Medical Device Reporting: User Facility Obligations under FDA Regulations, Study notes of Nursing

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Medical Device Reporting

for User Facilities

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service Food and Drug Administration

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FOREWORD

The Center for Devices and Radiological Health (CDRH), part of the Food and Drug Administration (FDA), develops and implements national programs and regulations to protect the public health in the fields of medical devices and radiological health. These programs are intended to assure the safety, effectiveness, and proper labeling of medical and radiation- emitting devices.

The Center publishes the results of its work in scientific journals and in its own technical reports. Through these reports, CDRH also provides assistance to industry and to the medical and health professional communities in complying with the laws and regulations mandated by Congress. The reports are sold by the Government Printing Office (GPO) and by the National Technical Information Service (NTIS). Many reports are also available on the Internet/World Wide Web.

We welcome your comments and requests for further information.

D. Bruce Burlington, M.D. Director Center for Devices and Radiological Health

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PREFACE

The Safe Medical Devices Act of 1990 (SMDA) imposed significant new reporting require- ments on the medical device industry and users of medical devices. SMDA requires user facilities to report device-related deaths and serious injuries to the Food and Drug Administra- tion (FDA) and/or the manufacturer. Although the user facility reporting requirements of SMDA were automatically effective November 28, 1991, this guidance document is based on the final Medical Device Reporting (MDR) rule which was published in the December 11, 1995, Federal Register. The final rule also addresses changes mandated by the Medical Device Amendments of 1992.

Much of the information in this document is general in nature and may not apply to a specific situation. Questions should be sent by facsimile (FAX) to (240) 276-34 54 or mailed to:

Food and Drug Administration Center for Devices and Radiological Health Division of Surveillance Systems (HFZ-530) Medical Device Reporting (MDR) Inquiries 1350 Piccard Drive Rockville, MD 20850

Please include your name, return address, phone number, and (if applicable) FAX number with your questions.

This guidance for user facilities is one of three documents written for a particular audience: user facilities, manufacturers, and distributors. All are available through the Internet/World Wide Web at: http://www.fda.gov and after June 1996, from the National Technical Informa- tion Service, Springfield, Virginia 22161, telephone no. (703) 487-4650. Other MDR docu- ments are:

• Medical Device User Facility and Manufacturer Reporting, Certification and Registration... Final Rules. December 11, 1995, Federal Register , pp. 63578-63607.
• Mandatory MedWatch FDA Form 3500A
• Instructions for Completing Form 3500A with Coding Manual for Form 3500A
• Abbreviated Instructions for FDA Form 3500A Specific to MDR
• MDR Semiannual Report Form FDA 3419
• MDR Baseline Report Form FDA 3417
• MDR Annual Certification Form FDA 3381
• Medical Device Reporting: An Overview
• Medical Device Reporting for Distributors
• Medical Device Reporting for Manufacturers (draft)
• User Facility Reporting Bulletin - all issues

Joseph A. Levitt Interim Director Office of Health and Industry Programs

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This guidance does not create or confer any rights, privileges or benefits for or on any person, nor does it operate to bind FDA or any other person. The agency will consider individual circumstances on a case-by-case basis. Where this document reiterates a requirement imposed by statute or regulation, the force and effect as law of the requirement is not changed in any way by virtue of its inclusion in this document.

• 1. Introduction Preface v
     • Table 1 - Summary of MDR Reporting Requirements
     • Table 2 - Summary of Other MDR Requirements
• 2. User Facility Reporting Requirements
  • Type of reports
    • Individual adverse event reports
    • Semiannual reports
  • Individual adverse event report data elements
  • Semiannual report data elements
  • When to report
  • “Information that reasonably suggests”
  • “Information that is reasonably known” to user facilities
  • Requests for additional information
  • When not to file
  • Exemptions, variances, and alternative reporting
  • English reporting requirements
  • Reporting codes
  • Electronic reporting
  • Where to get forms and coding manual
  • Where to submit reports
• 3. Written Procedures, Record Keeping, and Public Disclosure
  • Written procedures
  • Files
  • Public availability of reports
  • Disclaimers
• 4. Enforcement
  • Authority to Enforce MDR
    • Criminal penalty authority
    • Civil penalty authority
• 5. Definitions
  • Ambulatory surgical facility
  • “Becomes aware”
  • “Caused or contributed to”
  • Device user facility
  • Hospital
  • Malfunction
  • MDR
  • MDR reportable event
  • Medical personnel
  • Nursing home
  • Outpatient diagnostic facility viii
  • Outpatient treatment facility
  • Patient of the facility
  • Physician’s office
  • Serious injury
  • Permanent
  • User facility reporting number
  • Work day
• 6. Frequently asked questions
  • A. FDA Form 3500A (mandatory MedWatch form) Appendices
  • B. Form FDA 3419 (MDR Semiannual Report)
  • C. Abbreviated Instructions for FDA Form 3500A Specific to MDR

