improving medical device tracking a slow, imperfect process

by:Dino     2021-08-12
WASHINGTON —
Health advocates have been pushing for a standardized approach to medical device tracking and research for nearly 20 years.
They finally found a solution that others, including the rest of the medical industry, have adopted --
Unique code that helps track device types, manufacturers, and other critical information.
On 2007, Congress asked the United StatesS.
The Food and Drug Administration created the system, and the FDA passed the final rules for establishing it in 2013.
The unique device identifier is a code about 70 characters long, divided into two parts.
Part I identifies equipment and manufacturers;
The second one is made when and where, its expiration date and serial number. High-
Risk devices and implants already have UDI code
These types of products are required as of September-
And lower manufacturers
Risk devices have begun to include them.
The FDA will require code for all devices by the end of 2020.
However, there is currently no place to publish the code on the insurance claim.
This means that medical insurance and private insurance companies know when they will pay for the patient\'s artificial hip joint, but do not know the manufacturer, model and manufacturer.
The code in the patient\'s electronic health record also has no location, which is tracked between multiple providers.
Hospitals and clinics have no place to put them in their supply system, and there is no place to keep track of what equipment is on hand, and whether anything is recalled in their storage room.
These codes have begun to appear in some FDA reports about medical device failures, injuries and deaths, but are often edited from public versions of databases accessible to patients, researchers and doctors
Ben Moscovitch, who runs the Pew Charity Trust\'s health information technology work, concluded: \"It\'s not enough to have UDIs equipment.
They must actually be used.
Joel Weissman noted, \"without the unique identifier on the claims and health records, it is almost impossible for anyone to know what equipment can cause problems, chief science officer, the Center for Surgery and Public Health, Boston-Brigham Women\'s Hospital.
Diana zukman, president of a patient advocacy research organization based in Washington, D. C. C.
The National Center for Health Research says public health leaders have long asked for numbers to be identified.
\"The equipment company did everything it could to put it off. .
\"They have been retreating,\" she said . \".
\"Now they are doing everything they can to make it less useful.
\"During the UDI development process, the company has submitted hundreds of comments to the FDA, expressing general support for the system, but repeatedly asking for more time, saying that these requirements are cumbersome, it is expensive and difficult to implement.
The Medical Device Manufacturers Association wrote in its official comments to the FDA on 2012, \"This shift will require the medical technology industry to spend a lot of resources to comply.
It is essential to allow as much flexibility and time to comply as possible.
\"Some of the obstacles stem from the fact that the code is too long to be accepted by some old computer database systems.
Current plans to incorporate UDIs into insurance claims focus only on the first half of getting the code
Equipment name and manufacturer-
On the official form.
If the equipment needs to be recalled, the second half will be essential, says zukman.
But the industry says requiring longer numbers is a heavy task, as it forces hospitals and insurance companies to do too many computer upgrades and database changes.
FDA\'s guidance to the agency is to create industry requirements that are \"least burdened.
For the past two years, Weissman has been working with insurance companies and hospitals to test the feasibility of separating the first half of the unique identification number of each medical device into insurance claims.
\"Obviously, we need this,\" he said . \"
\"There is no way to systematically monitor equipment issues on a large scale.
At the end of the day, it\'s really about protecting patients from defective or ineffective products.
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