User Facility Reporting Bulletin Spring 1997


By Lily Ng, R.N, M.S.N, M.P.H, and Mary Ann Wollerton, M.P.A.

Medical devices that are rented or leased from third parties or exchanged with other healthcare facilities may not be properly cleaned, disinfected, or sterilized before they are delivered. FDA does not know how often this occurs or which devices are most likely to be involved. However, the problem is serious enough to alert healthcare personnel about this improper handling of devices between uses. Devices that are not processed correctly can contaminate the facilities, the healthcare providers, and the medical device couriers with infectious biohazardous material. Also, any organic material that remains on the devices may compromise the effectiveness of sterilization procedures.

Sometimes rental/leasing contracts between healthcare facilities and third parties fail to clearly identify who is to clean, disinfect, and/or sterilize the used devices. Often, there is no written contract.

FDA recommends to healthcare facilities the following:

  • Review all rental/lease contracts to ensure that the parties responsible for cleaning, disinfecting, and/or sterilizing are identified;
  • If the healthcare facility is responsible, it should adequately train and properly equip its personnel to properly clean, disinfect, and sterilize;
  • If a third party is responsible, the healthcare facility should make sure that the company has adequate equipment, procedures, and personnel to clean, disinfect, and sterilize properly. It is also important that the company follow the device manufacturer’s instructions during these three procedures;
  • If the third party is responsible, the healthcare facility should teach its personnel how to correctly handle, package, and label contaminated devices for shipment back to the supplier; and
  • If the third party also reprocesses or refurbishes medical devices, the healthcare facility should ensure that the company knows the device manufacturer’s specifications for each product. Healthcare facilities may wish to establish quality procedures to ensure that reprocessed and refurbished devices fulfill these specifications.

FDA is collecting data on this reuse problem. Please report any related adverse events to FDA’s MedWatch voluntary reporting program by mail: MedWatch, HF-2, 5600 Fishers Lane, Rockville, Maryland 20857; by FAX: 1-800-FDA-0178; or by telephone: 1-800-FDA-1088.

If you have any questions regarding this article, please contact Nancy Pressly, by mail at CDRH/OSB, HFZ-510, 1350 Piccard Drive, Rockville, MD 20850; by FAX at 301-594-2968; or by e-mail at .

Lily Ng is a member of the Issues Management Staff in CDRH’s Office of Surveillance and Biometrics. Mary Ann Wollerton is a public health advisor in CDRH’s Office of Health and Industry Programs.

User Facility Reporting
A Quarterly Bulletin

The User Facility Reporting Bulletin is an FDA publication to assist hospitals, nursing homes and other medical device user facilities in complying with their statutory reporting requirements under the Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992.

The publication’s contents may be freely reproduced. Comments should be sent to the Editor.

Editor: Nancy Lowe
Assistant Editors: Herb Spark and Mary Ann Wollerton
Publication Design: Edie Seligson

Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health, HFZ-230
Rockville, MD 20857
FAX: (301) 594-0067

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Victoria M. Steelman RN, PhD(c), CNOR AORN Journal Jul 1997

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User Facility Reporting Bulletin
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Oregon picks up latex glove controversy
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Facilities react to growing number of allergies to latex
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Latex Allergy and Contraception
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Don Groce Latex Allergy News Oct 1996

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Paving, Asphalt, Tires & Latex Allergies
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Special Bulletin: Latex Allergy
American College of Allergy, Asthma & Immunology

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