Apparatus and method to reduce the likelihood of wrong site surgery
The invention is an apparatus comprising a garment that prevents wrong site surgery. The garment comprises a garment portion, a warning, a patient information indicator, and a verification. The warning, patient information indicator and verification can be integral with the garment portion or printed on a separable medium. The method of the present invention comprises steps to prevent wrong site surgery including placing a garment on a non-operative body part, placing a warning on said garment, placing patient information on said garment, and requiring the patient or an authorized individual to verify that the patient is willingly undergoing the surgery. The above pieces of information can be removed from the garment and placed in the patient's medical record.
This application claims the benefit of U.S. provisional Application No. 60/545,667 filed Feb. 19, 2004.
FIELD OF THE INVENTIONThe invention is an apparatus and method designed to reduce the likelihood of wrong site surgery. One example of an operation being performed on a wrong body part occurs when, in the instance where there is an identical body part on either side of the body, an operation is performed on the incorrect side. The most obvious example is in the case of surgery that is performed on an extremity (arm or leg).
BACKGROUND OF THE INVENTIONWrong site surgery (WSS) is defined as: a) the wrong operation performed on a patient, b) an operation performed on the wrong patient or c) an operation performed on the wrong body part. Wrong site surgery is characterized as a preventable medical error and thus great efforts are being made to reduce the incidence of WSS.
Current methodologies to prevent WSS include the use of indelible markers and adhesive labels to identify appropriate surgical sites. These methodologies have inherent deficiencies and wrong site surgery continues to occur. A zero-tolerance policy for wrong site surgery has been mandated by major agencies and professional organizations that accredit health care providers. Therefore, a need exists for better methods to further reduce the likelihood of wrong site surgery.
SUMMARY OF THE INVENTIONIn one embodiment, the apparatus comprises a garment portion. The garment portion can be a sleeve, a partial sleeve or gown that is placed on a patient or worn by a patient during an operation. The garment portion is constructed from any material that would be suitable to come in contact with human tissue and would meet the operating room safety criteria. For example, the garment portion would be preferably made of a hypoallergenic and fire proof material. The sleeve embodiment of the garment is designed to be placed on and cover an entire extremity such as an arm or a leg. The partial sleeve embodiment of the garment is designed to be placed on and cover only a portion of an extremity such as a shoulder, elbow or wrist on the arm or a hip, knee or ankle on the leg.
In the instance where a surgeon is to perform an operation on a body part of which there are two, one on either side of the body, the garment is placed on the non-operative body part (“the non-operative body part”). An example is surgery to be performed on an extremity such as an arm or a leg. The presence of the garment on the non-operative side will prevent the creation of a sterile surgical field, and thus a wrong site surgery, on that part of the body.
The garment has several components that serve to collect, record, and convey important information regarding the surgery. A patient information indicator correctly identifies the patient name, surgery to be performed including the correct side, and the operating surgeon. A verification component confirms that the patient was an active participant in placing the garment on the non-operative body part. Said components can comprise data that is recorded on paper or other media suitable for printed information. In another embodiment, this information is recorded on material that has been integrated into the structure of the garment portion. Alternatively, the information may be recorded on paper or other media that is not integral to the garment. In this embodiment, the patient information indicator and the verification is recorded on separate material and then displayed by placing it into an information display means. In one embodiment, this display component is preferably a “pocket” with a transparent face that allows the information to be viewed by all who come into contact with the patient. The display means is placed on a visible area of the garment portion. The patient information indicator and the verification may be recorded on a suitable media, such as paper, that can be removed from the display means and then incorporated into the patient medical record.
Another feature of the garment communicates a warning, i.e., a message that the body part on which the garment is placed is not a surgical site and that the garment is to be removed only in the case of an emergency. The exact wording of this warning is discretionary and may be determined by medical staff, medical professionals or other personnel performing the surgery. One embodiment would result in the message being printed directly on the material that comprises the garment. Alternatively, the warning can be displayed in a display means as described above.
In another embodiment, a step of the inventive method is to place the garment on the side of the body on which surgery is not to be performed (“non-operative side”) or the non-operative body part. Patient information is also provided. Such information could preferably include the patient's name, the surgery to be performed including the correct side of the body, the surgeon who will be performing the operation as well as any additional information that may be necessary for patient safety. As described above, this information is recorded either on material integral to the garment or recorded on material that can be secured to the garment, for example, on paper that is inserted into a display means. Another step in the method is the verification step in which the patient or authorized individual verifies through a process such as a signature or an equivalent, that the patient is an active participant in the placement step and/or the patient identification step. In some embodiments, a witness may be required to verify the placement of the garment as well as the completion of the patient identification and/or verification steps. Preferably, copies of the patient information indicator and verification are made available for the health care provider.
