Standards Development

Scope

Full revision of currently published 2014 version. Additionally, expand scope to include plume evacuation systems for endoscopic procedures (e.g. minimally invasive, laparoscopic).

The scope is now the following:

This Standard specifies requirements and guidelines for the design, manufacture, installation, function, performance, maintenance, servicing, documentation, testing, and commissioning of equipment for evacuation of plume generated by medical devices.

It is applicable to:

a) portable and mobile plume evacuation systems,

b) local stationary plume evacuation systems,

c) dedicated central pipeline systems for plume evacuation systems, and

d) plume evacuation systems integrated into other equipment (e.g. laser equipment).

Purpose

The currently published 2014 version was a great first edition for plume evacuation system standardization. However, it carries several shortcomings that must be addressed to meet market needs, such as:

• It lacks a suitable test method to check conformity to a critical performance requirement. This enables manufacturers to devise their own test and can be very misleading to customers.

• Its healthcare facility guidelines are too ambiguous, which has caused confusion among clinicians, administrators, and legislators.

• It includes some overly burdensome device requirements not anchored in evidence-based rationale, preventing most manufacturers from compliance.

• It includes some design-restrictive device requirements that should be revised to be design-agnostic.

• It does not address a key class of device for endoscopic plume evacuation systems.