October 26, 2009
- Question 1. Who is required to file mandatory reports of device-related adverse events?
- Question 2. What is an ambulatory surgical facility (ASF)?
- Question 3. How is a physician's office affected by MDR?
- Question 4. How do I know if I am an ambulatory surgical facility (ASF) or a physician's office?
- Question 5. When does a user facility report information about adverse events?
- Question 6. What other MDR obligations apply to a user facility?
- Question 7. What is considered a serious injury under the MDR regulation?
- Question 8. Why has FDA inspected facilities that perform LASIK procedures?
- Question 9. Why does FDA want user facilities to report adverse events?
- Question 10. What does FDA do with the information from user facilities?
- Question 11. If a patient experiences dry eye symptoms following a LASIK procedure, is this reportable?
- Question 12. What about other visual disturbances that may be experienced after a LASIK procedure? Are these events reportable?
- Question 13. Are unintended over- or under-corrections or irregular corneal astigmatism considered to be reportable events?
- Question 14. Is eye pain or painful light sensitivity considered a reportable event?
A. The Medical Device Reporting (MDR) regulation is found in Title 21 of the Code of Federal Regulations, Part 803. This regulation specifies the reporting obligations of medical device manufacturers, importers, distributors, and user facilities. FDA has defined a device user facility as a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility. A user facility subject to MDR may be either an independent entity or operated by another medical entity.
A. An ambulatory surgical facility is a distinct entity whose primary purpose is to furnish same day outpatient surgical services to patients. A facility that offers LASIK as one of its ophthalmic surgical procedures may also provide non-ophthalmic surgical services. Consider all surgical services provided by a facility when determining whether a facility meets the MDR definition of an ambulatory surgical facility and is therefore subject to the user facility obligations under MDR. More information about mandatory reporting can be found at http://www.fda.gov/MedicalDevices/ Safety/ReportaProblem/default.htm
A. A facility that operates as the office of a physician or other health care professional for the primary purpose of examination, evaluation, and treatment or referral of patients is not required to file mandatory MDR reports. However, we encourage the use of the MedWatch program to voluntarily report device-related adverse events to the manufacturer and FDA. More information about MedWatch and instructions for filing a voluntary report can be found at http://www.fda.gov/Safety/MedWatch/default.htm
A. The activities of some facilities meet both the definition of an ASF and physician's office. If you are not sure whether you meet the definition of an ASF, or if you have other questions about MDR requirements, you may contact the MDR Policy Branch at 301-796-6670.
A. A user facility (UF) is required to report when it receives information that reasonably suggests that a medical device has (or may have) caused or contributed to a serious injury or death of a patient of the facility:
- the report must be submitted within 10 work days
- a serious injury must be reported to the manufacturer. (If the manufacturer is unknown, a serious injury must be reported to FDA.)
- a death must be reported to the manufacturer and FDA.
- the term “patient” is interpreted to include device users such as UF employees
A. A user facility is required to have written procedures that cover the handling of device-related adverse events and to maintain MDR files or records.
A. Serious injury means an injury or illness that:
- is life-threatening; or
- results in permanent impairment of a body function or permanent damage to a body structure; or
- requires medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.
An example of a serious injury is a patient who experiences persistent visual symptoms after a LASIK procedure such that the eye care provider reasonably concludes that the patient has suffered permanent visual impairment or permanent eye damage attributed to use of the laser during the LASIK procedure. FDA expects that user facilities will exercise due diligence and professional judgment in determining whether a serious injury has occurred. Further, FDA expects that a user facility will have written procedures for making this determination and for documenting such determinations.
A. Inspection of ambulatory surgical facilities that perform LASIK procedures is one of the options available to FDA to ensure that physicians and patients have current and accurate information to help them with their decisions about LASIK. These inspections allow FDA to identify reporting problems and provide opportunities to further educate user facilities about MDR reporting obligations. This should improve the quality of information reported to FDA and manufacturers about LASIK problems, and further enhance the quality of information made available to the public.
A. A user facility is knowledgeable about the adverse events that occur there. An MDR report that contains specific details about what happened during an adverse event and what device(s) were involved will help FDA to assess the event and make a determination about the need for action to correct a problem.
A. A user facility's reports to FDA of device-related deaths are entered in a database along with the MDR reportable death, serious injury and malfunction reports filed by manufacturers and importers, and the voluntary reports received from other sources. The information in the database is reviewed and analyzed by FDA staff to identify device problems such as manufacturing defects, design problems, or human engineering problems. In some cases, FDA will contact the user facility or manufacturer for more information about the adverse event. At other times, FDA will initiate an inspection of the manufacturer to assess the firm's adherence to the Quality System (QS) regulation, 21 CFR 820, as well as the requirements of the Medical Device Reporting (MDR) regulation, 21 CFR 803, Subpart E. The information provided by user facilities helps FDA to fulfill its mission to conduct ongoing surveillance of medical devices and thereby protect the public from hazardous devices.
Question 11. If a patient experiences dry eye symptoms following a LASIK procedure, is this reportable?
A. Dry eye symptoms are common following LASIK procedures with more than 95 percent of patients experiencing them within the first month following surgery.1 However, studies have shown these symptoms often resolve by 6 months post-operatively with a small percentage of patients developing severe dry eye unresponsive to treatment.2-4 This event would be reportable if:
- A patient experiences severe dry eye(s) following a LASIK procedure that persists beyond 6 months, such that it reasonably suggests that the patient has suffered permanent visual impairment or permanent eye damage attributed to the laser device used during the procedure.
- A patient has received a medical or surgical intervention to preclude a permanent impairment to preclude permanent visual impairment or permanent eye damage.
Question 12. What about other visual disturbances that may be experienced after a LASIK procedure? Are these events reportable?
A. Temporary visual disturbances can occur following a LASIK procedure. If clinical experience and judgment indicates the disturbances are temporary in nature, and can be expected to resolve without medical intervention, then these would not be considered reportable events.
- If a patient experiences persistent (i.e. 6 months or longer) visual disturbances after a LASIK procedure such that it reasonably suggests that the patient has suffered an injury causing permanent visual impairment or permanent eye damage attributed to any of the devices used in the LASIK procedure, or
- The patient needed medical or surgical intervention to preclude permanent visual impairment or permanent eye damage, then the event would be reportable.
Question 13. Are unintended over- or under-corrections or irregular corneal astigmatism considered to be reportable events?
A. We would consider the event to be reportable if the patient sustained:
- An unintended refractive error of greater than 2.0 diopters; or
- Irregular corneal astigmatism.
A. While pain itself is not an injury, the underlying cause of the pain may be considered an injury. Therefore, the cause of the injury would be reportable if both of the following conditions are met:
- The pain or painful light sensitivity may be traced to the LASIK surgery suggesting that one of the devices used in the surgery caused or contributed to an injury causing the pain or painful sensitivity.
- The pain impairs the patient’s ability to perform his/her usual activities and clinical experience indicates the pain is permanent or that the pain will only subside with medical or surgical intervention.
1 Yu EY, Leung A, Rao S, Lam DS. Effect of laser in situ keratomileusis on tear stability. Ophthalmology. Dec 2000;107(12):2131-2135.
2 Toda I. LASIK and dry eye. Compr Ophthalmol Update. Mar-Apr 2007;8(2):79-85; discussion 87-79.
3 Toda I, Asano-Kato N, Komai-Hori Y, Tsubota K. Dry eye after laser in situ keratomileusis. Am J Ophthalmol. Jul 2001;132(1):1-7.
4 Shtein RM. Post-LASIK dry eye. Expert review of ophthalmology. Oct 2011;6(5):575-582.