Hospital Reprocessors: Guidance on Adverse Event Reporting for Hospitals that Reprocess Devices Intended by the Original Equipment Manufacturer for Single Use
NOTE: Some enforcement dates in this document have been extended. For additional information about the enforcement extensions, see Letter to Hospitals (September 25, 2001).
Document issued on: April 24, 2001
U.S. Department Of Health and Human Services
Reporting Systems Monitoring Branch
Comments and suggestions regarding this document should be submitted at any time for Agency consideration to Reporting Systems Monitoring Branch, HFZ-533, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, Rockville, MD 20850. Comments may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the use or interpretation of this guidance contact the Reporting Systems Monitoring Branch by fax at 301-827-0038.
Additional copies are available from the Internet. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number 1334 to identify the guidance you are requesting.
2. Additional reporting requirements for a hospital reprocessor of devices intended for single-use
3. Major differences between user facility and manufacturer reporting obligations
4. Reporting adverse events as a manufacturer versus user facility
5. Adverse event reporting for reprocessed devices
6. Reporting requirements for hospitals not involving single-use devices (SUDs) reprocessed by the hospital
7. Reporting requirements for SUDs reprocessed by the hospital
8. Combining manufacturer and user facility requirements for reporting adverse events involving a patient death
9. Definition of serious injury
10. Definition of malfunction
11. Completing MedWatch 3500A as a user facility involving devices that are not SUDs reprocessed by the hospital
12. Completing MedWatch 3500A for SUDs reprocessed by the hospital
13. Requirements for filing reports of corrections and removals
14. Filing a report of corrections and removals versus an adverse event under MDR
15. Filing an initial Baseline Report Form as a SUD hospital reprocessor
16. Obtaining information on submission of electronic equivalents
17. Filing Supplemental Reports as a SUD hospital reprocessor
18. Additional manufacturer MDR requirements
19. Requests for exemptions and alternative reporting options
20. Obtaining additional information on user facility or manufacturer MDR requirements
Guidance on Adverse Events Reporting for Hospitals that Reprocess Devices Intended
by the Original Equipment Manufacturer for Single Use1
On November 3, 1999, we (the Food and Drug Administration) announced that we intended to regulate original equipment manufacturers (OEMs), third parties, and hospitals that engage in reprocessing devices for single use in the same manner2. In the past, we regulated third party reprocessors in the same manner as OEMs under the Federal Food, Drug, and Cosmetic Act (the Act), except we did not actively enforce premarket requirements for third party reprocessors. We did not actively enforce any requirements for hospital reprocessors related to reprocessed single-use devices (SUDs). Under our proposed strategy to regulate the reprocessing and reuse of SUDs, we stated that we were considering actively enforcing all the requirements of the Act that apply including:
- Registration and Device Listing (Section 510 of the Act; 21 Code of Federal Regulation (CFR) Part 807);
- Medical Device Reporting (MDR) regulation (Sections 519(a), (b), and (c) of the Act; 21 CFR Part 803);
- Medical Device Tracking (Section 519(e) of the Act; 21 CFR Part 821);
- Medical Device Corrections and Removals (Section 519(f) of the Act; 21 CFR Part 806);
- Quality System Regulation (QSR) (Section 520(f) of the Act; 21 CFR Part 820);
- Labeling (Section 502 of the Act; 21 CFR Part 801); and
- Premarket Requirements (Sections 510, 513, and 515 of the Act; 21 CFR Parts 807 and 814).
On August 14, 20003, we issued a guidance document entitled "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals" (SUD enforcement guidance) which finalized our policy on how we intend to regulate third parties and hospitals engaged in reprocessing SUDs for reuse in humans. In this guidance document, we stated that we intend to enforce premarket submission requirements within six (6) months of issuance of the final SUD guidance for all class III devices; within twelve (12) months for class II non-exempt devices; and eighteen (18) months for class I non-exempt devices.
1 This document is intended to provide guidance. It represents the Agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
2 64 FR 59782-59783, Nov. 3, 1999.
3 65 FR 49583-49585, Aug. 14, 2000.
