Compliance Tips

Beyond Compliance

All U.S. healthcare facilities are required to comply with the regulations of the Bloodborne Pathogens Standard (BPS), which aims to protect healthcare personnel at risk of harm from needlestick injuries and other potential transmission routes for infection. One of the best guides to compliance with the BPS is the Workbook for Designing, Implementing and Evaluating a Sharps Injury Prevention Program published by the Center for Disease Control (CDC).

The goal of every healthcare facility should be eliminating the risk of needlestick injuries wherever possible - not just complying with the law. Every healthcare worker knows that causing unnecessary harm to a patient should never, ever happen. Safe in Common subscribes to the same philosophy when it comes to protecting healthcare personnel at risk of harm from needlestick injuries.

Keeping healthcare personnel safe from needlestick injuries requires teamwork across all levels of an organization, strong awareness regarding safety procedures, tireless vigilance from all staff and a continuous pursuit of accessing the safest, simplest equipment.

Safe in Common urges all U.S. healthcare facilities to not only comply with minimum standards for compliance under the BPS, but to exceed them wherever possible. On this page are Safe in Common’s top ten suggestions to help maximize levels of protection provided to healthcare personnel within your facility.

1. Multi-Disciplinary Team Involvement
2. Equipment Selection Criteria
3. Regular Meetings to Review Areas of Risk
4. Record Specific Details of Reported Injuries
5. Require Proper Training on New Equipment
6. Review Risk for Drug Delivery Systems such as Prefilled Syringes
7. Don't Make Equipment Purchasing Decisions Based Solely on Upfront Cost
8. Seek to Minimize Sharps Disposal Volumes
9. Report Adverse Events to the FDA
10. It's not just about needlestick injuries!

1. Multi-Disciplinary Team Involvement

All healthcare personnel are at potential risk of needlestick injuries. Healthcare facilities should establish multi-disciplinary leadership teams that include representatives of all occupations identified as being at risk of harm. The greatest level of representation on a committee should be frontline healthcare personnel. Other representatives should include senior administration in charge of procurement, staff safety, institutional pharmacies, nursing unit management, quality management and infection control. Of equal importance is to have representation for those at risk downstream, including cleaning staff and those responsible for sharps disposal.

2. Equipment Selection Criteria

Not all safety devices are equal. OSHA states that “The employer must use engineering and work practice controls that eliminate occupational exposure or reduce it to the lowest feasible extent" (OSHA CPL 2-2.69 §XIII, D.2.). Removal of hazard as soon as possible after contamination is required. To comply with the BPS, an employer must use engineering and work practice controls that will "eliminate or minimize employee exposure" (Sec. 1910.1030(d)(2)(i)). The CDC notes that “The timing of activation (of the safety feature) has implications for needlestick prevention. The sooner the needle is isolated, the less likely a subsequent needlestick will occur”.

OSHA categorizes safety devices into the following categories:

Passive vs Active: Passive devices remain in effect before, during and after use. Active devices however require the worker to activate the safety mechanism.

Integrated vs Accessary: Integrated devices have a safety feature that is built in as an integral part of the device and cannot be removed. This design feature is usually preferred. Accessory safety devices have safety features that are external to the device and must be carried to, or be temporarily or permanently fixed to, the point of use. This design is dependent on employee compliance and according to some researchers, is less desirable.

The Premier Safety Institute further explains that: “hospitals that have adopted safety devices in all situations…and still experience needlestick injuries often see the injuries occur as a result of non-activation of the device. So compliance with activation is still an issue influencing many hospitals to select devices with a ‘passive’ activation feature where the needle is covered automatically as part of the use of the device, such as retractable needles”.

The Emergency Care Research Institute (ECRI) also recommends pre-removal activation of the safety mechanism, rendering the device safe from needlestick injuries before the needle is removed from the patient. ECRI states that any device that requires or compels the operator to activate the safety mechanism “after the needle is removed from the patient not only negates the pre-removal activation advantage, but also can lead to blood or medication splatter.”

Safe in Common recognizes that there are many criteria that must be reviewed to select the safest, simplest equipment that best comply with the routine procedures of your facility. While not applicable in all situations, the following criteria can help to review and select equipment that can delivery optimal protection to those at risk of harm:

• Passive activation of the safety mechanism during normal use of the device
• Pre-removal activation of the safety mechanism in-situ, with activation forces not causing additional discomfort to the patient
• The safety mechanism is fully integrated into the equipment, and cannot be removed
• The safety features eliminate any risk of the device being reused or tampered with after use, or the needle re-exposed

3. Regular Meetings to Review Areas of Risk

Many organizations recommend a review of new safety technologies be conducted on at least an annual basis. Safe in Common encourages committees to review areas of risk from needlestick injuries on a more frequent basis. Whenever a needlestick injury is reported, key members responsible for minimizing occupational exposure within a facility should review the incident and determine whether it is appropriate to immediately investigate ways to further minimize risk.

