Which Bioaerosol Capture Policy Will You Embrace?

I know that many of you have missed my pithy commentary on various aspects of surgical bioaerosol capture but my many hats have been revolving 360 degrees around my head of late. The advent of an increasing number of state-based mandates has developed a challenge for me since it has resulted in a round of “pencil wars” reminiscent of those in Canada in the 1990’s after that country issued a federal mandate for smoke evacuation. One distributor that I interviewed said that the legislation resulted in fierce competition that decreased his market share from 70% to 40%. The same has been unleashed in the United States now that the sleepy little smoke capture market is on its way to being a universal industry. Now involved companies no longer see a $M but a $B before their revenue stream.

Let us forget about the ULPA filters and smoke evacuator machines for a moment and just concentrate on the end piece; the “pencil” or its only alternative, the “miniSquair.” The former is made and distributed by the Big Boys like Stryker, Medtronic (Covidien) and Conmed (Buffalo Filter) among others. The alternative, which is unique, is manufactured and sold by a David to their Goliath called, Nascent Surgical. LLC located in a suburb of Minneapolis, Minnesota. That’s me!

Both of the devices are used for open surgical cases; one is hand-held and the other is attached to the drape immediately adjacent to the incision. One only works to capture smoke made by monopolar cautery while the other captures smoke made by bipolar as well as unipolar electrosurgical devices as well as smoke made by laser and aerosols produced by mechanical drills as used in orthopedic and nasal procedures. The miniSquair is certainly more versatile than the “pencil.” Both require suction for activation; the “pencil” can work on wall suction or a smoke evacuator machine, the miniSquair requires the higher air flow generated by a modern smoke evacuator. Both are disposable and both remove smoke but the similarities end there and the topic of smoke evacuation policy as mandated by multiple state legislatures begins.

In my last blog entitled, “Ineffective compliance vs. value-based outcomes,” I introduced the ISO 16571:2014 which defined an effective smoke evacuation device as used in the operating room as one that “… had a minimum smoke capture efficiency of 90% as demonstrated by the manufacturer (Section 4.3).”

Strangely, this standard has not been included in any of the 12 state-based mandates activated as of this date. Nor is it included in any of the pending legislation in nine other states. All that is required is that the involved states demand that their surgical facilities develop a “policy” for smoke evacuation but do not even suggest including such a standard as part of their policy. I think this is short sighted since compliance could be met by removing smoke with a straw which has an internal diameter close to that of a “pencil.” I think that clinicians should be asked to comply to a standard that brings value to the effort. For example, what does compliance mean if the chosen device does not protect the operating room staff from chronically inhaling surgical smoke which is associated with a plethora of serious systemic diseases including prostate, breast and pancreatic cancer, heart diseases, neurodegenerative diseases and even collagen diseases? What good is the non-standardized policy if it doesn’t demand a device that can offer a patient advantage such as reduced rates of post-operative infections? Absent such value, the compliance required has little to no value. Policies developed by the health care systems should be based on evidence that the method(s) chosen for smoke removal, offer staff and patient real advantages.

Get ready…here comes the punch line…The miniSquair has been shown to offer such advantages because it exceeds the ISO standard!

As a member of the bioaerosol capture device industry, and a small one at that, I ask hospital and out-patient surgical center Value Analysis Committees to include the ISO 16571:2014 standard in their evacuation policies so that compliance of their staff will advance the goal of a smoke free operating room.