FDA Approves First Implantable Identification Chip for Medical Use
FDA has approved for medical use an implantable microchip that will allow physicians and other health care providers to have access to patient identifications and medical records, the Washington Post reports. VeriChip, manufactured by Florida-based Applied Digital Solutions, marks the first such device to receive FDA approval (Stein, Washington Post, 10/14).
ADS applied for FDA approval of medical use of VeriChip last October (Howard Price, Washington Times, 10/14). ADS plans to market VeriChip to hospitals, physicians and patients as a technology that will improve care and help providers confirm the identities and medical records of patients to prevent medical errors.
ADS CEO Scott Silverman said, "In hospitals today, many deaths occur because people aren't able to communicate timely enough their medical information or because of wrong information. With VeriChip, you'll be able to have accurate information even if a patient can't talk. It's a way to modernize our antiquated system of medical records" (Washington Post, 10/14).
VeriChip, which is about size of a grain of rice, is a radio-frequency implant that functions similar to a bar code. Physicians will implant VeriChip, which is invisible after implantation and becomes inactive when removed, in the muscle tissue of patients with a syringe in a 20-minute procedure (Toner, Atlanta Journal-Constitution, 10/14). VeriChip contains 256 characters of memory, a radio transceiver and an antenna but not patient information. Physicians will use a scanner that reads the code on VeriChip to access patient information through a computer network.
ADS officials said that implantation of VeriChip will cost between $150 and $200 (Dolinar, Long Island Newsday, 10/13). ADS did not specify the cost to providers or patients for information storage and encryption (Singer, South Florida Sun-Sentinel, 10/14).
According to FDA spokesperson Kathleen Quinn, agency officials reviewed VeriChip in large part to consider safety concerns, such as the potential for infection and irritation at the site of implementation (Long Island Newsday, 10/13). ADS plans to donate to trauma centers about 200 of the $650 scanners required to use VeriChip as part of a marketing campaign for the device (Washington Post, 10/14).
The New York Times reports that FDA approval of VeriChip for medical uses "is expected to bring to public attention a simmering debate over" the technology (Feder/Zeller, New York Times, 10/14). ADS currently markets VeriChip for a number of other uses (Atlanta Journal-Constitution, 10/14).
However, privacy advocates raised concerns that FDA approval of VeriChip could "mark a dangerous step toward a Big Brother future in which people will be tracked by the implants or required to have them inserted for surveillance, identification and other purposes," the Washington Post reports. They also maintain that VeriChip would not improve care significantly because patients currently can wear medical identification bracelets that contain the same information (Washington Post, 10/14). "If privacy protections aren't built in at the outset, there could be harmful consequences for patients," Emily Stewart, a policy analyst at the Health Privacy Project of the Institute for Health Care Research and Policy at Georgetown University, said (Henderson, AP/Detroit Free Press, 10/14).
ADS has said that implantation of VeriChip is voluntary and that providers can access only medical records authorized by patients. Silverman said that FDA approval of VeriChip should help reduce "the creepy factor" of the device and help increase acceptance of the technology (New York Times, 10/14). Quinn added that FDA "did take into account privacy issues" in the decision to approve VeriChip (Long Island Newsday, 10/13).