Frequently Asked Questions

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Yes the A&E Medical sternum sutures contain nickel. The nickel content is 13.0 % to 15.5%.
A&E Medical sternum sutures meet the chemical requirements of ASTM F138 as shown below.

Chemical Composition
Element % Composition
Carbon 0.08 max
Manganese 2.00 max
Phosphorus 0.025 max
Sulfur 0.010 max
Silicon 0.75 max
Chromium 17.00 to 19.00
Nickel 13.00 to 15.50
Molybdenum 2.00 to 3.00
Nitrogen 0.10 max
Copper 0.50 max
Iron Balance
No, all A&E Medical products are latex free.
The higher cost of DoubleWires compared to single wires is minimal when you begin to figure what the hospital would incur in the event of one sternal dehiscence. According to a paper written by the cardiovascular surgeons at the Cleveland Clinic, the cost of an open-heart procedure can go up 2.8 times the original cost should a sternal complication occur. As of October 2008, Medicare will not pay the additional cost associated with a sternal dehiscence acquired after coronary artery bypass surgery.

For discharges occurring on or after October 1, 2008, Acute Inpatient Prospective Payment System (IPPS) hospitals will not receive additional payment for cases when a surgical site infection-mediastinitis (infection in the chest) after coronary artery bypass graft surgery is acquired during hospitalization (i.e., was not present on admission). The case would be paid as though the secondary diagnosis were not present.

http://www.cms.hhs.gov/HospitalAcqCond/Downloads/HACFactsheet.pdf
Any ferromagnetic object placed in a magnetic field will be subject to possible movement and/or induced electrical currents. It is impossible to make an absolute statement as the many variables of materials and MRI machine parameters can vary. There is published literature regarding MRI safety, which mostly states that patients with sternal wires can be safely scanned. The same literature also states that "in patients with retained epicardial pacing wires following cardiac surgery, there are no reports of adverse events or arrhythmias during CMR up to 1.5T with conventional pulse sequences. There is a small artefact but this is localised and rarely interferes with image analysis."1

The final decision to perform an MRI rests with the medical and MRI professionals familiar with the particular circumstances and the risk/benefit to the patient.

1Prasad SK, Pennell DJ. Safety of Cardiovascular Magnetic Resonance in Patients with Cardiovascular Implants and Devices. Heart 2004; 90: 1241-44
Yes, the ASTM F138 and ISO 5832-1 standards specify the chemical composition and mechanical requirements of the stainless steel sutures.

A&E Medical sutures fall within the required ranges mandated by the standards. By carefully controlling various parameters within specifications, A&E Medical is able to provide a more flexible and malleable sternotomy suture which still provides tensile strength within the specifications parameters.

A&E Medical sutures meet all the strength requirements of implantable stainless steel sutures.