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A quarterly
bulletin to assist hospitals, nursing homes, and other device user facilities |
EXTENSIONS GRANTED TO ENFORCEMENT PRIORITIES FOR REPROCESSED SINGLE-USE DEVICES
The Department of Health and Human Services has granted 6-month extensions to four reprocessors that had submitted premarket applications (PMAs) for class III single-use devices (SUD) to the Food and Drug Administration on February 14, 2001. This extension to February 14, 2002, was granted to allow the reprocessors time to obtain additional clinical information necessary for PMA approval. The extension is limited to the cardiac ablation catheter PMAs that are under current review. All other reprocessed class III SUDs may be available only under the Investigational Device Exemption (IDE) regulation. For additional information about SUDs reprocessing, see issue 34 of the UFR Bulletin (http://www.fda.gov/cdrh/fusenews/ufb34.pdf).
As stated in the SUD Enforcement guidance (http://www.fda.gov/cdrh/comp/guidance/1168.pdf), after August 14, 2001, FDA would actively enforce the non-premarket requirements (i.e., establishment registration, device listing, medical device reporting as a manufacturer, corrections and removals, quality system requirements, labeling, and tracking). Now, FDA will actively enforce only the non-premarket requirements for hospital reprocessors to register their establishments and to list their devices with the Agency. FDA will use the additional year (until August 14, 2002) to focus on education rather than enforcement of the other non-premarket requirements for hospital reprocessors. This revised policy does not apply to the premarket requirements or to third-party (commercial) reprocessors. (See the FDA Talk Paper of August 16, 2001, entitled FDA Actions on Reprocessed Single Use Devices on the Internet at http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01098.html.)
Revised Enforcement Priorities Timetable
Dates for Premarket Submissions and Approvals
Filing Date | Clearance or Approval Dates: | |
Class III | 2/14/2001 | 2/14/2002* |
Class II non-exempt | 8/14/2001 | 2/14/2002 |
Class I non-exempt | 2/14/2002 | 8/14/2002 |
This new date applies only to the four class III PMAs already submitted to FDA.
Dates for Enforcement of the Non-Premarket Requirements
Establishment Registration | 8/14/01 |
Device Listing | 8/14/01 |
Quality System Regulation | 8/14/02 |
Medical Device Reporting as a manufacturer** | 8/14/02 |
Medical Device Tracking | 8/14/02 |
Labeling | 8/14/02 |
Corrections and Removals | 8/14/02 |
**There is no change in a hospital's MDR reporting responsibilities as a user facility.
By Duane S. Sylvia, B.S.
Problem
The Food and Drug Administration (FDA) is concerned about continuing deaths and injuries resulting from medical gas mix-ups. Following are three examples of mix-ups.
On December 7, 2000, a nursing home in Bellbrook, Ohio, reported two patients dead and eight patients injured following a mix-up in the oxygen supply system. Several days later, two more patients died from exposure to industrial nitrogen, bringing the death total from this one incident to four. The nursing home had supposedly received a shipment of four cryogenic vessels containing medical grade oxygen. Included in the delivery, however, was a cryogenic vessel of industrial grade nitrogen. The nursing home was running low on oxygen and sent a maintenance employee to connect a new oxygen vessel to the oxygen supply system.
The employee mistakenly selected a nitrogen vessel and discovered that he was unable to connect the vessel to the oxygen system. (As a safeguard, the connectors for oxygen vessels are specially fitted so they are compatible only with oxygen delivery systems.) The employee removed a fitting from an empty oxygen vessel and installed it on the nitrogen vessel. He then connected the deadly nitrogen to the oxygen system.
On April 22, 1998, a hospital in Idaho discovered that a large cryogenic vessel of industrial nitrogen had been connected to the oxygen system supplying the operating rooms, labor and delivery rooms, and emergency room. The hospital discovered that the medical gas delivery person initially had been unable to connect the incompatible nitrogen vessel outlet fitting to the oxygen system. So, he used a wrench to disconnect the nitrogen fitting and replace it with an oxygen fitting. Two patients died as a result of this medical gas mix-up.
