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A quarterly
bulletin to assist hospitals, nursing homes, and other device user facilities |
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A male patient underwent surgery to repair a retinal tear. His eye was filled with a perfluoropropane gas bubble, and the retina was reattached. Four weeks after the retinal surgery, the patient had prostate surgery under general anesthesia. On awakening, he complained that he was unable to see light. He suffered central retinal artery occlusion that the ophthalmic surgeon thinks may have been caused by an expansion of the perfluoropropane gas bubble and increased intraocular pressure from the nitrous oxide used in general anesthesia during the prostate surgery.
Perfluoropropane and sulfur hexafluoride gases are surgical aids for treatment of retinal detachment. It takes several weeks for either type of gas bubble to diffuse from the eye. If nitrous oxide is administered while the gas bubble remains in the eye, it can diffuse rapidly into the gas bubble and raise intraocular pressure.
The U.S. Food and Drug Administration has received medical device adverse event reports of vision loss in patients who were injected with perfluoropropane for eye surgery and who, within a matter of weeks, received nitrous oxide as anesthesia during vascular, prostatic, and kidney transplant surgery. To help patients avoid potential health risks, ophthalmic operative staff can:
General surgeons, anesthesiologists, and general preoperative staff can remember to:
Eileen Woo, RN, BSN, is a nurse-consultant at the Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD.
* Adapted from Nursing Spectrum, October 27, 2002
| Editor's Note: The following questions about reporting incidents of needlesticks are excerpted from the Food and Drug Administration's guidance document entitled Needlesticks - Medical Device Reporting Guidance, November 12, 2002, available at http://www.fda.gov/cdrh/osb/guidance/250.html |
Q. What are the mandatory requirements, under 21 CFR Part 803, for device user facilities, importers, and manufacturers to report needlestick-related adverse events to the FDA?
A. The Medical Device Reporting (MDR) regulation, 21 CFR Part 803, requires that user facilities must submit medical device adverse event reports, on FDA Form 3500A, to the FDA and the device manufacturer whenever the facility become aware that a device used at the facility may have caused or contributed to a patient death. User facilities must also report adverse events to the device manufacturer or to FDA (if the manufacturer is unknown) whenever they become aware that a device may have caused or contributed to a serious injury to a patient of the facility.
In addition, user facilities are required to submit an annual report on FDA Form 3419 summarizing the reports submitted by the user facility during the reporting period. 21 CFR Part 803.3
The MDR regulation requires that device importers must submit medical device adverse event reports, on FDA Form 3500A, to the FDA and the device manufacturer whenever they become aware that one of their imported devices may have caused or contributed to a death or serious injury. Device importers must also submit adverse event reports to the device manufacturer whenever they become aware that one of their imported devices has malfunctioned, and such a malfunction would be likely to cause or contribute to a death or serious injury if it were to recur.
The MDR regulation requires that device manufacturers must submit medical device adverse event reports to the FDA, on FDA Form 3500A, whenever the manufacturer becomes aware that one of their manufactured devices may have caused or contributed to a death or serious injury. Device manufacturers must also submit adverse event reports to FDA whenever they become aware that one of their manufactured devices has malfunctioned, and such a malfunction would be likely to cause or contribute to a death or serious injury if it were to recur.
In addition, the manufacturer is required to submit a baseline report, on FDA Form 3417, for a device when the device model is first reported as required by Parts 803.50 and 803.52. 21 CFR Part 803.55
Q. Where can I find more information about the mandatory reporting requirements for device user facilities, importers and manufacturers?
A. The mandatory MDR requirements, forms, instructions for filling out the forms, guidance documents and Federal Register notices can be found on the Reporting Problems with Medical Devices homepage at: http://www.fda.gov/cdrh/mdr/.
You may also submit questions to the Reporting Systems Monitoring Branch, Division of Surveillance Systems, Office of Surveillance and Biometrics e-mail account at: rsmb@cdrh.fda.gov or by contacting them directly at (301) 594-2735.
Q. When to I have to report a needlestick-related event reportable under 21 CFR Part 803?
A. A needlestick-related event is reportable as a death, serious injury or malfunction as detailed below:
If a person who is exposed to infectious materials via a needlestick that resulted from a device failure is subsequently treated medically or surgically to prevent permanent impairment, then the event becomes reportable by the user facility, importer, and manufacturer as a serious injury report.
We do not consider first aid to constitute medical intervention, and this type of intervention will not require an MDR report. Examples of first aid are the application of a bandage or simple cleaning of the site of a needlestick. In addition, we do not consider an in-vitro diagnostic test for blood-borne diseases to constitute medical intervention. However, administration of a tetanus shot, a gamma globulin shot or stitches is considered medical intervention. This type of intervention triggers the submission of a mandatory serious injury adverse event report by a device user facility, importer, or manufacturer.
