PATIENTS beware. Medical devices that
manufacturers say should be used once are being used repeatedly in South
African hospitals, and all too often neither doctors nor medical
schemes are any the wiser.
Hospital budgets are under pressure, and regulatory oversight is lacking. Reusing devices poses health risks to patients, and is a form of fraud that medical schemes seem powerless to tackle.
Official policy is that single-use medical devices should not be used again, but several sources insist the practice is widespread at hospitals in the public and private sector.
"Single-use devices are reused because they cost an arm and a leg," says Shaheen Mehtar, a professor of infection-control at Stellenbosch University. "A lot of substandard disinfection and sterilisation is going on. We don’t know what infections are being passed on."
It is virtually impossible for patients to prove that a hospital-acquired infection originated from a poorly sterilised device that should have been disposed of after use, because there will be no record of who it was used on, she says.
"Every hospital has a non reuse policy. But it’s not what they are doing. Take suction tubing. It’s reused and it shouldn’t be. And it’s being charged for again and again," says a source with extensive industry experience, who asked not to be named for fear of losing a job.
"It’s all about cost-cutting. The hospital profits from the reuse. The surgeon and theatre staff have no idea it’s being done."
Sources say the reuse of implements ranges from relatively low-risk items such as forceps to much higher-risk devices with difficult-to-reach parts that are hard to clean properly, such as ventilator masks and cardiac catheters.
One way to regulate this practice would be to reconcile a manufacturer’s sales of a single-use device with the number billed to medical schemes. But getting the industry to co-operate appears virtually impossible because the incentives don’t align: even were rival medical scheme administrators willing to share data, they would need device companies willing to blow the whistle on their hospital clients, jeopardising their business.
SA’s biggest medical scheme administrator, Discovery Health, says it has 412,000 medical devices on its approved list, of which 90% are single-use devices.
"There has been a significant shift from suppliers over the last three years to have more multi-use items registered as single-use devices, which has driven up cost on these devices," says Discovery Health CEO Jonathan Broomberg.
In 2012, Discovery had 1,694 devices registered as multi-use; by 2015, the number had fallen to 677.
The guidelines aim to ensure sterile services departments at hospitals that reprocess single-use devices have the capacity, and the hospital accepts responsibility, he says. Manufacturers won’t accept liability for the reuse of products they have deemed single-use.
The SABS’s suggestion that reuse may be condoned under controlled conditions is opposed by the South African Medical Device Industry Association (Samed).
"Our view is not to reuse because it’s too risky," says Samed executive officer Tanya Vogt. "The risk assessment committees (established under the guidelines) that decide on which hospital equipment to reuse include the hospital manager, surgeons and the manufacturers: only manufacturers should determine which products can be reprocessed. There are very sound reasons for devices being single-use."
Vogt says single-use devices are being reused inappropriately. "We have met with private hospitals and they say it needs to be managed. It is definitely happening," she says.
SA’s biggest private hospital groups, Netcare, Mediclinic International, and Life Healthcare, deny that they condone reuse.
"Netcare does not endorse the reuse of medical devices designated for single-use. We … do not sanction any practice that could put the safety of patients at risk," says Anita Hamilton, Netcare’s general manager of procurement services.
Life Healthcare says its policy is in line with international best practice, and it adheres strictly to manufacturers’ instructions. It uses only devices that have been approved by quality-accreditation bodies, such as the US Food and Drug Administration.
"I’m fairly convinced it would not happen in our hospitals," says Mediclinic procurement executive, James Herbert. "There is no incentive to do so, (and) no reason to increase our risks."
Herbert says many expensive items in good condition are thrown away. He argues it is worth considering reusing some single-use medical devices, such as laparascopic forceps used in minimally invasive surgery, provided it is done safely.
Mediclinic would consider purchasing devices from manufacturer-approved third party reprocessors with international accreditation, but no such service is available in SA, Herbert says.
There are facilities for reprocessing medical devices in the US and Europe, and each device is tracked to ensure it is not used more than the number of times stipulated by the manufacturer, says industry consultant Jane Rogers. The facilities may have encouraged the reuse of single-use devices elsewhere because they suggest it can be safely done, she says.
Mehtar says hospitals and clinics in SA lack the resources to procure all the devices they need, and if health-care professionals threw out all single-use devices, many patients would die.
Staff are often forced to sterilise equipment intended to be used just once because they have no alternative, she says.
"Samed isn’t being practical. We need to identify where it is happening and why, and work out how to do it safely," she says.
"Ventilator tubing is reused, and while it is not easy, it can be done by experts trained in decontamination. It requires meticulous cleaning and sterilisation before it can be reused on another patient."
MEDICAL device distributor Amayeza says the biggest issue with reusing medical devices in SA is that it is not monitored.
"I have seen serious mistakes," says Amayeza CEO Patrick Godard.
"I’m not against reusing single-use devices, but it must be done properly. Reprocessing is well regulated and managed elsewhere."
The safety and performance of medical devices are not regulated in SA, although the government plans to apply more oversight when it replaces the Medicines Control Council with the South African Health Products Regulatory Agency, and gives it a broader mandate.
Vogt says Samed has asked the Office of Health Standards Compliance to look into the reuse of single-use medical devices, but has yet to receive a response.
The office’s acting CEO, Bafana Msibi, says the office will look into Samed’s "alleged claim".
All patients can do now is ask hard questions of their doctors, and hope their doctors ask harder ones at the hospitals in which they work.
