy before explants are released to patients?

ANSWER: Removed implanted hardware legally belongs to the patient as a purchased component of the surgical procedure; however, any item removed intraoperatively from a patient is considered a surgical specimen and should be sent to the laboratory for identification and documentation. (1,2) There is a growing trend in health care to release such devices to the patient after gross examination by the laboratory. With the exception of defective implants, which require mandatory reporting and return to the manufacturer, and explants that are regulated by the US Food and Drug Administration (FDA), some states may anecdotally hold health care organizations accountable for returning medical explants to requesting patients. (3,4) The Risk Management and Legal Departments should be consulted regarding state guidelines and the necessity for specific documentation before an item is released.

Some manufacturers require explants to be returned to their facility for compliance with FDA medical device tracking regulations and manufacturer investigation standards. In this situation, the clinician should counsel the patient regarding the FDA's requirements to return the item to the manufacturer. More information related to the FDA's medical device tracking regulation can be found in the document, "Guidance for industry and FDA staff medical device tracking," available at http:// www.fda.gov/cdrh/comp /guidance/169.pdf.

Policies and procedures for collecting and handling explanted medical devices should be developed to provide guidance to perioperative clinicians and to minimize risk to the patient recipient and the community. Minimum criteria for developing these documents include:

* specimen identification and safe handling guidelines;

* documentation procedures for the intraoperative record, laboratory examination, and specimen release forms;

* directions for how the hardware or medical device is to be cleaned, sterilized, and judged safe for release into the community;

* instructions not to release difficult-to-clean devices, including those with cracks, crevices, or other types of convoluted configurations;

* measures to take for hardware or medical device disposal when an item is not returned to the patient; and

* patient education requirements detailing the potential risks of keeping a medical specimen and the appropriate methods for disposing of the specimen. (1,5)

Policies regarding explants should be developed in collaboration with and approved by the Pathology Department chair and appropriate personnel from the Infection Control, Risk Management, and Legal Departments. (1,2,5) When properly written, a well-defined policy establishes authority and accountability while providing operational guidelines for the safe handling and release of explanted medical devices.

REFERENCES

(1.) Recommended practices for the care and handling of specimens in the perioperative environment. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc; 2008:557-564.

(2.) College of American Pathologists policy on surgical specimens to be submitted to pathology for examination. College of American Pathologists. http:// www.cap.org/apps/docs/laboratory_accreditation /surgical_specimens.pdf. Accessed March 25, 2008.

(3.) Medical device tracking: guidance for industry and FDA staff. US Food and Drug Administration. http://www.ffda.gov/cdrh/comp/guidance/16.pdf. Accessed March 25, 2008.

(4.) Title 21--food and drugs chapter I, subchapter h--medical devices; part 821 medical device tracking requirements. US Food and Drug Administration. http://www.accessdata.fda.gov/scripts/cdrh/cf docs/cfcfr/CFRSearch.cfm?CFRPart=821. Accessed March 25, 2008.

(5.) Merrick T, Carter D. Does the CAP have guidelines and recommendations regarding patient requests for gallstones? CAP Today. October 2002. http://www.cap.org/apps/cap.portal?_nfpb=true& cntvwrPtlt_actionOverride=/portlets/content Viewer/show&_windowLabel=cntvwrPtlt&cntvw rPtlt{actionForm.contentReference}=cap_toda y/q_and_a/qa_1002.html&_state=maximized &_pageLabel=cntvwr. Accessed March 25, 2008.

SHARON GIARRIZZO-WILSON

RN, MS, CNOR

PERIOPERATIVE NURSING SPECIALIST

AORN CENTER FOR NURSING PRACTICE