Why Uganda should regulate medical equipment

“Using this place as a dumping ground, that’s a concern,” Dr Josaphat Byamugisha, head of obstetrics and gynaecology at Mulago Hospital, says, lamenting the inadequacy of some medical device donations. “When you are walking around [the hospital], you can see it.”
Like other health facilities in Uganda, Mulago Hospital houses a lot of idle equipment, much of which is donated, but unused or unusable, according to hospital staff.
This is endemic in developing countries, where nearly 80 per cent of the medical equipment is donated, but up to 70 per cent of devices lie idle, the World Health Organisation reports.
In Mulago Hospital’s labour ward, where 60 to 100 babies are delivered daily, Sister Ziidah Namwaya, a nursing officer, says an invaluable delivery bed sits in a closet where it’s used to shelve cleaning products. It’s one of two beds that were “donated with no clear instructions” or training provided, she says. “It’s very difficult to use … even cleaning it is difficult because of the high number of deliveries here when blood pours into the joints, you can’t remove it.”
The neonatal special care unit also struggles with some equipment: 12 out of 20 incubators either don’t work at all or don’t work well, says Dr Jolly Nankunda, the clinical head of paediatrics. Most were donated and many are now “used as boxes” in a unit that sees 80 to 100 babies with complications at any given time, she says.
The WHO recognises the lack of working medical equipment as a barrier to meeting health-related Millennium Development Goals, such as reducing the rates of child and maternal mortality – the latter which has been particularly challenging for Uganda.
Despite the good intentions of donors and the billions spent equipping health facilities in developing countries, donated medical devices often sit unused.
The World Bank, for example, reports spending $1.5bn (Shs4.01 trillion) on medical equipment, but 30 per cent of the sophisticated devices donated weren’t used.
Local health workers and biomedical engineers say idle donations reflect equipment sent with parts or manuals missing or machines already too old to repair.
A lack of communication between donors and recipients and a lack of human resources and training also explains why some devices end up in closets instead of serving patients.

Old machines and missing parts
Donations can be very helpful as buying equipment, particularly expensive devices, can be difficult for hospitals, says Racheal Musasizi, a biomedical engineer at Gulu Regional Referral Hospital, where she services medical equipment.
She, like others in Uganda’s health sector, credits donations as being beneficial, when the necessary parts and manuals are provided. However, Musasizi says this is often not the case.
“When a piece of donated equipment arrives, the first step of installation usually requires repairing it,” says Musasizi, explaining equipment often comes secondhand or might be damaged during transportation. Repairing and maintaining equipment is challenging without spares or manuals, particularly as most donated equipment is manufactured abroad, which makes it difficult to find accessories or replacements in Uganda, she says.
In June, Musasizi repaired an incinerator that broke down five years earlier, causing bags of bio-hazardous waste and expired medicine to pile up alongside it. The machine, which is used to safely dispose of medical waste, was donated by the British High Commission in 1998. While it worked for many years, Musasizi says there were no manuals or spare parts to support its repair. Fortunately, another donor was able to send spares, she says.
Another issue with donated equipment that is manufactured overseas is it usually requires different power than the 240 V used in Uganda, Musasizi continues. This is manageable, but requires transformers to make the machines work.
“It’s not hard to buy transformers in Uganda, but government hospitals sometimes have limited budgets because they’re not profit-making.”
The Ministry of Health’s National Medical Equipment Policy establishes that, before shipping, “donors should verify with recipients that the electrical needs could be met only equipment that uses 240V should be accepted.”
Still, most donated equipment the biomedical engineer has serviced at facilities in the northern, southern and central regions don’t work at the local voltage or weren’t sent with transformers, she says.
One infant warmer in Gulu Hospital’s neonatal unit has sat idle for three years because it uses 110 V and didn’t come with a transformer, said Musasizi, adding that she borrows transformers from other machines to connect it occasionally. Another warmer was donated without a patient probe, which monitors an infant’s temperature, making it unsafe for use, she says. The machines are now used to store medicine or as a resuscitation table instead, says Musasizi.
Ashirae Segane is a biomedical engineer based at Kabale Regional Referral Hospital. There, and at other hospitals and health centres in the Kigezi and Ankole regions, he repairs medical equipment, like ultrasounds and anaesthetic machines. Much of his work is around donations with missing parts. Health facilities in the regions received 20 anaesthetic machines from a foreign donor more than nine months ago, Segane says. The machines arrived without oxygen cylinders or pressure regulators – parts critical to their operation, he says. Segane says he contacted the donor, but was told “they only supplied what they were meant to send.” The engineer says he sourced parts locally to repair four of the machines, but the others remain idle.
Sourcing missing parts is especially difficult for devices that are donated secondhand as they’re outdated by rapidly evolving technologies. Segane says he also faces this issue regularly.
Although the WHO’s Guidelines for Health Care Equipment Donations dictate “there should be no double standard in quality: if the quality of an item is unacceptable in the donor country, it is also unacceptable as a donation,” it’s reported that limping machines are still given because of the “mistaken belief that anything is better than nothing” in the recipient’s circumstances. Donations can, in fact, be liabilities for a facility when not made responsibly, the WHO cautions.
“The most important prerequisite for a successful donation is that the potential recipient truly needs the requested equipment and has the expertise and means to operate and maintain it,” the WHO’s guidelines state.
“Donations circumvent the selection and procurement systems of the recipient country. As a result, little consideration is taken of actual local requirements” and their resources, according to the WHO.
Dr Rosemary Byanyima, clinical head of diagnostics and chair of the equipment committee at Mulago Hospital, says she is familiar with the disconnect between donors and recipients.
“Sometimes we get a donation … and we requested to get details about the equipment then we just hear the equipment is already in the country and the donor is asking for it to be cleared at customs. We can’t even prepare,” she explains. She says the lack of communication she has experienced has been surprising, even when dealing with donations from the government.
Since starting at Mulago Hospital in 1993, she says she has also noticed a lack of communication from smaller donors and those donating to meet corporate social responsibility targets. Such organisations are often less experienced or interested in performing needs assessments before making donations or don’t have the capacity to do them, she says.
In such cases, “the hospital doesn’t participate in the specifications of equipment, [donors] just source it, bring it and then the hospital finds it difficult because it has no control over the type of machines,” she says. Hospitals have their own procurement requirements, like there being adequate staff or local biomedical engineers for maintenance, but these restrictions aren’t easily placed on outside parties, she explains.

