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A quarterly
bulletin to assist hospitals, nursing homes, and other device user facilities |
MEDICAL PRODUCT SURVEILLANCE NETWORK (MEDSUN)
READY TO LAUNCH FIRST SEGMENT OF THE PHASE II PILOT
By Marilyn Flack
Background
At the Food and Drug Administration (FDA), the Center for Devices and Radiological Health (CDRH) sees first hand the technological advances in healthcare as new medical devices are reviewed and cleared for marketing. The increasing complexity of medical technology, perhaps coupled with economic pressures and organizational change within health care institutions, increases the potential for unanticipated and unintended consequences.1 These changes demand that surveillance of marketed devices moves from a defensive to a proactive stance. This proactive strategy includes an understanding of how organizations encounter devices, how problems are perceived and reported, and what characteristics of the system contribute to any event.
To the extent possible to identify device failures before patients are injured, FDA can join with manufacturers and healthcare professionals in creating a safer healthcare environment. Along these lines, the Center has instituted as part of its planning process the concept of the Total Product Life Cycle (TPLC). TPLC follows the life of a medical device from its inception through its development and use, and finally its replacement by newer products.
Although there are mandatory reporting requirements for user facilities (under the Safe Medical Devices Act of 1990), there is evidence of significant under-reporting by the clinical community of adverse events associated with medical devices. FDA must have quality information about postmarket problems with devices, especially how they are used in the clinical setting, if it is to be successful in promoting patient safety.
The Food and Drug Modernization Act of 1997 mandated that FDA move away from the universal reporting requirement for user facilities to a smaller "sentinel-type" system. The current universal reporting system remains in place during the pilot stages of the new program and until FDA implements the new national system. This legislation provides FDA with the opportunity to design and implement a national surveillance network, composed of well-trained clinical facilities, to provide high quality data on medical devices in clinical use. This new system is called the Medical Product Surveillance Network (MedSun).
Before writing a regulation to implement the large-scale national MedSun reporting system, FDA plans to conduct a pilot project to ensure all aspects of the new system address the needs of both the reporting facilities and FDA. This pilot project will begin with a small sample (25) and increase to a larger sample (200) over a period of about three years. A regulation will then be promulgated reflecting the outcomes learned from the pilot project.
Goals for MedSun
Launching Phase II
Currently, the system is undergoing testing by 10 hospitals (Phase I). Following this testing, 25 hospitals will launch Phase II of MedSun in November 2001. An additional 25 hospitals and 20 nursing homes will quickly join these 25 facilities. The participating facilities will increase to about 200 during the Phase II pilot.
Recruitment for the first 25 facilities is occurring now. Any hospital that would like to participate in this exciting project, or would like to learn more about it, should call Tina Powell at CODA (the contractor administering the program): 301-588- 0177 or 1-800-859-9821. Reporting to MedSun fulfills a facility's SMDA reporting requirements.
How the program will work
During the pilot phase, up to 200 user facilities will send reports of deaths, serious injuries, and "close-call" events associated with medical devices to a secure webserver at the FDA via an Internet-based form. Two to three persons from each facility will be identified as the official MedSun participants and will have passwords to access the system. An important functionality of the software is that it is dynamic in nature. Certain questions appear only if particular responses were made to earlier questions, thus making it quick and efficient to complete. Further, it is constructed with the flexibility to permit FDA to design features that will permit specific questions to appear when certain medical devices are the topic of the report. For example, if the user facility is making a report about a catheter, the web site will automatically display several questions related to that device.
Feedback to the participating facilities is considered a key
element in this new system. Information from the project about medical devices
and related problems/health issues will be part of active outreach to the
facilities. This may include newsletters, safety information, study data posted
on the web site, etc. Types of feedback will be expanded as FDA learns from
the participating facilities what type of information would be most useful
to them.
__________
1 Cook, Richard I., Woods, David D., Miller, Charlotte. A
Tale of Two Stories: Contrasting Views of Patient Safety. Report from a Workshop;
Assembling the Scientific Basis for Progress on Patient Safety, National Health
Care Safety Council of the National Patient Safety Foundation at the American
Medical Association, 1998.
Marilyn Flack is a Senior Public Health Analyst in the Center for Devices
and Radiological Health's Office of Surveillance and Biometrics.
