​Over the past 18 months, the Department of Health Services was notified of events in healthcare facilities where reusable semicritical medical instruments were routinely not subjected to adequate high level disinfection or sterilization. These included the following:

1. An outbreak of Pseudomonas aeruginosa in an acute care hospital was related to rigid laryngoscopes used to intubate neonates which were subjected to cleaning but no further reprocessing. According to the hospital, the laryngoscope blade manufacturer recommends cleaning (including soaking in enzymatic solution) and then either disinfection using glutaraldehyde or autoclave sterilization. 

2. An acute care hospital reported that facility staff had not been disinfecting bougies (solid non-lumened silicon instruments used to dilate the esophagus) according to the manufacturer’s recommendations. This practice had been ongoing since 2003; 64 patients were identified for possible exposure to bloodborne pathogens. The identified patients were notified by their physicians.

3. An acute care hospital reported that a per diem medical assistant, previously trained and found to be competent to clean and sterilize gastrointestinal endoscopes, had been reassembling the parts of endoscopes incorrectly and may not have correctly sterilized the internal parts as recommended by the manufacturer. Patients on whom the endoscopes had been used were notified by their physicians. 

4. An acute care hospital reported that during infection control rounds it was discovered that flexible laryngoscopes used for difficult intubations were being reprocessed in the surgery department, using a single automated reprocessor. When the reprocessor was unavailable due to maintenance procedures, the laryngoscopes were cleaned but not disinfected. Patients who had been intubated at those times were notified and tested for tuberculosis. 

5. An outbreak of E. coli respiratory tract infections in an acute care hospital was related to the use of a transesophageal echocardiography probe that was frayed and should have been returned to the manufacturer for repair or replacement.

In addition to failures to perform disinfection or sterilization as recommended, the Department continues to be notified of deficiencies in reprocessing of endoscopes as described in the All Facilities Letter AFL 04-21, October 12, 2004, Immediate Assessment of Endoscope Reprocessing Procedures and Event Notification. These deficiencies, although less common than prior to the AFL, continue to be primarily the result of human error.

Attached are general recommendations for reprocessing rigid laryngoscopes. These are provided as a guide in the development of specific policies and procedures for the reprocessing these items, in conjunction with the reprocessing instructions provided by the laryngoscope’s manufacturer. Recommendations for the reprocessing of other semicritical devices have not been provided here; it is presumed that the facility will reference manufacturer’s recommendations for that equipment and write their reprocessing policies accordingly.

It is recommended that each facility review their existing policies and procedures, and modify them as indicated for the facility and the type and model of each instrument. It is also strongly recommended that infection control staff conduct a thorough inspection of all areas in their facilities where such instruments are used. Areas include crash carts on nursing units, surgery, emergency department, intensive care, invasive radiology, gastroenterology, pulmonology, etc. Actual practices for reprocessing should be observed. When reprocessing changes are indicated, stake-holding staff should be involved in the improvement process. Occurrences of inadequate reprocessing identified should be reported as unusual occurrences to the Licensing and Certification district office with jurisdiction over the facility as well as to the local health department. Please contact Jon Rosenberg or Sue Chen at (510) 620-3434 or Marian McDonald at (707) 576-2380 if you have any questions or comments.

Sincerely,

Original Signed by Pamela Dickfoss for Kathleen Billingsley, R.N.

Kathleen Billingsley, R.N.
Deputy Director

Attachments:

Disenfection of Medical Instruments

Recommendations for Reprocessing Rigid Laryngoscopes

cc: District Office Managers and Administrators
District Office Preceptors
Central Training Unit