|
Medical Devices That Use
Breathing Gas Pathways, Like Oxygen Masks, Can Pose Risks To
Patients?
Air from the device and its parts
can enter the patient's breathing passageways, exposing internal
tissues to chemical emissions and condensates. Patients receiving
supplemental oxygen can expose others to exhaled air, especially
if they cough. Patients with respiratory infections or COVID-19
who require oxygen therapy can spread viral particles through the
air. If the gas pathway of a medical device can reach 100 percent
saturation with water causing condensation to form, and that
condensate can then reach the patient, there could be a
considerable risk to patient safety. This is typically associated
with medical devices which deliver humidified gas to patients.
Traditionally, toxicologists and
biocompatibility experts considered the materials in breathing gas
pathways as external communicating devices and evaluated these
materials according to the ISO 10993 series of international
standards.
In March 2017, ISO 18562
(Biocompatibility Evaluation of Breathing Gas Pathways in
Healthcare Applications ) was published which is a four-part
standard aimed at providing the general framework required to
adequately determine the acceptability of medical devices that
contain breathing gas pathways.
ISO 18562 is comprised of four
parts:
1. Evaluation and testing within a
risk management process,
2. Tests for emissions of particulate matter,
3. Tests for emissions of volatile organic compounds (VOCs), and
4. Tests for leachables in condensate.
The scope of ISO 18562 covers the
gas pathways of every medical device, device parts, or device
accessories that are intended to provide respiratory care or
supply substances via the respiratory tract to patients.
Therefore, not only does the facemask of a breathing device need
to be tested, but also any connectors, filters, and tubing that
may come into contact with the gas being delivered to the patient.
Medical devices, parts or
accessories containing gas pathways that are addressed by this
document include, but are not limited to, ventilators,
anaesthesia workstations (including gas mixers), breathing
systems, oxygen conserving equipment, oxygen concentrators,
nebulizers, low-pressure hose assemblies, humidifiers, heat and
moisture exchangers, respiratory gas monitors, respiration
monitors, masks, medical respiratory personal protective
equipment, mouth pieces, resuscitators, breathing tubes, breathing
system filters and Y-pieces as well as any breathing accessories
intended to be used with such medical devices. The enclosed
chamber of an incubator, including the mattress, and the inner
surface of an oxygen hood are considered to be gas pathways and
are also addressed by this document..
* * * * *
|
|
