H.R. 3590 and the National Medical Device Registry
The idea behind the national medical device registry is to save lives, not monitor how you're living your life.
Here's how the registry would basically work, based on how it was laid out in H.R. 3200: A company manufacturers a medical device, and registers that device's type, model and unique ID with the FDA. (Each medical device has a serial number or a unique identification number of some kind -- in the industry those are called unique device identifiers, or UDIs, and those UDIs are stored in the medical device registry.) Each time a medical device is used on or in a patient, its UDI tag presumably would be scanned and associated with that patient's medical records.
Medical devices that would have been required to be registered are not mandated implants. Instead, they fall under the following descriptors: any medical device used in or on a patient; as well as Class II devices; and any Class III devices that are implantable, life-supporting or life-sustaining. Confusing? Yes. Let's look at what these medical devices are and what that means.
There are three classes of medical devices, I through III, and the higher the class the more regulations the device has.
Class I medical devices are the basics. Things that fall into this category include bandages, examination gloves and tongue depressors. Nearly half of all medical devices are Class I, and almost all of them are exempt from regulations [source: FDA]. Class II medical devices make up most of the other half, and include products such as amalgam dental fillings, infusion pumps, apnea monitors, and cardiac monitors. They are a little bit riskier than Class I-designated products and sometimes have special requirements such as with their labeling or performance standards.
When we get to the Class III devices, we're usually talking about cutting-edge medical breakthroughs, new technologies and devices that are too new to know how safe they may be. These might include life-support and life-sustaining systems, some of which are implantable. Drug-eluting coronary stents (which slowly release medication after implantation) and intra-aortic balloon pumps, for example, are Class III devices, but so are breast implants because they carry a health and safety risk. Some Class III devices such as drug-eluting stents, for example, already have their own tracking registry. About 10 percent of medical devices are considered Class III [source: FDA].
The idea behind the registry was to track the safety and effectiveness of these medical devices after they're already on the market -- there's where the word surveillance comes in -- especially those that are implanted inside of a person, such as hip replacements (and other orthopedic implants) and pacemakers. This is key: The registry would not have been linked to your identifiable personal information or medical records, but it would have provided data for statistical analysis to link, for example, a mechanical issue in hip replacement systems with faster and more effective patient notification and treatment.
Author's Note: Does 'Obamacare' require Americans to be implanted with microchips?
Well, isn't this a tricky topic to talk about: The future of health care in America, and specifically what the new Affordable Care Act (or Obamacare, if you prefer) means for us all. This was a bill that was so misunderstood when it was first drafted, and things didn't improve when it became law in March 2012. Some of the myths and misunderstandings come from wording that was cut from earlier drafts of bills that never made it to law. Hopefully, what I confirmed by reading through pages of legislative writing should have you covered on that whole microchip mandate myth next time you find yourself in a conversation with someone confused by the wording.
More Great Links
- Coghlin Companies Inc. "Class I Medical Devices and Class II Medical Devices." (Nov. 12, 2012) http://www.coghlincompanies.com/Cogmedix/cogmedix_class_I_class_II.php
- Gross, Thomas P.; and Jay Corwley. "Unique Device Identification in the Service of Public Health." The New England Journal of Medicine. Vol. 367. Pages 1583-1585. 2012. (Nov. 12, 2012) http://www.nejm.org/doi/full/10.1056/NEJMp1113608#t=article
- H.R. 3200. "America's Affordable Health Choices Act of 2009." (Nov. 12, 2012) http://www.gpo.gov/fdsys/pkg/BILLS-111hr3200ih/pdf/BILLS-111hr3200ih.pdf
- National Conference of State Legislatures. "Children's Health Insurance Program (CHIP)." 2010. (Nov. 12, 2012) http://www.ncsl.org/issues-research/health/childrens-health-insurance-program-overview.aspx
- National Medical Device Registry. "What is UDI?" (Nov. 12, 2012) http://nationalmedicaldeviceregistry.org/what-is-udi/
- Prahlow, Joseph A. "Implanted Medical Devices Encountered at Autopsy." Medscape. 2012. (Nov. 12, 2012) http://emedicine.medscape.com/article/1681045-overview#showall
- Public Law 111-148--Mar. 23, 2010. "The Patient Protection and Affordable Care Act." (Nov. 12, 2012) http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/pdf/PLAW-111publ148.pdf
- Sethi, Manish K.; Jahangir, Alex A.; and William T. Obremskey. "The Affordable Care Act and Medical Devices: What you need to know as an Orthopaedic Surgeon." American Academy of Orthopaedic Surgeons - AAOS Now. Vol. 6, no. 11. 2012. (Nov. 12, 2012) http://www.aaos.org/news/aaosnow/feb11/advocacy2.asp
- U.S. Food and Drug Administration. "Medical Devices: FDA Breast Implant Consumer Handbook -- 2004 -- Timeline of Breast Implant Activities." 2009. (Nov. 12, 2012) http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064242.htm
- U.S. Food and Drug Administration. "Medical Devices: Learn if a Medical Device Has Been Cleared by FDA for Marketing." 2009. (Nov. 12, 2012) http://www.fda.gov/medicaldevices/resourcesforyou/consumers/ucm142523.htm