Improving Medical Device Safety Through Better Surveillance

Background

In 2008, the Food and Drug Administration (FDA) launched the Sentinel Initiative, a national electronic system designed to “track the safety of drugs, biologics, and medical devices once they reach the market.”¹ By proactively monitoring data from electronic health records and other sources rather than relying on spontaneous reporting from manufacturers and health care providers, the Sentinel system can more quickly identify safety issues. However, it has been difficult to incorporate medical devices into the Sentinel Initiative in the same way as was the case for drugs due to the challenge of identifying specific devices in the available electronic health records and insurance claims.

Sentinel Progress

In 2009, FDA invested in the Mini-Sentinel pilot project. By leveraging health care information that is routinely collected, Mini-Sentinel conducts active safety surveillance of medical products and supplements FDA's existing systems.^2,3 The program has 31 collaborative academic and private organizations and includes information such as health plan enrollment, prescription drug dispensing, and health care utilization for more than 100 million people.⁴

To ensure that patient privacy is maintained, Mini-Sentinel utilizes a distributed data system, a model that stores patient health care information where it originates—at the hospital or doctor's office for example—rather than in a centralized location. Privacy is preserved by minimizing the transfer of identifiable information and storing such information behind local firewalls.⁵

Mini-Sentinel has already been utilized to answer specific questions about safety and medical products, such as the occurrence of heart attack and stroke among patients prescribed certain drugs for Parkinson's disease, as well as cardiac outcomes of patients prescribed smoking cessation drugs.⁶ Going forward, Sentinel is expected to expand by increasing the number of organizations that provide data and conducting new types of analyses, such as an evaluation of health impacts from FDA's regulatory actions.⁷

Although FDA has stated its intention to include medical devices in Sentinel, a recent compilation of 34 articles published on the Mini-Sentinel only included one devices-focused article, indicating a slow integration of medical devices into this pilot project.⁸

Unique Device Identifier

In 2007, Congress passed legislation directing the Department of Health and Human Services (HHS) to establish a unique device identification (UDI) system for medical devices to allow them to be tracked throughout distribution and use.⁹ A similar identification system has long been in place for pharmaceuticals. FDA has proposed a regulation for UDI implementation, but it has been under review by the Office of Management and Budget since July 2011.

The UDI system is an important patient safety advancement. Its use will allow information about specific medical devices to be integrated into patient health records and health insurance claims,
two of Sentinel's main data sources. Without a UDI in place, it will be extremely difficult to expand Sentinel to devices in the same comprehensive way it is now used to monitor drug safety.

There is broad support for UDI implementation. The many stakeholders who have backed the system include the largest medical device trade association, a coalition of organizations representing providers and health care systems, and Democrat and Republican members of Congress.^10,11,12

Recommendations

To better protect patient safety, medical devices must be tracked by the Sentinel system. To reach this end,

• FDA must release a final rule on UDI as quickly as possible.
• Health care providers and insurers must incorporate the UDI into electronic health records and billing systems so that this information can be available to Sentinel.

References

1 Food and Drug Administration, “FDA's Sentinel Initiative,” last modified April 25, 2012, accessed May 11, 2012, http://www.fda.gov/safety/FDAsSentinelInitiative/ucm2007250.htm.2 M. A. Robb et al., “FDA's Sentinel Initiative: Expanding the horizons of medical product safety,” Pharmacoepidemiology and Drug Safety 21, no. S1 (2012): 9–11.3 R. Platt et al., “The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction,” Pharmacoepidemiology and Drug Safety 21, no. S1 (2012): 1–8.4 Ibid.5 Robb et al., “FDA's Sentinel Initiative,” 9–11.6 Platt et al., “The U.S. Food and Drug Administration's Mini-Sentinel program,” 1–8.7 Ibid.8 “Supplement: The U.S. Food and Drug Administration's Mini-Sentinel Program,” Pharmacoepidemiology and Drug Safety 21, no. S1 (2012).9 Food and Drug Administration Amendments Act of 2007, Public Law 110-85, was signed into law in September 2007. See Title II, Section 226(a).10 AdvaMed submission to Docket No. FDA-2008-N-0661, Unique Device Identification System, February 27, 2009, accessed April 27, 2012, http://www.hibcc.org/News%20Center/Docket%20No%20%20FDA-2008-N-0661%20Unique%20Device%20Identification%20System%20022709-1.pdf.11 Advancing Patient Safety Coalition to Commissioner Hamburg, July 7, 2010, accessed April 27, 2012, http://www.aha.org/advocacy-issues/letter/2010/100707-let-ptsafetycoaltn-fda.pdf.12 U.S. Representatives Mike Doyle and Pete Sessions to Commissioner Hamburg, July 1, 2009, accessed April.