Hospital budgets are under pressure, and regulatory oversight is lacking. Reusing devices poses health risks to patients, and is a form of fraud that medical schemes seem powerless to tackle.
Official policy is that single-use medical devices should not be used again, but several sources insist the practice is widespread at hospitals in the public and private sector.
"Single-use devices are reused because they cost an arm and a leg," says Shaheen Mehtar, a professor of infection-control at Stellenbosch University. "A lot of substandard disinfection and sterilisation is going on. We don’t know what infections are being passed on."
It is virtually impossible for patients to prove that a hospital-acquired infection originated from a poorly sterilised device that should have been disposed of after use, because there will be no record of who it was used on, she says.
"Every hospital has a non reuse policy. But it’s not what they are doing. Take suction tubing. It’s reused and it shouldn’t be. And it’s being charged for again and again," says a source with extensive industry experience, who asked not to be named for fear of losing a job.
"It’s all about cost-cutting. The hospital profits from the reuse. The surgeon and theatre staff have no idea it’s being done."
Sources say the reuse of implements ranges from relatively low-risk items such as forceps to much higher-risk devices with difficult-to-reach parts that are hard to clean properly, such as ventilator masks and cardiac catheters.
One way to regulate this practice would be to reconcile a manufacturer’s sales of a single-use device with the number billed to medical schemes. But getting the industry to co-operate appears virtually impossible because the incentives don’t align: even were rival medical scheme administrators willing to share data, they would need device companies willing to blow the whistle on their hospital clients, jeopardising their business.
SA’s biggest medical scheme administrator, Discovery Health, says it has 412,000 medical devices on its approved list, of which 90% are single-use devices.
"There has been a significant shift from suppliers over the last three years to have more multi-use items registered as single-use devices, which has driven up cost on these devices," says Discovery Health CEO Jonathan Broomberg.
In 2012, Discovery had 1,694 devices registered as multi-use; by 2015, the number had fallen to 677.
...
THE
South African Bureau of Standards (SABS) is trying to draft guidelines
for the reuse of single-use devices. Drafting committee chairman Pat
Ayling says staff at some hospital sterile services departments have
indicated that they reprocess single-use devices because their managers
are under pressure to save money.The guidelines aim to ensure sterile services departments at hospitals that reprocess single-use devices have the capacity, and the hospital accepts responsibility, he says. Manufacturers won’t accept liability for the reuse of products they have deemed single-use.
The SABS’s suggestion that reuse may be condoned under controlled conditions is opposed by the South African Medical Device Industry Association (Samed).
"Our view is not to reuse because it’s too risky," says Samed executive officer Tanya Vogt. "The risk assessment committees (established under the guidelines) that decide on which hospital equipment to reuse include the hospital manager, surgeons and the manufacturers: only manufacturers should determine which products can be reprocessed. There are very sound reasons for devices being single-use."
Vogt says single-use devices are being reused inappropriately. "We have met with private hospitals and they say it needs to be managed. It is definitely happening," she says.
SA’s biggest private hospital groups, Netcare, Mediclinic International, and Life Healthcare, deny that they condone reuse.
"Netcare does not endorse the reuse of medical devices designated for single-use. We … do not sanction any practice that could put the safety of patients at risk," says Anita Hamilton, Netcare’s general manager of procurement services.
Life Healthcare says its policy is in line with international best practice, and it adheres strictly to manufacturers’ instructions. It uses only devices that have been approved by quality-accreditation bodies, such as the US Food and Drug Administration.
"I’m fairly convinced it would not happen in our hospitals," says Mediclinic procurement executive, James Herbert. "There is no incentive to do so, (and) no reason to increase our risks."
Herbert says many expensive items in good condition are thrown away. He argues it is worth considering reusing some single-use medical devices, such as laparascopic forceps used in minimally invasive surgery, provided it is done safely.
Mediclinic would consider purchasing devices from manufacturer-approved third party reprocessors with international accreditation, but no such service is available in SA, Herbert says.
There are facilities for reprocessing medical devices in the US and Europe, and each device is tracked to ensure it is not used more than the number of times stipulated by the manufacturer, says industry consultant Jane Rogers. The facilities may have encouraged the reuse of single-use devices elsewhere because they suggest it can be safely done, she says.
Mehtar says hospitals and clinics in SA lack the resources to procure all the devices they need, and if health-care professionals threw out all single-use devices, many patients would die.
Staff are often forced to sterilise equipment intended to be used just once because they have no alternative, she says.
"Samed isn’t being practical. We need to identify where it is happening and why, and work out how to do it safely," she says.
"Ventilator tubing is reused, and while it is not easy, it can be done by experts trained in decontamination. It requires meticulous cleaning and sterilisation before it can be reused on another patient."
...
"I have seen serious mistakes," says Amayeza CEO Patrick Godard.
"I’m not against reusing single-use devices, but it must be done properly. Reprocessing is well regulated and managed elsewhere."
The safety and performance of medical devices are not regulated in SA, although the government plans to apply more oversight when it replaces the Medicines Control Council with the South African Health Products Regulatory Agency, and gives it a broader mandate.
Vogt says Samed has asked the Office of Health Standards Compliance to look into the reuse of single-use medical devices, but has yet to receive a response.
The office’s acting CEO, Bafana Msibi, says the office will look into Samed’s "alleged claim".
All patients can do now is ask hard questions of their doctors, and hope their doctors ask harder ones at the hospitals in which they work.
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