ALL BRANDS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-11-03 for ALL BRANDS * manufactured by *.

Event Text Entries

[16033226] In over 20 years as a health care provider, it is the reporter's experience that there are a few health care practitioners who take the time to properly disinfect their stethoscopes. Furthermore, in support of the reporter's first-hand experience, there is conclusive evidence of the potential for extensive cross infection between stethoscope and pt. So, while the cdc, osha, ama and other healthcare organizations recommend disinfecting stethoscopes, in practice, it is generally ignored. Though the case for stethoscope cleanliness seems self evident, it becomes even more pressing in light of recent studies that find residual blood and organic matter on stethoscopes used in hospital emergency rooms and maternal/infant units even after these instruments were cleaned. Therefore, especially where blood borne pathogens may be an issue, a protective barrier between stethoscope and pt may be the only practical solution for stethoscope cleanliness, since sterilization is not a feasible option. The public is becoming increasingly aware of infection control issues in hospitals and nursing homes. By way of example, abc's tv news, prime time edition, thursday, 2003, aired a report on hospital acquired infections. On the program, the doctor stated that infections are spread "right there by your own doctor and your own nurse by contaminated stethoscopes. " likewise, recently several prestigious newspapers, such as the chicago tribune, the pittsburgh tribune review and the reader's digest have run articles concerning the problem of infection control in hospitals. Thus, the reporter respectfully requests that the fda incorporate into their recommendations and guidelines that in the case where disinfecting stethoscopes is not practical, hospitals, nursing homes, physicians and all healthcare professionals should use a disposable cover. Additionally, in areas of the hospital where stethoscopes commonly come in contact with blood, such as emergency rooms and maternal/infant units, disposable covers should be mandated since high level sterilization will damage the stethoscope.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1030037
• MDR Report Key: 498501
• Date Received: 2003-11-03
• Date of Report: 2003-10-28
• Date Added to Maude: 2003-12-03
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ALL BRANDS
• Generic Name: STETHOSCOPE
• Product Code: LDE
• Date Received: 2003-11-03
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 487248
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit	2003-11-03