It isn't difficult to understand the consequences of failing to properly clean, disinfect, reprocess or sterilise a reusable medical device. For most healthcare and infection control professionals, it ought to be second nature. Bad practice in this area can expose not only patients but also staff or even a whole healthcare facility to infectious or biohazardous materials.
Normally it is the reuse of single-use medical devices that makes the headlines, with the Wall Street Journal pointing out in March 2008 that more US hospitals, in a bid to save costs and stem a rising tide of medical waste, were recycling single-use devices, including scissors, scrubs and saws.
Similarly, in May 2008 a study in the journal Infection Control and Hospital Epidemiology found that a significant number of Canadian hospitals were reusing single-use devices such as biopsy forceps, and drill bits.
Legally, it is fine to do this as long as a medical facility follows US FDA guidelines. In the same way, in the US there are clear guidelines for reusing reusable devices published by the Centers for Disease Control and Prevention (CDC) and, in the UK, by the Department of Health.
Reprocessing methods and effects
The message when it comes to reprocessing reusable devices is a very simple one, says Dr Michael Jhung, medical officer and epidemiologist within the CDC's Division of Healthcare Quality Promotion – do it according to the manufacturer's instructions.
This is not as facile as it may initially appear. In the past, and a lot of the time still, the most common way to reprocess or sterilise a device has been through steam sterilisation. But as devices become more complex and in many cases more fragile, some do not respond well to such heat and need to be reprocessed at lower temperatures and with different methods.
"Technology is changing to allow people to reprocess devices in different ways," explains Jhung. "Devices are evolving all the time and there are now some devices that are in quite common use, such as endoscopes or bronchoscopes, that are too fragile for conventional reprocessing or sterilisation. In fact, part of the process when the US FDA clears a device for marketing is that the manufacturer must demonstrate that it can be reprocessed if it is a reusable device."
Generally, in most large, developed world healthcare facilities, and certainly within the US, the record when it comes to infection control and reprocessing of reusable devices is pretty good. "In the large hospital setting, the message has by and large been well received and the vast majority of institutions do an excellent job reprocessing devices," says Jhung. But when you move down from the bigger facilities the picture is not always quite so positive.
"Larger hospitals generally have in-house infection control teams who will oversee reprocessing activities," he explains. "'But often smaller organisations, those in an ambulatory or outpatient setting, do not have such a formal infection control presence. Where failures do occur it is normally because of a combination of a lack of awareness of the most appropriate way to reprocess a device or a piece of equipment, or lack of resources, lack of staff or some other conflicting pressure of patient care, such as an emergency."
Jhung is at pains to point out that, while the CDC frequently investigates outbreaks or infections that have occurred at a hospital and healthcare facility, he cannot recall any that have been definitively linked to a failure of reprocessing equipment.
Prevention and control
Infection control and reusable devices is very much a topical issue within the UK too, particularly in light of ongoing fears about 'Mad Cow Disease' and the possibility of residual protein contaminations remaining following reprocessing or, as the Department of Health terms it, decontamination. In 2006 it published a code of practice for the prevention and control of healthcare-associated infections and in 2007 issued updated guidance for primary, secondary and tertiary care settings on the decontamination of reusable devices.
This latter guidance cited research from 1999 that found that, in many instances, decontamination services had been falling short of acceptable standards, research that led in 2001 to the announcement of a £200m investment to improve decontamination services.
Since then, there had been a 'step change' in decontamination and infection control procedures, including a much wider and cultural acceptance of decontamination work as a core service. Nevertheless, the guidance highlighted the need for continual vigilance, oversight and education on this issue, with an emphasis in particular on developing appropriate risk management strategies.
When approached directly on this issue, the Department of Health said: "The crucial thing is to ensure whole organisation support. Set the expectation for staff, train, supervise and audit feedback to staff, let staff know what will happen if they do not comply with practice acknowledge and reward good practice, demonstrate positive effect for patients and carers."
Prioritising patient safety
It is imperative, agrees Jhung, that organisations foster or create cultures where patient safety and infection control are a priority, not platitudes or an add-on to be dealt with after or, at best, alongside the pressures of day-to-day treatment.
