Safe Medical Devices Act Reporting

Safe Medical Devices Act Reporting

Effective Date: [Original NPP Date]
Revised Date: [Current Date]

Policy:

Athena facilities will follow all reporting requirements outlined in the Safe Medical Devices Act. The Safe Medical Devices Act mandates that incidents where a medical device has or may have caused or contributed to a patient's death, serious illness, or injury be reported to the FDA and manufacturers.

Procedure:

I. Device Incident Reporting Requirements

1. All patient incidents resulting in a serious illness or injury and involving a medical device must be reported to the DNS and/or Administrator. A serious illness or injury, as defined by the Safe Medical Devices Act, is one that:

   • Is life-threatening
   • Results in permanent impairment of a patient's body structure or function, or
   • Requires any medical or surgical intervention to prevent permanent damage to a patient.

2. Health care professionals may voluntarily report device malfunctions that do not meet the above criteria for mandatory reporting.

3. The FDA defines a medical device as any instrument, apparatus, or other article used to prevent, diagnose, mitigate, or treat a disease or to affect the structure or function of the body, with the exception of drugs. This includes common hospital products such as catheters, thermometers, patient restraints, and syringes. Adverse effects of medications are not required to be reported.

II. Impounding and Examining Equipment

1. If a device is involved in a serious incident, the device should be impounded by the maintenance department, without changing any control settings, so that an analysis can be performed. Disposable devices and accessories, including packaging with lot numbers, should also be saved for later analysis.

III. Reporting Incidents

1. The Administrator will determine which incidents are reportable under the Safe Medical Devices Act and will coordinate all safe medical device reports to manufacturers and to the FDA. Reports should be filed within ten working days of discovering the malfunction.

IV. Device Incident Reporting Procedure

1. For incidents that meet the criteria for mandatory reporting:

   • FDA form 3500A should be completed and mailed to the FDA at: FDA, Center for Devices and Radiological Health, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002.
   • Form FDA 3500A is available online as a .pdf - www.fda.gov. A copy of this form, with instructions for completion, is attached.

2. For voluntary reporting of device malfunction:

   • FDA form 3500 should be completed. This form can be completed online: www.fda.gov/Safety/MedWatch/default. A copy of this form, with instructions for completion, is attached. This form should be mailed to: MedWatch, The FDA Safety Information and Adverse Reporting Program, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787.

3. If the facility has reported a device malfunction within the calendar year, FDA form 3419 must also be completed. A copy of this form is also attached.

4. The incident should be discussed at the Safety Committee.

V. Contact Information for User Facilities, Importers, and Manufacturers

1. To Report an Emergency:

   • FDA Office of Crisis Management, Emergency Operations Center
   • Voice (24hr/day) phone: 866-300-4374 or 301-796-8240
   • FAX: (301) 847-8543

2. For Questions about Medical Device Reporting, including interpretation of MDR policy:

   • Call: (301) 796-6670 (voice)
   • Email: RSMB@fda.hhs.gov
   • Or write to: Food and Drug Administration Center for Devices and Radiological Health Reporting Systems Monitoring Branch 10903 New Hampshire Avenue WO Bldg. 66, Room 3217 Silver Spring, MD 20993-0002

References:

• Centers for Medicare & Medicaid Services. State Operations Manual, Appendix PP - Guidance to Surveyors for Long Term Care Facilities. [Link to current CMS SOM]
• CMS Requirements of Participation for Long-Term Care Facilities. [Link to current guidelines]