Brass in medical equipment

EMengineer

Involved In Discussions
#1
Hi everyone,

We are developing surgical equipment (device which holds cardiovascular guidewire) and planning to use brass material as holder. The main question is brass a suitable material for such use? I find it antibacterial but not biocompatible. The contact with patient would be indirect contact with blood (according ISO 10993-1). This part is single use, thus we do not want to use expensive materials (titanium, cobal alloys, etc.), maybe there are alternatives? The main requirement is metal should be soft which allows easy processing. Maybe there is medical grade brass?
 
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EMengineer

Involved In Discussions
#4
After some research what I have found is that brass should not be used where biocompatibility is required. Maybe some manufacturers used "ECO-BRASS" or similar lead free alloys and somehow managed to pass biocompatibility requirements. I found that guidewire used in vascular surgeries sometimes is gripped with grabber made from brass. I was surprised how it complied biocompatibility requirements (should be indirect blood contact which means more requirements to comply) as well as brass hubs used in needles.
 

planB

Super Moderator
#5
Some food for thought:
  1. "medical grade" is a marketing term that does not relate to any legal or standard requirement
  2. There is no restriction to materials, as long as you can demonstrate biological safety of the _final_ medical device within a risk management process when applied according to ist intended use (and foreseeable misuse).
  3. Apart from the (indirect) contact you are claiming based on your device's intended use, the (maximum expected) contact duration is key for you biological risk assessment. Moreover, indirect contact means that adverse biological effect can only be caused by inacceptable quantities of leachables, including particulate matter, released to the patient during use. In case you can address the related biologcal effects with either existing data, or data to be generated, you may be a in a position to substantiate the biocompatibility of you device even when made out of materials not commonly used for this purpose.
HTH,
 

EMengineer

Involved In Discussions
#6
Some food for thought:
  1. "medical grade" is a marketing term that does not relate to any legal or standard requirement
  2. There is no restriction to materials, as long as you can demonstrate biological safety of the _final_ medical device within a risk management process when applied according to ist intended use (and foreseeable misuse).
  3. Apart from the (indirect) contact you are claiming based on your device's intended use, the (maximum expected) contact duration is key for you biological risk assessment. Moreover, indirect contact means that adverse biological effect can only be caused by inacceptable quantities of leachables, including particulate matter, released to the patient during use. In case you can address the related biologcal effects with either existing data, or data to be generated, you may be a in a position to substantiate the biocompatibility of you device even when made out of materials not commonly used for this purpose.
HTH,
Finally we decided to go with stainless steal 316L (easier to avoid risks related with misuse as you suggested in #2). You gave me some good thoughts in #3. Thank you!
 
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