A Medical Device Daily

The law of unintended consequences is liable to rear its head at any time, and so it goes for surgical procedures. FDA recently published a “Dear Healthcare Practitioner” letter that addresses one such category of events, urging surgeons to be more cautious in the use of devices during surgery and to be more conscientious in reporting any such events to the agency.

The Jan. 15 letter says that unretrieved device fragments are the subjects of “nearly 1,000 adverse event reports each year” in connection with “more than 200 different medical devices and numerous medical specialties.” As examples of potential problems from unretrieved fragments, the letter cites the possibility that magnetic resonance imaging (MRI) fields “may cause metallic fragments to migrate” and the associated radio-frequency energy field “may cause [the fragments] to heat, causing internal tissue damage and/or burns.”

Among the adverse events that FDA has seen reports for are local tissue reaction, perforation and blood vessel obstruction. Deaths have also been reported, although the agency offered no specific numbers.

The letter recommends that doctors inspect all devices “immediately upon removal.” Patients should be informed of any such incidents with the disclosure to include information on the material composition, the size and the location of the fragment(s) as well as any possible harm to the patient. The patient should also be advised as to any procedures he or she should avoid due to the fragments.

FDA noted that its regulations mandate that hospitals “and other user facilities ... report deaths and serious injuries associated with the use of medical devices,” but the agency encourages all concerned parties “to report adverse events related to unretrieved device fragments that do not meet the requirements for mandatory reporting” using MedWatch.

Updated recall by AM2PAT

AM2PAT (Chicago) recently reported a nationwide recall of lots of all sizes of pre-filled heparin and saline flush syringes. The Jan. 17 recall update comes shortly after the initial recall, announced in December, of a single lot of heparin flush syringes. The lot announced in the December recall was for 5-milliliter (ml) doses in 12 ml syringes and was contaminated with the Serratia marcescens bacteria, which is commonly associated with hospital-acquired infections. S. marcescens is fairly resistant to antibiotics and can cause eye disorders, including conjunctivitis.

FDA’s notice of the recall noted that the recall is associated with an inspection of the AM2PAT facility, but no warning letter for the company is currently posted on the FDA warning letter web page. AM2PAT manufactures the syringes on a contract basis for B. Braun (Bethlehem, Pennsylvania).

OIG says yes to gainsharing arrangement

Hospitals and doctors must walk a fine line when entering into cooperative agreements that might trim the nation’s healthcare bill, but two recent decisions by the Office of Inspector General at the Department of Health and Human Services shows that it can be done.

In a Dec. 28 decision, which was not posted until Jan. 14, OIG declared that it would not oppose an arrangement made between a hospital and a cardiac surgery group in which “the hospital agreed to pay the surgical group a share of cost savings directly attributable to specific changes in the group’s operating room practices.” The changes in part involved an evaluation of cardiac devices and supplies that the surgeons would standardize. The surgeons also agreed to “refrain from opening disposable components of the cell saver unit until the patient experiences excessive bleeding.” Other agreed-upon changes include as-needed use of a series of surgical supplies and the substitution of unspecified surgical products for those of lower cost.

The surgical group, according to the decision memo, “is the only group of cardiac surgeons that practices at the hospital,” described as an acute care hospital doing business with Medicare and Medicaid. All identifying information was purged by OIG before posting to the web site.

OIG said that part of the rationale for allowing the arrangement was that “the circumstances and safeguards of the arrangement reduced the likelihood that the arrangement was used to attract referring physicians” due to the fact that participation was limited to surgeons already with the practice. OIG also noted that while “many of the recommendations ... are simple common sense, they did represent a change in operating procedure.” Still, because the changes “carried some increased liability risk for the physicians,” it is “not unreasonable for the surgeon to receive compensation for the increased risk.”

In a similar decision issued in connection with a gainsharing arrangement between a hospital and an anesthesiology practice, OIG said that it would not object to shared savings engendered by product substitutions and standardizations as well as for the use of as-needed items. In this last category was the elimination of the use “a specific drug, and a device to monitor patients’ brain function” during cardiac procedures.

The OIG memo also noted that the hospital program administrator “tracked and measured the hospital’s performance of the covered cardiac procedures against the quality indicators established by the Society of Thoracic Surgeons (Washington) throughout the base year and contract year,” concluding that no cost-sharing was predicated on “procedures involving reductions in historical STS quality indicators.”