SUBMITTED ELECTRONICALLY AT: regulatorycomment@vdh.virginia.gov and https://townhall.virginia.gov/
September 28, 2026
Geoff Garner, J.D.
Senior Policy Analyst
Virginia Department of Health
9960 Mayland Dr., Suite 401
Henrico, Virginia 23233
Re: Public Comment on Medical Device Implant Serial Number Petition for Rulemaking
Dear Mr. Garner,
On behalf of the Virginia Hospital & Healthcare Association (VHHA) and its hospital and health system members, we are submitting these comments in response to the August 17, 2026, petition for rulemaking titled Medical Device Implant Serial Number.
Petitioner requests the State Board of Health to amend 12VAC5-410-420 regarding surgical services to mandate surgeons performing medical device implants of any kind to include the implants’ serial number information directly on their “Surgeon Summary Report” (“Report”) and/or to otherwise provide the serial number information directly to the patient before they are released to return home from a medical facility or surgery center.
Petitioner states that it can be difficult for a patient to receive serial number identifying information for each part named in the Report that is released to a patient. Petitioner noted experiencing this circumstance and that her surgeon relayed that no mandate exists in Virginia to provide a serial number listed next to the identified medical device implant part name on the Report. Additionally, Petitioner stated that identifying serial number information is archived separately from a patient’s medical record maintained at their physician’s office.
VHHA requested member feedback regarding the petition for rulemaking. While members indicated general support for patient access to implant information, they raised operational concerns regarding implementation and questions regarding the feasibility and appropriateness of a specific mandate in hospital licensure regulations. These responses emphasize the need for flexibility and highlight a preference for automated access rather than a new manual documentation or discharge obligation. In light of the foregoing, a possible alternative should the State Board of Health wish to pursue this further, would be increased patient education on the availability of, and options for obtaining, information about medical device numbers from health care providers.
Implant tracking is a common practice, but there are exceptions. In most cases, implant serial numbers are generally documented within existing medical record systems. When captured, serial numbers flow into operative documentation and are maintained in the permanent medical record when available from manufacturers.
For other cases, however, the serial number information may not be available at the time required to be captured for documentation workflows. For example, where orthopedic plates and screws are required, they are often removed from original packaging and sterilized on instrument sets, making serial number documentation difficult or impractical.
Members also report that existing electronic health records can be leveraged to support documentation, but are not yet fully operationalized. Current EHR systems already contain mechanisms for documenting implant information, such as a discrete implant documentation field, but this cannot be confirmed in all cases.
In cases where capture of serial numbers is not automated, a manual process could be required, which is less reliable and involves greater administrative burden:
Accordingly, automated integration of implant-tracking information into operative reports or other patient-facing documents is preferable to a manual discharge requirement. Moving too fast on implementation of any requirement could force more manual processes, which heightens the risk of mistake, unreliable information, and greater administrative burden. Manual discharge requirements would also create new responsibilities for clinical staff in surgical services.
Lastly, it is submitted that a regulatory mandate may not be an appropriate measure at this time. We are unable to identify a similar requirement in the law or regulation of other states and there are other measures that are already encouraging this practice and improving patient access to medical device information, without the need for a proscriptive regulatory mandate. For example, accreditation standards require hospitals to track implanted devices in patient records with tracing and audit trails. As another example, CMS’s TEAMS bundled payment model, set to launch in 2026, will require more precise implant documentation to optimize reimbursement. In light of the foregoing, a more appropriate next step could be heightened patient education on the availability of, and options for obtaining, information about medical device numbers.
Thank you for your consideration of this public comment.
Sincerely,
R. Brent Rawlings
Senior Vice President and General Counsel