Effective Date: 
Tue, 05/01/2012
Thu, 05/27/2021


The Safe Medical Devices Act of 1990 sought to impose new reporting requirements on both the medical device industry and those using medical devices. This act requires users of medical devices to report device-related deaths and serious injuries to the Food and Drug Administration. A final Medical Device Reporting Rule (MDR) was published in 1995 in the Federal Register.



A device user facility may be an ambulatory surgical center, a nursing home, a hospital, an outpatient treatment facility or an outpatient diagnostic facility. Physician’s offices are not inclusive in this definition of device user facility. Good laboratory practice, however, dictates that all laboratories have a system in place to voluntarily report device-related · adverse events, and some accreditation organizations, such as COLA, require this procedure within their inspection criteria (ORG 9).


When the user facility becomes aware of information that may reasonably suggest that a device utilized in the facility has or may have caused either a serious injury or death.


A serious injury is either life threatening, results in permanent impairment of a body function or permanent damage to a body structure, or requires medical or surgical intervention to alleviate permanent damage or impairment.


It is important that each employee within the laboratory receive training on device-related reporting, which includes guidance on how to recognize potential incidents and how to report them. This training should be documented in the employee personnel file. The following steps should be taken when investigating a device that has caused serious injury or death to a patient:

1. Immediately report the device-related incident to the Laboratory Director. The observer should initiate filling out the FDA 3500 form (https://www.accessdata.fda.gov/scripts/medwatch/) with any pertinent information. The Laboratory Director or designee may continue filling out this form with further investigation. Retain any materials that could be involved in the incident. These materials may include:

a. Information that was evaluated to determine if an event was reportable

b. Systems that ensure access to information that facilitates timely follow-up and inspections by the FDA

c. Information in the possession of the user facility or references to information related to the event, including all documentation of the reporting decisions and decision-making process

d. Copies of all completed MDR forms and other information submitted to the FDA, distributors and manufacturers

2. The Laboratory Director will determine if outside reporting requirements apply to the incident. The ordering physician will also be notified of the situation.

3. The Laboratory Director and laboratory staff with technical knowledge and experience will perform the evaluation and investigation of the incident. The Laboratory Director and laboratory staff have the authority to recommend changes in policy, procedure and process to resolve the problem and prevent a recurrence of the incident.

4. The Laboratory Director and staff will analyze the impact of the incident during the time prior to the initial report of the incident, during the investigation and for future testing. The Laboratory Director and staff have the authority to suspend testing until the problem has been corrected.

5. If deemed necessary, the ordering physician will notify any affected patients and re-evaluate their treatment.

6. The Laboratory Director and staff will perform an investigation, asking "Why did this happen”, along with questions on who, what, where and when to document the facts of the incident. The analysis may be performed with fact sheets, mapping or flowcharts to assist with documenting the events and circumstances surrounding the event, and any and all other pertinent reports, documents or findings which relate to the event.

7. The Laboratory Director and staff will document all facts, findings and conclusion, and the report will be given to the Laboratory Director for review and signature. The report should be documented on the Incident Management Report Form.

8. The Laboratory Director, in conjunction with the laboratory staff, will determine appropriate corrective action to be taken to prevent a recurrence of the event, and a timeline for implementation and correction will be established. The laboratory staff will document the date that each step is completed. The Laboratory Director ultimately will determine if this event is truly an incident or a mishap, but documentation should still be initiated and corrective action should be taken to prevent further negative events from occurring.

9. All findings and outcomes will be reported to the staff by the Laboratory Director. Any necessary policy and procedure revisions or retraining of staff will be documented.

10. Within a pre-determined period, the Laboratory Director and staff will perform a follow-up evaluation of the corrective action to ensure effectiveness and all findings will be documented.

11. Documentation must be retained for a minimum of two years and records must be available for surveyors when warranted.


The FDA 3500 form is a report form for the voluntary reporting of adverse events, problems and product use errors. It is to be filled out completely and sent to the Food and Drug Administration. Complete the 3500 form as follows:


A. Patient Information: Secure a confidential patient identifier for reporting purposes (do not use patient name or social security number), and record this identifier, along with date of birth, sex and weight of patient.

B. Adverse Event, Product, Problem or Error: Check all that apply. An adverse event is used when reporting a death or serious injury, a product problem is used for a malfunction that could lead to death or serious injury. Record outcomes from the device related incident. Describe completely the event that occurred, and document any laboratory tests that are relevant to the event. Include other relevant history, including medical conditions of the patient affected.

C. Product Availability: Check whether or not the device is still available for investigation, or on what date it was returned to the manufacturer.

D. Suspect Products: Used primarily for drug related events.

E. Suspect Medical Device: Document all pertinent information related to device, including name of device, manufacturer, address of manufacturer facility, model, serial or lot numbers, and whether this is a single-use device.

F. Other Concomitant Medical Products: List product names and therapy dates, excluding treatment of event.

G. Reporter: Document all information on reporting personnel, including name, address, phone number, email, occupation and licensure, and to whom else this information has been reported.


Voluntary reporting of medical devices may be reported to the FDA in several ways:

1. Mail 3500 form to:

FDA Safety Information and Adverse Event Reporting Program


5600 Fishers Lane

Rockville, Maryland 20852-9787

2. Fax report to 1-800-fda-0178

3. Call report to 1-800-fda-1088

4. Fill out online report at  https://www.accessdata.fda.gov/scripts/medwatch/


Copies of all records sent to the FDA must be retained for two years, along with all documentation which is related to the device-related incident, including the Incident Management Report, all laboratory results, copy of the MedWatch 3500 form and all supportive documentation gathered during the investigation.