Implant documentation

AORN Journal,  Feb, 2008  by Bonnie Denholm

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QUESTION: At a recent Surgical Services Department meeting, the definition of the term implant came up in our discussions about documentation. Some nurses believe that all devices including staples placed into the patient's abdominal cavity should be documented on the intraoperative record. Staff members suggested a variety of items that might be considered implants, including indwelling urinary catheters and percutaneous endoscopic gastrostomy (PEG) tubes, which may be in place when patients are discharged to home. What is AORN's definition of an implant? Are there criteria for including an item on the implant log? What information pertaining to implants should be documented on the intraoperative record?

ANSWER: AORN does not have a definition of an implant. Perioperative RNs should refer to the definition found in the US Food and Drug Administration (FDA) document titled "Medical device tracking; guidance for industry and FDA staff," which states:

   A permanently implantable device is a device
   that is intended to be placed into a surgically
   or naturally formed cavity of the human body
   for more than one year to continuously assist,
   restore, or replace the function of an
   organ system or structure of the human body
   throughout the useful life of the device. The
   term does not include any device which is intended
   and used only for temporary purposes
   or which is intended for explantation in one
   year or less. (1)

The FDA definition has been in place for many years, but perioperative RNs have asked questions about the definition of an implant in AORN Journal Clinical Issues columns dating back to 1989. At that time, Mary O'Neale, RN, MN, CNOR, clarified that

   Drains, such as penrose drains, gastrostomy
   tubes, nasogastric tubes, and chest tubes are
   not considered implants. These devices are
   not totally contained within the body, and
   probably will be removed within a short period
   of time after they are inserted. (2(p736))

Indwelling urinary catheters and PEG tubes are considered drains and do not need to be included on an implant log. Myringotomy tubes and Kirschner wires would not need to be included on an implant log if the plan is to remove them or, in the case of myringotomy tubes, if they are expected to work their way out of the ear canal as the tympanic membrane heals. If wires or tubes are used as a permanent solution for a patient's condition, they should be documented on the implant log for tracking purposes.

In an AORN Journal Clinical Issues column in 2000, Carol Petersen, RN, MAOM, CNOR stated that

   Surgical staples used for [gastrointestinal] GI
   anastomosis are considered implant[s] by the
   FDA according to [their] definition. Surgical
   staples, such as those used for GI anastomosis,
   however, do not meet the criteria the
   FDA uses to decide whether a device should
   be tracked. (3p238))

The FDA definition is not specific regarding staples or ligating clips that are used in place of sutures for anastomosis, hemostasis, or closure. These items do not meet the criteria for device tracking; therefore they do not need to be documented on an implant log.

According to the FDA requirements, devices that meet the following criteria are the only items that should be included on implant logs. Items that

* would be likely to cause a serious adverse health consequence if they fail,

* are life sustaining or life-supporting, or

* are designated in the Federal Register as required for tracking (Table 1). (1)

AORN does not have a specific list of what implants should be documented. According to AORN's "Recommended practices for documentation of perioperative nursing care," (4) intraoperative record documentation should include, but not be limited to, the following. For implants (eg, medical devices, synthetic and biologic grafts, tissue, bone), document the

* placement and location of the implants,

* name of the manufacturer or distributor,

* lot and serial numbers,

* type and size of implant,

* expiration dates as appropriate, and

* other information required by the FDA.

For drains and catheters, document the

* type of drain or catheter;

* location of the drain and catheter; and

* size, when applicable (eg, 18-fr indwelling urinary catheter, 12.5-fr Hickman catheter). (4)

Important considerations when creating policies and procedures for documentation of implants include

* the FDA definition of an implant,

* their requirements for tracking implantable devices, and

* documentation requirements for the intraoperative record.

The perioperative administrator should collaborate with the facility risk manager to evaluate facility compliance with federal, state, and local requirements regarding implant documentation.

The perioperative administrator also should be aware of updates to the FDA document entitled "Medical device tracking; guidance for industry and FDA staff," Recent changes to this document can be found in Table 2.