1. INTRODUCTION

In 1990, Congress enacted the Safe Medical Devices Act (SMDA) to increase the information that the Food and Drug Administration (FDA) and manufacturers receive about serious problems with medical devices. Although manufacturers and importers of medical devices have been required since 1984 to report to FDA all device-related deaths, serious injuries, and certain malfunctions, numerous reports show widespread under reporting. A 1986 General Accounting Office (GAO) study showed that hospitals reported less than one percent of problems with medical devices and, the more serious the problem with a medical device, the less likely it was to be reported. A GAO follow-up study in 1989 concluded that despite full implementation of the Medical Device Reporting (MDR) regulation, serious under reporting still existed.

Under SMDA, device user facilities and manufacturers must report deaths and serious injuries to which a device has or may have caused or contributed and must establish and maintain adverse event files. A device user facility is defined as a hospital, an ambulatory surgical facility, a nursing home, an outpatient treatment facility, or an outpatient diagnostic facility which is not a physician’s office. A medical device is any item that is used for the diagnosis, treatment, or prevention of a disease, injury, or other condition and is not a drug or biologic. (See sections 5 and 6 for definitions of terms and concepts.) The user facility reporting section of SMDA became effective on November 28, 1991.

To implement SMDA, FDA published a tentative final rule in the November 26, 1991, Federal Register and invited comments on the regulation. Over 300 comments were received. Then, on June 16, 1992, the President signed into law the Medical Device Amendments of 1992 (Public Law 102-300; the Amendments of 1992), amending certain provisions (section 519 of the Food, Drug, and Cosmetic Act) relating to reporting of adverse events. The primary impact of the 1992 Amend-ments on user facility reporting was to establish a single reporting standard for user facilities, manufacturers, and importers. The final medical device reporting rule published in the December 11, 1995, Federal Register addresses the comments received by FDA and the changes mandated by the Amendments of 1992. For easy reference, sections of the MDR regulation are enclosed in brackets following terms and concepts.

The following tables summarize the MDR requirements for user facilities and manufacturers.

2. USER FACILITY

REPORTING REQUIREMENTS

User facilities must report deaths and serious injuries when they become aware of information that reasonably suggests a medical device has or may have caused or contributed to the adverse event. They must also establish and maintain adverse event files.

2.1 Type of reports 2.2 Individual adverse event report data

User facilities are required to file two types of reports:

Individual adverse event reports [§803.30] • patient information (block A);

Individual adverse event reports include • description of adverse event or product reports of death and serious injury which are problem (block B); submitted on FDA Form 3500A or an electronic equivalent. • suspect medical device information

A user facility must report to the device manufacturer and FDA whenever the facility has information that reasonably suggests a device has or may have caused or contributed to a patient’s death. If a facility has information that reasonably suggests a device has or may have caused or contributed to a patient’s serious injury , it must report this information to the device manufacturer. If the manufacturer is not known, the report should be sent to FDA.

Semiannual reports [§803.33]

If any individual adverse event report was submitted during the previous 6-month reporting period, a user facility must submit a semiannual report to FDA on FDA Form 3419, or an approved electronic equivalent. Semiannual reports are due by January 1 (for reports made July through December) and by July 1 (for reports made January through June) of each year.

A semiannual report should not be submitted if no individual reports were submitted to FDA or manufacturers during the reporting period.

elements [§803.32]

User facility reports (using FDA Form 3500A) must contain the following:

(Block D);

• initial reporter information (Block E); and
• user facility information (Block F)

2.3 Semiannual report data elements [§803.33]

A semiannual report must contain the following information:

• user facility’s Health Care Facility Administration (HCFA) provider num- ber or number assigned by FDA;
• reporting year and period, e.g., January through June or July through December;
• facility’s name and complete address;
• total number of reports attached or summarized;
• date of the semiannual report and the lowest and highest report numbers submitted during the report period; e.g., 1234567890-1995-0001 through 1000;

• name, position title, and complete Semiannual reports are due on January 1 address of the individual designated and July 1. as the facility contact person responsible for reporting to FDA, and whether or not that person is a new contact for that facility; and
• information for each reportable event that occurred during the semiannual reporting period including:
• user facility report number;
• name and address of the device manufacturer;
• device brand name and common name;
• product model, catalog, serial, and lot number;
• a brief description of the event reported to the manufacturer and/or FDA; and
• where the report was submitted, i.e., to FDA, manufacturer, distributor, etc.

