Implant records after surgery: what every ortho hospital should keep

In 2010 a hip implant called the ASR was recalled worldwide. In India, a Health Ministry expert panel later estimated that about 4,700 people here had received it. Years after the recall, more than 3,600 of them could not be traced. A peer-reviewed review put the number traced at only 882.

The review of the case pointed to the lack of any registry that could answer a simple question: which patients got this implant, from which batch, in which hospital?

That question is the whole reason an implant record matters. Here is what Indian rules ask for, what they do not, and what a careful ortho hospital keeps anyway.

What the law asks of the implant, and of you

Under the Medical Devices Rules, 2017, orthopaedic implants are regulated devices, and long-term implants fall in the higher risk classes. The rules require the label to carry a lot or batch number, and an expiry date for sterile devices. A unique device identifier (UDI) is provided for in the rules, but the date it becomes compulsory has been left for the government to notify.

This is the part most owners do not expect. We read through the consolidated rules looking for a duty on hospitals to keep an implant register or to give patients an implant card, and did not find one. The traceability duty sits mainly with the manufacturer and the distributor. Europe gives patients an implant card. We found no Indian rule that requires one.

So in India, keeping a proper implant record is mostly a choice the hospital makes. It is a choice that pays for itself the first time it is needed.

The three times you will need it

A recall. When a manufacturer or the regulator recalls a batch, the first question is who received it. If your operation notes say "knee implant, size 3", that question takes weeks of file searching. If they say the brand, the REF number and the LOT number, it takes minutes.

An insurance claim. TPAs ask for the implant invoice and the implant stickers. One TPA's claim checklist asks for the "barcode sticker for the implants" and the original invoice. So it helps to keep both with the claim papers from the start.

A problem with the device. India runs a Materiovigilance Programme for reporting adverse events with medical devices. Its reporting form asks for the device's name, manufacturer, catalogue number, model number, lot or batch number, serial number, UDI if there is one, expiry date, and the date it was implanted. If those details were never written down, the report cannot be made properly.

The ASR compensation process shows the same thing from the patient's side. The claim form asked for the implant identification number, the discharge slip, proof of purchase, and the surgeon and hospital: the papers the implanting hospital holds.

What to record for every implant

For each implant used, against the patient and the operation:

• Manufacturer and brand
• The REF or catalogue number, and the model
• The LOT or batch number, and the serial number if it has one
• Size and quantity
• Expiry date, for sterile items
• The date of surgery, the surgeon and the side (right or left)
• The supplier and the invoice it came on

The simplest habit is the one most theatres already half-follow: peel the sticker off the implant box and fix it to the operation note, then make sure the same details are typed into the record. Paper stickers fall off and fade. A typed record can be searched.

Price is part of the record too

Since August 2017 the National Pharmaceutical Pricing Authority has capped the price of knee implants, with separate ceilings by the type of knee system and its material, and has extended the cap several times. The current order runs to 15 November 2026, or until further orders, so check the latest notification for the figures. In 2017 NPPA also named hospitals that were not displaying knee implant prices, and issued notices to others for the same omission.

Keeping the implant, its invoice and its billed price together in one record makes it easy to show, if anyone asks, that the patient was charged correctly.

A short routine for the OT

1. Keep the implant stickers with the patient's file in theatre, not on a loose sheet.
2. Before the patient leaves the OT, type the brand, REF, LOT, size and quantity into the record.
3. Give the patient a printed note of what was implanted, with the brand, REF and LOT. Their next surgeon will thank you.
4. Keep the supplier's invoice linked to the patient's bill.
5. Make sure your records can answer one question quickly: which patients received this LOT?

That last check is the one to try today. Pick a LOT number from last month's theatre list and see how long it takes to find every patient who received it. If the answer is minutes, you are in good shape.

Please note: this article is general information. Implant rules and price caps change; check the current CDSCO and NPPA notifications for the latest position.

Sources

• Medical Devices Rules, 2017 (consolidated), CDSCO, including the First Schedule and Rules 44 and 46. PDF
• Materiovigilance Programme of India, medical device adverse event reporting form. PDF
• Review on device traceability and the ASR recall in India. Article
• CDSCO, compensation claim form for ASR hip implant patients. PDF