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A quarterly
bulletin to assist hospitals, nursing homes, and other device user facilities |
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FDA's basis for approval of a PMA submission is a finding that the device has a reasonable assurance of safety and effectiveness for its intended use based on valid scientific evidence. Clinical data may be necessary to establish the safety and effectiveness of a reprocessed SUD. The PMA submission also should evaluate the unique characteristics of the reprocessed SUD. A description of what FDA considers a complete PMA submission is given in the PMA regulation (21 CFR814.20). FDA has general guidance on the required information in a PMA submission (see "Guidance for Preparation of PMA Manufacturing Information" at www.fda.gov/cdrh/ode/448.pdf).
The February 14, 2001, date is the first of FDA's announced enforcement dates for reprocessors of SUDs. On August 14, 2001, premarket notification submissions, also known as 510(k)s, will be required for all non-exempt class II devices. The non-premarket requirements which include registration, listing, medical device reporting, tracking (if applicable), corrections and removals, quality system, and label-ing will also be required on August 14, 2001. Finally, on February 14, 2002, 510(k)s will be required for all class I non-exempt devices. To obtain a copy of the August 14, 2000, SUD reuse guidance document, see http://www.fda.gov/cdrh/reuse/index.shtml
February 14, 2001
August 14, 2001
February 14, 2002
May 10 & 11, 2001 -
Orlando Florida
May 30 & 31, 2001 - Phoenix, Arizona*
*Information on the Phoenix, Arizona Workshop (May 30 & 31) will be posted on the Reuse web page at http://www.fda.gov/cdrh/reuse/index.shtml as soon as it becomes available.
by Deborah Yoder Blum, R.N., C.I.C.
An infant born at 28 weeks gestation had an extremely low birth weight and respiratory distress syndrome. A central venous line was placed in the right atrium to infuse total parenteral nutrition. The infant developed apnea and bradycardia after 3 days, and, despite resuscitation efforts, died.
What went wrong?
Cardiac tamponade occurs when sudden fluid accumulation in the pericardial space compresses the heart. An autopsy on the infant showed that the catheter tip in the right atrium eroded the myocardial wall, allowing fluid to enter the pericardium.
What precautions can be taken?
Deborah Yoder Blum, R.N, C.I.C., is a Nurse Consultant
in CDRH's Office of Surveillance and Biometrics.
*Adapted from the November issue of Nursing 2000.
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<-----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
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. -----> |
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by Suzanne Rich, R.N., B.A.
What happens after you reportan adverse event involving a medical device to MedWatch, the Food and Drug Administrations’ (FDA) Medical Products Reporting System?
The FDA's Center for Devices and Radiological Health (CDRH) handles the report. As the process begins, the information is entered in a database and a clinical analyst is assigned to review the report. The pool of analysts consists of a nuclear medicine technologist and 14 nurses with advanced degrees or expertise in specific areas. The analyst evaluates the nature, scope, and magnitude of the reported event. Next, FDA's adverse-event database is reviewed for similar events to determine if a follow-up investigation is warranted.
If an immediate review of the manufacturing and complaint records is needed, FDA may inspect the site where the device was manufactured. In most cases, the FDA analyst sends letters to the manufacturer and the facility where the incident occurred (or to the person who reported the incident) asking for more specific information. The manufacturer may also be asked about any other adverse events reported for the involved or similar device(s) and what corrective actions were taken. This information is then reviewed to determine if further FDA action is needed. Corrective measures may include regulatory actions (such as a recall), user notification of a problem, or a press release warning the public of potential hazards associated with the device. Even if no immediate action is warranted, the report of the event remains in the database for future research and monitoring.
If a death, serious injury, or malfunction involving a medical device occurs where you practice, notify the person at your facility who is responsible for reporting such problems or call MedWatch at 1-800-FDA-1088. Visit the FDA/CDRH homepage at www.fda.gov/cdrh/safety.html to learn about FDA safety alerts and public health advisories.
Suzanne Rich, R.N., B.A., is a Nurse Consultant and Branch Chief in CDRH's Office of Surveillance and Biometrics.
*Adapted from the November issue of Nursing 2000.
FDA will continue to actively enforce the Medical Device Reporting (MDR) requirements for all device users facilities, including hospital SUD reprocessors.
