OrthoHeal FlexiOH Full Arm

When the injury needs forearm rotation controlled, which is what reaching above the joint achieves. Immobilisation that stops below the elbow controls the wrist; crossing the joint neutralises the muscle forces originating above it and restricts pronation and supination. That is indicated for proximal and mid-shaft forearm fractures, injuries involving the elbow itself, and post-operative immobilisation where rotation must be prevented. Where the injury sits at the distal forearm or wrist, the case is far weaker, and the evidence says so — see the next question. Match the length of the device to what the fracture actually requires rather than treating more coverage as more safety.

It is worth knowing before specifying. A 2023 systematic review and meta-analysis of nine randomised controlled trials covering 1,049 children with displaced distal forearm fractures found below-elbow treatment favoured with statistical significance on both loss of fracture reduction and re-manipulation, without a higher rate of cast-related complications, and concluded that the accumulated evidence does not support above-elbow treatment for that indication. In adults, a comparison of above- and below-elbow casts for manipulated distal radius fractures found comparable performance in maintaining reduction. Trial work has also recorded higher total treatment cost and more school days lost in the above-elbow group. None of that makes this product wrong; it makes it wrong for distal injuries, where a shorter device is the better specification.

Not published, and this is the first question to ask. An above-elbow immobilisation is normally applied at an elbow flexion angle chosen for the injury, and that angle affects both the immobilisation achieved and the patient's ability to manage daily life. The manufacturer's photography shows the elbow at approximately a right angle, but no figure appears on the sheet. Ask what the angle is, whether it varies across the five size codes, and whether any adjustment is possible before the material cures. If the angle is fixed and a different one is clinically required, this is not the device for that case.

Also not published, and equally important. Above-elbow immobilisation is applied in a specific rotation — neutral, supination or pronation — chosen according to the fracture pattern and the reduction being held. A device that arrives pre-shaped fixes that choice at the factory. Ask which rotation the device holds, whether it is the same across all five codes, and whether it can be varied during the working window before curing. If the answer is a single fixed rotation, establish what it is and treat it as an indication limit rather than a detail.

This is the central fit question and it deserves scrutiny. Forearm circumference and upper arm circumference vary independently between people: a slight forearm with a heavy upper arm, or the reverse, is common rather than unusual. Five codes have to accommodate both, plus overall limb length, plus the elbow angle. Request the measurement chart showing what each code assumes at the forearm, at the upper arm and in length, then check it against a sample of your actual patients before committing to stock. Where a patient falls between codes at one segment and within one at the other, establish what the fitting guidance says to do.

The same problem as any device selected by size rather than moulded, with more of the limb enclosed. An acute injury swells over the first days and subsides afterwards, so the circumference at fitting is not the circumference at review. Too tight risks neurovascular compromise, compartment syndrome and pressure injury; too loose permits movement at the fracture and friction against skin. Crossing the elbow encloses more muscle compartments, which raises rather than lowers the stakes on getting this right. Ask how the device accommodates the change and whether a size change mid-treatment means a new device.

By the integrated zip, which is visible along the upper arm in the manufacturer's photography. That is a meaningful safety property: if compartment syndrome is suspected the immobilisation must come off completely and immediately, including any padding, with the limb elevated to heart level, and a zip achieves that without a cast saw and without saw injury risk. Two things to confirm before the first fitting: that the zip still runs freely once the polymer has cured, and that the full length opens rather than only a section. Cover both in staff familiarisation.

Documented neurovascular assessment. British Orthopaedic Association Standards for Trauma require clear documentation of peripheral nerve and vascular status after injury, manipulation, cast fitting and surgery, and fitting this device is a cast fitting for that purpose. UK audit work shows the standard is frequently not met — one hospital audit found detailed nerve function documented in only a tenth of cases, most entries reduced to the phrase "neurovascular intact", and arterial status missing from more than half. A device enclosing the upper arm as well as the forearm makes that assessment more consequential, not less.

The open lattice leaves much of the skin exposed along the whole limb and the material is described as washable, so washing and showering are part of intended use. Two practical points. Establish what sits underneath it, because if a liner is used its drying behaviour governs the outcome rather than the shell. And note that a full arm device covers more surface for longer, so drying time and patient instructions matter more than on a shorter device. Obtain the manufacturer's guidance on drying and on full immersion, and issue patient instructions with the device.

Request this in writing. A washable, zipped, removable device invites the assumption that it can be reprocessed between patients, and that assumption should never be made without the manufacturer confirming it. If single patient use, it is a per-episode consumable cost with a disposal route. If reprocessable, there will be a defined decontamination method, a cycle limit and a way of verifying the shell has not degraded — and the zip becomes a component to inspect. The commercial and infection prevention consequences differ entirely, so settle which applies before building it into a pathway.

OrthoHeal is an Indian manufacturer, and the FlexiOH range is distributed through European medical retail channels, which implies CE marking for the variants sold there. No CE marking or UKCA position is evidenced on the supplied sheet for the Full Arm variant, and this page makes no such claim on its behalf. Request the declaration of conformity, certificate scope, instructions for use and current UKCA position from the seller at quotation, and treat all four as conditions of order. Device classification under the UK Medical Devices Regulations 2002 is confirmed against the declaration at order.

Deliberately small, and preceded by four answers. Obtain the measurement chart and map it against real patients at both the forearm and the upper arm. Get the elbow angle and the forearm rotation in figures. Confirm the curing equipment requirement and whether it is included. Confirm single patient use or reprocessing. Then trial a small quantity against a defined indication — proximal or mid-shaft injuries where rotation genuinely needs controlling — with a defined review point. Medigear.uk can arrange a sample quantity and staff familiarisation alongside the quotation.