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• Standard Number: 1910.1030

April 25, 1994

Mr. Jeff Hennelly
Strategic Manager
Mallinckrodt Medical TPI, Inc.
263 Zvarick Road
Collegeville, Pennsylvania 19426

Dear Mr. Hennelly:

Thank you for your letter of March 29, 1993, in which you requested that OSHA provide an opinion concerning two different methods of inner cannula care, the disposable cannula and the reusable cannula.

OSHA does not review or endorse products as you have requested. The final determination of compliance with OSHA's Bloodborne Pathogens standard, 29 CFR 1910.1030, must take into account all factors pertaining to the use of such devices at a particular worksite. This must include an evaluation through direct observation of employee work practices as well as an evaluation of the potential exposure to blood or other potentially infectious materials (OPIM) which the use of the device will cause an employee.

As you are aware, the Bloodborne Pathogens standard attempts to minimize the employee's exposure to blood or OPIM. OSHA does not mandate that facilities use disposable devices in order to accomplish this goal. The employer should make the determination whether the reusable or the disposable device better satisfies their needs.

We are enclosing the copy of the videotape which you provided us for review. We appreciate your interest in safety and health.

Sincerely,



Ruth E. McCully, Director
Office of Health Compliance Assistance




March 29, 1993

Ruth McCully
OSHA
Director of the Office of Health Compliance
N 3469
200 Constitution Ave. N.W.
Washington, DC. 20210

Ms. McCully,

Presently, over ninety percent of adult tracheostomy patient's trach tubes employ inner cannulas. The inner cannula of a trach tube is primarily a safety feature as it collects secretions, and thus is taken out and replaced with a sterile inner cannula, or re-cleaned, depending on the type of trach tube.

I have enclosed sample protocols of tracheostomy care with disposable inner cannulas and tracheostomy care with reusable inner cannulas. I have also enclosed a video on trach care.

Since Mallinckrodt Medical manufactures trach tubes with disposable and reusable inner cannulas, we are very interested in OSHA's opinion on the two different methods of inner cannula care. Specifically: based on your 29 CFR 1910.1030 Occupational Exposure to Bloodborne Pathogens Guidelines, what protective measures should a care-giver take when re-cleaning a patient's inner cannula? And, could disposable inner cannulas be considered an engineering control devise' (ie. needleless syringes, Sharps Containers, ect.) as they are often used as a means to reduce the risk of infection?

Clinicians often come to us for advise on trach care and it is our desire to be in accordance with the Occupational Safety and Health Administration. Thank you for your attention to this matter.

Sincerely,



Jeff Hennelly
Strategic Manager
Mallinckrodt Medical

TRACHEOSTOMY: CARE WITH DISPOSABLE INNER CANNULA

POLICY:

Tracheostomy care is performed using aseptic technique and in accordance with a physician's order.

LEVEL OF RESPONSIBILITY: RN/LPN

EQUIPMENT:

1. Non-sterile gloves 2. Sterile gloves 3. Sterile normal saline solution 4. Hydrogen peroxide 5. Tracheostomy dressing 6. Tracheostomy brush 7. Sterile 4 x 4 gauze 8. Plastic bag 9. Tracheal and nasopharyngeal suctioning catheter and equipment 10. Velcro tracheostomy holder 11. Sterile Q-tips 12. Goggles, optional

PROCEDURE:

1. Verify physician's order, including

* Frequency of changing tracheostomy tube

2. Assemble equipment

An obturator and extra tracheostomy kit and suction catheter must be kept at the resident's bedside at all times.

3. Identify the resident

4. Explain procedure

5. Provide privacy

6. Wash hands

7. Position resident in a Semi-Fowler position, unless contraindicated

8. Put on non-sterile gloves

9. Remove and discard soiled dressing in impervious bag (glove may serve as impervious bag). Put new non-sterile glove on other hand

10. Assess condition of stoma (redness, swelling, character of secretions, presence of purulent drainage, and/or bleeding)

11. Suction the resident prior to cleaning inner cannula. Refer to MHC Nursing Policies and Procedures Manual: Section S, "Suctioning: Tracheostomy/Endotracheal"

12. Unlock the inner cannula and remove it gently, following the curvature of the tube

13. Discard the inner cannula

14. Dip applicator into solution of hydrogen peroxide and sterile normal saline and cleanse skin area around stoma site

15. Clean the flange of the outer cannula with applicators soaked in sterile normal saline solution

16. Insert the new inner cannula following the curvature of the tube

17. Snap the inner cannula into place

18. Remove and discard gloves

19. Secure Velcro tracheostomy holder in place. Change velcro holder when necessary

20. Wash hands

21. Put on sterile gloves

22. Place clean tracheostomy dressing around the tube

23. Reassess respiratory status

24. Assist resident with mouth care

25. Assist resident to comfortable position with call light within reach

26. Wash hands

TRACHEOSTOMY: CARE WITH DISPOSABLE INNER CANNULA

(continued)

SUGGESTED DOCUMENTATION:

* Date and time * Respiratory assesment during treatment (any evidence of respiratory distress) * Condition of stoma (redness, swelling, character of secretions, presence of purulence or bleeding)

AFTERCARE OF EQUIPMENT:

* Place used disposable articles and gloves in plastic bag and discard If not contaminated, dispose of in regular waste If contaminated, dispose of in infectious waste

DEPARTMENT NURSING

NURSING PROCEDURE MANUAL

TRACHEOSTOMY CARE: CHANGING DISPOSABLE INNER CANNULA

I. PURPOSE: KEY POINTS: To maintain a clear airway when an effective cough is not present.

II. EQUIPMENT: A. Disposable inner cannula Obtain from Central Medical (same size as being changed) Supply (CMS).

B. Sterile gloves (two pairs) Obtain from CMS. C. Sterile suction catheter Obtain from CMS. D. Tonsil tip suction tube Obtain from CMS.