The SUD enforcement guidance also stated our intent to continue to exercise our enforcement discretion with respect to the Act’s non-premarket submission requirements for hospital reprocessors for one year from the issuance of the final SUD policy. These non-premarket requirements include establishment registration, device listing, adverse event reporting (MDR), tracking (which is triggered only by a specific FDA Tracking order), corrections and removals, and quality system.
A copy of the SUD enforcement guidance is available on FDA’s web page "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals".
We believe we should consider the least burdensome approach in all areas of medical device regulation. This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that an alternative approach would be less burdensome, please contact us so we can consider your point of view. You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH Ombudsman. Comprehensive information on CDRH’s Ombudsman, including ways to contact him, can be found on the Internet.
In addition to their current obligation to report adverse events as user facilities4, hospitals that engage in manufacturing activities, such as reprocessing, are subject to the manufacturer’s reporting requirements (21 CFR Part 803) for adverse events involving SUDs that they reprocess. We recognize that hospital reprocessors may need additional guidance from us on how to submit adverse event reports as manufacturers. This guidance document serves two purposes:
- To describe our Medical Device Reporting (MDR) requirements for device manufacturers (21 CFR Part 803) to SUD hospital reprocessors; and
- To provide guidance to hospital SUD reprocessors on how to complete the Mandatory MedWatch report form (FDA Form 3500A) as device manufacturers.
4 The discretionary period for the MDR requirements for reporting adverse events related to SUDs that a hospital reprocesses only applies to manufacturer MDR reporting requirements (21 CFR 803 subpart E); it does not include user facility MDR reporting requirements (21 CFR 803 subpart C). FDA will continue to actively enforce device user facility MDR requirements for all device user facilities, including hospital reprocessors.
This guidance document only applies to hospitals that are defined as manufacturers in accordance with 21 CFR Part 803. A manufacturer is defined in 21 CFR 803.3(o) as "any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure."
The objective of the MDR regulation is to provide a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices so that problems may be detected and corrected in a timely manner. The statutory authority for the MDR regulation are Sections 519 (a), (b), and (c) of the Act as amended by the Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992. The final regulation for reporting adverse events involving medical devices was published on December 11, 1995, and became effective on July 31, 1996. This regulation implemented the reporting requirements for both health care (user) facilities and manufacturers.
The Food and Drug Modernization Act of 1997 made further changes to the MDR requirements. These changes were published as a Final Rule entitled "Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, Distributor Reporting" in the Federal Register on January 26, 2000 (65 FR 4112-4121). A copy of the December 1995 and January 2000 MDR Final Rule and other related MDR documents and guidances are available on FDA’s Medical Device Reporting (MDR) web page (see Appendix A for a partial listing of these documents).
E. Reporting Adverse Events as a User Facility7 and as a Manufacturer
What are the basic adverse event reporting obligations for user facilities and manufacturers?
Reports of individual adverse events required for user facilities and manufacturers:
User facilities and manufacturers report individual adverse events to us under a uniform, unified reporting system. Both user facilities and manufacturers report adverse events on the same MedWatch FDA form 3500A, the "Medication and Device Experience Report. " (You can find a copy of the Mandatory MedWatch report form at "How to Report a Medical Device Problem".
When a user facility receives information about a reportable adverse event, it must report the event to us and/or the manufacturer within ten (10) workdays. The user facility fills out certain parts of the MedWatch 3500A form and forwards copies of the form to both FDA and the manufacturer if the adverse event involves a death. If the adverse event involves a serious injury, the user facility is required to report the event to the manufacturer within ten (10) workdays. If the identity of the manufacturer is unknown, the user facility must report the serious injury to us within ten (10) workdays.
The manufacturer, after receiving the report form from the user facility, further investigates the event and provides additional information on the MedWatch 3500A form. The manufacturer must submit a completed 3500A form to us within thirty (30) calendar days after becoming aware of the adverse event. Manufacturers also are obligated to submit a 3500A form to FDA within five (5) workdays of becoming aware of a reportable MDR event that requires remedial action in accordance with 21 CFR 803.53. This requirement is further discussed in question 7.D.
