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A quarterly
bulletin to assist hospitals, nursing homes, and other device user facilities |
The Food and Drug Administration (FDA) announced on February 14, 2002, a change in the enforcement deadline for class II reprocessed single-use devices (SUD) and reminded hospital SUD reprocessors of the agency's enforcement policy for premarket requirements as follows:
FDA is extending the deadline for active enforcement of premarket notification submission requirements for class II SUDs until August 14, 2002, provided that the reprocessor:
FDA may actively enforce premarket approval requirements for class III SUDs on February 14, 2002.
FDA may take enforcement action against any class I SUD if:
*Other than the class II and class I devices that are exempt by regulation from the 510(k) requirements of the Food, Drug, and Cosmetic Act.
The Food and Drug Administration (FDA) has contracted with the Association for the Advancement of Medical Instrumentation (AAMI) to provide training for hospitals that are reprocessing single-use devices (SUDs). A 2-hour live virtual seminar is being offered on March 7, 2002, 11:30 a.m. - 1:30 p.m. EST. The seminar will cover essential FDA regulations pertaining to the reprocessing of SUDs such as:
See the AAMI flyer on below for additional information about the seminar.
AAMI VIRTUAL SEMINAR FOR HOSPITALS
FDA REGULATIONS
FOR REPROCESSING SINGLE-USE DEVICES
March 7, 2002, 11:30 am - 1:30 pm EST
This seminar is a 2-hour live virtual seminar on FDA regulations for hospitals and other institutions that are currently reprocessing single-use devices (SUDs) or thinking about reprocessing in the future. This program is offered only once, so be sure to mark your calendar.
BACKGROUND
In August 2000, the FDA released a final guidance on the practice of reprocessing
and reusing medical devices that are intended to be used only once entitled,
"Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties
and Hospitals." In this document the FDA states that hospitals and third
parties that reprocess SUDs will be regulated in the same way as original
equipment manufacturers. This means that hospitals, whether reprocessing SUDs
in-house or outsourcing reprocessing activities to a third party, are subject
to the requirements of the Food, Drug, and Cosmetics Act just as manufacturers
are.
In light of these requirements, the FDA has contracted with AAMI to develop this virtual seminar so that you can better understand the regulations. Organizations supporting AAMI in offering the seminar include the Association of Medical Device Reprocessors and the American Society for Healthcare Central Service Professionals.
WHY YOU SHOULD PARTICIPATE
This interactive and dynamic 2-hour seminar will cover essential FDA regulations
pertaining to reprocessing of SUDs and important information that you and
your hospital need to know about compliance. Learn about:
FACULTY
Thomas Muldoon, a member of the law firm Bell, Boyd & Lloyd, LLC, will
be the featured presenter for this program. A noted and recognized speaker
on the subject of Food and Drug law, Mr. Muldoon is an adjunct professor at
both DePaul University and Loyola University School of Law.
For registration information, please visit the AAMI web site: http://www.aami.org/meetings/reuse/virtualreg.html
Editor's Note: This article is particularly relevant for our readers who care for elderly patients |
Improper use of denture cleaners can have serious consequences as evidenced
by the following cases reported to the Food and Drug Administration through
its Medical Device Reporting (MDR) System.
Case 1: An 81-year-old man soaked his dentures in an over-the-counter (OTC) denture cleanser and then gargled with the remaining solution. His tongue became swollen and blue. Despite emergency efforts that included CPR and administration of isosorbide dinitrate, he died at the scene.
Case 2: An 84-year-old woman with a history of Alzheimer's dementia, confusion, and paranoia ate one tablet of an OTC denture cleanser. Afterward, she vomited a green substance, became delirious, and required treatment in the emergency department.
Case 3: A 74-year-old nursing home resident with bronchitis ate about six denture cleanser tablets. She was found foaming at the mouth and having difficulty breathing. Her esophagus was irritated and her chest distended. After suffering cardiopulmonary arrest, she received CPR, was admitted to the hospital, and survived.
What went wrong?
Denture cleansers are not intended for internal use, but in the above cases, they were gargled or swallowed. Some OTC denture cleansers contain ingredients associated with allergic reactions1, including anaphylaxis. Other ingredients may irritate mucosa and may be toxic if ingested.
What precautions can you take?
When your patients use denture cleaners, take these steps:
Reporting Adverse Events
Although you are encouraged to follow your facility's adverse event reporting requirements, you may voluntarily report medical device problems to FDA's MedWatch program. Reporting will help to identify and address device-related public health issues:
Reference
1LeCoz, C., and Bernard, M.: "Allergic Contact Cheilitis Due to Effervescent Dental Cleanser: Combined Responsibilities of the Allergen Persulfate and Prosthesis Porosity," Contact Dermatitis. 41(5):268-271, November 1999.
Janie Fuller, DDS, MPH, is the Director, Regulatory Review Office, in CDRH's Office of Surveillance and Biometrics.
* Adapted from Nursing 2001, Volume 31, Number 12.
If you would like to be notified electronically (via e-mail) when a new issue of the User Facility Reporting Bulletin is released, you can sign-up for our List Service at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCDRHNew/listman.cfm
Please share this information with your colleagues. They’ll thank you for it!
The Food and Drug Administration (FDA) plans to develop guidance on how reprocessed single-use devices (SUDs) may be labeled, including whether the original equipment manufacturer's (OEM) trademark or name should remain on the reprocessed device along with the identity of the remanufacturer (i.e., reprocessor). FDA invites comments and suggestions on the content of the guidance document. A notice entitled Medical Devices; Guidance on Labeling of Reprocessed Single Use Devices; Request for Comments and Information was published in the December 20, 2001 Federal Register (http://www.fda.gov/OHRMS/DOCKETS/98fr/122001b.htm).
Background
The Association of Disposable Device Manufacturers requested in a citizen's petition (March 22, 2001) that FDA:
On September 17, 2001, FDA denied the petition because it believed that any misleading implications from the OEM's labeling could be remedied by the reprocessor providing additional information about its responsibility for product problems. FDA also said that it would publish a guidance document that will recommend more specific language and directions on the matter.
Standards may be as useful in premarket notification (510(k)) submissions for reprocessed single-use devices (SUDs) as they are for 510(k)s from original equipment manufacturers. The following documents explain FDA's policy about the use of standards.
Standards recognized by FDA that may be useful to reprocessors of single-use devices, such as those for sterilization, biocompatibility, and safety/performance, can be found by searching the Standards web site at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
USER FACILITY REPORTING BULLETIN FDA produces the User Facility Reporting Bulletin quarterly 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, the Medical Device Amendments of 1992, and the Food and Drug Administration Modernization Act of 1997. The Bulletin's contents may be freely reproduced. Comments should be sent to the Editor. Editor: Nancy Lowe Department of Health and Human Services |
Updated March 1, 2002
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