III. GENERAL INSTRUCTIONS: A. Keep obturator and replacement tube of same size and type at bedside at all times.

B. Change inner cannula once per Prevents secretions from shift or more frequently if obstructing tracheostomy necessary. tube.

C. Patients who are to be Teaching in the hospital and discharged to their home with a competent demonstration by trach tube should be taught patient will increase sense care of their own inner of security when patient is cannula. discharged to their home.

D. Basics to remember: 1. Aseptic technique used for routine procedure.

2. Treat trach site as a surgical wound until healed.

3. Patients may experience Prepare patient for the sensations such as hurting, procedure to reduce emotional choking, or pressure distress & facilitate coping at the trach site. during activities involving movement of trach tube.

IV. STEPS IN PROCEDURE: A. Explain procedure to patient and reason for trach care.

B. Place patient in semi-fowlers position as tolerated.

C. Obtain supplies and check functioning of suction equipment.

D. Wash your hands. E. Set up equipment for changing inner cannula and open the disposable inner cannula.

F. Suction orolpharynx with tonsil tip suction tube prior to suctioning trach or have patient expectorate oral secretions.

G. Suction tracheostomy tube. Follow procedure, Tracheostomy or Endotracheal Tube Suctioning.

H. Put on sterile gloves. Keep dominant hand sterile throughout procedure.

DEPARTMENT OF NURSING

NURSING PROCEDURE MANUAL

TRACHEOSTOMY CARE: STOMA CARE WITH DISPOSABLE INNER CANNULA

I. PURPOSE: KEY POINTS: To keep tracheostomy stoma clean to minimize possibility of skin breakdown and infection.

II. EQUIPMENT: A. Twill tape Obtain A-D from C.M.S. B. Sterile disposable cannula and container C. One 4x4 pre-cut trach dressing D. Two 4x4 gauze or four sterile cotton tip applicators E. Normal saline (pour bottle) Obtain from C.S.S. F. Hydrogen peroxide Obtain from Pharmacy. G. Scissors Obtain from Nursing Unit.

III. GENERAL INSTRUCTIONS: A. Care includes cleaning around Frequent changing of stoma, changing dressing, and dressing minimizes presence replacing the trach tie. of bacteria near the stoma.

B. Stoma care is performed as needed to keep skin clean and dry. Performed routinely when disposable inner cannula is changed.

C. Trach tube ties should not be Notify physician if ties, changed during the first week need to be changed during after procedure. After the the first week. first week, R.N. may change the ties as needed.

D. Treat stoma as a surgical wound until it has healed.

E. If 4x4 non-cut dressing is used in place of pre-cut trach dressing, do not cut 4x4 as the threads from dressing could get into the trachea. Instead, fold 4x4 and place under the neck plate around trach tube.

IV. STEPS IN PROCEDURE: A. Wash your hands. B. Pour small amount of hydrogen peroxide into one well of disposable cannula container and small amount of normal saline into other well.

C. Remove and discard old trach dressing.

D. Clean stoma site with cotton applicators (or 4x4 gauze) dipped in hydrogen peroxide then rinse site with saline-soaked cotton applicators.

Subject: Tracheostomy Care Using Shiley Disposable Inner Cannula

Purpose: To provide guidelines for trach care using the DIC

Equipment: Simple suction set up, suction tubing, 1 liter bottle NS labeled with date opened (not to be used longer than 24 hours), hydrogen peroxide, Shiley Disposable Inner Cannula (DIC), sterile Q-tips.

Functions Affected: Nursing

1. Position patient's head to facilitate access to tracheostomy.

2. Insert suction catheter into trach tube to the desired length, remove in a rotating motion while applying suction. Note: Do not occlude airway for greater than 8-10 seconds in adult or 3-5 seconds in children. If the patient is on a ventilator or receiving oxygen therapy: Preoxygenate by delivering three breaths with ambu bag prior to and after suctioning.

3. Remove DIC (disposable inner cannula) from patient.

4. Discard DIC.

5. Open DIC package.

6. Remove DIC from package keeping package sterile.

7. Insert new DIC into trach.

8. Pour NS into sterile DIC package.

9. Clean stoma site with peroxide soaked Q-tips.

10. Rinse with NS.

11. Place 4x4 or precut sponge around trach.

12. Change tracheostomy ties every 24 hours and prn.

13. DIC is to be changed every 8 hours.

Product Use Guidelines: Shiley Disposable Inner Cannula 4497N


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