FDA SENDS ANOTHER LETTER TO HOSPITALS
ABOUT REUSE OF SINGLE-USE DEVICES
Recently, FDA sent a letter to hospitals explaining the change in its enforcement approach for hospital SUD (single-use device) reprocessors. At the discretion of Department of Health and Human Services Secretary Tommy Thompson, hospital SUD reprocessors were granted another year before FDA actively enforces the non-premarket requirements with the exception of registration and listing. Premarket requirements are still being actively enforced. The complete text of the September 25th letter is on page 2.
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 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!
CHANGES IN ENFORCEMENT OF FDA'S REQUIREMENTS ON
REPROCESSING OF SINGLE-USE DEVICES
Letter to Hospitals Re: Changes in Enforcement of FDA's Requirements on Reprocessing
of Single-Use Devices (Issued September 25, 2001):
ALARMING MONITOR ERROR*
By Beverly Gallauresi, R.N., M.P.H., B.S.
A 67-year-old man with a history of schwannoma tumors, hypertension, heart failure, hypertensive cardiomyopathy, and hyperlipidemia was admitted in serious condition to the intensive care unit. He developed a cardiac arrhythmia -- ventricular tachycardia that progressed to ventricular fibrillation -- but his bedside monitor never produced a "lethal-arrhythmia" alarm or printout. Several minutes elapsed before his condition was discovered and someone called for assistance. The patient died.
What went wrong?
The alarm never sounded because it was not turned on. According to the hospital's biomedical department, the alarm suspension log revealed that all alarms for this patient were turned off before he developed the arrhythmia. The manufacturer investigated and concluded that the device was performing to specifications and had not failed mechanically.
What precautions can you take?
Alarm modes vary according to the type of monitoring system, so become familiar with the ones you use.
Although you need to support the adverse-event reporting policy of your healthcare facility, you may voluntarily report a problem with a medical device that does not perform as intended by calling MedWatch at 1-800-FDA-1088 (fax: 1-800-FDA-0178).
For more information about telemetry and bedside monitors reported to the Food and Drug Administration, please contact the author at BXG@CDRH.FDA.GOV.
Beverly Gallauresi, R.N., B.S., M.P.H., is a Nurse-Consultant in the Center for Devices and Radiological Health's Office of Surveillance and Biometrics.
*Adapted from the September issue of Nursing2001, Volume 31 Number 9.
CHECK THESE OUT! BROCHURES AVAILABLE ON THE INTERNET
Reprocessing of Single-Use Medical Devices by Hospitals
A Guide to Bed Safety - Bed Rails in Hospitals, Nursing Homes and Home Health Care: The Facts
SUBJECT MATTER INDEX TO UFR BULLETIN, ISSUES 1-36
SUBJECT
|
ISSUE
|
---|---|
Computer Database | |
CDRH's MAUDE System | 2 |
MAUDE Update | 10 |
MAUDE Update | 11 |
MAUDE Update | 5 |
MAUDE Update: Errors in Reporting | 3 |
MAUDE Update: Semi-Annual Reports | 4 |
User Facility Reporting Bulletin and MDR Information Are Now on Internet | 14 |
Electromagnetic Interference (EMI) | |
FDA and AAMI to Present a Forum on Electromagnetic Compatibility for Medical Devices | 10 |
FDA Concerned About Interference With Medical Devices (EMI) | 18 |
FDA Warns About EMI Risks with Telemetry | 31 |
Implanted Pacemakers: Avoiding Electromagnetic Interference | 24 |
Interference Between Digital TV Transmissions & Telemetry Systems | 23 |
Review of MDR Reports Reinforces Concern About EMI | 20 |
Flowcharts | |
FDA Device Tracking Regulations: Device and Information Flowchart | 6 |
Flowcharts Promote Internal Reporting Procedures | 6 |
Sample Flowchart: How to Report Incidents Involving Medical Devices, Drugs, Utilities, and Security | 6 |
Forms and Instructions | |
Abbreviated Instructions for FDA Form 3500A Specific to Medical Device Reporting | 15 |
FDA Form 3419 | 15 |
