User Facility Reporting Bulletin, Issue No. 36, Fall 2001

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

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

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

SUBJECT

ISSUE

Computer Database

CDRH's MAUDE System

MAUDE Update

MAUDE Update: Errors in Reporting

MAUDE Update: Semi-Annual Reports

User Facility Reporting Bulletin and MDR Information Are Now on Internet

Electromagnetic Interference (EMI)

FDA and AAMI to Present a Forum on Electromagnetic Compatibility for Medical Devices

FDA Concerned About Interference With Medical Devices (EMI)

FDA Warns About EMI Risks with Telemetry

Implanted Pacemakers: Avoiding Electromagnetic Interference

Interference Between Digital TV Transmissions & Telemetry Systems

Review of MDR Reports Reinforces Concern About EMI

Flowcharts

FDA Device Tracking Regulations: Device and Information Flowchart

Flowcharts Promote Internal Reporting Procedures

Sample Flowchart: How to Report Incidents Involving Medical Devices, Drugs, Utilities, and Security

Forms and Instructions

Abbreviated Instructions for FDA Form 3500A Specific to Medical Device Reporting

FDA Form 3419

Mandatory MedWatch FDA Form 3500A

Where to Get MDR Materials

Hospital Beds and Vulnerable Patients

Hospital Side Rails: Preventing Entrapment

Hospital Bed Safety Work Group: Highlights of March Meeting

Working Group Formed to Address the Problem of Patient Entrapment in Hospital Beds

Workshop Held on Hospital Beds and Vulnerable Patients

Human Factors

AAMI/FDA Conference Will Address Human Factors in Medical Device Design, Regulations, and Safety

Human Factors and Medical Devices

Human Factors and Medical Devices: Lack of Device Feedback

Importance of Information About Use Error and Human Factors in Adverse Event Reporting

We Urge You to Report Medical Devices Design Problems

Index

Subject Matter Index to UFR Bulletin Issues 1-16

Subject Matter Index to UFR Bulletin Issues 1-26

Subject Matter Index to UFR Bulletin Issues 1-36

Latex

Adverse Reactions to Natural Rubber Latex

Cornstarch As A Glove Donning Powder

FDA Answers Latex Glove Questions

FDA Clarifies Latex Terminology

FDA Issues Final Rule on Natural Rubber Device Labeling

FDA Scientists Study Quality Assurance Tests for Latex Gloves

Glove Quality and Selection Criteria

How FDA Regulates Gloves

Natural Rubber Latex Allergy: A MedWatch Success Story

Natural Rubber /Latex Allergy: Recognition, Treatment, Prevention

New Labeling for Natural Rubber Latex

MDR Studies

Contracts Awarded for User Facility Reporting Study

Evaluation of Device User Facility Reporting

Medical Device Surveillance Network (MeDSuN)

Medical Product Surveillance Network (MeDSuN) Ready to Launch First Segment of the Phase II Pilot

MEDSUN - Using Facility Reporting for the New Millennium

Update on User Facility Reporting Study

Medical Device Problems

Adverse Reactions to Natural Rubber Latex

Alarming Monitor Error

Avoiding Sticks from Sharp Containers

Biliblanket Phototherapy Light Safety Tips

Central Venous Catheters and Cardiac Tamponade

Complications Related to the Use of Vascular Hemostasis Devices

Complications with the Use of Small-bore Catheters in Continuous Spinal Anesthesia

Cornstarch As A Glove Donning Powder

Cross Contamination of Hemodialysis Machines: An Unexpected Risk

Disposable Devices: Time for a Change

Explosions & Fires in Aluminum Oxygen Regulators

FDA Cautions Users of Vacuum Assisted Delivery Devices

FDA Concerned About Interference With Medical Devices (EMI)

FDA Publishes Results of Infusion Pump Investigation

FDA Sends Safety Alerts and Public Health Advisories to Warn of Medical Device Risks

