Why SecuSteri is a compliance tool

Sterilization traceability is not just record-keeping — it's a legal obligation with precise requirements. SecuSteri is designed to meet them.

What Malta's regulations require — and how SecuSteri meets them

In Malta, sterilisation requirements are anchored on named, recently published Healthcare Standards Directorate (HCSD) documents. Dental clinics follow the Standards for Dental Clinics (March 2024) — Class B steam steriliser (or evidence-based equivalent), documented validation of the sterilisation process, cycle parameter checks once each load is completed, and completed load verification. The Standards reference HTM 01-05, CDC Guidelines, Scottish Dental Clinical Guidance, and NHS Estates Decontamination Verification internally as source documents — the legal framework is Maltese (Health Care Professions Act Chapter 464 + Public Health Act Chapter 465 + EU Regulation 2017/745). Tattoo, body piercing, and semi-permanent makeup studios fall under the binding Standards for Tattoo and Body Piercing (January 2025), which explicitly cites EN 17169:2020, alongside the Control of Tattooing Act (Chapter 270 of the Laws of Malta) and the Body Piercing (Control) Regulations (S.L. 465.07). Podiatry is regulated by the Council for the Professions Complementary to Medicine (CPCM) under the Health Care Professions Act (Chapter 464); the State Registered Podiatrist (S.R.Pod) designation requires 1650 hours of supervised clinical practice across six areas including surgery (CPCM Podiatry Benchmark Document, 18 January 2024). SecuSteri is designed to address the compliance needs of every regulated profession.

Maltese dental clinics serving international patients gain credibility from documented compliance with the Standards for Dental Clinics — inspection-ready evidence at every visit.

Tamper-proof sterilisation register

The Standards for Dental Clinics (March 2024) requires sterilisation records to be maintained and accessible. SecuSteri generates a traceability record for each cycle, digitally signed by the operator with their PIN code. Once signed, the record is locked — no modifications are possible. It is the digital equivalent of a bound and initialled register, without the risks of torn pages or illegible handwriting.

Instrument-cycle traceability

The Standards for Dental Clinics (March 2024) and the Standards for Tattoo and Body Piercing (January 2025) require sterilisation records to be reconstructable cycle-by-cycle, with each instrument batch linked to its load and to the patient or client record. SecuSteri establishes this link automatically: every sterilised instrument is connected to its cycle, operator, container, and use-by date. The traceability chain is complete and verifiable.

Append-only audit trail

Every significant action in SecuSteri is recorded in a tamper-proof audit log: who did what, when, and on which record. This log is append-only — technically impossible to modify or delete, even by an administrator. In the event of a fitness to practise inquiry before the Medical Council of Malta or an HCSD inspection, the complete history of operations is available.

Digital PIN signing

Each operator signs cycles with their personal 4-digit PIN code. This signature individually identifies the person responsible for validating the cycle — essential for professional accountability. The PIN is stored as a cryptographic hash (bcrypt) — even the SecuSteri administrator cannot read it.

Compliant data retention

SecuSteri automatically retains your data according to your plan duration: 5 years (Standard), 10 years (Pro), unlimited (Clinic+). No risk of loss, fire, or water damage. Your sterilisation history is always accessible — whether for an HCSD inspection, a Medical Council of Malta fitness to practise proceeding, or your own quality assurance.

Hosted in the EU, GDPR compliant

Your data is hosted exclusively in the European Union on the Scaleway Paris infrastructure. It never leaves EU territory. The transfer between your browser and our servers is encrypted (TLS). Data at rest is encrypted. SecuSteri is GDPR compliant: right of access, right to data portability, right to erasure. We never sell your data and never use it for advertising purposes.

Data export at any time

You can request a complete export of all your data (cycles, instruments, autoclaves, audit log) as a zipped CSV archive, delivered by email. The export covers your plan's retention window. Your data belongs to you — you can retrieve it at any time.

SecuSteri vs the paper register

The paper register remains common in Malta. But it presents documented risks: missing pages, illegible handwriting, forgotten entries, inability to search quickly, and no backup in case of disaster. SecuSteri eliminates these risks by digitising the entire process while meeting the same professional obligations.

Simple pricing, from €29/month excl. VAT

One plan for solo professionals, one for growing teams, one for multi-site organizations. Cancel anytime.