Mandatory MedWatch FDA Form 3500A | 15 |
Where to Get MDR Materials | 15 |
Hospital Beds and Vulnerable Patients | |
Hospital Side Rails: Preventing Entrapment | 21 |
Hospital Bed Safety Work Group: Highlights of March Meeting | 35 |
Working Group Formed to Address the Problem of Patient Entrapment in Hospital Beds | 29 |
Workshop Held on Hospital Beds and Vulnerable Patients | 30 |
Human Factors | |
AAMI/FDA Conference Will Address Human Factors in Medical Device Design, Regulations, and Safety | 11 |
Human Factors and Medical Devices | 12 |
Human Factors and Medical Devices: Lack of Device Feedback | 14 |
Importance of Information About Use Error and Human Factors in Adverse Event Reporting | 23 |
We Urge You to Report Medical Devices Design Problems | 16 |
Index | |
Subject Matter Index to UFR Bulletin Issues 1-16 | 17 |
Subject Matter Index to UFR Bulletin Issues 1-26 | 26 |
Subject Matter Index to UFR Bulletin Issues 1-36 | 36 |
Latex | |
Adverse Reactions to Natural Rubber Latex | 19 |
Cornstarch As A Glove Donning Powder | 21 |
FDA Answers Latex Glove Questions | 21 |
FDA Clarifies Latex Terminology | 19 |
FDA Issues Final Rule on Natural Rubber Device Labeling | 21 |
FDA Scientists Study Quality Assurance Tests for Latex Gloves | 19 |
Glove Quality and Selection Criteria | 19 |
How FDA Regulates Gloves | 19 |
Natural Rubber Latex Allergy: A MedWatch Success Story | 19 |
Natural Rubber /Latex Allergy: Recognition, Treatment, Prevention | 22 |
New Labeling for Natural Rubber Latex | 25 |
MDR Studies | |
Contracts Awarded for User Facility Reporting Study | 2 |
Evaluation of Device User Facility Reporting | 2 |
Medical Device Surveillance Network (MeDSuN) | 26 |
Medical Product Surveillance Network (MeDSuN) Ready to Launch First Segment of the Phase II Pilot | 36 |
MEDSUN - Using Facility Reporting for the New Millennium | 30 |
Update on User Facility Reporting Study | 4 |
Medical Device Problems | |
Adverse Reactions to Natural Rubber Latex | 19 |
Alarming Monitor Error | 36 |
Avoiding Sticks from Sharp Containers | 25 |
Biliblanket Phototherapy Light Safety Tips | 25 |
Central Venous Catheters and Cardiac Tamponade | 33 |
Complications Related to the Use of Vascular Hemostasis Devices | 28 |
Complications with the Use of Small-bore Catheters in Continuous Spinal Anesthesia | 2 |
Cornstarch As A Glove Donning Powder | 21 |
Cross Contamination of Hemodialysis Machines: An Unexpected Risk | 29 |
Disposable Devices: Time for a Change | 21 |
Explosions & Fires in Aluminum Oxygen Regulators | 25 |
FDA Cautions Users of Vacuum Assisted Delivery Devices | 24 |
FDA Concerned About Interference With Medical Devices (EMI) | 18 |
FDA Publishes Results of Infusion Pump Investigation | 6 |
FDA Sends Safety Alerts and Public Health Advisories to Warn of Medical Device Risks | 8 |
FDA Warns About EMI Risks with Telemetry | 31 |
FDA Warns About Radioactivity in Radiation Protection Devices | 20 |
FDA Will Co-sponsor Conference on Unprotected Patient Cable and Electrode Lead Wires | 8 |
Full Field Digital Mammography Approved for Use in MQSA-Certified Facilities | 30 |
Glass Capillary Tubes Pose Risks | 25 |
Healthcare Community Alerted to Device Problems During 1994 | 10 |
Heating Devices: How to Avoid Burns | 21 |
Hospital Side Rails: Preventing Entrapment | 21 |
Hospital Bed Safety Work Group: Highlights of March Meeting | 35 |
How to Avoid Injuries from Liquid Chemical Disinfectant | 27 |
Implanted Pacemakers: Avoiding Electromagnetic Interference | 24 |
Incorrect Restraint Use: Deadly Protection | 21 |
Infections from Inadequately Reprocessed Endoscopes: FDA & CDC Issue Public Health Advisory | 28 |
Infusion Pump Mishap: Outside The Channel | 21 |
Interference Between Digital TV Transmissions and Telemetry Systems | 23 |
Labor and Delivery Beds: Keeping Newborns Safe from Falls | 27 |
Medical Device Year 2000 Update | 25 |
Medication Errors Associated with Medical Gas Mix-Ups | 35 |
Pacing Your Patients | 30 |