In October 1997, a hospital in Nebraska received a shipment of medical grade oxygen in large cryogenic vessels. The shipment included one cryogenic vessel of industrial grade argon that was properly labeled. The hospital was running low on oxygen and sent a maintenance employee to connect an oxygen vessel to the oxygen supply system. Without examining the label, the employee selected an argon vessel. Discovering that he was unable to connect the vessel to the oxygen supply system, he removed a fitting from an empty oxygen vessel, installed it on the argon vessel, and connected the deadly product to the oxygen system. Argon was administered to a patient undergoing minor surgery. The patient died.
These three cases reveal striking similarities:
Safe Practice Recommendations
To minimize the risk of medical gas mix-ups, the FDA makes the following recommendations to hospitals, nursing homes, and other health care facilities:
Duane S. Sylvia, B.S., is a Compliance Officer in the Center for Drug Evaluation and Research (CDER).
*Adapted from Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities by the Food and Drug Administration, March 2001. This guidance is available on the Internet at http://www.fda.gov/cder/guidance/4341fnl.htm.
FDA Public Health Advisory: Potential for Injury from Medical Gas Misconnections of Cryogenic Vessels
(available at: http://www.fda.gov/cdrh/safety/medical-gas-misconnect.html)
REPORTING PROBLEMS WITH MEDICAL DEVICES: OVERVIEW
User facilities, importers, and manufacturers must submit reports of device-related adverse events to the Food and Drug Administration (FDA) as specified by the Medical Device Reporting (MDR) regulation. The reports provide FDA with significant information that allows problems to be identified and corrected quickly. User facilities (e.g., hospitals and nursing homes) are required to report suspected device-related deaths to both FDA and the manufacturers. User facilities also must report device-related serious injuries to the manufacturer. If the medical device manufacturer is not known, the facility should report the device-related serious injury to FDA. Health professionals within a user facility should become familiar with their institution's procedures for mandatory reporting of device-related adverse events to the FDA.
Consumers and health professionals may report device problems and adverse events to the MedWatch program (http://www.fda.gov/medwatch), FDA's voluntary problem reporting program for medical products.
For
questions about Medical Device Reporting, contact FDA at:
Reporting Systems
Monitoring Branch (HFZ-533)
Center for Devices and Radiological Health
Food and Drug Administration
1350 Piccard Drive
Rockville, MD 20850
The following telephone numbers are for specific questions (please use FAX numbers except for emergencies):
Interpretation of MDR reporting policy:
Emergencies (after normal East Coast business hours):
Reporting Adverse Events and Device Problems:
Documents
Other MDR Information and User Facility Reporting Documents
Get this brochure from the FDA Reuse website at: http://www.fda.gov/cdrh/reuse/trifold1.pdf or by sending an e-mail to dsma@cdrh.fda.gov or a FAX to 301-443-8818. |
September 11, 2001, Central New York Healthcare Central Service Professionals, Verona, New York, FDA Speaker: Sharon Kalokerinos
October 4-5, 2001,Texas Society of Infection Control Practitioners, Harlingen, Texas, FDA Speaker: Lily Ng. For more information: LaurieD.Jonsson@vbmc.org.
November 4-7, 2001, RAPS 2001 Conference, Baltimore, Maryland, FDA
Speaker: Lily Ng.
For more information: http://www.raps.org/educ/uprogs.cfm
****
November 9-10, 2001, Japanese Association for Operative Medicine, Tokyo, Japan, - FDA Speaker: Tim Ulatowski
For more information visit the
Reuse website at: http://www.fda.gov/cdrh/reuse/index.shtml
****Any reference to a commercial product, process,
service, or company is not an endorsement or recommendation by the U.S. government,
the Department of Health and Human Services, FDA or any of its components. FDA
is not responsible for the contents of any off-site Internet information referenced
by or linked to the agency's internet site.
