Injectable Traceability: Lot Number, Label, and Patient Record

Traceability means being able to answer, at any moment, two questions: "which product, from which lot, was used on this patient?" and "which patients received this lot?" In HOF, that answer is no longer just good practice: it is the basis for acting on a recall, investigating an adverse event, reporting to ANVISA (Brazil's health regulatory agency), and defending yourself in a complaint.

This guide shows what to record, where, and when. Full clinical documentation is covered in patient records and documentation in HOF, and there is a lot and traceability record template ready to adapt.

Why does traceability matter so much in HOF?

• Alerts and recalls. When ANVISA or the manufacturer reports a problem with a lot, only those who recorded the lot per patient can find who was exposed.
• Adverse events. Reporting requires identifying the product and lot. See adverse event reporting in Notivisa.
• Counterfeit or irregular product. The registration and invoice show where the product came from and help separate product failure from procedure failure.
• Professional defense. In a complaint, a record with lot, expiration, and origin shows that the product was legitimate. See lawsuits over harmonization: how to prevent them.
• Continuity of care. Another professional who sees the patient later needs to know what was injected. The lack of this creates the problem described in patient with an unknown previous filler.

What should you record for each product?

For botulinum toxin, which is a drug, also record the date and time of reconstitution and what was done with any leftover, according to the package insert and health regulations. Storage conditions are in storage of botulinum toxin.

Hyaluronic acid fillers and biostimulators are medical devices, many of them class IV, the highest risk class. Hyaluronidase also goes in the record: when used, note product, lot, and expiration like any other injectable.

How do labels and the patient card work?

Many fillers and biostimulators come with self-adhesive labels inside the box showing name, lot, and expiration. The expected use is:

1. One label in the patient record, next to the entry for that procedure.
2. One label on the patient card, handed over that day, with the date, treated area, and the professional's identification.
3. Extra labels, if any, kept in the inventory outgoing record or discarded, never used on another patient.

When the product has no label, copy the data by hand or photograph the packaging with the lot legible and attach it to the record. Photograph only the product: the photo should not show the patient's face or personal data, to avoid creating an image file outside the control of the LGPD (Brazil's data protection law).

How do you link inventory to the patient record?

Traceability has two ends: the product entering the clinic and the product leaving for the patient.

Inventory organization, from a management perspective, is covered in injectable inventory in the HOF clinic. Disposal follows the clinic's PGRSS (health care waste management plan).

How do you check whether a lot is legitimate?

Professionals and patients sometimes search for a product's trade name together with "lot" wanting to know if it is genuine. There is no single public lookup by lot for all products, but there are objective steps:

• Registration. Check that the registration number on the packaging exists and is valid on the ANVISA portal.
• Packaging. Intact seals, labeling in Portuguese, importer or manufacturer details, and consistency between box and syringe.
• Origin. Purchase from a regular distributor, with an invoice in the name of the clinic or the professional.
• Manufacturer. The customer service of the manufacturer or importer can confirm whether a lot exists and was distributed in Brazil.
• Alerts. ANVISA publishes alerts about counterfeit and irregular products; check them before buying from a new supplier.

What should you do after an alert or adverse event?

1. Locate the lot in inventory and set the units aside, without discarding them.
2. Search the outgoing record for which patients received that lot.
3. Follow the official notice, which says whether patients must be contacted and product returned.
4. Report adverse events through ANVISA's channel, with product and lot.
5. Notify the manufacturer or importer.
6. Document every step in the records of the patients involved and in inventory control.

How long should you keep the records?

The lot record is part of the patient record and follows the same retention period. Law No. 13,787/2018, which covers the digitization and retention of medical records in Brazil, sets a minimum period of 20 years from the last entry. The rules of your professional council may add complementary requirements. Invoices and inventory records should also be kept, for the tax retention periods and for their usefulness in an investigation.

Events with long-lasting products, such as biostimulators, can appear years after the injection. A record lost in a system or clinic change leaves the professional with no way to prove the origin of the product. When changing systems, export and keep the old records.

How do you explain it to the patient?

The card also reinforces trust: the patient sees that the product is traceable and legitimate. Include in the informed consent the information that the product will be recorded with its lot in the patient record.

And in Harmy?

Traceability checklist

1. Registration, lot, and expiration checked at purchase; invoice kept.
2. Inventory entry with lot, expiration, quantity, and supplier.
3. Label in the patient record stuck on at the time of the procedure.
4. Traceability card given to the patient.
5. Inventory deduction with the patient's name.
6. Toxin reconstitution and hyaluronidase use recorded.
7. Procedure defined for alerts, recalls, and reporting.