Q. What is a medical device malfunction?
A. A malfunction is the failure of a device to meet its performance specifications or to perform as intended. If you are an importer or manufacturer of a device, you must report a malfunction when it is likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Once a malfunction has caused or contributed to a death or serious injury, a presumption that the malfunction is likely to cause or contribute to a death or serious injury has been established. This presumption will continue until the malfunction has caused or contributed to no further deaths or serious injuries for a period of two years, or valid data shows that the likelihood of another death or serious injury because of the malfunction is remote.
A malfunction that is or can be corrected during routine service or device maintenance should be reported if the malfunction is likely to cause or contribute to a death or serious injury if it were to recur.
You do not need to report a malfunction if it is not likely to result in a death or serious injury.
If you are a user facility, you are not required to report any device malfunctions. However, we encourage you to report device malfunctions to the device manufacturer and/or to the FDA through the voluntary MedWatch program.
Q. Do I have to report a needlestick-related event that involves blood spillage or splattering?
A. You do not need to report a device-related blood spillage or splattering event unless the incident is the result of a device malfunction. If you are a manufacturer or an importer, you should report any spillage or splattering malfunction event if a recurrence is likely to cause or contribute to a death or serious injury.
Q. Do I have to report a needlestick-related event due solely to user error?
A. It depends on the severity of the event. Events involving a death or a serious injury where user error may have caused or contributed to a needlestick-related event are reportable by a user facility, importer, and manufacturer.
Q. How can I submit voluntary MedWatch reports concerning needlestick-related events to FDA when those events are not required to be reported by 21 CFR Part 803?
A. User facilities are not required to submit mandatory malfunction adverse event reports involving needlesticks to the FDA. However, we encourage healthcare workers to report malfunctions involving needlestick-related events to the device manufacturer or to the FDA through the FDA MedWatch Voluntary Reporting Program on FDA Form 3500. Information about the FDA MedWatch Voluntary Reporting program and the Form FDA 3500 Voluntary Reporting Form can be found on the FDA MedWatch home page at: http://www.fda.gov/medwatch/. A voluntary report can be filled out on line by accessing the MedWatch homepage and clicking on “Submit Reports” or by direct access at: http://www.accessdata.fda.gov/scripts/medwatch/. In lieu of submitting a voluntary report via the internet, you may report to us by dialing 1-800-FDA-1088 or 1-301-827-0361.
Nancy Lowe, Editor of the User Facility Reporting Bulletin has retired. As
the founding editor, Nancy has been intimately involved in every step of the
Bulletin. She has diligently guided the changes over the past 10 years. The
Bulletin started as a vehicle to provide basic educational information to hospitals
on the Safe Medical Devices Act of 1990. It now provides hospitals with a wider
breadth of information including feedback on CDRH actions following adverse
event reporting, reprints of FDA public health notifications and specific information
important for hospitals on medical devices problems and issues.
As part of its study of the reuse and reprocessing of single-use-devices (SUDs), the U.S. Food and Drug Administration (FDA) sponsored a telephone survey of SUD practices in hospitals. The response rate for the survey was 79.1 percent and included all for-profit, non-profit, and government hospitals, except Veterans Administration (VA) and Department of Defense (DoD) hospitals.
FDA's primary goal was to estimate the extent of hospital reprocessing of SUDs that have been used on patients. Additionally, the survey provided data on the types of SUDs reprocessed and how FDA's SUD enforcement guidance affected hospital activities. The survey was designed to help FDA develop cost-effective hospital inspection protocols and enforcement strategies and was conducted between December 2001 and February 2002. The three major findings of the survey are:
For additional information about the survey, see the executive summary on the
Center for Devices and Radiological Health (CDRH) website at: http://www.fda.gov/cdrh/reuse/survey-execsum.html.
FDA Patient Safety News is a televised series for health care personnel, carried on satellite broadcast networks aimed at hospitals and other medical facilities across the country. Each edition features information on new medical devices, on FDA safety notifications and product recalls, and on ways to protect patients when using medical devices. This site (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/psn/index.cfm) contains the text for each broadcast, plus links for more information on each story. You can also search the Patient Safety News Headlines. It also has instructions for purchasing videotapes of previous broadcasts and sending comments to FDA about the broadcast. |
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Q. How will reprocessed single-use devices be regulated under the new law?
A. Before enactment of the new law, the regulatory requirements for manufacturers of reprocessed single-use devices (the persons who are reprocessing the devices) basically depended on the class of the device. Manufacturers of reprocessed class I and II single-use devices were required to have a 510(k), unless the device was exempt from this requirement. Reprocessors of class III devices were required to obtain premarket approval (PMA).
Under the new law, reprocessors of some exempt devices will no longer be exempt from the 510(k) submission requirements but rather will need to submit 510(k)s that include validation data. Validation data also will be required for many reprocessors of single-use devices that are currently the subject of cleared 510(k)s. Finally, reprocessors of class III devices will need to submit a premarket report (a new type of premarket application). More detail is provided below.