In lieu of submitting a summary of each reported event, a user facility may complete only Part 1 of FDA Form 3419 and attach a copy of each mandatory report (FDA Form 3500A, or an approved electronic equivalent) filed during the reporting period. The copies and envelope should be clearly identified as “Semiannual Report.”

2.4 When to report [§803.20]

All individual reports of death and serious injury must be submitted within 10 work days from the time that any medical relate the request to a reported event. All personnel of the facility becomes aware of a verbal requests will be confirmed in writing reportable event. by FDA.

2.5 “Information that reasonably suggests” [§803.20(c)]

Information that reasonably suggests that a medical device has caused or contributed to a MDR reportable event (i.e., a death or serious injury) includes any information such as professional, scientific, or medical facts and observations or opinions that a device has caused or may have caused or contributed to a reportable event.

2.6 “Information that is reasonably known” to user facilities [§803.30].

User facilities must provide all information that is reasonably known to them. This includes information found in documents in the possession of the user facility and any information that becomes available as a result of reasonable follow-up within the facility. A user facility is not required to evaluate or investigate the event by obtaining or evaluating information that is not reasonably known to it.

2.7 Requests for additional information [§803.15]

FDA may determine that protection of the public health requires additional or clarifying information for an MDR report. In these instances and when additional information is beyond the scope of FDA reporting forms, or is not readily accessible, the agency will notify the user facility of the additional information that is required. Any request will state the reason or purpose for which the information is being requested, specify the date that the information is to be submitted, and clearly

FDA Emergency Operations Branch, Office of Regional Operations, HFC- Telephone number 1-866-300-4374 or 301-796-

The telephone report should be followed by a FAX report to 240-276-3454.

3. WRITTEN PROCEDURES, RECORD

KEEPING, AND PUBLIC DISCLOSURE

User facilities must develop, implement, and maintain written procedures for reporting adverse medical device events. In addition to reporting device-related deaths and serious injuries, user facilities must establish and maintain MDR files.

3.1 Written procedures [§803.17] 3.2 Files [§803.18]

Written procedures include internal User facilities must establish and main- systems that provide: tain MDR event files. MDR event files are

• for timely and effective identifica- user facility. They must be prominently tion, communication, and evalu- identified as such and filed to facilitate timely ation of adverse events; access. MDR files must contain:
• a standardized review process and • information in the possession of the procedure for determining whether user facility or references to infor- or not an event is reportable; and mation related to the event. This
• procedures to assure the timely reporting decisions and decision- transmission of complete reports. making process; and

User facilities must also establish, • copies of all completed MDR forms implement, and maintain written procedures and other information submitted to to assure compliance with documentation and FDA, distributors, and manufac- record-keeping requirements. This includes: turers.

• information that was evaluated to Records related to an adverse event, determine if an event was whether reported or not, must be kept for two reportable; (2) years from the date of the event. A user
• all MDR reports and information access, at all reasonable times, to all required submitted to FDA and manufac- records for copying and verification. turers;
• any information that was evaluated for the purpose of preparing the submission of semiannual reports; and
• systems that ensure access to information that facilitates timely followup and inspection by FDA.

written or electronic files maintained by the

includes all documentation of the

facility must permit FDA employees to have

3.3 Public availability of reports [§803.9]

Certain information from MDR reports, including any FDA record of a telephone report, is available for public disclosure. Before public disclosure of a report, FDA will delete from the report:

• any information that constitutes trade secret or confidential commercial or financial information;

4. ENFORCEMENT

FDA has criminal and civil penalty authority to enforce the MDR requirements.

4.1 Authority to enforce MDR

Criminal penalty authority: Failure to comply with the MDR requirements is a prohibited act under the Food, Drug and Cosmetic Act (FD&C Act). Commission of a prohibited act may subject user facilities to injunction proceedings under Section 302 and criminal penalties under Section 303 of the FD&C Act.

Criminal penalties may be up to a $1,000 fine and one year imprisonment for the first offense if the offense was unintentional, and up to $10,000 and three years imprisonment for subsequent offenses, or for intentional offense.

Civil penalty authority : Failure to comply with MDR reporting requirements may result in civil penalties if the failure is a significant or knowing departure from the requirements, or a risk to public health. Civil penalties are fines imposed administratively by FDA for noncompliance with the provisions of SMDA. A person who receives a civil penalty is entitled to a hearing before an Admini-strative Law Judge (ALJ). The ALJ’s decision may be appealed to the Commissioner of FDA, and the Commissioner’s decision may be appealed to a U.S. Court of Appeals. Penalties may not exceed $15,000 per violation or $1,000,000 for all violations adjudicated in a single proceeding.