MIREGMGR
17th August 2008, 05:26 PM
As a fourteen-year employee of a 30-year significant player in the manufacturer of sterile drapes and covers that are utilized to create and maintain a sterile field during certain types of invasive medical procedures, you'd think that I would know this answer...but you'd be incorrect.
For all that time, all of our customers, end-users, technical advisors, etc., have used a uniform and coherent definition of the geometric extent of "the sterile field":
Lower bound, the top plane of the surgical table, under the patient.
Upper bound, as high as the surgeon or other sterile-garbed clinical personnel may reach to adjust overhead equipment, plus a safety margin.
Lateral bounds: outward in all directions from the patient to encompass the sterile surfaces of all of the sterile-garbed clinical personnel, and all of the sterile-covered equipment elements that are in proximity to the procedure.
As important as these definitions of geometric boundaries is the corollary definition that objects and surfaces outside of these boundaries are non-sterile in regard to the procedure under way, irrespective of their actual sterility status.
The term "sterile field" is referenced in many medical contexts, i.e. JCAHO guidelines, medical literature, FDA MAUDE/MEDSUN/Patient Safety News reports, and many, many 510(k)s. Yet I don't know the formal regulatory basis for the definition.
NFPA 99 defines some related concepts, i.e. the active zone for safe utilization of flammable anesthetic gases, oxygen, and ignition-hazard electrical and beam-energy equipment. As far as I know, it doesn't correlate its requirements to "sterile field", though.
It'd also be nice to have a formal definition of "sterile technique", in the context of the uniformly-understood-but-seemingly-undefined method for proper application of sterile drape and cover products.
Having a formal definition is relevant to us because several questions have accumulated that I need to answer, such as:
1. What is our regulatory stance on devices that inherently move in and out of the sterile field (if defined as above) during clinical operation, that are covered with one of our sterile barrier products, and for which the uniform clinical-personnel belief is that the device is sterile?
(For instance, a C-arm X-ray fluoroscopic imaging machine that is rotated by clinical personnal back and forth between AP orientation with the detector head above the patient and the X-ray tube below the table, to lateral orientation with both heads above the table surface.)
2. What about marketing a non-patient-contact drape-and-cover product in non-sterile form that historically users have expected to be sold sterile, when the use of the product is at a location below the top table surface and therefore by the historical definition the product is non-sterile as soon as it is installed to prepare for the procedure?
Etc., etc. :confused:
For all that time, all of our customers, end-users, technical advisors, etc., have used a uniform and coherent definition of the geometric extent of "the sterile field":
Lower bound, the top plane of the surgical table, under the patient.
Upper bound, as high as the surgeon or other sterile-garbed clinical personnel may reach to adjust overhead equipment, plus a safety margin.
Lateral bounds: outward in all directions from the patient to encompass the sterile surfaces of all of the sterile-garbed clinical personnel, and all of the sterile-covered equipment elements that are in proximity to the procedure.
As important as these definitions of geometric boundaries is the corollary definition that objects and surfaces outside of these boundaries are non-sterile in regard to the procedure under way, irrespective of their actual sterility status.
The term "sterile field" is referenced in many medical contexts, i.e. JCAHO guidelines, medical literature, FDA MAUDE/MEDSUN/Patient Safety News reports, and many, many 510(k)s. Yet I don't know the formal regulatory basis for the definition.
NFPA 99 defines some related concepts, i.e. the active zone for safe utilization of flammable anesthetic gases, oxygen, and ignition-hazard electrical and beam-energy equipment. As far as I know, it doesn't correlate its requirements to "sterile field", though.
It'd also be nice to have a formal definition of "sterile technique", in the context of the uniformly-understood-but-seemingly-undefined method for proper application of sterile drape and cover products.
Having a formal definition is relevant to us because several questions have accumulated that I need to answer, such as:
1. What is our regulatory stance on devices that inherently move in and out of the sterile field (if defined as above) during clinical operation, that are covered with one of our sterile barrier products, and for which the uniform clinical-personnel belief is that the device is sterile?
(For instance, a C-arm X-ray fluoroscopic imaging machine that is rotated by clinical personnal back and forth between AP orientation with the detector head above the patient and the X-ray tube below the table, to lateral orientation with both heads above the table surface.)
2. What about marketing a non-patient-contact drape-and-cover product in non-sterile form that historically users have expected to be sold sterile, when the use of the product is at a location below the top table surface and therefore by the historical definition the product is non-sterile as soon as it is installed to prepare for the procedure?
Etc., etc. :confused:
