Chile Technical Standard 247: what it requires from institutional health providers

What Technical Standard 247 is

Its full name is General Technical Standard No. 247 on patient safety and quality of care regarding traceability of medical devices in institutional health providers. It was issued by the Patient Safety and Quality of Care Department of the Undersecretariat of Healthcare Networks at the Chilean Ministry of Health, and approved by Exempt Decree No. 33 of 2025.

Its general objective is to implement a medical device traceability record system from reception through use or implantation in the patient, so as to reduce the risk of an adverse or sentinel event.

That is where the meaningful difference lies. Technical Standard 226 already required traceability records for medical devices up to the moment of reception. Standard 247 takes that finish line and turns it into a starting line: it requires following the device inside the facility, whether stored, in use or implanted in a patient.

Standard 247 does not replace 226, it complements it. The data required by 226 remains mandatory, and 247 adds the record inside the facility on top of it.

Who it binds

The scope is broad and does not distinguish by facility size or ownership.

• Institutional health providers and inpatient care facilities
• Outpatient care facilities
• Public and private sector alike
• Armed Forces and Public Order and Security institutions

The four obligations

The standard sets four concrete requirements for the institutional provider.

• Maintain a record system, manual or electronic, holding the minimum data set. It may be a centralised institutional application or be split across clinical services, provided the records can be linked and consulted in full
• Formally designate, through an institutional document issued by the Technical Directorate, a professional responsible for the implementation and a substitute, with protected hours for that function
• Record traceability from reception and entry of the device until it remains in the facility, whether stored, in use or implanted in a patient
• Run at least one traceability simulation per year on a randomly chosen device, reviewing processes, response times and implementation effectiveness, and producing a written report

The annual simulation is the practical test of everything else. A record that exists but cannot reconstruct one unit's history within a reasonable time is exposed precisely there.

The minimum data set

On top of the data already required by Technical Standard 226, Standard 247 requires the following information about the device and the clinical area.

• Device status, for example in the warehouse, in use, implanted, quarantined, on loan, returned to the supplier, destroyed, withdrawn or explanted
• Health registration number, where applicable and required
• Method of acquisition, for example public tender, direct award, donation or CENABAST
• Date of conforming reception of the device
• Inventory number, where applicable
• Name of the clinical area or service that will use the device, and reception date in that area

For implantable devices the record must extend to patient data from the clinical chart: national ID, implantation and explantation dates where applicable, the name of the professional performing the procedure and the name of the surgical service or procedure. For all other devices, reaching the location is enough.

Which devices it covers

In a first stage the standard applies to prioritised medical devices: the medical equipment covered by the technical standard on preventive maintenance of critical medical equipment, the devices considered in the Accreditation System for Institutional Health Providers, and the implantable devices listed in its annex.

What the record must look like, and who inspects it

The standard allows paper, but attaches conditions that make it hard to sustain in practice. Information must be current, accessible and available for inspection by the competent authority. It cannot be altered with amendments or leave blank spaces between entries. And when a correction is needed, evidence of it must remain along with the signature of whoever authorised the change.

That set of requirements describes a record with change history and an identified owner for every movement, which is exactly what an electronic system delivers by design and a notebook does not.

Compliance is subject to inspection by the Providers Intendancy of the Superintendency of Health.

How compliance works in practice

The distance between complying and not complying rarely lies in the team's willingness. It lies in whether the record happens on its own or depends on someone writing it down afterwards.

• Identify by unit, with lot, serial and expiry, because without a unique identifier there is no way to reconstruct one item's history
• Capture the event at the point of use, so withdrawal and implantation are recorded without adding a task for the clinical team
• Link the record to the clinical chart, which is what the standard requires for implantables
• Keep a change history, with author and date on every correction
• Be able to answer the annual simulation in minutes, walking the full path of a randomly chosen unit

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