Fungal Infections linked to Steroid Injections Lead to Injuries and Death

Oct. 15, 2012 - PRLog -- The Centers for Disease Control has taken the lead on investigating and reporting on the Fungal Infections linked to Steroid Injections.  This is one of the most serious healthcare associated infection outbreaks in recent years. As of October 13th there are 197 reported cases and 15 deaths.   This type of infection can often cause serious and permanent disability including paralysis as well as death.

Patients are suffering from injuries or death that may have been prevented if the proper precautions were taken. There’s an old adage often referred to as the 5 Ps: Proper planning prevents poor performance. When it comes down to it, that’s what will reduce both risk to patients and liability for healthcare providers and facilities regarding this type of healthcare infection.  According to The Centers for Medicare and Medicaid Services (CMS), “some [HAIs] may not be avoidable, but too often patients suffer from injuries or illnesses that could have been prevented if the hospital had taken proper precautions.” More on product related infections here: http://www.healthcareinfection.com/product-related-infect...

As this outbreak continues to impact patients, families, medical facilities and physicians certain questions need to be asked.  Currently the focus in on the quality control of the epidural steroid injection with preservative-free methylprednisolone acetate solution (MPA), compounded at New England Compounding Center (NECC) in Framingham, Massachusetts.  According to officials, the tainted spinal injections were shipped to 75 clinics in 23 states.  Investigations into the NECC and their related companies including their practice of shipping bulk product instead of patient specific product have begun.  Questions are being asked as to what regulation or oversight of these compounding companies was in place and if they were effective.  Congress has already begun to call for more effective oversight and a re-thinking of the reliance the healthcare providers in US have on these compounders.

The provider of these tainted injection vials could be found negligent, in addition question need to be asked by patients and their families about the healthcare providers who prescribed, and administrated the steroid injections.

These questions include:
Were the steroid shots prescribed for the correct reasons and ailments?  Were there positive results of previous shots?  Were the steroid medications in the vial being used appropriately or were they used off label for uses other than indicated by the medications FDA approval.

Were consent forms signed by patients and did these include the risk of meningitis.
Was there proper due diligence of the buyers responsible for procuring the steroid injections.  

Were the buyers aware that NCC did not have the proper license to distribute bulk injections?

Were the lot numbers recorded and tracked properly?  

Were the meds stored properly and used prior to their expiration.

Were protocols in place to allow for fast and effective patient notification of the product recall?

Each patient exposed to these tainted injections deserves to be provided with the best care possible.  In addition the patients who have been harmed should be allowed to learn exactly what factors allowed for them to be put at risk and who is responsible.   The healthcare providers who administer these type of steroid injections will need to re-consider the risk of these injections versus the benefit in pain relief to the patient. Can other less evasive or less risky treatments provide similar benefit?