SBAR: Multiple activations of single use breast biopsy guns
A paper prepared for the Welsh Decontamination Committee
P. Phillips[1], M. Campbell[2], N. Wigglesworth[3]
1 - Director, Surgical Materials Testing Laboratory, Bridgend.
2 - Service Manager Decontamination, Cardiff and Vale Health Board.
3 - Nurse Consultant, Welsh Healthcare Associated Infection Programme (WHAIP) Team, Public Health Wales
Revision: 1.0 Date: 21/05/2013
Situation
The Welsh Decontamination Committee (WDC) have been asked to provide advice regarding whether single use breast biopsy guns (BBGs) can be used more than once on a single patient.
Mark Campbell, Neil Wigglesworth and Pete Phillips, members of the WDC, have been asked to investigate and provide advice.
Background
Traditionally, the reusable devices were used to take more than one biopsy sample from a single patient. Since the partial move to single-use BBGs, which have an integral needle, clinicians will use the gun to take multiple samples until either the needle is blunt or the sample quality is unacceptable.
Appraisal
There are two questions to ask:
- Can single-use BBGs take multiple biopsies ?
- Should single-use BBGs be used to take multiple biopsies ?
Manufacturers™ instructions
The first element which requires clarification is what the manufacturers say about their device. i.e., what claims or instructions do they make/provide?
- Do they provide an IFU?
- If they do, does the IFU specifically state that a single sample should be taken, or does it not make reference to this at all?
Bard Magnum Biopsy Instrument
The Bard Magnum Reusable Core Biopsy Instrument and the Bard Magnum Disposable Core Biopsy Needle with Spacer are the devices presently in use, which hospitals are trying to replace with single-use devices. The Instruction manual states:
The Magnum Biopsy Needles are sold sterile for single patient use only ...
Note: If collecting multiple samples, inspect the needle for damaged point, bent shaft or other imperfections after each sample is collected. Do not use the needle if any imperfection is noted.
Therefore the reusable instrument has explicit instructions regarding multiple sampling on a single patient.
Carefusion Achieve Biopsy System
The Carefusion Achieve Programmable Automatic Biopsy System states:
For Single Use Only
on the instruction leaflet, including the struck-through number 2.
In the English section of the IFU, it states:
Step 5: Obtaining multiple samples
After the tissue sample is removed, additional samples from the same patient may be obtained by pulling the charging arm a second time, which will retract the stylet within the cutting cannula, placing the Achieve biopsy device once again in a fully charged position. Repeat steps 3-5.
Caution: For single use only. Re-use may result in a non-functional product or contribute to cross contamination.
Thus the single-use device also has explicit instructions for taking multiple samples from a single patient. The only outstanding issue is whether that advice conflicts with the single-use labelling and caution on the device.
Single-use labelling
This section deals with interpretation of the labelling and the medical device legislation.
The MHRA provide some useful guidance documents on single-use medical devices.
http://www.mhra.gov.uk/home/groups/dts-iac/documents/publication/con2025021.pdf
A device designated as ˜single-use™ must not be reused. It should
only be used on an individual patient during a single procedure
and then discarded. It is not intended to be reprocessed and
used again, even on the same patient.
http://www.mhra.gov.uk/home/groups/dts-iac/documents/publication/con2025015.pdf
Do not reuse. A single-use device is used on an individual
patient during a single procedure and then discarded. It is not
intended to be reprocessed and used again, even on the same
patient.
Finally, the Medical device Directive 2007-47-EC states:
˜single use device™ means a device intended to be used once only for a single patient.
The MHRA appear to concentrate on the reprocessing element of single-use “ i.e. all of their definitions mention reuse on the same patient linked to reprocessing. It is not clear whether a single procedure encompasses the act of obtaining just one or more biopsy samples. However, a sensible interpretation may be that we should look at this in the same way that a single use scalpel would be used multiple times in an operation by a surgeon “ we would not expect the surgeon to use the scalpel for a single incision and then discard.
The MDD appears to be less open to interpretation, but again, if interpreted strictly any single-use device should be used for a single action and then disposed of. Clearly this is not happening in theatres with scalpels, gloves, gowns and other similar medical devices.
Thus it appears we have an accepted interpretation of single-use already “ surgeons' gloves are not changed after every action in theatre, and scalpels will be used for more than a single incision. So the 'use' appears to be accepted as covering multiple actions on the same patient.
Where are the risks?
Another way of approaching this is to try to understand what the risks are.
If we accept that taking multiple samples on a single patient is acceptable for a single-use device, then the only other issues to be dealt with are whether the multiple gun actions cause a problem for the patient, for the member of staff, or for the biopsy sample. As far as we are aware, there are no additional risks for staff in activating the gun twice. There are no additional risks that a patient would be exposed to if the gun were activated twice. There is no infection risk, and as far as we know at present, there is no mechanical issue with reusing the device which would cause additional pain/discomfort to the patient. There are no problems with the biopsy samples themselves, having been told by Public Health Wales recently that the quality of biopsies with single-use BBGs was acceptable.
The only outstanding issue is related to the sharpness or trueness of the biopsy needle, and whether it loses its ability to take a good quality second sample after the first activation. Bard deal with this by recommending an inspection of the device between activations.
The Carefusion IFU explicitly allows the taking of multiple biopsy samples with the device in the same way that the Bard device does but makes no recommendations regarding inspection.
The needle on the Bard device is labelled as 'disposable' and 'for single patient use', which is more accurate than the Carefusion term 'single-use', although as discussed above, the NHS has a wide interpretation of what 'single-use' actually means.
Recommendation
Taking into account the following:
- The instructions for use (IFU) for the Bard disposable needle and the Carefusion single-use gun/needle both allow the taking of multiple samples
- There is no evidence that we are aware of that the quality of second (and subsequent) biopsy samples is compromised;
- Whilst it is unclear at what stage the needles may become unfit for purpose, the Bard device recommends checking for imperfections before second and subsequent use. It is also our understanding that clinicians are able to judge when the device is no longer acceptable;
- There is no evidence that we are aware of that the second (and subsequent) activations cause increased discomfort or harm to the patient;
there are therefore no reasons to suggest that the disposable Bard Magnum needle and the single-use Carefusion Achieve unit cannot be used to take multiple Biopsy samples on a single patient, and their documentation includes explicit instructions for doing this.
We would additionally recommend that users of the Achieve unit consider inspecting the needle before additional activations, and not use the needle if any imperfection is noted.