5 Opened-but-unused" devices are single-use, disposable devices whose sterility has been breached or compromised, or whose sterile package was opened but not used on a patient, that is, they have not been in contact with blood or bodily fluids.
6 For the purpose of this guidance, a "hospital" is defined as an acute health care facility.
7 A "device user facility" is defined under 21 CFR Part 803.3(2)(f) as "a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatement facility … ." However, we would like to remind you that the focus of this guidance document are hospitals that are reprocessing SUDs for reuse.
Other adverse event reports required for user facilities:
User facilities must complete and submit to FDA an annual report on January 1 of each year (see 21 CFR 803.33 – Annual reports). The information in the annual report must include:
The annual report information may be submitted to us using FDA form 3419 or its electronic equivalent as approved by FDA under 21 CFR 803.14. If no reports are submitted to either FDA or manufacturers during these time periods, no annual report is required.
Manufacturers are required to submit Baseline Reports (see 21 CFR 803.55(a) Baseline reports) and Supplemental Reports (see 21 CFR 803.56 – Supplemental reports). These requirements are further discussed in questions 15 and 17.
If the reportable event involved a SUD that you reprocessed, you must fulfill the reporting requirements of a manufacturer and a user facility.
If the reportable event involved a device that was not a SUD that you reprocessed, you only have to fulfill the reporting requirements of a user facility8.
8 The only exception to this might be if you have engaged in some other activities that would constitute remanufacturing, e.g., changing the intended use or changing the device’s original specifications.
As a user facility, you are obligated to report adverse events to us, and to the manufacturer, if known, within ten (10) workdays when information reasonably suggests that a device has or may have caused or contributed to the death of a patient at your facility (see 21 CFR 803.30(a)(1)).
As a user facility, you are obligated to report adverse events to the manufacturer, or to us if the identity of the manufacturer is not known, within ten (10) workdays when information reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient at your facility (see 21 CFR 803.30(a)(2)).
What types of events must I report as a manufacturer when the event is related to a SUD reprocessed by my hospital?
FDA considers reprocessing of a device originally intended for single-use for reuse in humans to be a manufacturing process. As such, any hospital that reprocesses SUDs for reuse is a manufacturer.
As the SUD hospital reprocessor, you are obligated to report adverse events to us within thirty (30) calendar days when information reasonably suggests that a SUD reprocessed by your hospital has or may have caused or contributed to the death of a patient at your facility (see 21 CFR 803.50(a)(1)).
As a SUD hospital reprocessor, you are obligated to report adverse events to us within thirty (30) calendar days when information reasonably suggests that a SUD reprocessed by your hospital has or may have caused or contributed to a serious injury to a patient at your facility (see 21 CFR 803.50(a)(1)).
As a SUD hospital reprocessor, you are obligated to report adverse events to us within thirty (30) calendar days when information reasonably suggests that the SUD device reprocessed by your hospital has malfunctioned and such device or similar SUD also reprocessed by your hospital would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur (21 CFR 803.50(a)(2)).
As a SUD hospital reprocessor, you are obligated to report adverse events to us within five (5) workdays of becoming aware of:
As a SUD reprocessor, I am obligated to report deaths, serious injuries, and malfunctions within 30 calendar days and remedial actions within five (5) workdays (see question 7 above) to the agency when the reportable adverse event involves a SUD reprocessed by my hospital. However, under the user facility reporting requirements, it appears that I must report all deaths to FDA within 10 workdays. Do I complete two separate MedWatch 3500A report forms for the same event?
As the user facility, you must complete sections A – F (skip section C) of the MedWatch 3500A form and submit reports of all deaths to both FDA and the device manufacturer within ten (10) workdays of becoming aware of the event.
To avoid filing the same event twice, we suggest that you complete sections A – H (skip section C) of the MedWatch 3500A form and submit the completed form to the agency within ten (10) workdays if the event involves a patient death. Additional detail on which sections of the 3500A report form should be filled out are addressed in questions 11 and 12 below.