FDA Warns About EMI Risks with Telemetry

FDA Warns About Radioactivity in Radiation Protection Devices

FDA Will Co-sponsor Conference on Unprotected Patient Cable and Electrode Lead Wires

Full Field Digital Mammography Approved for Use in MQSA-Certified Facilities

Glass Capillary Tubes Pose Risks

Healthcare Community Alerted to Device Problems During 1994

Heating Devices: How to Avoid Burns

Hospital Side Rails: Preventing Entrapment

Hospital Bed Safety Work Group: Highlights of March Meeting

How to Avoid Injuries from Liquid Chemical Disinfectant

Implanted Pacemakers: Avoiding Electromagnetic Interference

Incorrect Restraint Use: Deadly Protection

Infections from Inadequately Reprocessed Endoscopes: FDA & CDC Issue Public Health Advisory

Infusion Pump Mishap: Outside The Channel

Interference Between Digital TV Transmissions and Telemetry Systems

Labor and Delivery Beds: Keeping Newborns Safe from Falls

Medical Device Year 2000 Update

Medication Errors Associated with Medical Gas Mix-Ups

Pacing Your Patients

Peritoneal Dialysate Overfill and Human Factor Implications

Potential Hypersensitivity Reactions to Chlorhexidine-Impregnated Devices

Potential Injury from Circumcision Clamps

Problems with Biological Indicators

Problems with Circumcision Clamps

Protecting Your Patient's Eyes

Public Health Advisory on Electric Heating Pads Prompted by MDR Reports

Public Health Advisory: Potential for Injury from Medical Gas Misconnections of Cryogenic Vessels

Public Health Message: Electrode Lead Wires and Patient Cables

Risk with Collagen Hemostasis Devices

Safeguarding Cardiac Guide Wires: Follow These Tips to Avoid Breakage

Safeguarding Contrast Media Injections

Safe Infusions

Safety Alert Issued for Hospital Bed Side Rails

Sending the Wrong Signals

Serious Complications Associated with Pulmonary Artery Catheters

Serious Injuries from Microwave Thermotherapy Used for Benign Prostatic Hyperplasia

Some Antimicrobial Susceptibility Tests Fail to Detect Resistance

Steam Resterilization Roughens Surface of Zirconia Ceramic Femoral Heads

Working Group Formed to Address the Problem of Patient Entrapment in Hospital Beds

Workshop Held on Hospital Beds and Vulnerable Patients

Medical Device Reporting (MDR)

A Review of Mandatory MedWatch Form 3500A and Semiannual Report Form 3419

Applying the Safe Medical Devices Act to Nursing Homes

Comments Received on Proposed Medical Device Reporting Regulation

FDA Begins Inspection of User Facilities

FDA Begins Train the Trainer Courses

FDA Extends Effective Date for MDR to 7/31/96

FDA Holds Train the Trainer Courses

FDA Regions Offer MDR Training

FDA Sends Public Health Notice About Important Y2K Planning Information

FDA Will Present Live Satellite Teleconference

Final Civil Penalties Rule Published

Handling Adverse Events Reports

How to Handle Failed Devices

Live Satellite Teleconference on MDR Final Rule

MDR Final Regulation to Be Published Soon

MDR Program Starter Kit (Table)

MDR Teleconference Reaches Large Audience

MDR: A Public Health Partnership

Medical Device Amendments of 1992

Medical Device Tracking: A Case Study

Preserving the Evidence! The First Step in An Accident Investigation

President's Council on Year 2000 Conversion

Public Availability of User Reports

Reporting Problems with Medical Devices: Overview

Reporting Y2K Adverse Events

Review of MDR Reports Reinforces Concern About EMI

Those Codes

Training Medical Personnel to Comply with SMDA

User Facility ID Number

What to Expect During an FDA User Facility Inspection

When to File an MDR Report

MedWatch

FDA Announces New MedWatch Program

MedWatch Software Available On Internet

MedWatch

Natural Rubber Latex Allergy: A MedWatch Success Story

Obtaining MedWatch Forms and Instructions

Miscellaneous

A Note from James L. Morrison, Acting Director

Applying the Safe Medical Devices Act to Nursing Homes

HCFA to Hold Conferences on Year 2000 (Y2K) Readiness Strategies

How to Request MDR Records Under the Freedom of Information Act

Lyme Disease: Difficult to Diagnose

MDR from an Insurance Company Perspective

New Mammogram Requirements Effective April 28

Public Health Advisories and Alerts

FDA Sends Safety Alerts and Public Health Advisories to Warn of Medical Device Risks