Donations require human resources
“Although donors’ intentions are unquestionable,” the WHO asserts, successful donations require human resources – a key consideration when deciding what equipment and where to send it.
The 13-bed Intensive Care Unit donated to Jinja Regional Referral Hospital in 2009 has never been fully operational because of the shortage of qualified staff. The ratio of nurses to ICU beds should be 8:1, explained hospital director, Dr Michael Osinde.
“There are only six nurses in ICU so when we spread thin, we can use three beds,” he says of the largely unused equipment donated by an American company, General Electric, and NGO, Assist International. The doctor says submissions have been made to the ministries of health and public service to recruit more staff with no success so far. Whether a health facility has staff or is recruiting, users must be trained before equipment is delivered, says Musasizi. This will prevent waste.
“Sometimes you see equipment that has been kept [aside] and what will the user tell you? ‘We weren’t trained how to use it,’ and they’re right.” The biomedical engineer says this is a reality she has seen across Uganda, including recently at a health centre in Kaabong District, where an infant weighing scale, donated in working condition, had sat idle because nurses weren’t shown how to use it.
The WHO recommends donation plans be prepared between a donor and recipient to avoid such shortcomings.
The International Medical Equipment Collaborative (IMEC) “recognises that donations are, counter-intuitively, expensive for hospitals to receive the initial purchase price is often only 20 per cent of the total lifetime cost of a piece of equipment.”
To avoid adding costs, the major American donor takes a unique approach: instead of sending equipment independently, Dr Sue Crawford, project coordinator for Africa, says IMEC only donates medical equipment ‘suites’ that include all tools necessary to deliver specific services. For instance, an ‘exam suite’ wouldn’t just have a table, but, one with stirrups, as well as stethoscopes, blood pressure cuffs, etc.
“Donations of medical technology must include maintenance and training or most technology becomes idle fixtures and is a waste of resources and investments,” IMEC’s director of medical technology, Mark Heydenburg explained over email. IMEC supports its donated equipment for three years through onsite training in partnership with local organisations, troubleshooting assistance, technical literature and help procuring parts, he wrote.
Despite the challenges,` some medical equipment donations present, Ugandan health workers say they’ve worked with many other donors, like the Baylor College of Medicine, Rotary Club, and USAID, who communicate well before and after making donations and ensure users are trained to use the equipment delivered to their facilities.
Still, biomedical engineers and others in the health sector said there needs to be more regulation to prevent inadequate donations from even entering Uganda.

Medical equipment regulatory body needed

“Right now, we don’t have a regulatory framework for regulating devices … the [National Aisory Committee on Medical Equipment] isn’t legal in the current statute,” says Dr Jacinto Amandua, commissioner of clinical services at the Ministry of Health. This means donors aren’t legally required to come through the Ministry of Health, although the policy recommends it, or adhere to other elements of the National Medical Equipment Policy.
Although the policy echoes the WHO’s donation guidelines, requiring that “all donated medical equipment have a useful life of at least two years” and include manuals, for example, Dr Amandua says the national guidelines need to be buffered by a regulatory body, if they’re to be enforceable.
Dr Amandua says he wants a body modelled after the UK’s Medicines and Health Care Products Regulatory Agency, which vets, registers and classifies all medical equipment based on quality and potential risk to users and patients before devices enter health facilities.
Ensuring medical equipment entering the country is usable and safe is “the biggest challenge we have,” the doctor, who helped develop the national policy, says. The new bill, National Foods and Medicines Authority Act, which was approved by Cabinet earlier this year, proposes creating a regulatory body to oversee medical devices.
“We hope Parliament will expedite the law so we can really regulate medical equipment in the country,” Dr Amandua says. “We need this urgently.”


SOURCE: Daily Monitor

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