"You must not let that priority take a back seat to cost saving measures or trying to perform a greater number of procedures," he stresses. "There are pressures to do more procedures every day or week, but patient safety still needs to be the first priority."
Having a formal infection control presence is a good, practical start, says Jhung. "It could be just identifying a member of staff who will take responsibility for it. If someone takes responsibility, it makes it much harder for it to slide." This individual needs the authority to get the message across effectively and to be listened to. But once in place it can make the whole bedding in of the message and education issue much easier to manage.
Then there is the whole issue of communication and education. Clearly, education about best practice has to be in place when someone is starting in a new position. But, given that workers in healthcare often move around posts frequently or even rotate, education has to be ongoing and continuous.
When it comes to devices, clearly, the risk of infection varies from one device to another and from one location in the body to another. A device that is completely contained within the body, like a joint prosthesis, carries a lower risk than, say, a catheter, which is exposed to bacteria on the outside of the body. Therefore, combating infection within medical devices very much requires a two-pronged approach: prevention and treatment.
Manufacturers are also recognising the growing importance of infection control when it comes to new devices. More widely, the issue of infection control will come under the spotlight from October 2008 when Medicare brings in a new regime. It will no longer pay for eight conditions that can be acquired by patients during hospital stays and which could have been reasonably prevented by following evidence-based guidelines.
These include a range of conditions such as bed sores and objects left in a patient during surgery but also surgical site infections (SSIs) following certain elective procedures, deep vein thrombosis or pulmonary embolism, S. aureus septicemia and C. difficile-associated disease.
There will also be three hospital-acquired infections on the list: central venous catheter-related bloodstream infections, catheter-associated urinary tract infections and mediastinitis. The intention, argues Centers for Medicare and Medicaid, is not only to improve accuracy of Medicare's payment regime but also to create incentives for the healthcare community to improve how it treats patients and controls infections.
Fostering a culture of control
At a day-to-day level, one of the most critical elements of infection control is ensuring people are working in a culture or environment where they are not afraid to raise concerns or improvements that could be made in infection control procedures, suggests Jhung.
"Part of creating an atmosphere of patient safety is ensuring that every staff member knows it is OK to speak up when an infection control issue is suspected; that it is not going to get anyone into trouble," he says.
In a way the goal is to get to the point where, in much the same way that a healthcare worker would not even consider reusing a needle, they would not even consider using a reusable device that has not been appropriately reprocessed.
The trend toward patients being treated in an ambulatory or outpatient setting is creating its own set of new challenges when it comes to infection control. "This is mostly around the fact that many ambulatory care facilities are very specific and so may not have access to the infection control resources that a big hospital or healthcare facility will have," explains Jhung.
The CDC recommends that:
- Reusable medical devices or patient-care equipment that enters normally sterile tissue or the vascular system or through which blood flows should be sterilised before each use.
- The major sterilising agents used in hospitals are a) moist heat by steam autoclaving, b) ethylene oxide gas, and c) dry heat. However, there are a variety of chemical germicides (sterilants) that have been used for purposes of reprocessing reusable heat-sensitive medical devices and appear to be effective when used appropriately, such as according to the manufacturer's instructions.
- Heat-stable reusable medical devices that enter the blood stream or enter normally sterile tissue should always be reprocessed using heat-based methods of sterilisation (for example steam autoclave or dry heat oven).
- Laparoscopic or arthroscopic telescopes should be subjected to a sterilisation procedure before each use; if this is not feasible, they should receive high-level disinfection. Heat-stable accessories to the endoscopic set (for example trocars, operative instruments) should be sterilised by heat-based methods (steam autoclave or dry heat oven).
- Reusable devices or items that touch mucous membranes should, at a minimum, receive high-level disinfection between patients. These devices include reusable flexible endoscopes, endotracheal tubes, anaesthesia breathing circuits and respiratory therapy equipment.
The CDC is drawing up guidelines for infection control in the ambulatory setting in conjunction with the Healthcare Infection Control Practices Advisory Committee. A lot of it will mirror guidelines already in place in hospitals. The message is that ambulatory centres, alongside hospitals, need to be aware of infection control. All facilities need to make infection control a priority, and device use/reuse is a significant part of that.