Infections from Inadequately Reprocessed Endoscopes: FDA & CDC Issue Public Health Advisory

Public Health Advisory on Electric Heating Pads Prompted by MDR Reports

Public Health Advisory: Potential for Injury from Medical Gas Misconnections of Cryogenic Vessels

Public Health Message: Electrode Lead Wires and Patient Cables

Safety Alert Issued for Hospital Bed Side Rails

Questions

Frequently Asked MDR Questions

Frequently Asked Questions

How to Avoid Problems with MDR Reports

Questions and Answers

Quiz: Are These Medical Incident Reports Required?

Reader Survey

Analysis of Bulletin Questionnaires

Preliminary Results of the Reader Survey

Questionnaire

Report to Congress

Highlights of the Report to Congress on User Facility Reporting

Reporting Requirements

First Semiannual Report Due by July 31

Food and Drug Administration Modernization Act of 1977

Reuse/Single-Use/Disposable

AAMI/FDA to Hold Conference on Reuse of Single-Use Devices

August 14, 2001: Important Enforcement Date for Hospital Reprocessors of Single-Use Devices

Applying the Quality System Regulation to Hospitals that Reprocess SUDs

Changes in Enforcement of FDA's Requirements on Reprocessing of Single-Use Devices: Letter from Dr. Feigal (September 25, 2001)

Disposable Devices: Time for a Change

Establishment Registration & Medical Device Listing

Extensions Granted to Enforcement Priorities of Reprocessed Single-Use Devices

FDA Alerts Users of Reusable Medical Devices

FDA Releases Final Guidance on the Reprocessing and Reuse of Single-Use Devices

FDA Sends Another Letter to Hospitals About Reuse of Single-Use Devices

Labeling and Tracking Requirements

Medical Device Reporting

PMA Submissions Now Due for Reprocessed Class III Single-Use Devices

Premarket Approval

Premarket Notification

Reports of Corrections and Removals

Reprocessing of Single-Use Devices: Letter from Dr. Feigal (September 28, 2000)

Reuse Events

30-36

Reuse of Single-Use Devices

Reuse of Single-Use Devices Workshops

Reuse Teleconference, December 13, 2000

Tracking

Device Tracking

Devices to Be Tracked (Table)

Devices to Be Tracked as of 8/29/93 (table)

5,6

Implementing a Medical Device Tracking System at Thomas Jefferson University Hospital

Tracking for 26 Devices Is Required 8/29/93

User Facility Reporting Bulletin

Cost of Printing Bulletin May Lead To Availability Only On Internet

Future of Bulletin Uncertain

Last Printing of User Facility Reporting Bulletin

List Serve Announcements

34-36

Two Ways to Get the Bulletin In the Future

User Reports

A Look at the First 50 User Facility Reports

Accessing User Facility Reporting Information on the World Wide Web

Confidentiality of User Facility Reports Is Governed by Freedom of Information Act

FDA Introduces Study for User Facility Reporting

Public Availability of User Reports

Summary of User Facility Reporting: 1992-1996

The First Year of User Facility Reporting: Part I. A User Facility Perspective

Part II. The FDA Perspective

What Does FDA Do With Adverse Event Reports?

Highlights of the User Facility Medical Device Reporting (MDR) Requirements (Table)

It's the Law: User Facility Reporting Under SMDA

Safe Medical Devices Act of 1990

Semiannual Reports Were Due by July 31