The Hospital Bed Safety Work Group (HBSW) met on March 28-31, 2001, for a fourth time. (See Issues 29 and 30 of the Bulletin for previous reports of the HBSW.) Participants were representatives from national healthcare associations, the Federal government, the medical bed industry, and consumer advocacy groups. This work group has made strides toward its goal of reducing the problem of patient entrapment in hospital bed rails and has completed or nearly completed a number of educational products. These are discussed below.
Hospital Bed Safety Brochure
A brochure entitled "A Guide to Bed Safety" was completed in October 2000 and 50,000 copies were printed. Participating members distributed the brochures. Because of the success of the brochure, FDA funded the printing of an additional 50,000 copies. You can read and download the brochure at: http://www.fda.gov/cdrh/beds. You can also order a limited number of brochures by contacting:
Beryl Goldman
Kendal Corporation
P.O.
Box 100
Kennett Square, PA 19348
Telephone: 610-388-5586.
Many organizations are actively distributing the brochures, writing journal and newspaper articles, and placing the HBSW information on their websites.
Clinical Guidance
The Clinical Guidance provides a uniform set of recommendations for caregivers in hospitals, long term care facilities, and home care settings to use when assessing their patients' needs for and possible use of bed rails. The Guidance stresses assessment of an individual patient by an interdisciplinary team to determine the extent of his or her vulnerability to entrapment. Every patient, regardless of care setting, must be assured a safe, comfortable and dignified sleeping environment. When at-risk patients are identified, the health care team should consider the interventions that promote the highest level of independent functioning specific to the patient's health and safety needs. The HBSW group will launch a major outreach effort when the Clinical Guidance is ready for distribution.
Dimensional and Assessment Guidance
The HBSW developed measurement recommendations that define maximum and minimum dimensions for gaps or openings in the bed systems' component. Complying with these recommendations will reduce the risk of entrapment. The U.S. Food and Drug Administration received the dimensional recommendations of the HBSW and will incorporate them as a guidance document to be published in the Federal Register. Watch for this guidance in early November and send FDA any comments that you wish to have considered.
The dimensional recommendations
were derived by extensive examination of anthropometric data and by reviewing
previous incident data. Three key parts of the body were found to be of the greatest
risk of entrapment. These are the neck, the head, and the chest. Entrapment involving
any of these body areas could lead to a life-threatening situation.
The working group established seven zones in the bed system with the potential for entrapment. The bed system includes the bed frame, bed rails, mattress, and bed ends. The dimensional tests involve the use of assessment tools, a cone and a cylinder-shaped object, designed to simulate the size of the body part considered at risk of entrapment. This cone or cylinder is placed into or moved through the open space to determine if entrapment is likely to occur. For some of the tests, a load is applied to the cone to simulate body forces or gravity that can be generated as a portion of the body moves through an opening in the bed system.
In addition to defining the design limits on the bed systems and developing a tool to effectively measure the bed systems, the HBSW prepared instructions for evaluating the bed systems, an instructional videotape to demonstrate the assessment process, and a bed system corrective action plan.
To conduct an assessment, one individual is needed to physically measure the bed system with a second person to record the results. The assessment time is about 15 minutes per bed system. The bed should be unoccupied to allow for mattress movement and ease of measurement.
The Hospital Bed Safety Group plans to have the assessment kits available for hospitals, nursing homes, and home care use. Each kit will include the Bed System Entrapment Dimensional and Assessment Guidance, the measurement tools, an instructional video, Clinical Guidance, and the Bed System Corrective Assessment Plan. It will be available for purchase from ECRI by early 2002.
Mary Lou Pijar, B.A., is a General Health Scientist and Mary Ann Wollerton,
M.P.A., is a Public Health Advisor in CDRH's Office of Communication, Education,
and Radiation Programs.
Get this brochure from the FDA Hospital Bed website at: http://www.fda.gov/cdrh/beds or by sending an e-mail to dsma@cdrh.fda.gov or a FAX to 301-443-8818. |
ELECTRONIC NOTIFICATION FOR THE USER FACILITY REPORTING BULLETIN IS NOW AVAILABLE
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 new
List Service at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCDRHNew/listman.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.
|
Updated September 5, 2001
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