Medical Device Reporting

Surgical sutures are sterile, flexible strands used to close wounds or to tie off tubular structures such as blood vessels. Made of natural or synthetic fiber and usually attached to a needle, they are available ia monofilament or multifilament forms. Sutures are classified by the United States Pharmacopeia (USP) (1) as either absorbable or nonabsorbable. The USP also categorizes sutures according to size (diameter) and Hsts certain performance requirements. Sutures are regulated by the Food and Dmg Administration (FDA) as medical devices under the Food, Dmg, and Cosmetics (FDC) Act of 1938, the Medical Device Act of 1976, and the Medical Device Reporting regulation of 1995. 

The requirements for market vigilance and oversight in the US are set out in 21 CFR 803, Medical Device Reporting, 21 CFR 806, Reports of Corrections and Removals and 21 CFR 822 Post market Surveillance. 

Table 12.4 Summa of Medical Device Reporting (MDR) requirements for individual adverse incidents.

E. Medical Device Reporting. The manufacturers, distributors, importers, and users of all devices, including those regulated by CDER, shall report to CDRH under Section 519 of the Act as required. The Center for Devices and Radiological Health will provide monthly reports and special reports as needed to CDER for investigation and follow-up of those medical devices regulated by CDER. 

The Medical Device Reporting Regulation (21 CFR 803) applied to sutures approved for commercial distribution. A report must be submitted to the FDA within 30 days after the manufacturer becomes aware of information that reasonably suggests that the suture may have either caused or contributed to death or serious injury, malfunctioned, or the potential of causing death or serious injury. However, if the event would cause the manufacturer to take immediate action to prevent a significant risk to health caused by the suture, then a report must be submitted within five working days. 

There are five types of postmarketing medical device reports (MDRs) for medical devices. 

Center for Devices and Radiological Health (CDRH), Medical Device Reporting for Manufacturers, March 1997. 

In accordance with 21 CFR 814.84(a), you must also comply with Medical Device Reporting (MDR) requirements, 21 CFR Part 803, and any requirements made applicable by other regulations or by order approving the device, including the following. 

Shapiro, J. K, Medical Device Reporting A Risk-Management Approach, MD DI, Jan. 2003. 

Is a 72 h field alert needed A medical device report (MDR) Biologic product errors and accident (E/ A) report ... 

Suspicions were expressed in the Mealey Publication s Drug and Medical Device Report that the Lyme disease vaccine LYMErix could cause an incurable form of autoimmune arthritis. It was hjrpothesized that blood concentrations of OspA after three doses of vaccine place vaccinees classified by genetic type HLA-DR4-I- at risk of developing treatment-resistant Ljme arthritis. The premarket trials for the vaccine were assessed by an independent advisory committee, which found no link between Ljme disease immunization and autoimmune arthritis (10). However, the committee stressed the need for long-term surveillance and further studies in those over 70 years and in children, and the effect of the vaccine in patients with chronic arthritis the possible development of autoimmunity deserves further study (11). After licensing of the vaccine, more than 1 rmlfion Americans received it and no unusual adverse effects were reported to the manufacturer (10). 

The number of medical device reports has risen over the past decade, as technology has become more complex and sophisticated, patients and professionals have been encouraged to report problems, and the number of devices in use has dramatically increased. Increased reporting reflects a high level of awareness and therefore the effectiveness of the safety monitoring system. It does not mean that manu cturing standards have fallen or that devices have become less safe, overall... 

Emergency Hold Orders Mental Health/Chemical Dependency Medical Accidents and Disclosure, including Sentinel Events Medical Device Reporting Infant Abduction... 

FDA Form 3419, Medical Device Reporting Annual User Facility Report... 

Incidents in which a device may have caused or contributed to a death or serious injury must be reported to the FDA under the Medical Device Reporting Program. In additions, certain malfunctions must also be reported (16). 

Postmarketing controls include estabUshment registration, device listing, quality system compliance inspection, and medical device reporting (MDR). 

Code of Fedtral Regulatimis Title 21, Chapter I, Subchapter H, Part 806—medical devices reports of craiectimis and removals. http //www.ecfr.gov/cgi-binAext-idx SID= 4f03a00bda668d3977dl260056f8d423 mc=true node=pt21.8.806 rgn=div5... 

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