MedWatch Reporting Forms
MedWatch Reporting forms are available in PDF (Acrobat) format. Download the form(s) to your computer from the links below. PC Users: right click the link and select "Save Target As..." (IE 4/5 users) or "Save As..." (Netscape 4/6 users). Mac users may click and hold the link and select "Download Link to disk..." (IE4) or "Save This Link As..." (Netscape 4).
by Diane Dwyer, R.N., B.S.N.
A patient in the operating room receiving mechanical ventilation had something in common with a patient connected to a cardiac monitoring system in the critical care unit. Both patients had implanted pacemakers, and both had experienced unintended maximum pacing rates up to 120 beats per minute. Medical intervention was needed to turn off the minute ventilation sensor in each pacemaker. When the sensors were turned off, the patients' heart rates returned to normal.
What went wrong?
Minute ventilation sensor-driven pacemakers set their pacing rates by measuring thoracic impedance and adjusting pacing outputs accordingly. Some medical devices, including cardiac monitors and mechanical ven-tilators, emit weak electrical currents that may interfere with minute ventilation sensors. In the above cases, such interference appears to have led to incorrect measurement of thoracic impedance and pacemaker rate increases.
Devices That May Interfere with Pacing Rates
What precautions can be taken?
If a patient has an implanted pacemaker, document the type when admitted to the facility. Record the manufacturer, model, and sensor type. Make sure the minute ventilation rate-adaptive sensor mode is turned off while the patient is connected to any equipment that could interfere with the pacemaker. Carefully monitor heart and respiratory rate.
Share with the patient and your colleagues the Food and Drug Administrative Public Health Advisory "Interaction Between Minute Ventilation Rate-Adaptive Pacemakers and Cardiac Monitoring and Diagnostic Equipment." You can get a copy at http://www.fda.gov/cdrh/safety.html by scrolling down to and clicking on 10-14-98.
Diane Dwyer, R.N., B.S.N., is a Nurse Consultant in CDRH's Office of
Surveillance and Biometrics.
*Adapted from the September issue of Nursing 2000.
The Spring Issue will be devoted entirely to reprocessing and reuse of single-use devices.
by Beverly Albrecht Gallauresi, R.N., B.S., M.P.H.
A 62-year-old man came to the Emergency Department complaining of mid-sternal pain, shortness of breath, diaphoresis, and nausea after shoveling snow. A diagnostic cardiac catheterization indicated arterial blockage. The patient underwent angioplasty without incident. A venogram was performed afterward to evaluate left ventricular function. During the procedure, the patient experienced cardiac arrest and died.
What went wrong?
This event was directly attributed to error by medical personnel. The biomedical engineering department at the facility evaluated the contrast medium injector device involved in the event and found no mal-functions that could have been responsible. The manufacturer performed a failure analysis and concurred with the facility.
Further investigation revealed that the disposable syringe used during the venogram was not filled with contrast medium before the procedure. At least 30 cc of air was injected directly into the patient's left ventricle causing an air embolism that led to cardiac arrest.
What precautions can be taken?
If a death, serious injury, or malfunction involving a contrast medium injector occurs where you practice, notify the person at your facility who is responsible for reporting such problems or call MedWatch at 1-800-FDA-1088. To learn about the FDA Center for Devices and Radiological Health (CDRH), visit our homepage at www.fda.gov/cdrh.
Beverly Albrecht Gallauresi, R.N.,
B.A., M.P.H., is a Nurse Consultant
in CDRH's Office of Surveillance
and Biometrics.
*Adapted from the January issue of
Nursing 2001.
April 23, 2001, New Jersey Healthcare Central Service Association, Atlantic City, New Jersey -FDA Speaker: Larry Kessler
May 10-11, 2001, FDA Workshop: Reuse of Single-Use Devices, Orlando, Florida
May 23-26, 2001, Club Espanol de Esterilizacion, Salamanca, Spain - FDA Speaker: Larry Spears
May 30-31, 2001, FDA Workshop: Reuse of Single-Use Devices, Phoenix, Arizona
November 9-10, 2001, Japanese Association for Operative Medicine, Tokyo, Japan, - FDA Speaker: Tim Ulatowski
For more information visit the Reuse Home Page at: http://www.fda.gov/cdrh/reuse/index.shtml
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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 Asst.Editor: Mary Ann Wollerton 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 e-mail:nsl@cdrh.fda.gov |
Updated March 20, 2001
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