In recent Standard Practices columns, I have referenced how variation (and lack of standardization) reduces visibility needed to improve the quality and safety of patient care. This month, I would like to add some additional thoughts related to our ability to effectively vaccinate the nation and monitor the performance of medical products, from personal protective equipment (PPE) to implantable devices.
Vaccine distribution varies
In February, we saw measurable improvement in the rate of vaccination, but visibility remained a problem. The new director of the Centers for Disease Control and Prevention (CDC), Rachel Walensky, MD, said in late January that she did not know how many vaccine doses the nation had, which makes it hard for the states to plan effectively for vaccine distribution.
This is the first break in the chain as the federal government is the primary distributor to the states. Speaking at an IDN Summit Executive Exchange, Maj. Gen. Vinny Boles said the metric given to Gen. Gustave Perna, Chief Operating Officer for Operation Warp Speed, was to deliver the vaccine to the states, which he did. Had the metric been to deliver doses into arms, Boles is confident Gen. Perna would have figured that out. The problem currently is that national visibility is lost once the vaccine is delivered to the states.
At the state level, variation is widespread by design. Early in the pandemic, then-President Donald Trump told governors, who had requested more federal intervention, that they needed to take responsibility, famously saying the federal government “is not a shipping clerk.” Director Walensky has a different opinion, noting the need for more harmonization, as least as to how we are prioritizing specific populations for vaccination.
Penn State Health Chief Supply Chain Officer Richard Bagley said during the Executive Exchange that many states have further delegated the last mile, if not the last inch, to local health departments, which are staffed with qualified clinicians, not supply chain experts. In other states, vaccinations are being handled by retail pharmacies, which conceivably have more supply chain expertise. It will be interesting to watch and see if there are notable differences.
Maj. Gen. Boles still believes in more federal involvement, noting that this is a war against the virus: “When you go to war, we send in the federal troops, not state or local forces.” He adds that two of the states with the most success to date both leveraged the resources of the national guard, which have both the medical and logistics expertise. To me, it also seems a missed opportunity that the government (at any level) did not call upon the supply chain expertise within our nation’s hospitals.
Device performance clearance eases
Last month, I wrote about how the federal government had created roadblocks to achieving its own vision for how unique device identifiers (UDIs) can provide earlier visibility to poor if not deadly device performance, while generating evidence to accelerate the market approval for new devices or expanded use of existing devices. But the federal government may be once again undermining its own intentions.
In the waning days of the Trump Administration, the Department of Health and Human Services proposed permanently exempting 84 Class II devices – including infusion pumps, fetal monitors and certain kinds of PPE – from having to undergo typical 510K clearance review, the process by which the U.S. Food and Drug Administration (FDA) approves a device (or expanded use of the device) based on the fact that it is substantially equivalent to a device already approved on the market. The rationale behind the move was to make it easier and cheaper for manufacturers to bring them to market. The problem, according to critics of the move, is that some of the devices on the list have been associated with 46 deaths according to the FDA’s MAUDE database.
UDI data storage separation
Finally, here’s a note about the AHRMM Learning UDI Community (LUC) efforts to convince the Office of the National Coordinator for Health IT (ONC) to require that the UDI be parsed into its two components – the UDI device identifier (UDI-DI) and the production data (UDI-PI) – with each part stored in discreet fields in electronic health records and other systems. Without such a requirement, the UDI could be stored as a single number in an open text field, making it hard for health systems, researchers and regulators to find critical production data, such as lot or serial numbers and expiration dates. Storing such data separately allows easier access to the data for a variety of purposes, such as:
• Identifying when a particular batch of products, not the product itself, is faulty.
• Managing expiration dates to use the products expiring the soonest first and making sure not to use an expired product in patient care.
• More quickly removing unused recalled products from the supply chain and identifying if recalled products were used in patient care, and specifically on which patients, in order to take corrective, and potentially life-saving, action.
As noted last month, the FDA’s original vision for UDIs was to help capture more data on device performance in routine clinical practice, to not only have visibility to adverse events faster, but also to generate evidence that could help bring new and especially life-saving/sustaining technology to market sooner. The problem is, use of the data requires the right data to be in the right place for easy analysis.
Hospitals across the country have made significant investments in health information technology (IT) to be able to share data with patients and with other providers caring for patients. This data has the potential to help us understand what delivers value (best outcomes at the best cost) to patients and to minimize the still high levels of medical error. Let’s not make the error of failing to capture data in a manner that makes that vision a reality.
