According to the CDC, in American hospitals alone, hospital-acquired infections (H.A.I.) account for an estimated 1.7 million infections and 99,000 associated deaths each year (source).  A recent study in Emerging Infectious Diseases found that hospital-acquired infections are the sixth leading cause of death nationally, costing the health care industry $6 billion annually.  Most H.A.I’s are commonly correlated with invasive medical devices or surgical procedures.

H.A.I.’s could be easily prevented, if “effective cleaning” were to be a consideration during the design phase of the medical device.  As we all know, if a device can’t be cleaned – it definitely can’t be sterilized.  Here are a few points to ponder upon when designing:

  • Have your engineers and designers met with your end user customer?
  • Have you performed Field Research to gather data that’s relevant?
  • Before and after design, how much consideration is given to the end user?

In a recent interview with a colleague, who is tasked with maintaining the cleanliness and guaranteeing device sterility, he voiced his frustration with newly designed medical devices.  Some of his concerns were that today’s devices are:

  • More Complicated to clean
  • Had more cracks and crevices
  • Were more difficult to assemble
  • Had less re-usability
  • Had more turn-over time

Medical Device Manufacturers can improve each facet of these concerns just by taking time to meet with the end user in order to gather relevant data to design devices that can be easy cleaned, assembled and are user friendly.

Today, with the newly enacted Affordable Care Act, hospitals and medical communities are faced with huge challenges to contain cost and improve the overall health of patients.  Even without the ACA challenging the way health care is being provided today, we each play a role and have a moral responsibility to do what’s right.

If you are in the process of developing and designing a new medical device, it would be highly beneficial to consult with a contract sterilization or full-cycle manufacturing provider.  Turnkey service, FDA approved Contract medical device manufacturers, such as LSO, usually have in-house engineers as well as Microbiologists and Sterilization experts who can provide you with suggestions on design for manufacturing optimization as well as ‘Effective Cleaning’ optimization.

We all have someone we know or love who’s been affected by an H.A.I.  Let’s do our part to design devices that are simple, easily cleaned, and user friendly to save lives and not contribute the loss of lives.  Talk it over….