HL Technology Press Release

The shift from the ALARP principle to the AFAP principle in the 2019 edition of ISO 14971, in line with Regulation (EU) 2017/745, changes the nature of the requirement: it is no longer enough for a risk to be acceptable – it must be reduced as far as the state of the art allows. This shift has direct, concrete consequences for a gesture repeated multiple times per procedure: torque-controlled tightening.

Two residual mechanisms, well known to quality engineers, are still present today in certain torque-instrument design families:

• A safety function that can be bypassed. When the operator can grip the fixed part of the instrument, the torque limitation is circumvented and the applied torque becomes unlimited – a reasonably foreseeable misuse under ISO 14971, with a direct consequence: screw or implant fracture.
• A torque that depends on hand position or reading angle. Depending on where the instrument is held, or the angle at which a mark is read, the torque transmitted varies – without the operator being alerted to it.

Under AFAP, a residual risk that depends on the operator’s grip position or reading angle is difficult to justify once a design exists that removes it at the source.

That is the answer provided by OMEGA, the torque wrench developed by HL Technology®, designed so that the transmitted torque is independent of how it is held and how it is read.

On OMEGA, the torque value, adjustable from 10 to 70 Ncm, is guaranteed by design, with ±10% precision maintained over the instrument’s full-service life (3 years, 300 sterilization cycles, or 6,000 clicks), with no recalibration required. The practitioner can focus on the clinical procedure: neither finger position nor reading angle affects the torque actually transmitted.

One more requirement for your risk analysis? Let’s talk.