DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850

April 17, 1997

Dear Colleague:

I am writing to ask that you alert your members to a potential infection problem with medical devices that are rented or leased by health care facilities. I am also asking that you convey to your members the recommendations listed below, which can help avoid this problem.

It has recently come to our attention that reusable (nondisposable) medical devices rented or leased from third parties may not be properly cleaned, disinfected and/or sterilized prior to delivery to the health care facility. Also, when health care facilities exchange equipment with other institutions, it may be improperly cleaned, disinfected and/or sterilized either before or after patient use.

Although we do not have information on how often this occurs, nor which devices are most likely to be involved, we believe the potential seriousness of the problem warrants bringing it to your attention. Improper handling of devices between uses can contaminate facilities and expose individuals, including health care providers and couriers who come into contact with this equipment, to infectious, biohazardous material. Also, the presence of residual organic material on such equipment may compromise the effectiveness of sterilization procedures.

• Rental/leasing contracts between health care facilities and third parties may fail to clearly identify the party responsible for cleaning, disinfecting and/or sterilizing used medical equipment. In some cases, no contract may exist.

• It may be unclear whether health care facility personnel who handle this equipment must clean, disinfect, and/or sterilize it after use, before it is returned to the third party supplier.

1. Health care facilities renting or leasing reusable medical devices from a third party should review all rental/leasing contracts, agreements and other written documents to ensure that the parties responsible for cleaning, disinfecting and/or sterilizing the equipment are clearly identified.
2. If the health care facility is responsible for cleaning, disinfecting and/or sterilizing equipment for reuse, it should ensure that all appropriate personnel are aware of this responsible and are properly trained and equipped to perform these tasks.
3. If a third party is responsible for cleaning, disinfecting and/or sterilizing equipment for reuse, the health care facility should review the third party's operating procedures to determine that its facilities, equipment, processes and personnel are adequate to perform these operations. The health care facility should be sure that the third party is familiar with the manufacturer's instructions for cleaning, disinfecting and sterilizing the device. (FDA is now recommending that such instructions be provided for newly marketed devices.)
4. If a third party is responsible for cleaning, disinfecting and/or sterilizing equipment for reuse, the health care facility must ensure that its own personnel are properly trained and equipped to handle, package, and label contaminated equipment for shipment back to the supplier.
5. In some cases, third-party suppliers may also reprocess or refurbish medical devices between uses. When the contract calls for these services, the health care facility should ensure that the supplier is familiar with the device manufacturer's specifications for the product. Health care facilities may wish to establish quality assurance procedures to be sure that reprocessed or refurbished devices fulfill these specifications.

The Center for Devices and Radiological Health is interested in collecting data on adverse events that may have resulted from improperly cleaned, disinfected and/or sterilized medical devices. We ask that you encourage your members to report such incidents. Practitioners employed by health care facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Practitioners not employed by facilities required to submit such reports can report the incident directly to MedWatch, the FDA's voluntary reporting program. The reports and be submitted by phone at (800) FDA-1088, by FAX (800) FDA-0178, or by mail to:

If you have any questions regarding this letter, please contact Nancy Pressly, Office of Surveillance and Biometrics, Center for Devices and Readiological Health, HFZ-510, 1350 Piccard Drive, Rockville, MD 20850; by Fax at (301) 594-2968; or by e-mail nap@cdrh.fda.gov.

Thank you for helping us disseminate this information.

Sincerely yours,

D. Bruce Burlington, M.D.
Director,
Center for Devices and Radiological Health

1. Association for the Advancement of Medical Instrumentation (AAMI) and American National Standards Institutes (ANSI): Good Hospital Practice: handling and biological decontamination of reusable medical devices. In AAMI standards and recommended practices. Vol. 1.1: sterilization. Part 1: good hospital practices. Arlington VA: AAMI, 1995:393-414.
2. Association for the Advancement of Medical Instrumentation (AAMI). Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities. In: AAMI standards and recommended practices. Vol. 1.2: sterilization. Part 1: hospital equipment and industrial process control. Arlington VA: AAMI, 1995: 581-641.
3. Recommended practices for sterilization and disinfection. In AORN standards and recommended practices for perioperative nursing. Denver: Association of Operating Room Nurses, 1991.
4. ECRI. Healthcare Risk Control Vol.3 [Risk Analysis] Medical Technology 6. Borrowing and lending equipment. Reissued Jan. 1996. Plymouth Meeting, PA 19462-1298.
5. Questions and Answers for the FDA Reviewer Guidance: Labeling reusable medical devices for reprocessing in health care facilities. CDRH, FDA. (A copy of this document can be obtained by FAXing (301) 443-8818 and requesting document #198.)