Peritoneal Dialysate Overfill and Human Factor Implications | 27 |
Potential Hypersensitivity Reactions to Chlorhexidine-Impregnated Devices | 23 |
Potential Injury from Circumcision Clamps | 32 |
Problems with Biological Indicators | 10 |
Problems with Circumcision Clamps | 28 |
Protecting Your Patient's Eyes | 31 |
Public Health Advisory on Electric Heating Pads Prompted by MDR Reports | 16 |
Public Health Advisory: Potential for Injury from Medical Gas Misconnections of Cryogenic Vessels | 35 |
Public Health Message: Electrode Lead Wires and Patient Cables | 24 |
Risk with Collagen Hemostasis Devices | 26 |
Safeguarding Cardiac Guide Wires: Follow These Tips to Avoid Breakage | 24 |
Safeguarding Contrast Media Injections | 33 |
Safe Infusions | 31 |
Safety Alert Issued for Hospital Bed Side Rails | 13 |
Sending the Wrong Signals | 33 |
Serious Complications Associated with Pulmonary Artery Catheters | 30 |
Serious Injuries from Microwave Thermotherapy Used for Benign Prostatic Hyperplasia | 32 |
Some Antimicrobial Susceptibility Tests Fail to Detect Resistance | 9 |
Steam Resterilization Roughens Surface of Zirconia Ceramic Femoral Heads | 20 |
Working Group Formed to Address the Problem of Patient Entrapment in Hospital Beds | 29 |
Workshop Held on Hospital Beds and Vulnerable Patients | 30 |
Medical Device Reporting (MDR) | |
A Review of Mandatory MedWatch Form 3500A and Semiannual Report Form 3419 | 16 |
Applying the Safe Medical Devices Act to Nursing Homes | 17 |
Comments Received on Proposed Medical Device Reporting Regulation | 2 |
FDA Begins Inspection of User Facilities | 13 |
FDA Begins Train the Trainer Courses | 17 |
FDA Extends Effective Date for MDR to 7/31/96 | 15 |
FDA Holds Train the Trainer Courses | 18 |
FDA Regions Offer MDR Training | 18 |
FDA Sends Public Health Notice About Important Y2K Planning Information | 27 |
FDA Will Present Live Satellite Teleconference | 14 |
Final Civil Penalties Rule Published | 13 |
Handling Adverse Events Reports | 33 |
How to Handle Failed Devices | 27 |
Live Satellite Teleconference on MDR Final Rule | 15 |
MDR Final Regulation to Be Published Soon | 10 |
MDR Program Starter Kit (Table) | 14 |
MDR Teleconference Reaches Large Audience | 16 |
MDR: A Public Health Partnership | 14 |
Medical Device Amendments of 1992 | 2 |
Medical Device Tracking: A Case Study | 31 |
Preserving the Evidence! The First Step in An Accident Investigation | 23 |
President's Council on Year 2000 Conversion | 27 |
Public Availability of User Reports | 4 |
Reporting Problems with Medical Devices: Overview | 35 |
Reporting Y2K Adverse Events | 28 |
Review of MDR Reports Reinforces Concern About EMI | 20 |
Those Codes | 18 |
Training Medical Personnel to Comply with SMDA | 3 |
User Facility ID Number | 4 |
What to Expect During an FDA User Facility Inspection | 24 |
When to File an MDR Report | 12 |
MedWatch | |
FDA Announces New MedWatch Program | 5 |
MedWatch Software Available On Internet | 18 |
MedWatch | 6 |
Natural Rubber Latex Allergy: A MedWatch Success Story | 19 |
Obtaining MedWatch Forms and Instructions | 5 |
Miscellaneous | |
A Note from James L. Morrison, Acting Director | 8 |
Applying the Safe Medical Devices Act to Nursing Homes | 17 |
HCFA to Hold Conferences on Year 2000 (Y2K) Readiness Strategies | 26 |
How to Request MDR Records Under the Freedom of Information Act | 11 |
Lyme Disease: Difficult to Diagnose | 26 |
MDR from an Insurance Company Perspective | 11 |
New Mammogram Requirements Effective April 28 | 26 |
Public Health Advisories and Alerts | |
FDA Sends Safety Alerts and Public Health Advisories to Warn of Medical Device Risks | 8 |
Infections from Inadequately Reprocessed Endoscopes: FDA & CDC Issue Public Health Advisory | 28 |
Public Health Advisory on Electric Heating Pads Prompted by MDR Reports | 16 |
Public Health Advisory: Potential for Injury from Medical Gas Misconnections of Cryogenic Vessels | 35 |
Public Health Message: Electrode Lead Wires and Patient Cables | 24 |
Safety Alert Issued for Hospital Bed Side Rails | 13 |
Questions | |
Frequently Asked MDR Questions | 16 |
Frequently Asked Questions | 1 |
Frequently Asked Questions | 3 |
How to Avoid Problems with MDR Reports | 11 |
Questions and Answers | 5 |
Questions and Answers | 9 |
Quiz: Are These Medical Incident Reports Required? | 2 |
Reader Survey | |
Analysis of Bulletin Questionnaires | 10 |
Preliminary Results of the Reader Survey | 9 |
Questionnaire | 8 |
Report to Congress | |
Highlights of the Report to Congress on User Facility Reporting | 7 |
Reporting Requirements | |
First Semiannual Report Due by July 31 | 1 |
Food and Drug Administration Modernization Act of 1977 | 22 |
Reuse/Single-Use/Disposable | |
AAMI/FDA to Hold Conference on Reuse of Single-Use Devices | 25 |
August 14, 2001: Important Enforcement Date for Hospital Reprocessors of Single-Use Devices | 34 |
Applying the Quality System Regulation to Hospitals that Reprocess SUDs | 34 |
Changes in Enforcement of FDA's Requirements on Reprocessing of Single-Use Devices: Letter from Dr. Feigal (September 25, 2001) | 36 |
Disposable Devices: Time for a Change | 21 |
Establishment Registration & Medical Device Listing | 34 |
Extensions Granted to Enforcement Priorities of Reprocessed Single-Use Devices | 35 |
FDA Alerts Users of Reusable Medical Devices | 19 |
FDA Releases Final Guidance on the Reprocessing and Reuse of Single-Use Devices | 31 |
FDA Sends Another Letter to Hospitals About Reuse of Single-Use Devices | 36 |
Labeling and Tracking Requirements | 34 |
Medical Device Reporting | 34 |
PMA Submissions Now Due for Reprocessed Class III Single-Use Devices | 33 |
Premarket Approval | 34 |
Premarket Notification | 34 |
Reports of Corrections and Removals | 34 |
Reprocessing of Single-Use Devices: Letter from Dr. Feigal (September 28, 2000) | 32 |
Reuse Events | 30-36 |
Reuse of Single-Use Devices | 29 |
Reuse of Single-Use Devices Workshops | 34 |
Reuse Teleconference, December 13, 2000 | 32 |
Tracking | |
Device Tracking | 2 |
Devices to Be Tracked (Table) | 3 |
Devices to Be Tracked as of 8/29/93 (table) | 5,6 |
Implementing a Medical Device Tracking System at Thomas Jefferson University Hospital | 6 |
Tracking for 26 Devices Is Required 8/29/93 | 5 |
User Facility Reporting Bulletin | |
Cost of Printing Bulletin May Lead To Availability Only On Internet | 18 |
Future of Bulletin Uncertain | 24 |
Last Printing of User Facility Reporting Bulletin | 20 |
List Serve Announcements | 34-36 |
Two Ways to Get the Bulletin In the Future | 20 |
User Reports | |
A Look at the First 50 User Facility Reports | 1 |
Accessing User Facility Reporting Information on the World Wide Web | 20 |
Confidentiality of User Facility Reports Is Governed by Freedom of Information Act | 9 |
FDA Introduces Study for User Facility Reporting | 22 |
Public Availability of User Reports | 4 |
Summary of User Facility Reporting: 1992-1996 | 18 |
The First Year of User Facility Reporting: Part I. A User Facility Perspective | 4 |
Part II. The FDA Perspective | 4 |
What Does FDA Do With Adverse Event Reports? | 2 |
Highlights of the User Facility Medical Device Reporting (MDR) Requirements (Table) | 2 |
It's the Law: User Facility Reporting Under SMDA | 1 |
Safe Medical Devices Act of 1990 | 1 |
Semiannual Reports Were Due by July 31 | 5 |
November 4-7, 2001
RAPS 2001 Conference, Baltimore, Maryland,
FDA Speaker: Lily Ng
For more information: http://www.raps.org/educ/uprogs.cfm
November 14, 2001
Association for Professionals in Infection Control of Greater Detroit, Detroit,
Michigan,
FDA Speaker: Eric Joneson
For more information go to their website: www.APICGD.org; or contact Lisa
Sturm by electronic mail: lsturm@umich.edu.
For additional information about reuse, visit the Reuse Website
at:
http://www.fda.gov/cdrh/reuse/index.shtml
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 November 9, 2001
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