Reprocessing single-use medical devices

AORN Journal,  March, 2002  by Barbara D. Cohoon

• E-mail
• Print
• Link

POLICY MODIFICATION

Some policy modifications that need to be considered include

* increasing research by professionals at facilities that are known for accurate data collection;

* developing and enforcing strict standards for the proper method of reprocessing;

* sterilizing, disinfecting, and recalibrating SUDs; and

* reflecting the savings created by the justification of reprocessing in the fees charged by hospitals.

The requirement for PMAs by the FDA will create clinical trials, which must be performed by an organization best suited for research (eg, the National Institutes of Health). Clinical trials must require the consent of the patient. This will satisfy proposed legislation requiring informed consent and relieve the added burden and concerns of the AMDR. Currently, third-party reprocessors decide which instruments will be reprocessed; however, SUDs should not be reused after being reprocessed without sound clinical data to back up their safe use, along with permission from the FDA.

A search of FDA warning letters to third-party reprocessors yielded seven since December 1997. The concern about strict standards for reprocessing SUDs was highlighted by a certified biomedical equipment technician employed as a medical device service person in Minnesota. (54) He elaborates on unknown requirements when calibrating SUDs, and states that, without directions from the OEMs, reprocessors decide on their own how to calibrate SUDs. With patient safety in question, this no longer can be tolerated. Strict standards must be implemented to guarantee uniformity in reprocessing all SUDS.

Savings created by reprocessing SUDs must be reflected in patient charges. It is considered fraudulent to charge the same price for a SUD from the OEM as a reprocessed SUD. Hospitals must demonstrate equitable sharing of savings for all patients. The Centers for Medicare and Medicaid Services should not reimburse at the same rate for a SUD that has been reused as one that has not been reused. (55)

Even though the proposed change is believed to be the best solution, it may not become a reality. There always is the possibility for an outside disruptive force to directly affect the forward movement of a proposal. The policy process does not happen overnight; patience is the key, and astute individuals or organizations will look for an opportunity for their proposal to arise when the ground is more fertile. According to one author, "Once a solution is carried out, it creates whole new sets of issues, ensuring that no public problem ever really dies." (56) The finalization of the FDA's guidelines for the reprocessing and reuse of SUDs may be an opportunity to implement the new proposed solution. For updates on the status of proposed changes, go to http://www.fda.gov.

POLITICAL ACTION PLAN

A political action plan on reprocessing SUDs would require a rational, comprehensive model of policy (ie, the problem must be clarified and properly identified). (57) This requires gathering additional data through research. Prioritizing change areas is paramount in solving the problem. Constantly re-evaluating the pros and cons, searching for alternatives, or evaluating leaving the proposal as it is must be done on a regular basis. Identifying individuals and organizations directly affected, both favorably and negatively, by the proposal is useful when proposing an effective change because it is important to have a clear understanding of their views and obtain accurate data detailing the exact cost and benefits before moving ahead.