FDA Finds Residual Contaminants, Shoddy Documentation at Compounding Pharmacy

Conditions at the New England Compounding Center were practically filthy, according to the report the FDA issued to the now-closed pharmacy. The FDA observed — and has since confirmed — contaminated products and listed a number of observations regarding conditions in the clean-room at NECC's Framingham, Mass., facility. Among the agency's observations:

  • Vials of preservative-free methylprednisolone acetate contained "greenish black foreign matter" or "filamentous material."
  • Formula worksheets stated that raw materials were sterile — but the pharmacy director "stated that the firm uses non-sterile active pharmaceutical ingredients and raw materials, with the exception of sterile water for injection, to formulate injectable suspensions."
  • The interior chamber of an autoclave used for the steam sterilization of formulated bulk drug suspensions — the final sterilization step for formulations such as preservative-free methylprednisolone and triamcinolone — appeared to be tarnished and discolored.
  • "Greenish yellow discoloration" lined the interior surface of the viewing lens of another autoclave, used for sterilizing components and equipment used in formulating sterile drug products.
  • Yellow residue lined the rear return of a weigh station hood, where active ingredients and other raw materials were measured, and greenish residue was found on another.
  • A boiler within 30 feet of the entrance to the prep room was leaking water into puddles, and the floor "appeared to be soiled with thick white debris and thick black, granular material."
According to the agency, the FDA issues this type of report — known as a Form 483 — at the end of an inspection in which investigators believe they've observed conditions or practices that, in their judgment, may indicate violations of the Federal Food, Drug, and Cosmetic Act or related regulations. It is not a final determination, but is among the information and documentation the FDA considers when deciding upon further action.

Thirty people have died and 419 have been sickened so far in the fungal meningitis outbreak.

Stephanie Wasek

Epidural Steroids Increase Fracture Risk

Contaminated vials are apparently not the only worry for patients undergoing steroid injections for chronic back pain. A recent study suggests that the epidural pain management treatment can put patients at increased risk of spinal fractures.

For the study, researchers at Henry Ford Hospital in Detroit, Mich., examined the cases of 6,000 back pain patients (average age: 66 years) who sought treatment between 2007 and 2010. Half of the patients had received at least one steroid injection, while the other half had never been administered the drug.

An analysis of the cases showed that each steroid injection increased a patient's risk of fracture by 29%. The hospital noted that researchers "did not use the steroid injection medication at the center of the meningitis outbreak."

The patient safety implications of the discovery is potentially huge, says orthopedic surgeon and lead author Shlomo Mandel, MD. "For a patient population already at risk for bone fractures, steroid injections carry a greater risk than previously thought and actually pose a hazard to the bone," he says, adding that pain management patients must be made aware of the potential risks and even undergo bone testing.

The study was presented at the North American Spine Society's annual meeting last month in Dallas, Texas.

David Bernard

Improved Laparoscopic Ergonomics?

It's no secret that laparoscopic surgery is an ergonomic nightmare for docs, but now a researcher at the University of Connecticut Health Center in Farmington is hoping to reduce the repetitive strain injuries often suffered by surgeons specializing in minimally invasive techniques.

Donald Peterson, head of the center's biodynamics laboratory in the division of occupational and environmental medicine, is using opto-electronic motion-capture technology to measure the physical strain various laparoscopic techniques put on surgeons.

Mr. Peterson — who said at this year's SAGES conference in San Diego that at least 85% of laparoscopic surgeons experience discomfort in their shoulders and upper extremities — attached electrodes to the forearm muscles that control hand movements to measure muscle activity and fatigue. He also placed sensors on laparoscopic instruments to measure how much force surgeons use to push and pull the devices during surgery.

He discovered that surgeons are constantly applying about 3 pounds of pressure and 3 to 4 pounds of torque to instruments as they're using them, which can lead to numbness and tingling in the hands and arms. Mr. Paterson hopes his research leads to improved laparoscopic instrument designs and, ultimately, a more ergonomically friendly OR.

Related research published in the Journal of Urology by Richard Babayan, MD, chief of the department of urology at Boston University School of Medicine in Massachusetts, suggests laparoscopic surgeons who perform warm-up exercises — 15 to 20 minutes of suturing exercises (forehand and backhand sutures and knot-tying), using both hands — before complex procedures perform surgery quicker.

"Completing warm-up exercises before athletic competition or stage performance is very common," writes Dr. Babayan, "However, most surgeons do not warm-up before performing complex surgery, even though it may improve operative times and their performance."

Daniel Cook

InstaPoll: Have You Ever Revoked a Surgeon's Block Time?

A surgeon's block time is considered sacred ground. Tell us in Outpatient Surgery Magazine's InstaPoll if you've ever revoked it.

Your sharps exposure control plan should include an annual review of sharps safety devices to reflect changes in technology. Nearly two-thirds (62%) of the 280 facility managers who took last week's InstaPoll have trialed sharps safety devices in the past year.

Dan O'Connor

News & Notes
  • Medicare upholds CRNA reimbursement Among its other provisions, the final rule on Medicare's 2013 physician payment policies that CMS issued on Nov. 1 confirmed that the program will directly reimburse CRNAs for all state-sanctioned services rendered, including chronic pain management. While the American Society of Anesthesiologists protested the move as a risk to patient safety and quality care, not to mention a potential spark for healthcare fraud and drug abuse, the American Association of Nurse Anesthetists praised it as a safeguarding of patient access to pain care.
  • Better knee outcomes with regional Using regional instead of general anesthesia reduces the need for blood transfusions in patients undergoing bilateral total knee replacement, according to a study by researchers at the Hospital for Special Surgery in New York City. The study, which appears in the current issue of the journal Regional Anesthesia & Pain Medicine, looked at 15,687 patients. Of those patients, 6.8% received neuraxial anesthesia, 80.1% received general anesthesia and 13.1% received a combination of both. The 3 groups had similar pre-op co-morbidities, but just 28.5% of regional block patients received blood transfusions, compared with 44.7% of general patients and 38% of combination patients.
  • Documentation improves safety Adverse event reporting systems improve staff's focus on a culture of safety and may reduce error rates, according to researchers at the University of Pennsylvania's Perelman School of Medicine in Philadelphia. They presented their findings last week at the annual meeting of the American Society for Radiation Oncology. By reporting and investigating safety breaches, researchers say, staff are more confident in the care they provide and better able to identify any holes in processes aimed at reducing adverse events.