FDA report underscores need for qualified providers

Wednesday, March 3, 2010

WASHINGTON - A December Food and Drug Administration (FDA) advisory about the potential risks of negative pressure wound therapy (NPWT) underscores the importance of ensuring that the therapy is offered by qualified providers, say industry stakeholders.

"The FDA's real objective is to be sure that providers and patients are aware that there are serious risks associated with NPWT," said Patricia Burns, senior director of clinical affairs for Smith & Nephew. "We are very committed to the appropriate and safe use (of NPWT) as it provides substantial benefits to patients in closing hard-to-heal wounds."

The FDA said it has received reports of six deaths and 77 injuries associated with NPWT in the past two years. The advisory recommends patients receive adequate training on how to use NPWT and understand the possible complications and their warning signs.

HME providers play an important role in that education, says Susan Morris, vice president of health policy and government affairs for KCI, a pump provider/manufacturer.

"It's critical that the suppliers of NPWT make sure that the clinicians and the patients are trained well," she said. "It's also important for the HME provider to have patient customer support programs so if there is a problem, the patient can contact that supplier quickly."

Smith & Nephew, which partners with Apria to offer the therapy, has a variety of educational resources for providers and patients.

"We have educational programs about appropriate utilization and we do onsite training at the customer's facility," said Burns. "We have multimedia educational resources, 24/7 customer care and a 24/7 clinical care line. We also have patient-specific material and a patient Internet site."

NPWT was originally included in Round 1 of national competitive bidding, but many bid winners had no experience in providing the complicated--and costly--therapy. That raised concerns that patient care could be compromised (See HME News, July 2008).

KCI bid in all 10 MSAs and didn't win a single contract.

"We had winning suppliers call us and tell us they never intended to do this," said Morris. "It makes no sense to give a contract to someone who has no experience with these complex therapeutic products."