Archive for the ‘GS1’ Category

Oct 24th

Posted in GS1, Healthcare Solutions, Life Sciences News, MHRA

Colour-Coded Syringe Labels Increase Patient Safety

The statistics are frightening. With all of the advancements in medical science it’s often oversights and human error that lead to death and serious injury – especially when it comes to medical injections.

• Deaths occur in the UK in approximately one in every 200,000 anesthetics administered. http://news.bbc.co.uk/2/hi/health/medical_notes/4966162.stm
• The preparation of injectable medicines is a highly complex process, involving many steps where errors can happen. Problems in preparing and administering injectable medicines account for 62 per cent of all medication safety incidents reported to the National Reporting and Learning Service (NRLS) as leading to death or severe harm (Safety in Doses, 2009).

In the fast-paced world of surgery and medical treatment, it’s easy for a mistake to be made and the wrong medication or dosage to be administered to a patient. To help alleviate this problem, a joint initiative by the Royal College of Anaesthetists, the Association of Anaesthetists of Great Britain and Ireland, the Intercollegiate Faculty of Accident and Emergency Medicine and the Intensive Care Society recommends using a single standard for syringe labelling. The recommendation includes adopting a colour-coded labelling system that is currently used in North America and APAC.

PRISYM ID and Codonics make it easier for hospitals and healthcare providers to adopt these standards, as well as other barcode and labelling criteria, with a safe labelling system for syringes called the Codonics Safe Label System (SLS) 500i. The SLS 500i (designed and manufactured in the USA) was developed by Massachusetts General Hospital anaesthesiologists to prevent intravenous medication errors via barcode assisted medication labelling. The technology scans drug vial barcodes, and prints a full-colour label containing labelling data elements recommended by the initiative. Click here for more information on SLS 500i.

Any steps that can be taken to reduce human error and anaesthetist’s reliance on memory when it comes to administering injectable drugs will be a step forward. We expect the healthcare industry will continue to focus on labelling standardisation, the use of protocols and checklists, and the elimination of look-alike products as a way to help ensure patient safety. What have you observed regarding labelling protocol? Has the new colour-coding system had an impact on safety? Share your thoughts and predictions.

Aug 25th

Posted in FDA, GS1, Life Sciences News, PRISYM Medica

FDA UDI Regulations – An Updated Look at the Timeline

In June 2010 PRISYM ID hosted a webinar titled, “Tips for Implementing FDA UDI without Derailing Production”. Featured speakers included Jay Crowley from the FDA and Janice Kite from the GS1 Global Office. The webinar gave an overview of UDI (Unique Device Identification) in practical terms and went through the planned timeline for proposed FDA UDI regulations.

Now that a year has passed, we thought it would be beneficial to provide you with an updated timeline around FDA UDI. While nothing is official, the following is the most recent information on how the FDA UDI rollout might look:

12 Months after the FDA UDI Standard is Published (2013)

The first set of deadlines focus on Class III Medical Devices. These are devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury to the patient, such as implantable pacemakers, replacement heart valves, automated external defibrillators, and implants.

• UDI will apply to all levels of packaging
• An engraved UDI may be required for some Class III medical devices
• If a device has a serial number, the UDI will also be serialized

36 Months after the FDA UDI Standard is Published (2015)

The next class of medical devices to be effected is Class II, which are items like x-ray systems, gas analyzers, pumps, and surgical drapes.

• UDI will apply to all levels of packaging

60 Months after the FDA UDI Standard is Published (2017)

The final group is Class I Medical Devices, such as tongue depressors, arm slings, examination gloves, and hand-held surgical instruments.

• UDI will probably just apply to the device (not packaging)

Medical devices are classified by intended use and potential risk to the patient, and as you can see from the timeline above, the UDI regulations address the most critical devices first. The years listed are based on the FDA UDI standard being published in 2012, which is the current plan. Stay tuned!

Mar 10th

Posted in GS1, Industry News, Labeling Regulations

National Audit Office puts its weight behind GS1 standards in NHS*

The National Audit Office (NAO) has made an explicit recommendation that the Department of Health (DoH) should call for the adoption of universal bar coding standards in the NHS.

(more…)

Nov 2nd

Posted in GS1, Healthcare Solutions, Knowledge Base, Labeling Regulations

HIBC or GS1- Which Way Should We Go?

There’s been an ongoing debate regarding two barcode systems for medical products, HIBC and GTIN from GS1. There’s a school of thought that the industry needs to standardize on one system. But which option is better? And do we really need to pick just one? (more…)

Aug 2nd

Posted in GS1, Knowledge Base, Labeling Regulations, Technology News

Choosing Your Method: RFID vs. Barcodes

At the heart of tracking pharmaceuticals, clinical trials and medical devices is the debate about whether to use barcodes or RFID tags. Both have their advantages and disadvantages, and there really isn’t a clear winner. It’s a matter of understanding your circumstances and knowing which method will deliver the best results for your organization. (more…)

Jul 1st

Posted in GS1

GS1 – Increase Efficiency, Reduce Costs & Increase Patient Safety

GS1 adoption is vital as life sciences and healthcare companies focus on reducing operating costs and increasing efficiency. Software companies are rising to the challenge as the life sciences industries focus on reducing operating costs and increasing efficiency in these tough economic times.
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