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Pharmaceutical Manufacturing and Packing Sourcer

To Be Blunt

The safety of healthcare workers can sometimes be overlooked, yet thousands are injured daily by needles and other sharp objects. With the expansion of legislation, it is intended that there will be better protection for those at risk

Over the past quarter-century, the US has issued recommendations and regulations to protect healthcare workers from exposure to bloodborne pathogens. In 2000, the Federal Needlestick Safety Act set sweeping regulations and was, in part, the foundation for an EU Directive on preventing sharps injuries in the healthcare sector, adopted in 2010 and set to take effect in the UK by May 2013. However, every day 5.6 million US healthcare workers are still in harm’s way, and in hospitals alone some 1,000 personnel are injured per day. Clearly the mission remains unfinished. There is a unique opportunity to learn from the mistakes of the US and to better protect healthcare workers in all settings.

As a veteran nurse, I have been involved in healthcare worker safety through my work with the American Nurses Association, where I was President from 2000-2002. I played a key role in the adoption of several state initiatives and worked at a national level to secure passage of the Federal Needlestick Safety and Prevention Act in 2000.

I welcome the start of a six-month review of the Directive by the Health and Safety Executive in the UK. The review will seek to mandate the use of safety-engineered devices and other controls to protect healthcare workers from sharp object injuries. The EU Commission for Employment has estimated that needlestick injuries are one of the most serious health and safety threats in European workplaces, and the cause of approximately one million injuries each year.

It is encouraging that EU countries, including the UK, are seeking feedback from industry leaders regarding the development of the most effective national legislation to protect healthcare workers. We believe it is important for the EU and UK to understand what has transpired in the US since it began to mandate and enforce the use of safety products in healthcare facilities.

Change for the Better

There continue to be incremental improvements regarding safety which are closing some of the gaps. On 30th May 2012, the FDA, the National Institute for Occupational Safety and Health, and the Occupational Safety and Health Administration (OSHA) issued a joint statement recommending that healthcare professionals in surgical settings use blunt-tip needles when clinically appropriate to suture muscle and fibrous tissue to help prevent needlestick injuries.

OSHA began to enforce legislation in 2002 mandating the use of safety-engineered medical devices within US healthcare facilities. However, the number of reported needlestick injuries caused by suture needles in the operating room (OR) has remained largely stable over the last decade. It has become clear that the use of blunt-tip suture needles dramatically reduces the risk of needlestick injury when suturing fascia and muscle in the OR. Such safety devices should be utilised wherever possible, regardless of the upfront cost.

The majority of US acute-care facilities have now largely converted to the use of safety-engineered medical devices. This has helped to reduce overall rates of reported needlestick injuries. Home care, ambulatory care, and other non-hospital settings remain at risk, however. We must continue to address a number of outstanding challenges regarding compliance, enforcement and the selection of the safest, simplest medical products with frontline staff involvement. This is a great opportunity for the UK and European countries to learn from mistakes made by the US and to get it right the first time.

Setting Regulations As the UK continues to review the EU's Directive, the following guidelines could prove beneficial when implementing needlestick regulations:

  • All healthcare facilities should select the safest, simplest devices for every procedure. Devices with automatic (passive) and fully integrated safety features have, in particular, been found to minimise the risk of occupational exposures. Frontline healthcare workers should be involved in the process of considering the safest devices for the specific procedures being performed. Where such devices are available and compliant with the procedures of the facility, they must be required for use, regardless of upfront cost
  • All healthcare facilities should be inspected at least every two years by occupational healthcare safety authorities to ensure they are fully compliant with needlestick prevention laws, with strict penalties in place to discourage non-compliance
  • Device manufacturers should be required to give full training within each facility where their safety products are being adopted, and on regular periods afterwards, to ensure healthcare personnel are using them correctly. The healthcare facility should also train expert users who can assist in ongoing educational efforts
  • After the introduction of new devices, it is recommended that close attention be paid to the trends in injuries. Some devices may take a short period of use before becoming familiar to staff. Other devices, although promoted as safety devices, may introduce new types of injuries. Careful evaluation of those trends is important, especially in the first few months after adoption
  • All occupational exposures, including needlestick injuries and other sharp object injuries, need to be reported in a logbook that captures key information, including user occupation, type of device involved, whether a safety mechanism was available and correctly engaged, and at what stage of a procedure the accident occurred. This data should be collated by government occupational health and safety authorities and published on an annual basis. Frontline staff must have immediate access to that data
  • Each hospital must be required to take into account the level of needlestick safety features provided in drugs and vaccines supplied by pharmaceutical companies in a prefilled syringe format. Facilities should demand those products be supplied with safety device
  • The EU should develop and aggressively promote a national database on available safety-engineered medical devices
It is also recommended that the UK and other European agencies consider the expansion of legislation and regulations to protect those at risk of needlestick injuries outside of healthcare facilities.

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Safe in Common (SIC) is a non-profit organisation led by Chairperson Mary Foley, former President of the American Nurses Association, and other industry leaders. The organisation works to eradicate needlestick and sharpsrelated injuries and to promote the adoption of safer engineering controls in healthcare settings through education and training. SIC is hosting a series of online conferences to address these issues, including 'The Unfinished Agenda' series, which assembles the foremost needlestick prevention experts from across the globe to determine how the healthcare community can optimise levels of protection for personnel at continued risk of sharps-related injuries.
Mary Foley
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