4. Record Specific Details of Reported Injuries

Healthcare personnel should be encouraged to report needlestick injuries whenever they occur. Furthermore, detailed records should be maintained of all occupational exposures. Federal OSHA and some state laws or regulations now require a record of the brand and manufacturer of any device involved in an injury to a worker.

To effectively monitor injuries for sharps injury prevention planning purposes, it is recommended that the minimum data ele¬ments be recorded:

• Unique identification number for the incident; (records shall be maintained in a way that pro¬tects the confidentiality of the healthcare worker);
• Date and time of the injury;
• Occupation of the worker;
• Department or work area where the exposure incident occurred;
• Type of device involved in the injury;
• Presence or absence of an engineered sharps injury prevention feature on the device in¬volved;
• Brand of the device
• Purpose or procedure for which the sharp device was being used; and
• When and how the injury occurred.

Safe in Common also recommends that report forms categorize the following information whether:

• The device had a passive or active safety feature
• There was safety feature fully integrated within the device
• The safety feature was activated
• The injury occurred before use, during use, whilst attempting to activate the safety mechanism or after use.
• The exposure occurred during standard recommended procedures

5. Require Proper Training on New Equipment

Many healthcare personnel sustain needlestick injures because they have not received adequate training on the correct recommended use of a safety device. While the goal of any type of safety equipment should be to function as closely as possible to standard routine procedures, training is always recommended. Most medical device manufacturers now offer in-servicing of new equipment on units of a healthcare facility. Safe in Common strongly encourages healthcare facilities to request on-site training during the evaluation and implementation of new safety equipment.

6. Review Risk for Drug Delivery Systems such as Prefilled Syringes

It’s not just standard consumable products such as hypodermic needles and syringes that may represent a risk for occupational exposure within a healthcare facility. The use of drug-device combination products, such as prefilled syringes or procedural kits, is now common.

Most pharmaceutical companies now provide their prefilled drugs or vaccines in a device that is either pre-supplied with a safety product, or allows for its attachment prior to the start of an injection.

Safe in Common recommends that institutional pharmacies select and purchase prefilled drugs or procedural kits that enable the safest, simplest injection of medication to the patient. In particular, it is recommended that healthcare facilities seek to drugs that:

• Supplied in a prefilled format, rather than in a vial or ampoule, so that they are ready for injection to support dose accuracy and procedural efficiency.
• Have a passive safety feature
• Utilizes a fully integrated safety feature, or where not possible, is pre-attached to the device.
• In the case of vaccines or drugs targeted for intramuscular administration, it is recommended that prefilled syringes are utilized that allow for the attachment of needles.

7. Don’t Make Equipment Purchasing Decisions Based Solely on Upfront Cost

OSHA states that the selection of safety devices based solely on the lowest cost is not appropriate. Selection must be based on employee feedback and device effectiveness. For example, equipment with passive safety features may be fractionally more expensive than equivalent products with an active (manual) safety feature. However studies have found that passive safety devices are around ten times more effective in preventing needlesticks.

Safe in Common recognizes that direct costs for testing and follow-up treatment of healthcare personnel receiving a needlestick injury are up to $5,000, even without them contracting a bloodborne pathogen. For incidents which lead to infection of HIV, long-term costs can exceed $1 million. These long-term costs, and potential insurance risks, to a facility must be taken into account during the selection of safety equipment. Safe in Common considers it vital that healthcare facilities take a long-term perspective when selecting safety equipment and implementing other measures to protect employees at risk of harm from occupational exposure.

8. Seek to Minimize Sharps Disposal Volumes

The disposal of sharps equipment is becoming a major financial expense for hospitals. Many reported occupational exposures also occur when a sharps disposal container is over-filled. Safe in Common recommends that the selection of safety equipment take into account the size of a safety device after use, to minimize disposal volumes.

9. Report Adverse Events to the FDA

The FDA has a database that allows healthcare facilities to report adverse events involving medical devices or drug delivery systems. MAUDE (Manufacturer and User Facility Device Experience) can be a beneficial reporting tool for healthcare facilities seeking to improve the safety and simplicity of medical devices. See link here for accessing MAUDE

10. It’s not just about needlestick injuries!

President Bill Clinton signed into the law the Federal Needlestick Prevention Act in 2000, which resulted in amendments being made to the BPS. However needlestick injuries represent only one potential transmission mode for infection with bloodborne pathogens. Healthcare facilities should embrace a culture of safety that seeks to minimize the risk of occupational exposure in all areas. Other potential transmission modes can include aerosolization of blood, tissue residue or medication (also known as splatter) that may occur with some types of retractable or prefilled syringes, and the re-use of non-sterile medical equipment.