9 "Permanent" means, for purposes of 21 CFR Part 803 Subpart A "General Provisions", irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage (21 CFR Part 803.3(bb)(2)).
|A.||On the upper right-hand corner on the front page of the 3500A form, enter your user facility number under UF/Dist report #. The UF # is a combination of your hospital’s Health Care Financing Administration (HCFA) number (or a number FDA assigned to your hospital), the current 4-digit calendar year, and a 4-digit sequence number for each report filed during the current year (e.g., 1234567890-2001-0001, 1234567890-2001-0002, etc.).|
Complete all items in section A. Patient information.
(Note: skip section C. Suspect medication(s).)
Complete all items in section D. Suspect medical device. Note that specific device identification information should be entered exactly as it appears on the device or on the device labeling.
Complete all items in section E. Initial reporter. The initial reporter is the person who provided the information about the adverse event to the user facility.
Complete all items in section F. For use by user facility/distributor- devices only.
|A.||On the upper right-hand corner on the front page of the 3500A form, enter your establishment registration number under Mfr. report #. The mfr. report # is composed of the registration number that FDA assigned to your hospital when you registered and listed with the agency as a manufacturer, the current 4-digit calendar year, and the 5-digit sequence number for each report filed during the current year (e.g., 9876543210-2001-00001, 9876543210-2001-00002, etc.). You also must enter your user facility report number under Uf/Dist report # of the MedWatch 3500A form (see 11A above).|
Complete all items in section A. Patient information.
(Note: skip section C. Suspect medications(s).)
Complete all items in section D. Suspect medical device. Note that specific device identification information should be entered exactly as it appears on the device or on the device labeling. For item D.3. Manufacturer name and address enter the name and address of the SUD reprocessor. You should enter the name and address of the SUD’s OEM in section H.10.
Complete all items in section E. Initial reporter. The initial reporter is the person who provided the information about the adverse event to the user facility or manufacturer.
Complete items in section F. For use by user facility/distributor-devices only. As the SUD reprocessor, you must provide this information as specified in 21 CFR Part 803.52(f)(11). To facilitate reporting, enter the user facility data directly in Section F rather than in Block H.11 Corrected data.
|G.||Complete all items in section G. All manufacturers. |
|H.||Complete all blocks in section H. Device manufacturers only. As the SUD reprocessor, you must complete all sections regardless of where the device analysis was performed. |
See Appendix C for a mock MedWatch 3500A report submitted to FDA for a device malfunction involving a SUD reprocessed by a hospital.
Detailed instructions for completing the MedWatch 3500A form are available in "Mandatory MedWatch Reporting Form 3500A Instructions and Code (dated 4/11/01)". (You can find a copy of the instructions and codes at How to Report a Medical Device Problem.)
If I file an adverse event report on MedWatch 3500A form for an adverse event related to a SUD that I reprocessed, do I have to file a corrections and removals report too?
No. If you have already filed an adverse event report on MedWatch 3500A form for an adverse event related to a SUD that you reprocessed, you do not have to file a corrections and removals report under 21 CFR Part 806 (see 21 CFR 806.10(f)) (see question 13 above).
Copies of these documents are available at the Medical Device Reporting (MDR) web page.
Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, Distributor Reporting. Federal Register, vol. 65, no. 17, Jan. 26, 2000, pages 4112-4121.
Medical Device Reporting for Manufacturers (dated March 1997).
Abbreviated Instructions for FDA Form 3500A Specific to MDR.
What types of device-related adverse events must be reported?
|Who should receive a copy of the report?||What is the time frame for reporting the adverse event?||Which sections of the MedWatch 3500A form must be completed?|
1. A SUD that your hospital reprocessed, that is, you are reporting as a device manufacturer of the reprocessed SUD
|For all reports: |
|2. A device that is not a SUD reprocessed by your hospital, that is, you are only reporting as a user facility|
|For all reports: |
Appendix C: Mock MedWatch 3500A report of an adverse event (malfunction) involving a SUD reprocessed by a hospital reprocessor.