Medical Device Alert MDA/2008/051

The MHRA have issued  a medical device alert (MDA/2008/051) which concerns the Kimal safety fistula needle. Kimal is aware of the potential for the unintentional retraction of the cannula into the protection sheath, which can result in exsanguination.  As a result, Kimal is recalling all lots of the device. 

 Click here to view the alert. 

 

Revised EU monographs for heparin

The MHRA have reported a revision of European Pharmacopoeia monographs for heparin.

“Following increased reports of adverse events associated with heparin preparations in the United States of America and some European countries, the European Pharmacopoeia monographs for Heparin Calcium (0332) and Heparin Sodium (0333) have undergone rapid revision and implementation in order to strengthen the level of testing required for quality control.

The revised monographs were adopted by the European Pharmacopoeia Commission on 25 June 2008 and are expected to come into effect on 1 August 2008, pending a decision by the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH).

The revised monographs will be published in European Pharmacopoeia Supplement 6.4 and supersede the relevant monographs published in the British Pharmacopoeia 2008 and 2009 editions.

Further information and copies of the monographs can be obtained from the EDQM (European Directorate for Quality of Medicines & HealthCare) website“.

Syringe disconnection alert

The MHRA have issued an alert warning of inadvertent syringe disconnection.

The issue is with procedure packs from various manufacturers which contain BD Medical Surgical Systems 2ml, 5ml and 10ml Plastipak Luer slip syringes.

The warning points to potential for the BD Luer slip syringes supplied in procedure packs to spontaneously disconnect or fail to maintain a secure connection to Luer fittings of other devices.

Click here for further information.

Potential infusion error

The MHRA have  issued an alert warning of potential infusion device drug error when using the Smiths Medical Graseby Omnifuse and Omnifuse PCA syringe pumps.

The MHRA have warned of the possibility of patients being given an additional/unnecessary infusion when syringes are changed or infusions restarted when using DrugPro software. If the user selects – but does not confirm – a drug protocol from the drug protocol library and then resets/stops the pump, the previously infused volume will not be added to the ‘total volume infused’ display.

Click here for further information.

FDA update on heparin

The FDA have recently released a video update on the contaminated heparin issue.

Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recommendations on this continuing issue.

If the video does not show click here.

FDA update page here.

 

MADRI conference on CRBSI

The Multidisciplinary Alliance Against Device-Related Infections (MADRI) hosted its eighth annual conference June 6-8, 2008 in Lansdowne, VA where leading infection specialists presented on a variety of topics, including research goals in epidemiology and infection control, legal perspectives on MRSA and catheter-related blood stream infections (CRBSIs).

“Driven by discussions around improving patient care and the prevention of device-related infections, the eighth annual MADRI conference was a huge success,” said Rabih Darouiche, M.D., VA distinguished service professor, Departments of Medicine (Infectious Disease Section) and Physical Medicine and Rehabilitation and director of Center for Prostheses Infection and MADRI founder. “In an open and educational atmosphere, experts across disciplines were able to discuss challenges associated with device-related infections and exchange ideas about prevention and improvement of patient care.”

One of the main themes of the conference was CRBSIs, a common nosocomial infection that develops when bacteria enter the blood stream through a central venous catheter (CVC).

Click here for the full story.

 

Heparin flushes

The use of heparin has suddenly come under the spotlight in the UK. However, the reason for this attention is different to previous concerns in countries such as the US.

“An independent report has recently been published reviewing the circumstances of four patient safety incidents where an anaesthetist mis-selected sodium heparin 25,000 units in 5 ml (Monoparin) instead of sodium heparin 50 units in 5 ml (Hepsal) and administered the more concentrated solution in unlabelled syringes to four children. Thankfully the four children only experienced some temporary bleeding and otherwise are not reported to have suffered longer term harm. However, the potential for serious harm was recognised by the hospital trust” (NPSA 2008).

The NPSA state:

• Organisations should review local policies to minimise the use of heparin flush solutions in all devices, including complex central venous or arterial catheters.  This should take into account the evidence reviewed by UK Medicines Information (UKMi) which confirms that heparin flushes should not normally be used to flush peripheral intravenous catheters.  
• All flush solutions should only be administered following a prescription or patient group direction.
• Local policy and procedures should be reviewed to ensure risk with heparin flush solutions is minimised.
• Healthcare organisations should ensure that all relevant staff are made aware of this guidance and revised policy.

The Rapid Response Report from the NPSA can be viewed here and further support information can be viewed here.

HepC contamination - CDC full report

The Morbitity and Mortality Weekly Report (MMWR) from the CDC into “Acute Hepatitis C Virus Infections Attributed to Unsafe Injection Practices at an Endoscopy Clinic, Nevada, 2007″ has been published. The report is very thorough, it describes the investigation and highlights how the contamination may have occurred. Click here for the full report.

The CDC write “On January 2, 2008, the Nevada State Health Division (NSHD) contacted CDC concerning surveillance reports received by the Southern Nevada Health District (SNHD) regarding two persons recently diagnosed with acute hepatitis C. A third person with acute hepatitis C was reported the following day. This raised concerns about an outbreak because SNHD typically confirms four or fewer cases of acute hepatitis C per year. Initial inquiries found that all three persons with acute hepatitis C underwent procedures at the same endoscopy clinic (clinic A) within 35–90 days of illness onset. A joint investigation by SNHD, NSHD, and CDC was initiated on January 9, 2008. The epidemiologic and laboratory investigation revealed that hepatitis C virus (HCV) transmission likely resulted from reuse of syringes on individual patients and use of single-use medication vials on multiple patients at the clinic. Health officials advised clinic A to stop unsafe injection practices immediately, and approximately 40,000 patients of the clinic were notified about their potential risk for exposure to HCV and other bloodborne pathogens. This report focuses on the six cases of acute hepatitis C identified during the initial investigation, which is ongoing; additional cases of acute hepatitis C associated with exposures at clinic A might be identified. Comprehensive measures involving viral hepatitis surveillance, health-care provider education, public awareness, professional oversight, licensing, and improvements in medical devices can help detect and prevent transmission of HCV and other bloodborne pathogens in health-care settings”.

Click here for the full report.

Needlefree alert

The MHRA have issued an alert that describes how the septum of a needleefree device may remain recessed. Click here to view the alert.

The colour purple

Interest in high pressure, high flow PICC’s is growing. However, Deborah Bolton, IV Clinical Nurse Specialist from Brighton has questioned the colour of these devices. The NPSA issued a patient safety alert in 2007 that promoted the use of identifiable oral only compatible equipment. This was in response to… Read more

MHRA alert MDA/2007/089

The MHRA have recently published an alert to warn practitioners of the risk of back tracking when more than one IV line is connected through a single access point. I would hope when practitioners setup the IV plumbing they always consider the risk of backtracking and put actions/devices in place that will prevent this problem. View the document here.

Should NPSA alert include saline flushes

In March 2007 the NPSA issued a patient safety alert that looks at the issue of promoting safer injections. One of the key recommendations from the alert is for the NHS and the independent sector to “Undertake a risk assessment of injectable medicine procedures and products in all clinical areas to identify high risks, and develop an action plan to minimise them”.

Is it now the time to include saline flushes in this risk assessment… I hope so.