Q. If my reprocessed single-use device was 510(k) exempt before the new law, is it still exempt?
A. Not necessarily. By April 26, 2003, FDA will review the types of critical reprocessed single-use devices1 that are currently exempt from 510(k) and determine which of these exemptions will be terminated. FDA must publish a Federal Register notice listing these devices. 510(k)s submitted for these devices must include validation data (as described below) and must be submitted within 15 months of publication of the list.
By April 26, 2004, FDA will review the types of semi-critical reprocessed single-use devices2 that are currently exempt from 510(k) and determine which of these exemptions will be terminated. FDA must publish a Federal Register notice listing these devices. 510(k)s submitted for these devices must include validation data and must be submitted within 15 months of publication of the list.
Reprocessed single-use devices not included on either the critical or semi-critical
device lists or may otherwise be exempt from premarket notification requirements
may continue to be marketed without submission of a 510(k).
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1. A “critical reprocessed single-use device”
is a reprocessed single-use device that is intended to contact normally sterile
tissue or body spaces during use.
2. A “semi-critical reprocessed single-use device” is reprocessed
single-use device that is intended to contact intact mucous membranes and
not penetrate normally sterile areas of the body.
Q. When will FDA require validation data for reprocessed single-use devices that already require 510(k) clearance (i.e., devices that are not 510(k) exempt)?
A. By April 26, 2003, FDA will review the types of reprocessed single-use devices now subject to 510(k) clearance and identify those that FDA will now require to submit “validation data . . . regarding cleaning and sterilization, and functional performance” to show that the reprocessed device “will remain substantially equivalent . . . after the maximum number of times the device is reprocessed as intended” by the person who submits the 510(k). FDA must publish a list of these devices in the Federal Register and update the list when necessary. A 510(k) for one of these devices, submitted after publication of the list, must include validation data. Validation data must also be submitted for a device that already has a cleared 510(k), or marketing must cease; the validation data must be submitted within nine months of the date FDA includes the device on the list of devices for which validation data are required.
Q. When will FDA require premarket reports for class III reprocessed single-use devices?
A. The requirement for submission of premarket reports for class III reprocessed single-use devices went into effect on the Act’s effective date, October 26, 2002. Previously, PMAs were required for these devices.
Q. What labeling changes are required for reprocessed single-use devices and when must the new labeling be used?
A. Any reprocessed single-use device (i.e., devices exempt from 510(k) requirements, subject to 510(k) requirements, or subject to a premarket report) introduced into interstate commerce after January 25, 2004, must “prominently and conspicuously” bear the statement:
Reprocessed device for single use. Reprocessed by [name of manufacturer that reprocessed the device].
This provision will make it easier for patients and healthcare professionals to know when a reprocessed device is being used.
Q. How do I obtain additional information on the requirements of the new law?
A. FDA currently is developing its implementation plans for MDUFMA, so we may not be able to answer all your questions at this time. However, we have a variety of materials that will help you gain an understanding of the new law.
The web page at www.fda.gov/cdrh/mdufma will be updated and expanded periodically and will provide the latest information and guidance from FDA concerning the new law.
If you have a question that is not answered by DSMICA or the available reference
materials, send an e-mail message to MDUFMA@cdrh.fda.gov.
The Center for Devices and Radiological Health developed a CD ROM entitled: "An Overview of the Regulatory Requirements for Reprocessing of Single-Use Devices by Hospitals." While supplies last, a free copy of the CD-ROM is available by request at http://www.fda.gov/cdrh/Reuse/reuse-messages.html.
The two-disc set covers the regulatory requirements that a hospital must meet if it reprocesses single-use devices (SUDs). Topics include:
To see the PowerPoint presentations from the CD ROM, visit the Reuse Events Page at http://www.fda.gov/cdrh/reuse/reuse-documents.html#10.
The following two questions about registration and listing were added to the
Reuse Website (http://www.fda.gov/cdrh/reuse/index.html)
on December 11, 2002.
Q. My establishment is registered as a manufacturer of medical devices, some of which are labeled for single use. We also reprocess for reuse some of the single-use devices that we manufacture. Do we have to add the establishment operation type of "Reprocessor of Single-Use Devices" to our existing registration information?
A. Yes, your establishment needs to be registered for all of the operations that are being performed at the same location.
Q. My establishment is registered as a manufacturer of medical devices, some of which are labeled for single use. We also reprocess for reuse some of the single-use devices that we manufacture. Do we have to update our existing device listing information?
A. Yes, your establishment needs to have all of the operations
that are being performed on a particular device listed with FDA.
is available at: http://www.fda.gov/cdrh/safety/121902.html
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 January 17, 2003
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