In this way, the garment portion is visible to those involved with the surgery. The part of the body that is not scheduled for surgery is covered with the garment. As an example, if the operating surgeon mistakenly approaches the wrong body part to begin to prepare for the surgery he/she will encounter the garment. The presence of the garment will prevent the surgeon from preparing the body part for surgery. One of the invention's features will clearly inform the surgeon of the intent of the garment with a message such as “THIS IS NOT A SURGICAL SITE. REMOVE ONLY IN THE CASE OF AN EMERGENCY.” The surgeon can confirm all the important patient identification information from the area of the garment designed to display said information. An embodiment of the garment and method allows for the surgeon to confirm, by means of a signature or an equivalent, that he/she reviewed the important patient identification information prior to the start of the surgery.
One embodiment of the method allows for a copy of the patient identification and verification data to be removed from the garment at the end of the case and be incorporated into the patient medical record.
BRIEF DESCRIPTION OF DRAWINGS
Also shown in
Other embodiments of the garment involve the use of partial sleeves rather than full sleeves as shown in
The full sleeve embodiment of the garment 500 on a lower extremity comprise a garment portion 20 that covers the leg 65 from hip 34 to foot 36 thus preventing a wrong site surgery. The leg 65 is inserted into a first opening 501, and the foot 36 exits at a second opening 502 so that the entire extremity is covered. The garment portion 20 comprises a warning 60 that preferably indicates that no surgery is to be performed on the body part covered by the garment 500 and that the garment 500 should only be removed in the case of an emergency. The garment portion 20 also comprises a patient information indicator 70, which comprises information such as the name of the patient, the surgery to be performed including the correct location and the name of the operating surgeon. The patient information indicator 70 preferably also comprises verification 75 information such as the patient's signature verifying that he or she was an active participant in placing the garment 500.
While the invention has been illustrated and described in detail in the drawings and the foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes, equivalents, and modifications that come within the spirit of the invention defined by the following claims, are desired to be protected.
Claims
1. A garment to assist in the prevention of wrong site surgery, said garment comprising:
- a. a garment portion to be placed on a body part of a patient on which surgery is not to be performed;
- b. a warning on said garment portion, said warning comprising information indicating that surgery is not to be performed on said body part; and
- c. a patent information indicator.
2. A garment to assist in the prevention of wrong site surgery, said garment comprising:
- a. a garment portion to be placed on a body part of a patient on which surgery is not to be performed;
- b. at least one display means having a transparent face and secured to said garment portion, said display means having at least one opening;
- c. a warning dimensioned to fit inside of said at least one display means, said warning comprising information indicating that surgery is not to be performed on said body part, and
- d. patent information indicator dimensioned to fit inside of another of said at least one display means,
- wherein said patient information indicator and said warning able to be removed from said display means and placed in said display means.
3. A garment as claimed in claim 1 further comprising a verification.
4. A garment as claimed in claim 2 further comprising a verification.
5. A garment as claimed in claim 1 wherein said patient information indicator comprises information of an appropriate surgical sight.
6. A garment as claimed in claim 2 wherein said patient information indicator comprises information of an appropriate surgical sight.
7. A garment as claimed in claim 1 wherein said patient information indicator comprises said patient's name.
8. A garment as claimed in claim 2 wherein said patient information indicator comprises said patient's name.
9. A garment as claimed in claim 1 wherein said patient information indicator comprises a surgeon's name.
10. A garment as claimed in claim 2 wherein said patient information indicator comprises a surgeon's name.
11. A method to prevent wrong site surgery comprising the steps of:
- a. placing a garment on a body part on which surgery is not to be performed;
- b. placing a warning on said garment, said warning comprising information that surgery is not to be performed on said body part;
- c. placing patient information indicator on said garment.
12. The method of claim 10 further comprising the step of requiring said patient to verify that said patient is willingly participanting in said surgery thereby creating a verification.
13. The method of claim 10 further comprising the step of requiring an authorized individual to verify that the patient is willingly participating in said surgery thereby creating a verification.
14. The method of claim 10 further comprising the steps of:
- a. removing said patient indicator from said garment; and
- b. placing said patient information indicator in a medical record of said patient.
15. The method of claims 11 or 12 further comprising the steps of:
- a. removing said verification from said garment; and
- b. placing said verification in a medical record of said patient.
16. The method of claim 10 wherein said verification comprises a signature.
17. The method of claim 11 wherein said verification comprises a signature.
18. The garment of claim 1 wherein said garment portion is a sleeve.
19. The garment of claim 2 wherein said garment portion is a sleeve.
20. The garment of claim 1 wherein said garment portion is a wrap having two ends with a securing means on each end.
21. The garment of claim 2 wherein said garment portion is a wrap having two ends with a securing means on each end.
Type: Application
Filed: Feb 18, 2005
Publication Date: Aug 25, 2005
Inventor: Donald Keenan (Wexford, PA)
Application Number: 11/061,360